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Study cum Research Report: WIPO-JPO Long Term Fellowship -2010- Dr. S. S.Singh, India

Patenting in Pharmaceuticals: INDIA and JAPAN of 142

Patenting in Pharmaceuticals: India and Japan

(Implication of Recent Transformations)

Final ReportIn

Fulfillment of the Long Term FellowshipSponsored By:

World Intellectual Property Organization (WIPO)

in Collaboration with the Japan Patent OfficeApril 2 - September 30, 2010

Submitted By:

Dr. Suman Shrey Singh

Asstt. Controller of Patents & DesignsThe Patent Office

Govt. of India, Ministry of Commerce and Industry (DIPP)Plot No 32, Sector-14, Dwarka, New Delhi-110078

Supervised By:

Prof. Tomoko Saiki,Tokyo Institute of Technology, Department of Technology Management,

Graduate School of Innovation Management3-3-6 Shibaura, Minato-ku, Tokyo-108-0023, JAPAN

This report is a mandatory requirement of this fellowship; views and findings are those of the author and donot necessarily reflect the views and policy considerations of his organization or sponsor of this study.



PrefaceThis study-cum-research is granted by World Intel lectual Property

Organizat ion (WIPO), Geneva in the framework of fellowship programfinanced by the Japan Funds- in-Trust arrangement (Industr ial Property)to potential Govt. of f ic ials. This t ime there were three off icials invited oneeach from India, China and Vietnam.

The object ive of this fellowship program is to enhance theknowledge and understanding of the fellows on the topical issues in thef ield of industr ial property, by providing them with an opportunity forindependent research.

Durat ion of the fellowship is from April 2010 to September 2010.The Japan Patent Off ice (JPO) has assumed the responsibi l i ty for theoverall program in Japan as the local organizer and has entrusted themanagement of this program to an aff i l iated organizat ion Asia-Pacif icIndustr ial Property Center (APIC)1, under The Japan Inst itute of Inventionand Innovat ion (JII I)2. Research faci l i t ies of the Tokyo Inst itute ofTechnology (TIT) and opportunity to have consultat ion and discussionwith faculty member have also been provided.

Throughout the fellowship period, faci l i t ies have been offered tofree use of the research/training faci l i t ies, including l ibrary, some off icespace and use of personal computers by APIC-JII I . We have been invitedfor various training courses in the f ield of IPR for overseas professionalorganized by APIC-JII I .

Opportunit ies have been provided to vis it industr ies, attorney f irms,JPO-aff i l iated organizat ions and IP high court.

( Dr S S Singh )

1 http://www.jiii.or.jp/apic/us/e_top.htmhttp://www.jiii.or.jp/english/e.htm

2http://www.jiii.or.jp/english/e.htm



CONTENTS

Preface …………….…………………………2

Acknowledgement …………. ……………………... 6

CHAPTER I INTRODUCTION Page

Background …………………………………………………… 8

Objectives ………………………………………………….. 9

Methodology …………………………………………………. 10

CHAPTER II LEGISLATIVE PROVISIONS AND OBLIGATIONS - JAPAN

Patent Law ……………………………………………… 11

Examination Guidelines for Patents and Utility Model in Japan ……..

Part II Chapter 1 Industrially Applicable Inventions ………………….15

Part VII Examination Guidelines For Inventions in Specific Fields

Chapter 3 Medical Inventions ……………………………………………… 23

CHAPTER III LEGISLATIVE PROVISIONS AND OBLIGATIONS - INDIA

The Patent Act,1970 (As Amended) ………………………………. 43

Draft Examination Guidelines for Patents …………………………… 47

International Provisions: Provisions in TRIPS ………………………….. 60

CHAPTER IV PHARMACUTICAL INDUSTRIES IN JAPAN

Introduction ……………………………………………………. 63

How the Japanese Pharmaceutical Industry Operates ………………… 64

Japanese Pharmaceutical Law and Regulations ……………………….. 65

Japan Pharmaceutical Market ………………………………………….. 67



Federations of Pharmaceuticals …………………………………………... 68

Financial and Patenting profile of Key Players 69

CHAPTER V PHARMACUTICAL INDUSTRIES IN INDIA

Introduction …………………………………… 71

Report from Business portal of India ………………………………….. 71

Pharmaceutical associations …………………………………… 77

Key Players in Pharmaceutical Industry ………………………………. 78

Significant Statistics ……………………………………. 82

Govt. Initiatives …..………………………………………. 85

CHAPTER VI PARTICIPATION IN TRAINING COURSES AND INDUSTRYVISITS AND MEETINGS

Training Course attended 93

Meetings arranged 96

Salient Features …………………. 98

CHAPTER VII STUDIES ON PATENTING TRENDS IN INDIA and JAPAN

1. Comparative study in Granted Patents ………………………. 105

2. Comparative Study of Patent on same PCT Application ………… 112

3. Comparative Study in Published Patent Applications ……………. 116

4. Patenting in India by Leading Japanese Pharmaceutical companies … 120

5. Statistical Analysis of Pharma Patents Granted in India 2005-10……. 123

6. Patents granted extension of term in Japan………………………….. 125



7. Web Search for NCE introduced by Indian companies………………… 128

8. Meeting with the Pharmaceutical Association - JPMA ………………… 130

9. Meeting with the Pharmaceutical Industry: Daiichi Sankyo Co. Ltd. ………….. 133

10. Patenting Trend in NDDS in India……………………………………………….. 136

CHAPTER V CONCLUSIONS AND SUGGESTIONS …………………. 137

Other Reference …………………………………….. 139



Acknowledgements

First of all, I thank GOD for keeping me in good health and inspiration throughoutthe elaboration of this Study and Research program away from my home.

I would like to express my thanks to The Office of The Controller General ofPatents, Designs and Trade Marks, Department of Industrial Policy and Promotion,Ministry of Commerce and Industry, Govt. of India, The World Intellectual PropertyOrganization, Geneva and The Japan Patent Office, Tokyo Japan for providing me thisopportunity of exploring the knowledge and experiences in my field of working.

I would like to express my thanks to The Asia Pacific Industrial Property Center(APIC) of the Japan Institute of Invention and Innovation (JIII); and The Graduate Schoolof Tokyo Institute of Technology (TIT) who has been a great tool to accomplish thepresent task.

I would like to express my sincere gratitude to Sh P H Kurian, IAS, ControllerGeneral of Patents, Designs, Trade Marks and Registrar of Geographical Indications,Govt. of India, and Mr. Koichi Minami, Deputy Commissioner, Japan Patent Office, METIGovt. of Japan, for this assignment, and to Mr. Yoki Kawata, President, JIII and MrTakao Ogiya , Director General, APIC JIII, for taking care of all infrastructuralrequirement during my studies.

I would like to express my gratitude’s to the JPO Officials-, Mr. TakashiYamashita, Director for PCT Task Force, International Affairs Division (IAD); Mr.Masayoshi Omachi, Director, Regional Policy office, IAD, Mr Satoshi Moriyasu, DirectorIAD, Mr. Masayuki Koyanagi, Director, Medical Science Division,Patent Examination Department, Mr. Toru Yamazaki, Deputy Director, DevelopingCountry Cooperation Section, IAD, Mr. Akiyoshi Imaura, Deputy Director, RegionalPolicy Office, IAD, Mr. Ichiro Kohara, Deputy Director, PCT Reform Office, IAD, Mr.Terukage Saiki, Asstt. Director, Developing Country Cooperation Section, Mr. MakotoSakano, Asstt. Director, IAD, Mr. Isao Honzawa, Developing Country CooperationSection, I T Planning Office, Gen Affairs Deptt., Mr. Yuichi Ihara, Developing CountryCooperation Section International Affairs Division; Ms. Fusako Akutsu, AdministrativeOfficial of METI, Developing Country Cooperation Section, IAD; Ms. Atsuko Watanabe,Developing Country Cooperation Section IAD, and Mr. Kazuhiro Nakajima, EconomicPartnership Section, IAD of JPO.

In person, I am extremely grateful and express my deepest gratitude andacknowledge the support of Professor Ms. Tomoko Saiki, Tokyo Institute of Technology,Mr. Masakazu Yokoyama, Manager, International Training Team, Asia-Pacific TrainingGroup, and Ms. Yukiko Koyanagi, International Training Team, Asia-Pacific TrainingGroup, APIC. Beside all their technical supports Ms. Yukiko had been a very good



teacher of Japanese language and dialect and Mr. Yokoyama a good friend to me. It willbe my great pleasure to extend my sincere thanks to all the officials of APIC who havebeen always a great support to me as to realize me at home. Yuichi San, Kazumi San,Tadao San, Toshihiko San, Takahiro San, Takayuki San, Kenjiro San, and Sato San andAiko San, Mariko San, Mineko San, Ayako San, Chie San, Sachiko San, Chieko San,and Kimiko San. I have kept their name cards with photo to keep them fresh in mymemories forever.

I would like to express my sincere thanks to my fellow researcher, Ms DuanXiaomei, Adjudicative Division V State Administration for Industry and CommerceTrademark Review and Adjudication Board The Peoples Republic of China, and especialthanks to Ms. Ha Thi Nguyet Thu, Examiner Trade Marks Div No.2 National Office ofIntellectual Property of Vietnam for her kind and cooperative nature.

I would like to express my thanks to my colleagues and seniors for just not beingcolleagues but sharing their time in keeping contact through messenger, or mail fromIndia and keeping me feeling at home out of the country. Sh Bhagwan Datta, ManishaSharma, Sardar Pritam Singh ji, Dr. Nilanjana, Ms Kanika Malik, Sh S D Bhatnagar, ShBuchi Babu, Sh Ram Jawahar Sh P K Patni ,Sh K S Kardam, Sh B P Singh, Sh AmitabhChakraborty, Sh Shah Alam ji, Sh Rakesh Kumar from Indian Patent Office and myfriend Mr Vijay Raghvan, Technical Director NIC.

I would like to extend my warm regards to all Japanese and Japanese culturewhich has taught me several teachings among which I like the most is < care aboutothers>. “Watashiwa Nihango ga Suki Desu”.

Lastly, I would like to give my heartfelt thanks and love to my family, My fatherDr V P Singh, Mother Smt Saraswati Devi, My beloved Wife Alka, Son Vibhanshu,Shubhanshu, Divyansh and daughter Meghna, My brother Dr. Raman and his wifeManisha Singh for their patience, encouragement and co-operation they extendedbeyond country borders and time zone in fulfillment of this assignment.

“Arigato Gozai Masu”

(Dr. Suman Shrey Singh)

Asstt. Controller of Patents & Designs

The Patent Office,Govt. of India, Ministry of Commerce and Industry

Deptt. Of Industrial Policy and Promotion (DIPP)Plot No 32, Sector-14, Dwarka, New Delhi-110078



CHAPTER I

INTRODUCTION

Background:

In order to strengthen and enhance global competitiveness and to realizesustainable economic growth in any country, it is important to enhance innovationthrough patents and other intellectual property rights.

In Patents, it has been observed that innovations in different field of technologywork differently in different field of industries. In case of engineering products oftencontains many patented technologies and patents are often shared among competitorsthrough pooling or cross licensing. However, in the field of pharmaceutical, chemical andbiotechnology industries the patent normally cover/protects the particular product orprocess for achieving that product which involves extensive investment in research anddevelopment and requires clinical testing before placing it on the market and notpracticed competitors pooling. Patent protection in the field of pharmaceutical products isespecially important compared with other industries because such inventions are ofteneasy to replicate and can be copied with a little change and also haveapplication/implication in domestic and international industries differently.

With TRIPS Agreement in 1994 many developing countries which do not providepatent protection for pharmaceutical products and joined WTO have obligatedthemselves to provide such protection. Least developed countries have been given tomeet this obligation until 2016. India provided black box application provisions since1995 and adopted product patent in the field of pharmaceutical and food in 2005.

The Indian drugs and pharmaceutical industry, over the years, has showntremendous progress in terms of infrastructure development, technology base creationas well as product usage. On the global platform, this promising industry holds fourthposition in terms of volume and thirteenth position in terms of value of production inpharmaceuticals3. The pharmaceutical industry has been producing bulk drugsbelonging to all major therapeutic groups requiring complicated manufacturingprocesses as well as a wide range of pharma machinery and equipments. It has alsodeveloped excellent 'good manufacturing practices' (GMP) compliant facilities for theproduction of different dosage forms.

In this changing scenario, research and development activities in this sector hasbeen increased quantitatively as well as qualitatively. Presently, at-least 10 leadingIndian pharmaceutical companies are into new drug discovery and some of them haveincreased their R&D spending by over 5 per cent of their respective sales turnover.There are other efforts from govt., like providing fiscal incentives to R&D units in pharmasector as well as streamlining procedures related to development of new drug

3 Reference : (http://business.gov.in/Industry_services/drugs.php)



molecules, clinical research and new drug delivery systems. As a result, India isemerging as an alliance and outsourcing destination of choice for global pharmaceuticalcompanies across the value chain.

The accumulated knowledge of traditional medicinal system and large bio-diversity of India offers great advantage to its drug industry. The rapidly changingeconomic, trade and intellectual property scenario, nationally and internationally, posesmany challenges to this industry, including the challenge of becoming leaders andcompetitors globally. This necessitates a shift in the approach of the industry that is,moving away from manufacturing only known drugs called generics to discovering andcommercializing new molecules called New Chemical Entities (NCE) through innovativeprocess routes utilizing well established expertise human resource and infrastructure. Itwould mean that the Indian pharmaceutical industry has to focus more on research anddevelopment (R&D), so as to enable India to maintain its status in the worldpharmaceutical market and move ahead to become a global leader.

The Doha Declaration was a landmark in the history of WTO in the sense that itrecognizes the gravity of the public health concern afflicting many developing countriesand the need for the TRIPS Agreement to be part of the wider national and internationalaction to address these problems.

Objectives:

The objective of this study-cum-research is to understand the significantprovisions of the patentability and their implementation practices on both sides and theirimplications in overall developments in pharmaceutical industry and public healthconcerns. Understanding the same will further allow filling any gap to provide morestrong and effective IP protection to the pharmaceutical industry both side.

Hypothesis----

“Transformation of the national patent regime in the field of pharmaceuticals will catalyzethe domestic research and development in medicine and public health care and newmolecules will come-up keeping the pace for generic drug manufacturing and there willbe larger scope of business relationship in this field between the two countries, Japanand India.”



Methodology:

Following methodology was adopted in order to accomplish the objective of mystudies and to understand the feasibility of the hypothesis made.

I. Studying the overall patenting system and examination guidelines in

specific field of medicines in Japan and India.

II. Studying the presence of pharmaceutical industries in India and Japan.

III. Understanding the relation between legislative provisions and

examination guidelines and industrialization in this specific field in both

the countries.

IV. Procuring the data for the trend of filing of Patent applications, type of

applicants, type of claims w.r.t. the type of applicants in the field of

pharmaceuticals in India and Japan.

V. Studying and analyzing the trend of grant of Patent, type of applicants,

type of claims w.r.t. the type of applicants and making a comparative

study.

VI. Studying and analyzing the Patents granted in India after the

implementation of The Patent Amendment Act, 2005 which introduced

the product patent in the field of pharmaceuticals.

VII. Attending various training courses in the field of IPR organized by APIC

and Industry visit as and when get opportunity and have time out of

routine study and research work.

VIII. Meeting with representative of Pharmaceutical industries of

pharmaceutical industry.

IX. Studying New Chemical Entities developed in India and patenting for

Novel Drug Delivery system (NDDS) if get time.

X. Meeting with JPO officials from examination division in Chemistry or

pharmaceuticals.

========= End of Chapter I ===========



CHAPTER II

LEGISLATIVE PROVISIONS AND OBLIGATIONS - JAPAN

PATENT LAW (LAW NO 121 OF APRIL 13) AS AMENDED:

(Definitions)

Article 2

(1) "Invention" in this Act means the highly advanced creation of technical ideas utilizing

the laws of nature.

(2) "Patented invention" in this Act means an invention for which a patent has been

granted.

(3) "Working" of an invention in this Act means the following acts:

(i) in the case of an invention of a product (including a computer program, etc.,

the same shall apply hereinafter), producing, using, assigning, etc. (assigning

and leasing and, in the case where the product is a computer program, etc.,

including providing through an electric telecommunication line, the same shall

apply hereinafter), exporting or importing, or offering for assignment, etc.

(including displaying for the purpose of assignment, etc., the same shall apply

hereinafter) thereof;

(ii) in the case of an invention of a process, the use thereof; and

(iii) in the case of an invention of a process for producing a product, in addition to

the action as provided in the preceding item, acts of using, assigning, etc.,

exporting or importing, or offering for assignment, etc. the product produced

by the process.



(Patentability of inventions)

Article 29 — (1) Any person who has made an invention which is industriallyapplicable may obtain a patent therefor, except in the case of the following inventions:

(i) inventions which were publicly known in Japan or elsewhere prior to thefiling of the patent application;(ii) inventions which were publicly worked in Japan or elsewhere prior to thefiling of the patent application;(iii) inventions which were described in a distributed publication or madeavailable to the public through electric telecommunication lines in Japan orelsewhere prior to the filing of the patent application.

(2) Where an invention could easily have been made, prior to the filing of the patent

application, by a person with ordinary skill in the art to which the invention pertains, on

the basis of an invention or inventions referred to in any of the paragraphs (1), a

patent shall not be granted for such an invention notwithstanding paragraphs (1).

Article (29-2) — Where an invention claimed in a patent application is identical with aninvention or device (excluding an invention or device made by the same person as theinventor of the invention claimed in the patent application) disclosed in the description,claim(s) for patent or utility model registration or drawing(s) originally attached to therequest of another application for patent (in the case of a foreign language fileapplication referred to in Section 36bis(36-2)(2) of this Law, the foreign language filereferred to in Section 36bis(36-2)(1) of the said Law) or of an application for utility modelregistration which was filed prior to the filing date of the patent application and for whichthe Patent Gazette which states the matter referred to in each paragraph of Section66(3) of the said Law (hereinafter referred to as “the Gazette containing the Patent”) waspublished under the said subsection or the laying open for public inspection (Kôkai) waseffected or the Utility Model Gazette which states the matter referred to in eachparagraph of Section 14(3) of Utility Model Law (No. 123 of 1959) (hereinafter referred toas “the Gazette containing the Utility Model”) was published under the said subsectionafter the filing of the patent application, a patent shall not be granted for the inventionnotwithstanding Section 29(1). However, this provision shall not apply where, at the timeof filing of the patent application, the applicant of the patent application and the applicantof the other application for patent or the application for utility model registration are thesame person.



(Unpatentable inventions)

Article 32. — The inventions liable to contravene public order, morality or public healthshall not be patented, notwithstanding Section 29.

(Registration of extension of term of patent right)

Article (67-2) — (1) A person desiring to apply for registration of an extension of theterm of a patent right shall submit to the Commissioner of the Patent Office anapplication stating the following matters:

(i) the name and the domicile or residence of the applicant;(ii) the patent number;(iii) the term of the extension applied for (limited to a period not exceeding five years)(iv) particulars of the disposition as provided for in Cabinet Order referred to in

Section 67(2).(2) The application under the preceding subsection shall be accompanied by materialswhich give reasons for the extension, as provided for in an ordinance of the Ministry ofEconomy, Trade and Industry.(3) The application for registration of an extension of the term of a patent right shall bemade within the time limit prescribed by Cabinet Order counting from the date ofobtaining the disposition provided for in Cabinet Order referred to in Section 67(2).However, the application shall not be made after the expiration of the term of a patentright provided for in Section 67(1).(4) Where a patent is owned jointly, each of the joint owners may not, except jointly withthe other owners, apply for registration of an extension of the term of a patent right.(5) Where an application for registration of an extension of the term of a patent right is

filed, the term of the patent right shall be deemed to have been extended. However, thisprovision shall not apply when the examiner’s decision that the application is to berefused has become final and conclusive or when an extension of the term of the patentright has been registered.(6) When an application for registration of an extension of the term of a patent right isfiled, the matters as set forth under each of the paragraphs in subsection (1) and thenumber and the filing date of the application shall be published in the Patent Gazette.

Article (67-2-2) — (1) When it is anticipated impossible to obtain the disposition asprovided for in Cabinet order referred to in Section 67(2) by the day before six monthsprior to the date of expiration of the term of a patent right as provided for in Section67(1), a person desiring to apply for registration of an extension of the term of a patentright shall submit by that day to the Commissioner of the Patent Office a documentstating the following matters:

(i) the name and the domicile or residence of the person desiring the application;(ii) the patent number;(iii) the disposition as provided for in Cabinet Order referred to in Section 67(2).



(2) Where the document required to be submitted under the preceding subsection is notsubmitted, application for the registration of an extension of the term of a patent rightmay not be made for after six months prior to the date of expiration of the term of apatent right as provided for in Section 67(1).(3) When the document referred to in subsection (1) is submitted, the matters set forthunder each of the paragraphs in subsection (1) shall be published in the Patent Gazette.

Article (67-3) — (1) The examiner shall make a decision that an application forregistration of an extension of a patent right is to be refused where it falls under any ofthe following paragraphs:

(i) where it is not deemed that the obtaining of the disposition as provided for inCabinet Order referred to in Section 67(2) was necessary for the working of thepatented invention;

(ii) where the disposition as provided for in Cabinet Order referred to in Section 67(2)was not obtained by the patentee, or an exclusive licensee or a registered non-exclusive licensee under the patent;

(iii) where the term for which an extension is applied exceeds the period of timeduring which the patented invention could not be worked;

(iv) where the person applying for an extension is not the patentee concerned;(v) where the application does not comply with Section 67bis(67-2)(4).

(2) When the examiner finds no reasons for refusing an application for registration of anextension of the term of a patent right, he shall render a decision that the registration ofthe extension is to be made.(3) When the examiner’s decision or the trial decision is rendered to the effect that theregistration of an extension of the term of the patent right is to be made, the registrationis made to the effect that the term of the patent right has been extended.(4) When the registration under the preceding paragraph is made, the followingparticulars shall be published in the Patent Gazette:

(i) the name and the domicile or residence of the patentee;(ii) the Patent Number;(iii) the number and the filing date of the application for registration of the extension ofthe patent right;(iv) the date of the registration of the extension;(v) the term of the extension;(vi) particulars of the disposition as provided for in Cabinet Order referred to in

Section 67(2).

Article (67-4) — Sections 47(1), 48, 50 and 52 shall apply mutatis mutandis to the

examination of an application for registration of an extension of the term of a patent right.

(Effects of the term extended patent right)

Article (68-2)— The effects of the patent right of which the term has been extended(including cases in which the term is deemed to be extended under Section 67bis(67-2)(5)) shall not extend to acts other than the working of the patented inventionconcerned in respect of the product (where, in the disposition concerned, any specificuse of such product to be used was specified, the product used for such specific use)



which was the subject of the disposition as provided for in Cabinet Order referred to inSection 67(2) and as being the ground for the registration of the extension.

EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN

JAPAN4:

Part II Chapter 1 Industrially Applicable Inventions5.

1. Statutory Inventions

Article 2(1) of the Patent Act defines a statutory invention as a highly advanced creationof technical ideas utilizing a law of nature. It should be noted, however, that the term"highly" has been introduced in the definition to differentiate "invention" from "device"under the Utility Model Act, and this term is disregarded in judging whether an inventionis statutory or not.The following is a list of non-statutory inventions.

1.1 List of Non-statutory Inventions

Since it is not a "creation of a technical idea utilizing a law of nature," any one of thefollowing is not considered to be a statutory invention.

(1) A law of nature as suchSince statutory inventions shall utilize a law of nature, a law of nature as such, likea law of preservation of energy or a law of universal gravitation, is not consideredas a statutory invention.(2) Mere discoveries and not creationsOne of the requirements for a statutory invention is to be a "creation", and thus,mere discoveries, such as discoveries of natural things like an ore or naturalphenomena, for which an inventor does not consciously create any technical idea,are not considered to be a statutory invention.However, if things in nature such as chemical substances or microorganisms have

been isolated artificially from their surroundings, then those are creations andconsidered to be a statutory invention.(3) Those contrary to a law of natureIf a matter necessary to define an invention involves any means contrary to a lawof nature, the claimed invention is not considered to be a statutory invention (See:Example 1). The so-called perpetual motion is an example contrary to the secondlaw of thermodynamics.(4) Those in which a law of nature is not utilizedIf claimed inventions are any laws as such other than a law of nature (e.g.economic laws), arbitrary arrangements (e.g. a rule for playing a game as such),mathematical methods or mental activities, or utilize only these laws (e.g. methods

4 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/t_tokkyo_e/1312-002_e.htm5 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/t_tokkyo_e/1312-002_e.htm



for doing business as such), these inventions are not considered to be statutorybecause they do not utilize a law of nature (see Examples 2-4).

Example 1: Computer programming languagesExample 2: A method of collecting money for an electricity bill or a gas bill etc.,by rounding off the total amount to be collected to the nearest 10 yen unit.Even if a part of matters defining an invention stated in a claim utilizes a law ofnature, when it is judged that the claimed invention considered as a wholedoes not utilize a law of nature, the claimed invention is deemed as notutilizing a law of nature.Example 3: A method of plying a container vessel to transport a large amountof fresh water from a region where crude oil is expensive and fresh water isinexpensive to another region where crude oil is inexpensive and fresh water isexpensive, and after unloading the fresh water, transporting a large amount ofcrude oil instead of the water to the homeward voyage.Example 4: A method of billboard advertising using utility poles, characterizedby forming in advance groups A, B, C, D, ... with a prescribed number of polesin each group, placing a holding frame to post thereon a billboard for eachpole, and posting the billboards in each group on holding frames placed topoles in each group in circulation in a certain time interval (See: Tokyo HighCourt Judgment Sho 31.12.25 (Syowa 31 (Gyo Na) 12))

On the contrary, even if a part of matters defining an invention stated in a claimdoes not utilize a law of nature, when it is judged that the claimed invention as awhole utilizes a law of nature, the claimed invention is deemed as utilizing a law ofnature.As stated above, the characteristic of the technology is to be taken into account injudging whether a claimed invention as a whole utilizes a law of nature.

Notes:For inventions relating to a method for doing business or playing a game, since there arecases in which the claimed invention a part of which utilizes an article, apparatus, device,system, etc., is judged as not utilizing a law of nature when considered as a whole,careful examination shall be required. (See: Examples 5-7)There is possibility for an invention to be qualified as statutory where the invention ismade not from a viewpoint of a method of doing business or playing a game but from aviewpoint of computer software-related inventions such as software used in doingbusiness or in playing a game. (See: "Part VII: Chapter 1. Computer Software-RelatedInventions, 2.2”)

(5) Those not regarded as technical ideas(a) Personal skill (which is acquired through personal experience and cannotbe shared with others as a knowledge due to lack of objectivity)Example: A method of throwing a split-fingered fast ball characterized in theway of holding the ball in fingers and throwing the same(b) Mere presentation of information (where the feature resides solely in thecontent of the information, and the main object is to present information)[Examples]written manual for instructing an operation of a machine or directing a use ofa chemical substance, audio compact disc (where the feature resides solelyin music recorded thereon), image data taken with a digital camera, programof an athletic meeting made by a word processor, or computer program



listings (mere representation of program codes by means of printing them onpaper, displaying them on a screen, etc.)

However, if technical features reside in presentation of information(presentation per se, a means for presentation, a method for presentation,etc.), claimed inventions are not considered as mere presentation ofinformation.Example 1: A test pattern for use in checking the performance of a televisionset (where a technical feature resides in the pattern per se)Example 2: A plastic card on which information is recorded with characters,letters and figures embossed on it (enabling one to copy the information byaffixing the card on a paper, in this sense the technical feature residing inthe means for presentation)(c) Aesthetic creationsExample: paintings, carvings, etc.

(6) Those for which it is clearly impossible to solve the problem to be solvedby any means presented in a claim

Example: A method for preventing explosion in a volcano by forming balls ofneutron-absorbing material (e.g., boron) covered with substance having highmelting temperature (e.g., tungsten) and throwing them into the volcanic vent (Thisinvention allegedly works on the assumption that volcanic explosion is caused bynuclear fission of substances like uranium at the bottom of the volcanic vent.)

2. Industrial Applicability

Here, the word "industry" is interpreted in a broad sense, including mining, agriculture,fishery, transportation, telecommunications, etc., as well as manufacturing.The following is a list of industrially inapplicable inventions. In principle, an invention

which does not correspond to any one of the followings is considered as industrially

applicable.

2.1 List of Industrially Inapplicable Inventions

2.1.1 Methods of surgery, therapy or diagnosis of humans

Methods of surgery, therapy or diagnosis of humans have been termed "medicalactivity" and are normally practiced by medical doctors (including those who aredirected by medical doctors, hereinafter referred to as “medical doctors”).Methods for contraception or delivery are included in “methods of surgery, therapyor diagnosis of humans.”Even if methods of surgery, therapy or diagnosis are practiced on animal bodies ingeneral, unless it is clear that the methods practiced on a human body areexplicitly excluded, the methods are deemed as being “methods of surgery,therapy or diagnosis of humans.”

2.1.1.1 Types of methods considered to be classified as “methods ofsurgery, therapy or diagnosis of humans”



(1) Methods of surgery of humans (Refer to Examples 8-1, 9-1, 10-1, 11-1,12-1)

Methods of surgery of humans include the followings:(a) Methods for surgical treatment (such as incision, excision, centesis,injection and implant)(b) Methods of using (e.g., inserting, moving, maintaining, operating andextracting) a medical device (e.g., a catheter and an endoscope) inside thehuman body (excluding inside the mouth, inside the external nostril, andinside the external ear canal)(c) Preparatory treatment for surgery (e.g., anesthetic treatment for surgeryand method of disinfecting skin before injection)Cosmetic methods having surgical operations whose purpose is not

therapeutic or diagnostic are also considered as “methods of surgery of

humans.”

(2) Methods of therapy of humans (Refer to Examples 13-1, 14-1, 15-1, 16-1,17-1, 18-1, 22-1)Methods of therapy of humans include the followings:

(a) Methods of administrating medicine or giving physical treatment to apatient for curing or restraining a disease

(b) Methods of implanting substitute organs such as artificial internalorgans or artificial limbs

(c) Methods of preventing a disease (e.g., methods of preventing toothdecay or influenza)

Methods of treatment for the maintenance of physical health (e.g., methodsof massage or shiatsu therapy) are also considered to be methods ofpreventing a disease.

(d) Preparatory treatment for therapy (e.g., method for arranging electrodesfor the electrical therapy), supplemental methods for improving treatmenteffects (e.g., rehabilitation methods), or methods for nursing associatedwith the treatment (e.g., methods to prevent bedsores)

(3) Methods of diagnosis of humans“Methods of diagnosis of humans” include methods of judging for the

medical purpose the physical condition of a human body such as diseasesand physical health, the mental condition of a human body, or prescriptionor treatment/surgery plans based on these conditions.Case 1: Methods of judging whether the patient has had a stroke byobserving the image obtained by the MRI scan.

2.1.1.2 Types of methods not considered to be classified as “methods ofsurgery, therapy or diagnosis of humans”

(1) A medical device or a medicinal substance is a product, and is notconsidered as “methods of surgery, therapy or diagnosis of humans.” Itshould be noted that the combination of two or more products is notconsidered as “methods of surgery, therapy or diagnosis of humans.”(Examples 13-2, 14-2, 15-2)(2) A method for controlling the operation of a medical device is notconsidered to be classified as “methods of surgery, therapy or diagnosis ofhumans” as long as the function of the medical device is represented as a



method. The method for controlling the operation of the medical device heremay include not only a method for controlling the internal operation of themedical device but also a functional and/or systematic operation provided tothe medical device, such as the moving, opening and/or closing of anincising means in accordance with an operating signal, the emitting and/orreceiving of a radioactive ray, an electromagnetic wave, a sound wave, orthe like. (Examples 8-2, 9-2, 10-2, 11-2, 12-2, 16-2 to 16-4, 17-2, 18-2, 19-2,20-2, 24-2, 25-3)

However, a method including a step, as a matter to define claimedinvention, with an action of a medical doctor (for example, a step where amedical doctor operates a device in order to provide medical treatment inaccordance with a symptom) and/or a step with an influence on the humanbody by a device (for example, the incision and/or excision of a specific partof a patient by a device or the irradiation of radiation, electromagnetic waveor sound wave by a device) is not considered to be a method for controllingthe operation of the medical device.(3) The following methods for gathering various kinds of information by, e.g.,measuring structures and functions of the various organs of the humanbody, is not considered to be methods of diagnosis of humans unless itincludes the steps of judging for the medical purposes the physical conditionof a human body such as diseases and physical health, the mental conditionof a human body, or prescription or treatment/surgery plans based on theseconditions. (Example 19-1, 20-1, 21)(a) Methods of extracting samples and data from the human body, ormethods of analysing, e.g., comparing such samples and data withstandards.

Case 1: A method for an influenza test by extracting oral mucousmembranes with cotton budCase 2: A method for capturing the image of the lung by X-ray irradiationto the chestCase 3: A method for measuring the body temperature by inserting anelectronic ear thermometer into external ear canalCase 4: A method for judging the sugar level in the urine by dipping thetest strip in the collected urine sample, and comparing the color of the teststrip with the colors on the color chartCase 5: A method of examining the susceptibility of the examinee tohypertension by determining the type of base on the nth line of the basesequence of the X gene of the examinee and comparing the base with astandard in which when the base type is A the susceptibility is low, andwhen the type is G the susceptibility is high

(b) Preparatory treatment for measuring structures or functions of variousorgans of the human body

Case 6: A method of preventing the uneven smear of the jelly for theultrasonography that is spread on the bodyHowever methods that include steps corresponding to methods of surgery

or therapy of humans are deemed to be “methods of surgery or therapy ofhumans.” (Examples 9-1, 10-1, 11-1, 18-1)

2.1.1.3 Methods for treating samples that have been extracted from thehuman body



Methods for treating samples that have been extracted from the human body(e.g., blood, urine, skin, hair, cells or tissue) and methods for gathering data byanalyzing such samples are not considered to be “methods of surgery, therapy ordiagnosis of humans.” (Example 25-2)However, if a method for treating these samples or analyzing the samples in theprocess is performed on the presumption that the samples are to be returned tothe same body (e.g., a method of dialyzing blood), then, such a method isqualified to be placed under the category of “methods of surgery, therapy ordiagnosis of humans.” (Example 24-1, 25-1)Even if a method for treating these samples is performed on the presumption thatthe samples are to be returned to the same body, the following are not consideredto be “methods of surgery, therapy or diagnosis of humans.” (Example 22-2, 23-1,23-2, 23-3)

(1) A method for manufacturing a medicinal product (e.g., blood preparation,vaccine, genetically modified preparation and cell medicine) by utilizing rawmaterial collected from a human body(2) A method for manufacturing a medical material (e.g., an artificialsubstitute or alternative for a part of the human body, such as an artificialbone, a cultured skin sheet, etc.) by utilizing raw material collected from ahuman body(3) A method of manufacturing an intermediate product for a medicinalproduct or a medical material (e.g. methods for differentiation and inductionof the cells, methods for separation and purification of the cells) by utilizingraw material collected from a human body(4) A method of analyzing a medicinal product or a medical material, orintermediate product thereof which is manufactured by utilizing raw materialcollected from a human body

2.1.2 Commercially inapplicable inventions

An invention concerning marketable or tradable subject matter is consideredcommercially applicable. On the other hand, inventions indicated in (i) and (ii)below are regarded as commercially inapplicable, and hence industriallyinapplicable.

(i) an invention applied only for personal use, such as a method of smoking(ii) an invention applied only for academic or experimental purposes

It should be noted that such an invention as a "method of waving hair", which isused in the beautician field while being personally applied, is not considered as an"invention applied only for personal use." Likewise, a "kit for scientificexperiments," which is used in experiments at school, is not considered as an"invention applicable only for academic or experimental purposes" as it ismarketable and tradable.

2.1.3 Practically inapplicable inventions

An invention which can not be practically implemented is not considered as an"industrially applicable invention" even if it works in theory.Example: A method for preventing an increase in ultraviolet rays associated with

the destruction of the ozone layer by covering the whole earth's surface with an



ultraviolet ray-absorbing plastic film

3. Notes for examining the requirement for Industrial Applicability

The burden of proof regarding the requirement for industrial applicability is placed on the

applicant. However, upon noticing that a claimed invention does not comply with the

requirements for industrial inapplicability, the ground should be indicated as specifically

as possible in the notification of reasons for refusal.

4. ExamplesThese examples were put together to explain the requirement of “Industrially ApplicableInventions” in the first paragraph of Article 29(1) of the Patent Act. Therefore, it is to benoted that some of the scope of claims in the examples have been modified, e.g.,simplified in parts to provide an explanation easier to understand. Additionally, it doesnot mean the examples do not have reasons for refusal such as lack of novelty/inventivesteps or description requirements of the description and the claims.

The list of examples is shown below.

4.1 Statutory invention requirement

4.1.1 Methods contrary to a law of natureExample 1 A method of plating copper with iron (contrary to a law of nature)4.1.2 Methods not utilizing a law of nature

Example 2 A method for calculating the sum of natural numbers n to n+k (not utilizing alaw of nature)

Example 3 A method of teaching in science and mathematics courses (not utilizing a lawof nature)

Example 4 A method for drawing a regular N-polygon inscribed in a given circle (notutilizing a law of nature)

Example 5 A method of playing a game (not utilizing a law of nature)Example 6 A method for determining a selling price of a commodity (not utilizing a law of

nature)Example 7 A method for holding a party (not utilizing a law of nature)

4.2 The requirement of industrial applicability

4.2.1 Methods of surgery of humans

Example 8-1 A method for treating an affected part by micro operation robot (Aninvention considered as “methods of surgery, therapy or diagnosis of humans”)

Example 8-2 A method for controlling the operation of a micro operation robot

system (An invention not considered as “methods of surgery, therapy or diagnosis of



humans”)

Example 9-1 A method for sampling body fluid (An invention considered as “methodsof surgery, therapy or diagnosis of humans”)

Example 9-2 A method for controlling the operation of a body fluid sampling device(An invention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

Example 10-1 A method for the observation of the celom by using an endoscope (Aninvention considered as “methods of surgery, therapy or diagnosis of humans”)

Example 10-2 A method for controlling the operation of an endoscope (An inventionnot considered as “methods of surgery, therapy or diagnosis of humans”)

Example 11-1 A method for contrast magnetic resonance imaging (An inventionconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 11-2 A method for controlling a magnetic resonance imaging device (Aninvention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

Example 12-1 A method for displaying superimposed images of an object being cutand a cutting apparatus (An invention considered as “methods of surgery,therapy or diagnosis of humans”)

Example 12-2 A method for controlling a device for displaying superimposed imagesof an object being cut and a cutting apparatus (An invention not considered as“methods of surgery, therapy or diagnosis of humans”)

4.2.2 Methods of therapy of humans

Example 13-1 A method for the treatment of cancer (An invention considered as“methods of surgery, therapy or diagnosis of humans”)

Example 13-2 A system for cancer treatment (An invention not considered as“methods of surgery, therapy or diagnosis of humans”)

Example 14-1 A method for regenerating cartilage (An invention considered as“methods of surgery, therapy or diagnosis of humans”)

Example 14-2 An implant material for cartilage regeneration (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 15-1 A method for the treatment of cardiac infarction (An inventionconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 15-2 A composition for treatment of cardiac infarction (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 16-1 A method for giving electrical stimulus by a pacemaker (An inventionconsidered as “methods of surgery, therapy or diagnosis of humans”)

Examples 16-2 A method for controlling a pacemaker (An invention not consideredas “methods of surgery, therapy or diagnosis of humans”)

Examples 16-3 A method for controlling a pacemaker (An invention not consideredas “methods of surgery, therapy or diagnosis of humans”)

Examples 16-4 A method for controlling the operation of a pacemaker (An inventionnot considered as “methods of surgery, therapy or diagnosis of humans”)

Examples 17-1 A method for retinal stimulation using an artificial eye system (Aninvention considered as “methods of surgery, therapy or diagnosis of humans”)

Examples 17-2 A method for controlling an artificial eye system (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 18-1 A method for X-ray irradiation (An invention considered as “methodsof surgery, therapy or diagnosis of humans”)



Example 18-2 A method for controlling the operation of an X-ray device (Aninvention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

4.2.3 Methods for gathering data

Examples 19-1 A method for X-ray CT scanning (An invention not considered as“methods of surgery, therapy or diagnosis of humans”)

Examples 19-2 A method for controlling an X-ray CT scanner (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Examples 20-1 A method for magnetic resonance imaging (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Examples 20-2 A method for controlling the operation of magnetic resonanceimaging device (An invention not considered as “methods of surgery, therapy ordiagnosis of humans”)

Example 21 A method for nuclear medicine imaging (An invention not considered as“methods of surgery, therapy or diagnosis of humans”)

4.2.4 Methods for treating samples that have been extracted from the human body

Examples 22-1 A method for Gene therapy (An invention considered as “methods ofsurgery, therapy or diagnosis of humans”)

Examples 22-2 A method for manufacturing cells for gene therapy (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Examples 23-1 A method of inducing differentiation of cells (An invention notconsidered as “methods of surgery, therapy or diagnosis of humans”)

Examples 23-2 A method of separating and purifying differentiation-induced cells (Aninvention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

Examples 23-3 A method of analyzing a ratio of separated and purified cells (An

invention not considered as “methods of surgery, therapy or diagnosis of humans”)

Example 24-1 A method for blood purification (An invention considered as “methodsof surgery, therapy or diagnosis of humans”)

Example 24-2 A method for controlling the operation of a blood purifying device (Aninvention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

Example 25-1 A method for measuring hematocrit values of blood (An inventionconsidered as “methods of surgery, therapy or diagnosis of humans”)

Example 25-2 A method for measuring hematocrit values of extracted blood (Aninvention not considered as “methods of surgery, therapy or diagnosis ofhumans”)

Example 25-3 A method for controlling a blood hematocrit measuring device (An

invention not considered as “methods of surgery, therapy or diagnosis of humans”)

4.2.5 Methods relating to assisting devicesExamples 26-1 A method for judging a motion state of walking (An invention not

considered as “methods of surgery, therapy or diagnosis of humans”)Examples 26-2 A method for controlling a power assisting device (An invention not

considered as “methods of surgery, therapy or diagnosis of humans”)



Examples 26-3 A method for power assisting (An invention not considered as“methods of surgery, therapy or diagnosis of humans”)

All these examples are further elaborated in succeeding text of Examination Guidelinesof Japan Patent Office.6

PART VII EXAMINATION GUIDELINES FOR INVENTIONS AS A SPECIFIC FIELD

Chapter 3: Medicinal Inventions:

In this chapter, matters requiring special judgment and handling in examiningpatent application relating to medicinal inventions are mainly explained.A medicinal invention here means “an invention of a product” which intends to provide anew medicinal use (Note 2) of a material (Note 1), based on discovering an unknownattribute of the material.(Note 1) “A material means a component used as an active ingredient, including a compound, a

cell, a tissue and a chemical substance (or a group of chemical substances) whose chemicalstructure is not specified, such as an extract from a natural product, and a combinationthereof. Hereinafter, the material concerned is referred to as “compounds etc.”

(Note 2) “A medicinal use” means (i) an application to the specific disease or (ii) an application tothe specific disease in which dosage and administration such as dosing time, dosingprocedure, dosing amount or administration areas (hereinafter referred to as “dosage andadministration”) is specified.

Refer to Part I or Part II for those matters not explained in this Chapter in relation to descriptionrequirements of the Description and the Claims, and requirements for patentability.

1. Description Requirements of the Description and the Claims

1.1 Claims

1.1.1 Article 36(6)(i) of the Patent Act

As Article 36(6)(i) of the Patent Act requires that an invention for which a patent issought shall be stated in the detailed explanation of the invention, an invention stated inthe claim should not extend the scope described in the detailed explanation of theinvention. A determination on whether the statement in a claim complies with Patent ActArticle 36(6)(i) shall be made based on comparison and review of the claimed inventionand an invention described in the detailed explanation (Refer to Examination GuidelinesPart I, Chapter 1, 2.2.1).

Typical examples of violation of Article 36(6)(i) are as follows.(1) While an antiemetic drug having an ingredient A as an active ingredient is claimed,

neither description about pharmacological test method nor pharmacological data aredescribed in the detailed explanation of the invention, and furthermore it would notbe possible to presume that the ingredient A was effective as an antiemetic drug inthe light of the common general technical knowledge as of the filing (Refer toExamination Guidelines Part I, Chapter 1, 2.2.1.1 Example 9),

6 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/t_tokkyo_e/1312-002_e.htm



(2) While therapeutic agents for a specified purpose whose active ingredients arecompounds defined by desired properties are comprehensibly claimed, and in thedetailed explanation of the invention usefulness as therapeutic agents for a specifiedpurpose is verified for only a small part of the compounds which is included in theclaim, a person skilled in the art could not presume, beyond this, the usefulness ofchemical substances in general included in the claim as therapeutic agents in thelight of the common general technical knowledge as of the filing (Refer toExamination Guidelines Part I, Chapter 1, 2.2.1.1 Example 7).

(Reference: Tokyo High Court Judgment Hei 15.12.26 (Heisei 15 (Gyo Ke) 104),Intellectual Property High Court Judgment Hei 19.3.1 (Heisei 17 (Gyo Ke) 10818))

1.1.2 Article 36(6)(ii) of the Patent Act

As Article 36(6)(ii) of the Patent Act requires that an invention for which a patentis sought is clear, a claim shall be stated in such a manner that an invention for which apatent is sought can be clearly identified from a single claim.

Considering the purport of Article 36(5) of the Patent Act, various forms ofexpression can be used in the claim by the applicant to define an invention for which apatent is sought. For example, in the case of “an invention of a product”, various forms ofexpression such as operation, function, property, characteristics, method, usage andothers can be used as matters to define an invention in addition to the forms ofexpression such as combination of products or the structure of products. As for amedicinal invention, various forms of expression can be used as well (example 3).

On the other hand, since a claim should be stated in such a manner that aninvention for which a patent is sought can be clearly identified from a single claimaccording to the provision of Article 36(6)(ii), it should therefore be noted that suchdefinition of an invention by applicant using the various forms expression is allowed asfar as the claimed invention can be clearly identified.

For example, it should be noted that the scope of the medicinal inventionusually cannot be deemed clear, if the active ingredient of the medicinal invention isdefined by its function or characteristics and a person skilled in the art cannot conceiveof a concrete active ingredient even by taking into consideration the common generaltechnical knowledge as of the filing (refer to Examination Guidelines, Part I; Chapter 2,2.2.2.1(6)3(i)).In case that the statement in the claim does not express a specific medicinal use but ageneral medicinal use, where the claim directed to a medicinal invention (for example, incase where the statement expresses not a “pharmaceutical agent for disease Xconsisting of...” but a “pharmaceutical agent consisting of...”), it should not be deemed aviolation of Article 36(6)(ii) merely because the statement expresses a general use (i.e.,merely because the scope of the claim is relatively broad) unless the expression makesunclear the invention for which a patent is sought. The detailed explanation of theinvention, however, shall comply with the provision of Article 36(4)(i) (Refer toExamination Guidelines, Part I, Chapter 1, 2.2.2.2).

Medicinal invention can be described in a claim as “an invention of a product”as follows:

Example 1: A medicine for disease Z containing an active ingredient AExample 2: A medicinal composition for disease Y containing an active ingredient B



Example 3: A medicine for disease W containing active ingredients C and D incombination

Example 4: A kit for disease V comprising an injection agent including an activeingredient E and an oral agent including an active ingredient F.

1.2 Detailed Explanation of the Invention

1.2.1 Enablement Requirement

As a medicinal invention resides in technical field where it is generally difficult toinfer how to make and use a material on the basis of its structure and its name, normallyone or more representative embodiments or working examples are necessary whichenable a person skilled in the art to work the invention, except the case where a personskilled in the art can manufacture the compounds etc. and can use the compounds etc.for medicinal use, in the light of common general technical knowledge as of the filing. Asfor working examples supporting the medicinal use, a description of the result of thepharmacological test is usually required (Refer to Examination Guidelines, Part I,Chapter 1, 3.2.1 (5)). The following examples display concrete practices regarding thedescription of the result of the pharmacological test sufficient to support apharmacological effect.(1) Description of the Result of the Pharmacological Test

Since the result of the pharmacological test is to confirm the pharmacologicaleffect of compounds etc. of the claimed medicinal invention, all of the followings shouldbe made sufficiently clear, in principle; (i) which compounds etc. are (ii) applied to whatsort of the pharmacological test system, (iii) what sort of result is obtained, and (iv) whatsort of relationship the pharmacological test system has with the medicinal use of theclaimed medicinal invention. It should be noted that the result of the pharmacologicaltest should be described with numerical data as a general rule, but when the resultcannot be described with the numerical data due to the nature of the pharmacologicaltest system, an objective description equivalent to the numerical data for example, adescription of the objective observation result by a medical doctor may be accepted.Furthermore, a clinical test, an animal experiment, and in-vitro test are employed as thepharmacological test system.(2) Examples of Cases where Reasons for Refusal are Notified(a) A case in which the result of the pharmacological test is not described

Generally, since it is difficult to predict whether the compounds etc. are actuallyusable for a specific medicinal use from only the structure and name of the compoundsetc., it is still difficult for a person skilled in the art to predict whether the compound etc.are actually usable for the specific medicinal use when an effective dose, a mode ofadministration, and formulation method are described in the description as filed but theresult of the pharmacological test is not described. Accordingly, in such a case, inprinciple, reasons for refusal are notified. It should be noted that even if the result of thepharmacological test is submitted afterward, the reasons for refusal are not overcome.(Tokyo High Court Judgment Hei 10.10.30 (Heisei 8 (Gyo Ke) 201) “Judgment onAntiemetic Drug”: Examination Guidelines Part I, Chapter 1 5. Examples 5.3, Example 3-5: Tokyo High Court Judgment Hei 14.10.1 (Heisei 13 (Gyo Ke) 345: Tokyo High CourtJudgment Hei 15.12.22 (Heisei 13 (Gyo Ke) 99)



(b) A case in which the existence of a pharmacological effect of the compounds etc. of aclaimed medicinal invention can not be confirmed, as the compounds etc. used in thepharmacological test are not specified

It should be noted that, in many cases the existence of the pharmacologicaleffect of the compounds etc. of the claimed medicinal invention cannot be confirmed; forexample, when the compounds etc. used in the pharmacological test system describedin the description as filed are merely stated as being “any of a plurality of the compoundsetc.” and it is not concretely specified which compounds etc. are actually used, this casecomes under the case where (i) in “(1) Description of the Result of the PharmacologicalTest” is not clear.

2. Requirements for Patentability

2.1 Industrial Applicability

As a medicinal invention means “an invention of a product.”, it does not comeunder the category of “methods of surgery, therapy or diagnosis of humans” despite thefact that the application possibly involves the administration of a dosage to a humanbody or the spreading on the human body, and it is considered to be an “industriallyapplicable invention.” It should be noted that a medicinal invention defined bycombination of two or more medicines, or defined by dosage and administration ishandled in the same way because it is also “an invention of a product” (Refer to theExamination Guidelines Part II, Chapter 1, 2.1 “Industrial Applicability”).

2.2 Novelty

2.2.1 Principle of Method of Determining whether a Claimed Medicinal Invention isNovelA medicinal invention means “an invention of a product” based on discovering anunknown attribute of compounds etc. and finding that compounds etc. are suitable for anew medicinal use due to the presence of such attribute, and its novelty is judged fromtwo points of view;

(i) compounds etc. having a specific attribute and(ii) a medicinal use based on the attribute.

(Tokyo District Court Judgment Hei 4.10.23 (Heisei 2 (Wa) 12094))

2.2.2 Methods of Judging Novelty

(1) Finding of a claimed medicinal inventionThe finding of a claimed invention should be made on the basis of the

statements in the claim. Matters (terms) stated in the claim defining the claimedinvention should be construed in the light of the statements in the description, thedrawings and the common general technical knowledge as of the filing. (Refer toExamination Guidelines Part II, Chapter 2, 1.5.1.)

(2) Finding of an invention described in a publication

Since a medicinal invention consists of compounds etc. having a specificattribute and a medicinal use based on the attribute, it is necessary that both compounds



etc. and the medicinal use are described in a publication (or essentially described,though not literary, in the publication) in order to find that the medicinal invention isdescribed in the publication.Unless it is clear that an invention is described in a publication in such a manner that aperson skilled in the art can make or acquire compounds etc. of claimed medicinalinvention based on the description of the publication and common general technicalknowledge as of the filing, the medicinal invention shall not be deemed to be describedin the publication.Furthermore, if it is unclear that the invention is described in the publication in such amanner that a person skilled in the art can use the compounds etc. for a medicinal usebased on the description of the publication or common general technical knowledge asof the filing, the medicinal invention also shall not be deemed to be described in thepublication (refer to Part II, Chapter 2, 1.5.3(3)(ii)).For example, in the case where a medicinal use is merely listed without any support inthe publication, it cannot be considered that the invention is described in the publicationin such a manner that it is clear that a person skilled in the art can use the compoundsetc. for the medicinal use, and the medicinal invention shall not be deemed to bedescribed in the publication.

(3) Determining whether a claimed medicinal invention is novel

Guidelines for determining whether a claimed medicinal invention is novel arestated below in sections (3-1) to (3-2), based on “Determining whether a ClaimedInvention is Novel” in Examination Guidelines Part II, Chapter 2, 1.5.5 and “Method ofDetermining whether a Claimed Medicinal Invention is Novel” of this Chapter 2.2.1.Hereinafter, “a cited invention” means a cited invention as provided in Patent Act Article29(1)(i)-(iii).

(3-1) Regarding the compounds etc. having a specific attribute > When the compoundsetc. having a specific attribute of the claimed medicinal invention differs from thecompounds etc. of a cited invention, the novelty of the claimed medicinal invention is notdenied.

(3-2) Regarding the medicinal use based on a specific attribute

(3-2-1) Application to a specific disease> Even if the compounds etc. of the claimedmedicinal invention do not differ from the compounds etc. of the cited invention, thenovelty of the claimed medicinal invention is not denied when the claimed medicinalinvention and the cited invention differ in medicinal use of applying to a specific diseasebased on the attribute of such compounds etc. (Examples 1 to 3)

For example, when a claimed invention is “a medicine for disease Z comprisingan active ingredient A,” and a cited invention is “a medicine for disease X comprising anactive ingredient A,” the novelty of the claimed medicinal invention is not denied, in thecase that it is clear that the disease X and the disease Z are different diseases in thelight of the common general technical knowledge as of the filing.

The lines of thoughts regarding the differences in medicinal use are as follows.

(a) Even if the medicinal use of the claimed medicinal invention and the medicinal use ofthe cited invention are different in expression, the novelty of the claimed medicinal



invention is denied when the medicinal uses are judged to come under (i) or (ii)described hereunder taking into consideration the common general technicalknowledge as of the filing.

(i) In the case that the medicinal use is conceived from a working mechanismthereof,

(ii) In the case that the medicinal use inevitably results from closely relatedpharmacological effect.

[Example of (i) above](Cited invention) Bronchodilator→(Claimed medicinal invention)Therapeutic agent for Asthma(Cited invention) Vasodilator→ Claimed medicinal invention) Hypotensive agent(Cited invention) Coronary vessel dilator→(Claimed medicinal invention) Therapeutic agent for Angina(Cited invention) Histamine release inhibitor→ (Claimed medicinal invention) Anti-allergy drug(Cited invention) Histamine H-2 receptor inhibitor→ (Claimed medicinal invention) Therapeutic agent for Gastric ulcer

[Example of (ii) above]

(Cited invention) Cardiotonic agent→ (Claimed medicinal invention) Diuretic agent(Cited invention) Anti-inflammatory agent→ (Claimed medicinal invention) Painkiller

(Note) It is known in the field of medical treatment that there are certain compounds etc.having two or more medicinal uses inevitably. However, in the examples listed under (ii)above, it is also well known that all the compounds etc. having a first medicinal usecoming under (ii) above do not have necessarily a second medicinal use. Accordingly,when the novelty of the claimed medicinal invention in such a case is considered, it isnecessary to consider the common general technical knowledge as of the filingregarding the structure-activity correlation or the like of the compounds etc.

(b) When the medicinal use of the cited invention is expressed in a more specificconcept of the medicinal use of the claimed medicinal invention, the novelty of theclaimed medicinal invention is denied.

[Example](Cited invention) Antipsychotic agent→ (Claimed medicinal invention) Agent acting on central nervous system(Cited invention) Therapeutic agent for Lung cancer→ (Claimed medicinal invention) Anticancer agent

(c) When the medicinal use of the cited invention is expressed as a generic concept ofthe medicinal use of the claimed medicinal invention and the medicinal use of theclaimed medicinal invention is expressed as a more specific concept which can beconceived from the medicinal use of the cited invention based on the common generaltechnical knowledge as of the filing, the novelty of the claimed medicinal invention isdenied.



(Note) It should be noted that a medicinal use expressed as a more specific concept cannot be conceived only because the medicinal use expressed as a more specificconcept is conceptually included in the medicinal use expressed in a generic conceptor the medicinal use expressed in a more specific concept can be listed from themedicinal use expressed in a generic concept.

(d) When the medicinal use of the claimed medicinal invention is only expressed as anewly found working mechanism in place of the medicinal use of the cited inventionand both uses cannot be substantially distinguished from each other, the novelty of theclaimed medicinal invention is denied.

[Example](Cited invention) Antibacterial agent→ (Claimed medicinal invention) Bacterial cell membrane formation inhibitor

(e) When there is no difference in the component compositions and the medicinal usesof the claimed medicinal invention and the cited invention, and the componentcontained in the claimed medicinal invention is merely expressed in a manner that theworking mechanism of a part of the component of the cited invention is defined as if itis a use, the novelty of the claimed medicinal invention is denied.

[Example](Cited invention) Skin anti-inflammatory agent containing indomethacin andcapsicum extract→ (Claimed medicinal invention) Skin anti-inflammatory agent containing

indomethacin and long-term stability improving agent for indomethacin composed ofcapsicum extract

(Note) As the component constitutions of the composition are the same, it is obvious thatthe components contained in the skin anti-inflammatory agent of both inventionsperform the same working effect despite the subjective object for adding. Accordingly,even if the capsicum extract is defined as a stabilizer for improving long-term stabilityof the indomethacin, this cannot make the invention different from the inventiondescribed in the publication. (Tokyo High Court Judgment Hei 13.12.18 (Heisei 13(GyoKe) 107)

(3-2-2) Application to a specific disease in which dosage and administration is specifiedEven if compounds etc. of a claimed medicinal invention do not differ from those of acited invention and there is no difference in the applied disease, the novelty of theclaimed invention is not denied when there is a difference between the claimedmedicinal invention and the cited invention in medicinal use of applying to a specificdisease with a specific dosage and administration based on the attribute of compoundsetc. thereof (Example 4 to 6).

2.3 Inventive Step

2.3.1 Inventive Step regarding Medicinal Invention

(1) Finding of a claimed medicinal inventionThe finding of a claimed invention is handled as described in “2.2.2(1).”(2) Finding of an invention described in a publicationThe finding of a invention described in a publication is handled as described in “2.2.2(2).”(3) The judgment of the inventive step



The judgment of the inventive step regarding medicinal invention is handled asdescribed in Examination Guidelines Part II, Chapter 2, 2. Inventive Step.

2.3.2 Examples of Concrete Practices Regarding Judgment of Inventive Step

(1) Relationship between the medicinal use and the working mechanismEven if the medicinal use of the claimed medicinal invention differs from the

medicinal use of the cited invention, when the relevance of the working mechanismbetween both has been derived from the state of the art as of the filing, the inventivestep of the claimed medicinal invention is usually denied, unless there is another groundfor inferring inventive step such as advantageous effect or the like.(2) Conversion of a medicine for animals other than human beings to a medicine forhuman beings

A claimed medicinal invention, derived by merely converting compounds etc. ofa cited invention used for the same or a similar kind of diseases of animals other thanhuman beings into a medicine for human beings, usually does not involve an inventivestep even if there is no suggestion in the contents of the cited invention about thepertinent conversion, unless there is another ground for inferring inventive step such asadvantageous effect or the like.

The situation is the same with the conversion of a medicine for human beings tointo a medicine for animals other than human beings.(3) Medicine formulated by combining two or more medicinal components

In order to solve a problem well known to a person skilled in the art such as theincrease in a medicinal effect, or the reduction of a side effect, optimization of thecombination of two or more medicinal components is among exercise of ordinarycreativity of a person skilled in the art. When the difference between the claimedmedicinal invention and the cited invention falls only on these points, ordinarily, theinventive step of the claimed medicinal invention is denied.

For example, if the pertinent combination corresponds to the followings, in mostcases, it is reasoned that a person skilled in the art would have easily arrived at theclaimed medicinal invention and the inventive step is usually denied (Example 8 to 11):

(a) combination of publicly known components of which major effects are the same,(b) combination of a major component having a publicly known problems related to the

efficacy thereof with a subordinate component having publicly known ability toeliminate the problem (for example, in case of the combination of the majorcomponent having a publicly known side effect and a subordinate component havinga publicly known ability of reducing the side effect), and

(c) combination of publicly known components having respective curative effects for avariety of symptoms arising from a major disease, and the like.

However, in the case where there is another ground for inferring the inventive step suchthat an advantageous effect compared with the cited invention cannot be foreseen by aperson skilled in the art from the state of the art, the claimed medicinal invention isconsidered to involve an inventive step (Example 7).

Although the medicine formulated by combining two or more medicinalcomponents can be assumed to be claimed in such a manner as “combination drug forthe treatment of…,” “composition for the treatment of…,” “…medicine characterized inthat … and …are combined,” there is no fundamental difference in any of the cases asthe method of judgment.(4) Medicine characterized in the medicinal use of an application to a specific disease

with a specific dosage and administration



As for a specific disease, in order to solve a problem well known to a person skilled inthe art such as the increase of a medicinal effect, the reduction of an adverse effect orthe improvement in drug compliance, the optimization of dosage and administration of amedicine is among exercise of ordinary creativity of a person skilled in the art.Accordingly, in the case where the advantageous effect compared with the citedinvention can be foreseen by a person skilled in the art, the inventive step is usuallydenied, even if the claimed medicinal invention is novel compared with the citedinvention in that applied disease does not differ but dosage and administration differfrom each other (Example 6).However, in the case where there is another ground for inferring the inventive step suchthat an advantageous effect compared with the cited invention cannot be foreseen by aperson skilled in the art from the state of the art, the claimed medicinal invention isconsidered to involve an inventive step (Example 4 and 5).

2.4 Patent Act Article 29-2

2.4.1 Application of Patent Act Article 29-2

(1) Finding of a claimed medicinal invention :The finding of a claimed invention ishandled as described in “2.2.2(1).”(2) Finding of a invention described in a initial description etc. of another application: Thefinding of a invention described in a initial description etc. of another application ishandled as described in “2.2.2(2).”(3) The judgment of the requirement of “Patent Act Article 29-2” : The judgment of therequirement of “Patent Act Article 29-2” is handled as described in ExaminationGuidelines Part II, Chapter 3, Patent Act Article 29-2.

2.4.2 Examples of Concrete Practices Regarding Judgment of Patent Act Article29-2

A claimed medicinal invention and an invention described in a prior applicationare deemed to be substantively identical if the difference between them is considered tobe a very minor difference (e.g. addition, deletion, or replacing of well-known orcommonly used art, generating no new effects) in an embodied means to solve aproblem.

2.5 Patent Act Article 39

2.5.1 Application of Patent Act Article 39(1) Finding of a claimed medicinal invention : The finding of a claimed invention ishandled as described in “2.2.2(1).”(2) The judgment of the requirement of “Patent Act Article 39”: The judgment of therequirement of “Patent Act Article 39” is handled as described in Examination GuidelinesPart II, Chapter 4, Patent Act Article 39.

2.5.2 Examples of Concrete Practices Regarding Judgment of Patent Act Article 39

In a case in which the invention of a prior application having a generic concepthas a relationship with the invention of subsequent application having a more specificconcept, and in a case in which the matters necessary for defining the subsequentapplication are disclosed in the prior application and the invention of the prior application



having the generic concept is deemed to have de facto choices in the range of thedisclosed matters, the invention of the subsequent application is the same as theinvention of the prior application.

The same method is practiced in judging an identity between each claimedinvention of two applications filed on the same day.

3. Examples

Explanation of Examples: These examples are prepared for the purpose ofexplaining examination practices regarding medicinal inventions. Therefore, it is to benoted that the descriptions of claims etc. in these examples are not necessarilyexemplary cases because they are modified, e.g., simplified to make the explanationeasier to understand. Additionally, it is to be noted that it does not mean that there is noreason for refusal except for reasons discussed in each example (for instance,description requirements for description and claims and the like).

3.1 Medicine characterized in a medicinal use applied to a specific disease

[Example 1] An active ingredient is publicly known, a medicinal use is novel

Claim :[Claim 1] A pharmaceutical composition for treatment of Alzheimer’s diseasecomprising a compound A as an active ingredient,Outline of Detailed Explanation of the Invention

It is found that a compound A, which is known as an active ingredient for anantimicrobial agent, can inhibit the function of acetylcholine-esterase, and suppress adegradation of acetylcholine.

It is shown in the example with the result of the pharmacological test that acompound A has an excellent inhibitory activity of acetylcholine-esterase, and decreasesthe symptom of Alzheimer’s disease.

Result of Prior Art Search

Although it is already known that a compound A is an active ingredient for anantimicrobial agent, the prior art documents do not describe a pharmaceuticalcomposition for treatment of Alzheimer’s disease comprising a compound A as an activeingredient. Moreover, the documents do not describe or suggest the existence of thestructural similarity between a compound A and compounds having an acetylcholine-esterase activity and the relationship between a mechanism of a compound A foraffecting as an antimicrobial agent and the treatment of Alzheimer’s disease.

Outline of Reasons for Refusal >> No reason for refusal.

[Explanation] As a medicinal use of a compound A for a treatment of Alzheimer’sdisease is clearly distinguished from a known medicinal use for antimicrobial agent, themedicinal invention of claim 1 is novel, and because there are no prior artdocuments showing a motivation for applying a compound A to the treatment ofAlzheimer’s disease, such as the existence of structural similarity between acompound A and a compound having an acetylcholine-esterase activity, or therelationship between a mechanism of a compound A for affecting as antimicrobial



agent and a treatment of Alzheimer’s disease, the medicinal invention of claim 1involves an inventive step.

[Example 2] Medical materials (cells etc.) derived from the living organism whichis publicly known, but a medicinal use is novel

Claim : [Claim 1] An implant material for treatment of cardiac infarction, which containscell sheets consisting of A-cells.

Outline of Detailed Explanation of the Invention

It was found that cardiac function was recovered by transplantation of cell sheetsconsisting of A-cells to a site of cardiac infarction.It is described in the example with the result of the pharmacological test that cardiacfunction is recovered and the symptom of cardiac infarction is reduced by transplantationof the said cell sheets to the site of cardiac infarction in a model rat of cardiac infarction.Result of Prior Art Search

It is publicly known that cell sheets are obtained from A-cells and that they are used asimplant materials. However, it is not described in any prior art documents that the saidcell sheets are transplanted to the site of cardiac infarction and that the symptom ofcardiac infarction is reduced by the transplantation.Furthermore, from the state of the art as of the filing, it is not possible to predict thatcardiac function is recovered and the symptom of cardiac infarction is reduced bytransplantation of A-cells.


[Explanation] The medicinal invention of the claim 1 is considered to be novel becausethe medicinal use (treating cardiac infarction) of cell sheets consisting of A-cells isdifferent from the conventionally-known medicinal use of the sheets.The medicinal invention of the claim 1 is considered to involve the inventive stepbecause the prior art documents have not been publicly known which describe therelationship between the A-cell and recovery of cardiac function etc., and then motivatethe use of cell sheets consisting of A-cells for treatment of cardiac infarction.

[Remark] It should be noted that, if the claimed invention is related to the cell withthe limitation of use such as “A-cell for the treatment of cardiac infarction”, suchlimitation of use usually only indicates the utility of the cell itself and the claimshould be construed to represent the cell per se with no limitation of use.Therefore, in this case, the difference between “A-cell for the treatment of cardiacinfarction” and publicly known “A-cell” with no limitation of use cannot beacknowledged in view of composition of matters (refer to ExaminationGuidelines, Part II; Chapter 2, 1.5.2(2)).

[Example 3] Medicine characterized in a medicinal use of the cells specified bymanufacturing process

Claims :



[Claim 1] An anticancer agent comprising the cells as an active ingredient obtained bythe following process consisting of the steps of;

(1) culturing W-cells obtained from a human body in medium A containing0.1~0.2 weight % of protein X for 5 to 10 hours and collecting them, and(2) disseminating the collected cells in the step (1) on an extracellular matrix Y,culturing them in medium B containing 0.1~0.2 weight % of protein Z for 24 to 48hours, and collecting them.

[Claim 2] A method of manufacturing an anticancer agent consisting of the steps of;(1) culturing W cells obtained from a human body in medium A containing0.1~0.2 weight % of protein X for 5 to 10 hours and collecting them,(2) disseminating the collected cells in the step (1) on an extracellular matrix Y,culturing them in medium B containing 0.1~0.2 weight % of protein Z for 24 to 48hours, and collecting them, and(3) a step of producing a pharmaceutical formulation by using the cells collectedin the step (2),wherein the anticancer agent contains the cells obtained by the processconsisting of the steps (1) and (2) as an active ingredient.


It was found that the anticancer agent containing cells obtained by the processconsisting of the steps of (1) and (2) as an active ingredient inhibited angiogenesispeculiar to a cancer tissue and diminished the cancer growth.It is described in the example with the result of the pharmacological test that the cellsobtained by a process consisting of the steps of (1) and (2) in the example have anexcellent inhibitory effect of angiogenesis and of diminishing effect of the cancer growth.


It is publicly known that W-cell obtained from a human body is processed through thesteps of (1) and (2) and that cells processed through the steps have animmunosuppressive effect. However, it has not been known that W-cell itself or the cellsprocessed through the steps consisting of (1) and (2) has an inhibitory effect ofangiogenesis and an anticancer effect.Furthermore, from the state of the art as of the filing, it is not possible to predict that thecells obtained by processing W-cells derived from the human body through the stepsconsisting of (1) and (2) have an inhibitory effect of angiogenesis and an anticancereffect.


[Explanation] The medicinal invention of claim 1 is considered to be novel because amedicinal use (anticancer) of cells obtained from the steps consisting of (1) and (2) isdifferent from the conventionally-known medicinal use (immunosuppression).The medicinal invention of the claim 1 is considered to involve the inventive stepbecause the prior art documents have not been publicly known which disclose therelationship between an immunosuppressive effect and angiogenesis and then motivatethe use of the cells obtained by the steps consisting of (1) and (2) as an anticanceragent.



In addition, the invention of claim 2 is considered to be novel and to involve inventivestep based on the same idea of the invention of the claim 1.It should be noted the cells could be specified by manufacturing process, even when it isdifficult to specify the cells with cell markers etc. In this example, the inventions of claim1 and 2 are considered to be clear, because original cells and culture condition areidentified in details in the steps consisting of (1) and (2). As for handling of claimsincluding specification of a product by the manufacturing process, please refer to Part IChapter 1, 2.2.2.1(7), Part II Chapter 2, 1.5.5(4) and 2.7

3.2 Medicine characterized in a medicinal use of an application to a specificdisease in which dosage and administration is specified

[Example 4] Medicine performing remarkable effect by an application to a specificdisease in which dosage and administration is specified

Claim[Claim 1] A therapeutic agent for asthma containing compound A wherein 30~40 µg/kg

of compound A is orally administered to humans once per 3 months.


Although it has been publicly known that the symptom of asthma is reduced by daily oraladministration of 1µg/kg/day of compound A to asthma patients, the reduction of thesymptom is only during the administration period of compound A. It was necessary thusto continue to administer compound A daily, because the symptom relapses if theadministration is stopped. In addition, in case of the daily oral administration of1µg/kg/day of compound A, it has been pointed out that the side effect B arises with highfrequency.It was found in this invention that the symptom of asthma is improved for a long term andthe incidence of side effect B is reduced compared to before, by orally administering30~40µg/kg of compound A to asthma patients once per 3 months.It is described in the example with the result of the pharmacological test that thesymptom of asthma was reduced at least for 3 months by every single oraladministration of 30~40 µg/kg of compound A to a group of asthma patients (weighing30kg to 90kg), that body weights didn’t bring clear difference in pharmacological efficacy,and that the incidence of side effect B significantly decreased from the case of daily oraladministration of 1µg/kg/day of compound A.

Result of Prior Art SearchIt is publicly known that the symptom of asthma is reduced by daily oral administration of1µg/kg/day of compound A and that side effect B arises with high frequency in that case.However, administering 30~40µg/kg of compound A once per 3 months is not describedin the prior art documents.Furthermore, from the state of the art as of the filing, it is not possible to predict that thesymptom of asthma decreases at least for 3 months by a single oral administration of30~40µg/kg of compound A and that the incidence of side effect B decreases comparedto the prior art.




[Explanation] Regarding dosage and administration of compound A for asthmatreatment, dosage and administration of this invention is different from the alreadyknown dosage and administration. Therefore, the medicinal invention of claim 1 is novel.Furthermore, by a single administration of 30~40µg/kg of compound A, the symptom ofasthma is reduced at least for 3 months and the incidence of side effect B significantlydecreases compared to the case of the daily oral administration of 1µg/kg/day ofcompound A. As they are remarkable effects which cannot be foreseen from the state ofthe art as of the filing, the medicinal invention of claim 1 involves an inventive step.

[Example 5] Medicine performing remarkable effect by an application to a specificdisease in which dosage and administration is specified

Claim[Claim 1] A therapeutic agent for ovary cancer containing compound A as an active

ingredient wherein 100~120µg/kg of compound A is administered to the particular site Zin human brain.

Outline of Detailed Explanation of the InventionIt has been known that compound A exhibits growth-inhibitory effect against ovarycancer by intravenous administration to humans but arises hepatotoxicity as a side effectat the same time.In this invention, it is found that the blood level of hormone Y secreted from the pituitarygland changes by administration of compound A to the particular site Z in the humanbrain, and consequently ovary cancer significantly diminishes compared to theconventional treatment by intravenous administration.It is described in the example with the result of the pharmacological test that the bloodlevel of hormone Y secreted by the pituitary gland changes by administration ofcompound A to the particular site Z in the human brain, and that as a result ovary cancerdiminishes more compared to the conventional treatment by intravenous administration.It is also described in the example with the result of the pharmacological test thatcompound A is not delivered to the liver and does not show hepatotoxicity when it isadministered to the particular site Z in the brain.


It is publicly known that compound A exhibits growth-inhibitory effect against ovarycancer by intravenous administration to humans and hepatotoxicity as a side effect.However, it is not described in the prior art documents that the intravenouslyadministered compound A is delivered to the brain through the blood brain barrier, or theadministration of compound A to the particular site Z in the human brain results in moreshrinking of ovary cancer than the prior art.Furthermore, from the state of the art as of the filing, it is not possible to predict thatovary cancer diminishes without causing a side effect of hepatotoxicity by administeringcompound A to the particular site Z in the human brain.


[Explanation] Regarding dosage and administration of compound A for ovarycancer treatment, dosage and administration (administration to the particular siteZ in the human brain) of this invention is different from the already known dosage



and administration (intravenous administration). Therefore, the medicinalinvention of claim 1 is novel. Moreover, as it is a remarkable effect which cannotbe foreseen from the state of the art as of the filing that compound A does notcause a side effect of hepatotoxicity by administration to the particular site Z inthe brain, or ovary cancer diminishes more compared to the treatment byintravenous administration, the medicinal invention of claim 1 has an inventivestep.

[Example 6] Medicine characterized in an application to a specific disease inwhich dosage and administration is specified

Claim[Claim 1] An antitussive agent containing compound A wherein 400~450µg/kg per

dose of compound A is orally administered to humans once per day.


Although it has been known that orally administering 160µg/kg per dose of compound Ato humans three times a day has the antitussive effect, it was found in this invention thatthe antitussive effect improves compared to before by oral administration of400~450µg/kg per dose of compound A to humans.It is described in the example with the result of the pharmacological test that oraladministration of 400µg/kg per dose of compound A to a patient once per day improvesthe antitussive effect compared to the oral administration of 160µg/kg per dose ofcompound A to a patient three times per day. Furthermore, it is also described that drugcompliance improves because the number of doses per day decreases.


It is publicly known that the antitussive effect is obtained by oral administration of160µg/kg per dose of compound A three times per day. Furthermore, the degree of theantitussive effect and improvement of drug compliance disclosed in the detailedexplanation of the invention falls under the predictable range in the light of the state ofthe art as of the filing.

Outline of Reasons for Refusal >> It is publicly known that an antitussive agentincluding compound A as an active ingredient is orally administered. In general, in orderto solve a problem well known to a person skilled in the art, such as an increase in amedicinal effect and improvement of drug compliance, optimization of dosage andadministration of a medicine is among exercise of ordinary creativity of a person skilledin the art. Therefore, it would have been easily arrived at by a person skilled in the art toexperimentally decide appropriate dosage and administration of compound A.Furthermore, that a medicinal effect and drug compliance can be improved by optimizingdosage and administration of a medicine can normally be foreseen to a person skilled inthe art, and the degree of improvement in this invention is not remarkable oneunforeseeable from the state of the art as of the filing.



Measures for Reasons for Refusal < Ordinarily, the above-described reason for refusalis not overcome.

[Remark] How much effect is “remarkable one unforeseeable from the state ofthe art as of the filing” is judged individually taking into consideration the contentof disclosure of the description, results of the prior art search, and commongeneral technical knowledge as of the filing or the like.

3.3 Medicine characterized by combination of materials having a specific attribute

[Example 7] A medicinal drug performing remarkable effect by combination ofactive ingredients

Claim[Claim 1] An antidiabetic composition containing a compound A and a compound B at

a ratio by weight 5:1 to 4:1.

Outline of Detailed Explanation of the InventionIn this invention, reduction of the side effects such as a weight gain or the like,

which have conventionally been observed when the compound A is independently used,is found to be the result of combining and using of the compound A and the compound Bat a ratio by weight 5:1 to 4:1.

In the example the result of the pharmacological test is described, which showsthe reduction of the side effects in case that using a combination of a compound A and acompound B at a specific ratio.Result of Prior Art Search

Although it is publicly known that the compound A and the compound B arerespectively used as antidiabetic agents, the prior art documents do not describe theantidiabetic agent composition by combining and using the compound A and thecompound B. Furthermore, decrease in the side effects such as a weight gain or the likeby combining and using compound A and compound B at the specific ratio cannot beforeseen from the state of the art as of the filing.


[Explanation] As the result of the pharmacological test or the like shows aremarkable effect of reducing the side effects that cannot be foreseen by aperson skilled in the art from the state of the art as of the filing by combining andusing of the compound A and the compound B at the specific ratio, the inventioninvolves an inventive step.

[Example 8] Combination of a component with another component having thesame major effect which is publicly known

Claim[Claim 1] A liquid antiflatulent containing 1 to 30g of dietary fiber and 1 x 106 to 1 x

108 cells of the YY bacterium.




In this invention, an antiflatulent, which fortifies the intestine regulating function,is formulated by combining the dietary fiber and the YY bacterium, both affecting thefunctions of the intestines. Furthermore, in the description, the result of thepharmacological test of an antiflatulent having this combination is shown. However, theresult of the pharmacological test in case that using the dietary fiber and the YYbacterium respectively is not described.

Result of Prior Art SearchIt is publicly known that there is an intestine regulating function when 1 to 30g of

the dietary fiber is taken or when 1 x 106 to 1 x 108 cells of the YY bacterium are taken.And it is also publicly known to make the bacterium and the dietary fiber co-exist in orderto maintain the activity of the bacterium having the intestine regulating function andfortify intestine regulating function.

Outline of Reasons for Refusal >> It is publicly known that there is an intestineregulating function when 1 to 30g of the dietary fiber is taken or when 1 x 106 to 1 x 108cells of the YY bacterium are taken. Furthermore it is publicly known to make thebacterium and the dietary fiber co-exist, in order to maintain the activity of the bacteriumhaving the intestine regulating function and to fortify the intestine regulating function, itwould have been easily arrived at by a person skilled in the art to formulate medicine forintestinal disorder by combining 1 x 106 to 1 x 108 cells of the YY bacteria having theintestine regulating function with 1 to 30g of the dietary fiber also having the intestineregulating function. Furthermore, it is considered as a mere exercise of ordinarycreativity of a person skilled in the art to formulate a liquid medicine in view of the easeof taking medicine or the like, and in addition, the effect thereof cannot be found to beremarkable one.

� Measures for Reasons for Refusal < In the detailed explanation of the inventionin this example, the result of the pharmacological test on the antiflatulent of thisinvention formulated by combining the dietary fiber and the YY bacterium isshown, and a fortification of the intestine regulating function is also described.Therefore, in a written opinion etc., it is possible to insist and demonstrate thatthere is the advantageous effect of the antiflatulent composed of the combinationof the dietary fiber and the YY bacterium compared to a cited invention, withshowing the experimental result in case of the administration of the dietary fiberand the YY bacterium respectively. However, reasons for refusal should besustained if the effect does not exceed beyond the scope expected from the stateof the art as of the filing.

[Example 9] Combination of a publicly known main component having a sideeffect with a publicly known sub-component having the ability to reduce the sideeffect

Claim[Claim 1] Therapeutic agent for a paclitaxel responsive tumor formulated by combining

paclitaxel with a compound X in a effective dose for suppressing a vomiting caused byadministration of paclitaxel.Outline of Detailed Explanation of the Invention

In this invention, it is found that the paclitaxel responsive tumor can be curedwhile suppressing the vomiting which is the side effect caused at the time of



administering the paclitaxel by using the paclitaxel together with the compound X at thesame time.In the example, the result of the pharmacological test is described which shows thereduction of the side effect by using the paclitaxel together with the compound X at thesame time.Result of Prior Art SearchAlthough the paclitaxel is an excellent anti-tumor agent, it is publicly known that vomitingis a side effect caused by the paclitaxel at the time of administration, and using thepaclitaxel together with sub-component reducing vomiting. On the other hand, it ispublicly known that the compound X generally weakens the vomiting. Furthermore, theeffect of reducing the vomiting disclosed in the detailed explanation of the invention fallsunder the predictable range from the state of the art as of the filing.Outline of Reasons for Refusal >> Since it is known that paclitaxel is used together, atthe same time, with the sub-component for weakening the vomiting which is the sideeffect of the administration of paclitaxel, and furthermore the compound X is well knownas a compound for generally weakening the vomiting, the combined use of the paclitaxelwith the compound X can be easily made by a person skilled in the art, in order toweaken the vomiting which is the side effect of the administration of paclitaxel.Furthermore, there is no remarkable effect that cannot be foreseen as a result of thecombined use as described.

Measures for Reasons for Refusal < Ordinarily, the above-described reason for refusalis not overcome.

[Example 10] Combination with a publicly known sub-component having theability to eliminate a problem related to the efficacy of a publicly known maincomponent

Claim[Claim 1] A combination drug for anti-inflammation formulated by compounding 1 to

100 weight parts of compound X and 0.2 to 20 weight parts of compound Y for the total100 weights parts of diclofenac or its salts and acetaminophen.

Outline of Detailed Explanation of the InventionIn this invention, it is shown that the pain threshold value can be increased and

the duration time of the function can be extended in a test for painkiller functions byadding compound X and compound Y in the anti-inflammatory drug formulated bycombining diclofenac or its salts with acetaminophen.In the embodiment, the result of the pharmacological test is described, which shows thesaid effects by adding compound X and compound Y at a specific ratio to thecombination of the diclofenac or its salts and acetaminophen.

Result of Prior Art SearchA combination drug for anti-inflammation formulated by combining diclofenac or

its salts with acetaminophen is publicly known, and it is also known that there is a so-called ceiling effect in which the anti-inflammatory and painkiller effect does not increasewhile only the side effect increases, even if the dose thereof is increased by more than acertain dose, generally, in the non-steroidal type anti-inflammatory drug.

In general, it is publicly known that, by adding compound X and compound Y tothe non-steroidal type anti-inflammation drugs, the pain threshold value can be



increased to the same degree as the invention of the present application and theduration time of the effect can also be extended to the same degree as the invention ofthe present application in a test for painkiller functions.

Outline of Reasons for Refusal >> A non-steroidal type anti-inflammation drugsformulated by combining diclofenac or its salts with acetaminophen is publicly known,and it is known that the pain threshold value can be increased and the duration time ofthe effect can be extended in the analgestic effect test by adding compound X andcompound Y to the non-steroidal type anti-inflammation drugs. Accordingly, addingcompound X and compound Y to the non-steroidal type anti-inflammation drugsformulated by combining the diclofenac or its salts with acetaminophen in order toincrease the pain threshold value and extend the duration time of the function wouldhave been easily arrived at by a person skilled in the art, and it is considered that therange of the compounding ratio of the components would have been experimentallyoptimized by a person skilled in the art. In addition, the effect thereof cannot be found tobe remarkable one.

Measures for Reasons for Refusal < Ordinarily, the above-described reason forrefusal is not deemed overcome.

[Example 11] Combination of publicly known components having respectiveefficacy for various symptoms caused by major disease

Claim [Claim 1] Therapeutic agent for AIDS formulated by combining azidothymidine(AZT), an anti-HIV medicine, with compound Z.

Outline of Detailed Explanation of the InventionIn this invention, it is shown that, in order to cure a patient with AIDS which

appears after the patient has been infected by HIV, the combination of the anti-HIVmedicine AZT and compound Z which is effective in curing pneumonia caused as asymptom of the AIDS inhibits the proliferation of the HIV and cures pneumonia.

Result of Prior Art SearchIt is publicly known that azidothymidine (AZT) can be used as therapeutic agent

for AIDS. It is also publicly known that the pneumonia is caused as one mode of theAIDS. Furthermore, the inhibitory effect of the proliferation of the HIV and curing effect ofpneumonia disclosed in the detailed explanation of the invention falls under thepredictable range from the state of the art as of the filing.

Outline of Reasons for Refusal >> It is known that the azidothymidine (AZT) iseffective as therapeutic agent for AIDS, and also known that the pneumonia is easilycaused as a symptom of the AIDS. Furthermore, curing the pneumonia by use ofcompound Z is widely practiced.

Accordingly, it is among exercises of ordinary creativity of a person skilled in theart to use a combination of the anti-HIV medicine AZT with the compound Z whenmedicinally treating AIDS patients for the purpose of suppressing the proliferation of theHIV which causes the AIDS while curing also the pneumonia which is caused as asymptom of the AIDS. Furthermore, remarkable effects that cannot be foreseen are notshown by the combined use.



Measures for Reasons for Refusal >> Ordinarily, the above-described reason forrefusal is not overcome.

======= End of Chapter II ===========

CHAPTER III

LEGISLATIVE PROVISIONS AND OBLIGATIONS - INDIA

THE PATENT ACT, 1970 (39 of 1970) As Amended

CHAPTER I PRELIMINARY

Section 2. Definitions and interpretation.—(1) in this Act, unless the context

otherwise requires,—

(ac) "capable of industrial application", in relation to an invention, means that the

invention is capable of being made or used in an industry;

(j) "invention" means a new product or process involving an inventive step and

capable of industrial application;

(ja) "inventive step" meaning a feature of an invention that involves technical

advance as compared to the existing knowledge or having economic significance

or both and that makes the invention not obvious to a person skilled in the art;

(ta) "pharmaceutical substance" means any new entity involving one or more

inventive steps;

CHAPTER III INVENTIONS NOT PATENTABLE



Section 3. What are not inventions.—The following are not. inventions withinthe meaning of this Act,—

(a) an invention which is frivolous or which claims anything obviously contrary towell established natural laws;

(b) an invention the primary or intended use or commercial exploitation of whichcould be contrary public order or morality or which causes serious prejudice tohuman, animal or plant life or health or to the environment;

(c) the mere discovery of a scientific principle or the formulation of an abstracttheory or discovery of any living thing or non-living substances occurring innature;

(d) the mere discovery of a new form of a known substance which does not resultin the enhancement of the known efficacy of that substance or the mere discoveryof any new property or new use for a known substance or of the mere use of aknown process, machine or apparatus unless such known process results in a newproduct or employs at least one new reactantExplanation.—For the purposes of this clause, salts, esters, ethers, polymorphs,metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,combinations and other derivatives of known substance shall be considered to bethe same substance, unless they differ significantly in properties with regard toefficacy;]

(e) a substance obtained by a mere admixture resulting only in theaggregation of the properties of the components thereof or a process forproducing such substance;

(f) the mere arrangement or re-arrangement or duplication of known deviceseach functioning independently of one another in a known way;

(g) omitted w.e.f. 20.05.2003

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic 2ldiagnostic,therapeutic] or other treatment of human beings or any process for a similartreatment of animals 3[***] to render them free of disease or to increasetheir economic value or that of their products.

(j) plants and animals in whole or any part thereof other than microorganismsbut including seeds, varieties and species and essentially biologicalprocesses for production or propagation of plants and animals;

(k) a mathematical or business method or a computer programe per se oralgorithms;

(l) a literary, dramatic, musical or artistic work or any other aesthetic creationwhatsoever including cinematographic works and television productions;

(m) a mere scheme or rule or method of performing mental act or method ofplaying game;



(n) a presentation of information;

(o) topography of integrated circuits;

(p) an invention which in effect, is traditional knowledge or which is anaggregation or duplication of known properties of traditionally knowncomponent or components.

Section 4. Inventions relating to atomic energy not patentable.—No patent shall begranted in respect of an invention relating to atomic energy falling within sub-section(1) of section 20 of the Atomic Energy Act, 1962 (33 of 1962).

CHAPTER VIII GRANT OF PATENTS AND RIGHTS CONFERRED THEREBY

Subsection 4 of Section 47.Grant of patents to be subject to certain conditions.—Thegrant of a patent under this Act shall be subject to the condition that—

“in the case of a patent in respect of any medicine or drug, the medicine or drugmay be imported by the Government for the purpose merely of its own use or fordistribution in any dispensary, hospital or other medical institution maintained by or onbehalf of the government or any other dispensary, hospital or other medical institutionwhich the Central Government may, having regard to the public service that suchdispensary, hospital or medical institution renders, specify in this behalf by notification inthe Official Gazette.”

CHAPTER XVI WORKING OF PATENTS, COMPULSORY LICENCES ANDREVOCATION

Section92.Special provision for compulsory licences on notifications by CentralGovt.—

(1) If the Central Government is satisfied, in respect of any patent in force incircumstances of national emergency or in circumstances of extreme urgency or in caseof public non-commercial use, that it is necessary that compulsory licenses shouldbe granted at any time after the sealing thereof to work the invention, it may make adeclaration to that effect, by notification in the Official Gazette, and thereupon the followingprovisions shall have effect, that isto say—

(i) the Controller shall on application made at any time after the notificationby any person interested grant to the applicant a licence under the patenton such terms and conditions as he thinks fit;

(ii) in settling the terms and conditions of a licence granted under this section,the Controller shall endeavour to secure that the articles manufacturedunder the patent shall be available to the public at the lowest pricesconsistent with the patentees deriving a reasonable advantage from theirpatent rights.

(2) The provisions of sections 83, 87, 88, 89 and 90 shall apply in relation to thegrant of licences under this section as they apply in relation to the grant of licencesunder section 84.



(3) Notwithstanding anything contained in sub-section (2), where the Controller issatisfied on consideration of the application referred to in clause (i) of sub-section (1)that it is necessary in—

(i) a circumstance of national emergency; or

(ii) a circumstance of extreme urgency; or

(iii) a case of public non-commercial use,

which may arise or is required, as the case may be, including public health crises,relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus,tuberculosis, malaria or other epidemics, he shall not apply any procedure specified insection 87 in relation to that application for grant of licence under this section:

Provided that the Controller shall, as soon as may be practicable, inform, the patentee of thepatent relating to the application for such non-application of section 87,

Section 92A. Compulsory licence for export of patented pharmaceuticalproducts in certain exceptional circumstances.—

(1) Compulsory licence shall be available for manufacture and export of patentedpharmaceutical products to any country having insufficient or no manufacturing capacityin the pharmaceutical sector for the concerned product to address public healthproblems, provided compulsory licence has been granted by such country or suchcountry has, by notification or otherwise, allowed importation of the patentedpharmaceutical products from India.

(2) The Controller shall, on receipt of an application in the prescribedmanner, grant a compulsory licence solely for manufacture and export of theconcerned pharmaceutical product to such country under such terms andconditions as may be specified and published by him.

(3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extentto which pharmaceutical products produced under a compulsory license can beexported under any other provision of this Act.

Explanation.—for the purposes of this section, 'pharmaceutical products' meansany patented product, or product manufactured through a patented process, ofthe pharmaceutical sector needed to address public health problems and shall beinclusive of ingredients necessary for their manufacture and diagnostic kits requiredfor their use.

Section 94.Termination of compulsory licence.—

(1) On an application made by the patentee or any other person deriving title orinterest in the patent, a compulsory licence granted under section 84 may beterminated by the controller, if and when the circumstances that gave rise to thegrant thereof no longer exist and such circumstances are unlikely to recur:

Provided that the holder of the compulsory licence shall have the right to object tosuch termination.

(2) While considering an application under section (1), the Controller shall take intoaccount that the interest of the person who had previously been granted the licence isnot unduly prejudiced.



Section 107A. Certain acts not to be considered as infringement.—For the purposesof this Act,—

(a) any act of making, constructing, using, selling or importing apatented invention solely for uses reasonably related to thedevelopment and submission of information required under any lawfor the time being in force, in India, or in a country other than India,that regulates the manufacture, construction, use, sale or import ofany product;

(b) importation of patented products by any person from a person whois duly authorised under the law to produce and sell or distribute theproduct,

Shall not be considered as a infringement of patent rights.

DRAFT EXAMINATION GUIDELINES FOR PATENTS7

CHAPTER IV INVENTIONS NOT PATENTABLE

4.1 The section “Inventions - non-patentable” describes certain products andprocesses, which are not to be regarded as patentable inventions as per the Act.These statutory exclusions are illustrated in the following paragraphs.

For Section 3(a) “An invention which is frivolous or which claims anything obviouslycontrary to well established natural law.

4.2 Some examples of a frivolous nature and contrary to natural laws are:-

a) A machine purporting to produce perpetual motion.b) A machine alleged to be giving output without any input.c) “A method of showing time on the basis of metric system” wherein dial of

time piece having three hands for indicating, hour, minutes andseconds was divided into 10 parts for hours, each hour into 100 minutesand each minute into 100 seconds. The invention was held frivolous andnot considered a patentable invention. (Indian patent applicationNo.101/Bom/72).

d) Merely making in one piece, articles previously made in two or morepieces is frivolous. Mere usefulness is not sufficient [Indian VacuumBrake’ Company Ltd v. Laurd (AIR 1962, Cal 152)].

7 http://ipindia.nic.in/ipr/patent/DraftPatent_Manual_2008.pdf



e) A machine allegedly giving 100% performanceFor Section 3(b) “An invention the primary or intended use or commercial exploitationof which could be contrary public order or morality or which causes serious prejudice tohuman, animal or plant life or health or to the environment.”

4.3 Some examples are: (i) An invention, the use of which is contrary to the law which isin force, or use of which is prohibited such as,

a) Any device, apparatus or machine or method for committing theft/burglary,b) Any machine or method for counterfeiting of currency notes,c) Any device or method for gambling,d) An invention the use of which can cause injury to human beings, plants and

animals.(ii) Inventions, the established or intended use or commercial exploitation of which isfound to be injurious to public, animal or plant life or health, such as, a method ofadulteration of food.(iii) An invention, the present or intended use of which is likely to violate the well

accepted and settled social, cultural, legal norms of morality, e.g. method of cloning(iv) An invention, the primary or proposed use of which would disturb the public order

e.g. a device for house-breaking.(v) Terminator gene technology

4.4 For Section3(c) “The mere discovery of a scientific principle or the formulation of anabstract theory or discovery of any living thing or non-living substances occurring innature”

4.4.1 There is a difference between discovery and invention. A discovery adds tothe amount of human knowledge by disclosing something already existent, whichhas not been seen before, whereas an invention adds to the human knowledgeby creating a new product or processes involving a technical advance ascompared to the existing knowledge.

4.4.2 A claim for discovery of scientific principle is not considered patentable, butsuch a principle when used with process of manufacture resulting into asubstance or an article may be patentable.

4.4.3 A scientific theory is a statement about the natural world. These theoriesthemselves are not considered patentable, no matter how radical or revolutionaryan insight they may provide, since they do not result in a product or process.However, if the theories lead to practical application in the process ofmanufacture of article or substance, they may well be patentable. A claim forformulation of abstract theory is not patentable. For example, the fact that aknown material or article is found to have a hitherto unknown property is adiscovery and not an invention. But if the discovery leads to the conclusion thatthe material can be used for making a particular article or in a particular process,then the article or process could be patentable.

4.4.4 Finding out that a particular known material is able to withstand mechanicalshock is a discovery and therefore not patentable, but a claim to a railwaysleeper made of the material would not fall foul of this exclusion, and would be



allowable if it passed the tests for novelty and inventive step. Similarly, finding ofa new substance or micro-organism occurring freely in nature is a discovery andnot an invention e.g. in Kirin-Amgen v. Hoechst Marion Roussel [2005] RPC 9].

4.4.5 A claim as relating to a method of analyzing samples which were subject tochromatographic and spectrometric analysis techniques such that a multivariantstatistical analysis technique was employed to make it easier to identify timelocations where the characteristics of samples were different. The contributionwas identified as being “A method for comparing two samples by an analyticaltechnique which uses chromatography and then spectrometry, followed by aparticular sequence of data analysis techniques, to give results which enable theretention time at which the samples differ to be identified.” [Waters InvestmentsLimited’s Application (BL O/146/07)].It was held that the contribution lay intechnical field of sample analysis using chromatography and spectrometrictechniques and hence the invention was patentable

4.5 For Section 3(d) “The mere discovery of a new form of a known substance whichdoes not result in the enhancement of the known efficacy of that substance or the merediscovery of any new property or new use for a known substance or of the mere use of aknown process, machine or apparatus unless such known process results in a newproduct or employs at least one new reactant. Explanation:- For the purposes of thisclause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,mixtures of isomers, complexes, combinations and other derivatives of known substanceshall be considered to be the same substance, unless they differ significantly inproperties with regard to efficacy”.

4.5.1 Mere discovery of a new form of a known substance which does not resultin the enhancement of the known efficacy of that substance is not patentable.According to the proviso to this sub-section, a known substance in its new formsuch as amorphous to crystalline or crystalline to amorphous or hygroscopic todried, one isomer to other isomer, metabolite, complex, combination of pluralityof forms, salts, hydrates, polymorphs, esters, ethers, or in new particle size, shallbe considered same as of known substances unless such new forms significantlydiffer in the properties with regard to efficacy.

4.5.2 In order to be patentable, any salts, esters, ethers, polymorphs,metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,combinations and other derivatives of known substance, they must differsignificantly in the properties with regard to efficacy. The requirement here thatnamely the new form must result in enhancement of known efficacy of knownsubstance and that in order to be distinct from the known substance, the newform must differ in the properties with regard to efficacy.

4.5.3 The examiner makes comparison with regard to properties or enhancementof efficacy between the known substance and the new form of known substance.In case the new form is further converted into another new form, the comparisonis made between the already existing form and another new form but notbetween the base compound and another new form.



4.5.4 The comparison with regard to properties or enhancement of efficacy isrequired to be made at the time of date of filing of the application or priority date ifthe application is claiming the priority of any earlier application but not at thestage of subsequent development.

4.5.5 The efficacy need not be quantified in terms of numerical value todetermine whether the product is efficacious because it is not possible to have astandard numerical value for efficacy for all products including pharmaceuticalproducts.

4.5.6 In regard to ‘efficacy’ in pharmaceutical products, the Madras High Courtobserved: “going by the meaning for the word “efficacy” and “therapeutic” … …,what the patent applicant is expected to show is, how effective the new discoverymade would be in healing a disease/ having a good effect on the body? In otherwords, the patent applicant is definitely aware as to what is the “therapeuticeffect” of the drug for which he had already got a patent and what is thedifference between the therapeutic effect of the patented drug and the drug inrespect of which patent is asked for.” “Due to the advanced technology in allfields of science, it is possible to show by giving necessary comparative detailsbased on such science that the discovery of a new form of a known substancehad resulted in the enhancement of the known efficacy of the original substanceand the derivatives so derived will not be the same substance, since theproperties of the derivatives differ significantly with regard to efficacy.” (NovartisAG v.Union of India W.P. 24760/06).

4.5.7 Some of the examples of new forms are given below without limiting thescope of the application of the provisions of the Act.

(i) Isomers: Isomers are different compounds that have the samemolecular formula which may be broadly divided into two kinds, namely, -structural isomers or positional isomers and, - stereo isomers. Structuralisomers or positional isomers may be structurally similar or dissimilarcompounds. The simplest examples are butane and isobutane andethanol and dimethyl ether. In the former case the compounds are havingstructural and functional similarity. However, In the second set ofcompounds, although they have the same molecular formula but arestructurally and functionally different. Such isomers even having closesimilarity may be considered to be novel over the prior art. Isomershaving the same empirical formula but having structural differences maybe considered novel and may not normally offend “obviousness” as theyare structurally different.Example: Cyclohexylstyrene is not considered prima facie obvious overprior art isohexyl styrene.

(ii) Stereo Isomers: Stereo isomers are prima facie obvious. Once acompound having a chiral center is known, its enantiomers are obviousbecause a person skilled in the art knows that a compound having achiral center exists in two optically active forms. Hence, a product patentmay not be granted for the enantiomer form. However, when a newcompound is claimed having chiral center(s) for the first time, such a new



compound may be patentable. In a case where an (S)-enantiomer of acompound, capable of exhibiting better efficacy over the (R)-enantiomer,for instance producing enhanced anti-diabetic effects is claimed, whereinthe said claim is not allowable when the same chemical compoundpossessing anti-diabetic property is known from the prior art.

(iii) Homologues: Homologues normally display add-on property. Theyare structurally similar and provide the example of Structure – Functionlinearity and may lack inventive step. However the cases are to bedecided on case to case basis. e.g. Polymerization process using asterically hindered amine was held non-obvious over a similar prior artprocess because the prior art disclosed a large number of unhinderedamines. Further, prior art structures do not have to be true homologs orisomers to render structurally similar compounds prima facie obvious. e.g.Claims and Prior art were for heterocyclic carbamoyloxmino compoundshaving pesticidal activity. The only structural difference was that the ringstructures of the claimed compounds had two carbon atoms between twosulphur atoms whereas the prior art ring structures had either one orthree carbon atoms between two sulphur atoms. The court held thatalthough the prior art compounds were not true homologs or isomers ofthe claimed compounds, the similarity between the chemical structuresand properties is sufficiently close that one of ordinary skill in the artwould have been motivated to make the claimed compounds in searchingfor new pesticides.

(iv) Polymorphs: Some compounds are present in polymorphic forms,i.e., they crystallize in diverse forms. Such forms can be deemed withinthe prior art and therefore not patentable. However, process patent maybe allowed for the new polymorph, if the polymorph is prepared by novelprocess involving inventive step.Some therapeutically active ingredients,present in polymorphic forms, may have different properties that are moreor less significant in terms of their therapeutic use. Such forms can bedeemed within the prior art, and therefore, non-patentable if they wereinevitably obtained following the process of the basic patent on the activeingredient or if they were covered by a previous product patent.

(v) Metabolites:Metabolites are the compounds that are formed inside aliving body during metabolic eaction. The types of metabolites are-

(i) Active metabolites formed from inactive precursors (e.g DOPA &Cyclophosphamide)

(ii) Active metabolites formed from precursors that show mechanism ofaction that is different from that of parent compound (e.g Buspirone & 1-pyrimidyl piperzine Fenflouromine & norfenfleuromine)

(iii) Active metabolites which contribute to the duration of action of theparent compound (e.g. Hexamethylmelamine & Clobazam)



(iv) Active metabolites that show antagonistic effect on the activity of theparent compound (e.g Trezodone & m-chlorophenyl pierzine, Aspirin &salicylate) A metabolite is not patentable since giving the drug to a patientnaturally and inevitably results in formation of that metabolite.

(vi) Prodrugs : Prodrugs are inactive compounds that can produce anactive ingredient when metabolized in the body. Hence prodrugs andmetabolites are interlinked. When metabolyzed in the body, inactivecompounds(pro-drug) can produce a therapeuticallyactive ingredient. It must be determined whether the patent on thecompound covers the prodrug and the extent to which claims relating tocertain compounds should also be allowed to include their prodrugs. Theinventive aspects of a prodrug may be decided based on the merits of thecase.

(vii) Hydrates and other Substances: Hydrates, acid addition salts andother derivatives, which are routinely prepared, prima facie lack aninventive step. However, where there is a problem like stability,absorption etc., and there is a long standing problem in preparing thederivatives, patentability of such process may be considered.

(viii) Purification Compounds: Mere purification of known material isnot patentable as they are considered the purified compound. However,the purification process or the purified compound which never existedbefore due to inherent long standing problem can be consideredpatentable.

4.5.8 Mere discovery of new property of a known substance: A mere discoveryof a new property of known substance is not considered patentable. For instance,the paracetamol has antipyretic property. Further discovery of new property ofparacetamol as analgesic can not be patented. Similarly, ethyl alcohol is used assolvent but further discovery of its new property as anti knocking, thereby makingit usable as fuel, can not be considered patentable.

4.5.9 Mere discovery of any new use of known substance: A mere discovery ofnew property of known substance is not considered patentable. For instance,new use of Aspirin for treatment of the cardiovascular disease, which was earlierused for analgesic purpose, is not patentable. However, a new and alternativeprocess for preparing Aspirin is patentable. Similarly, the new use of methylalcohol as antifreeze in automobiles. The use of methanol as a solvent is knownin the prior art. A new use has been claimed in this claim as antifreeze which isnot allowable Further, a new use of Chloroquine for Sarcoidosis (a fungaldisease) and for Infectious mononucleosis (a viral disease) and for Diabeticneuritis(inflammation of nerves) is not patentable.

4.5.10 The mere use of a known process, machine or apparatus unless suchknown process results in a new product or employs at least one new reactant.Similarly mere use of known apparatus or machine for another purpose is alsonot considered patentable.



4.5.11 In 101/Bom/72 "Metric time showing device" was held not patentable. Thedevice comprised a normal clock or watch having usual hands for indicatinghours, minutes and seconds; wherein dial or like visual numerical indicators weredivided into 10 large divisions for hours, hours divisions are divided into 100divisions indicating minutes and each minute is divided into 100 partsrepresenting seconds. It was held to be a mere use of known device and hence,not patentable.

4.5.12 In a claim relating to a food-packing machine used for packing the desiredamount of talcum powder, since it did not characterize any changes in the food-packing machine, it was presumed that the same machine had been used for thepurpose of packing talcum powder. Therefore, it was understood from the claimthat the same packing machine, which was in vogue, was used for packing thematerial other than food. Hence this was not allowed.

4.5.13 In a patent application No. 782/Cal/l981, dated 13th July, 1981, aninvention related to pharmaceutical composition exhibiting anti-phlogistic,antipyretic and analgesic activity and high gastroenteric tolerance in unit dosesform which contained imidazol salicylate as the active ingredient in the amount of100-600 mg and an inert carrier was claimed which was later amended to aprocess for the preparation of novel composition containing imidazole salicylatehaving formula 1, as the active principle . The invention was characterized in aproduct that was previously obtained by reacting, mole by mole, acetylsalicylicacid with imidazole in an inert organic solvent and that, using the solid productobtained in the reaction after purification by recrystalization , homogenouscomposition were produced with pharmaceutically acceptable vehicles suitablefor oral, parental or topic administration. It was held by the Controller that theactive compound such as imidazole salicylate was known in the art and applicantcould not develop any special property or even improve upon the property of thecompound to be mixed up with the usual carrier to form the composition.Furthermore, the description contained no indication of using any special type ofsolvent for its purification by re-crystallization and, therefore, the invention wasnot patentable under section 3(d) of the Act. (Decisions on Patent and Designs vol.(4) published by Patent Office Technical Society, page 21).

4.5.14 In the application for patent No. 134883, Dated 8th March, 1972, amethod of control of post-embryonic development stages of coleoptera andDiptera inhabiting in the soil was claimed. The invention was characterized byapplying to the particular soil a toxic amount of a compound selected from thegroup consisting of o,o-diethyl S-(tert butylthio) methyl phosphorodithuoate ando.o-diethyl S-[(1,,1-dimethypropyl)thio]methyl phosphorodithicate. It wasamended to a method for preparing a long effective pasticidal preparation usefulin the control of the postembryonic stages of coleoptera and dipterainhabiting the soil having long residual pesticidal activity and unobjectionableodour which comprised treating sorptive or non -sorptive granular particles of amaterial like di-atomite or silica with 5% to 25% of o,o-diethyl 3-(tertbutylthio)methyl phospho-rodithicate and when preferred (a) applying a super coating ofan inert material like clay or talc on the treated granular nonsorptive material or(b) applying a deactivator to the surface of the sorptive material before treatingwith the said phosphorodithicate, using one or more conventional solvents. It was



held by the Controller that materials and solvent specified in the claim wereconventional and customary application well known in the pesticidal art. Further,the method for preparation of formulation was conventional and gave apesticidally active compound, which every person skilled in the pesticidal artwould make as a formulation by applying active compound by conventionalmethod to the conventional applicators for using the pesticidal active compound.Accordingly, a method of making a formulation by applying a conventionalmethod a pesticidal compound to a conventional applicator was only steps in theuse of compound or substance for treating the object. Therefore, invention fallswithin section 3(d) as the mere known substance or known compound.

4.5.15 In the case of M/s. Astra Aktiebolag [Patent Application No.1354/del/1998], the Controller in his decision dated 12th June, 2007, held thatthe claimed invention is not patentable under section 3(d) of the Patent Act 1970,as “present pharmaceutical formulation is a selection from the prior artformulation due to the specific selection of HPMC of cloud point above 45.6° Chaving similar medicinal use and with the same therapeutic efficacy… the benefitclaimed by the applicant in the present application is not accruable to the user interms of therapeutic quality of the product but to the manufacturer only in termsof consistency in the production of formulation…”.

4.5.16 Patent application No. 1577/Del/1996 was refused, inter alia, under theprovisions of section 3(d) of the Patents Act, 1970. The Controller in his decisiondated 12th June, 2007 held that “the present invention provides a new form ofknown substance either in anhydrous or hydrated form III of Atorvastatine havingsame therapeutic activity and in the same field. It only claims some improvementin physical property, which does not make any change in therapeutic efficacy ofthe compound as compared to the prior art compound. Therefore this new formdoes not qualify the requirement under section 3(d).”

For Section 3(e) “A substance obtained by a mere admixture resulting only in theaggregation of the properties of the components thereof or a process for producing suchsubstance”;

4.6.1 In the patent application No. 782/Cal/l981, dated 13th July, 1981 referred toin para 4.5.13, it was held by the Controller that the pharmaceutical vehiclehaving the primary intended function of acting as vehicle or carrier or diluentsperformed the very function when incorporated in the composition. There was noexplicit disclosure or experimental data to indicate that the presence of the carrierin any way influenced the antiphlogistic, ntipyretic and analgesic activity of theactive ingredients. Therefore, the invention was held not allowable under Section3(e) of the Act as well as and merely an admixture.

4.6.2 A mixture of sugar and some colourants in water to produce a soft drink is amere admixture resulting into aggregation of the properties. Similarly, a mixtureof different types of medicament or medicine to cure multiple diseases is also amere admixture of substances and is not a patentable invention.



4.6.3 However, an admixture resulting into synergistic properties of a mixture isnot considered as mere admixture, e.g., soap, detergent, lubricants and polymercomposition etc.

4.6.4 A process for producing a substance by admixing, which is resulting intothe aggregation of the properties of the components thereof, is also notpatentable invention.

4.6.5 In assessing the inventive step involved in an invention based on acombination of features, consideration must be given to whether or not the stateof the art was such as to suggest to a skilled person precisely the combination offeatures claimed. The fact that an individual feature or a number of features wereknown does not conclusively show the obviousness of a combination.

4.6.6 A mere aggregation of features must be distinguished from a combinationinvention. The existence of a combination invention requires that the relationshipbetween the features or groups of features be one of functional reciprocity or thatthey show a combinative effect beyond the sum of their individual effects. Thefeatures should be functionally linked together which was the actualcharacteristic of a combination invention.

4.6.7 A composition of two drugs, i.e. Paracetamol and Ibuprofen for curing feverand pain or process of preparation thereof is not patentable for the reason thatthe composition is a mere admixture of two drug components resulting intoaggregation of properties thereof; since Paracetamol is well known for treatmentof fever and Ibuprofen for treatment of pain. However, if the mixture of drugsexhibits some unexpected results or synergistic properties in their action, thensuch composition is considered as patentable subject matter.

4.6.8 In general all the substances which are produced by mere admixing, or aprocessof producing such substances should satisfy the requirements of synergisticeffect in order to be patentable. The synergistic effect should be clearly broughtout in the description and examples by way of comparison at the time of filing ofthe application and should be stressed in the principal claim.

4.6.9 In the matter of an application for Patent No. 63/Bom/75 (Decisions onPatents and Designs, vol.1, published by The Patent Office Technical Societyp.17), Hindustan Lever Limited, applied for patent for an invention relating to anantiperspirant composition. It was held by the Controller that an admixture havingonly the aggregation of the individual properties of the components thereof is notan invention within the meaning of the Act and is thus not patentable, A processfor producing such an admixture is also not patentable. In case the presence ofone or more components of the composition influence the properties of the othercomponents of the composition with the result that the ultimate properties of thecomposition would be different from the aggregation of the individual propertiesof the components thereof, such an admixture would be patentable under thePatents Act, 1970.[Page 26, point 10] 4.6.10 In the patent No. 143270 for theinvention entitled "A fertiliser composition”, it was held that alleged invention fallswithin sub-section(e) of Section 3 of the Act and the opponent had established



the fourth ground of opposition, i.e. "not an invention or not patentable as thecrop nutrient properties of the constituents like zinc sulphate, manganesesulphate, copper sulphate and magnesium sulphate were known as seen fromknow-how report and the steps of grinding, mixing and homogenizing wereconventionally used in manufacture of the fertiliser.

For Section 3(i) “Any process for the medicinal, surgical, curative, prophylactic,diagnostic therapeutic or other treatment of human beings or any process for a similartreatment of animals to render them free of disease or to increase their economic valueor that of their products”.

4.9.1 A method of treatment of malignant tumour cells and method of removal ofdental plaque and caries are not patentable, since they are held as treatment ofhuman beings. Also, treatment of sheep for increasing wool yield (1958 RPC 85)was held as not patentable.

4.9.2 An invention of a method of treatment of the human or animal body bysurgery or therapy or of diagnosis practised on the human or animal body shallnot be taken to be capable of industrial application.

4.9.3 The art of curing illness cannot be said to be patentable.

4.9.4 The term “therapy’’ includes prevention as well as treatment or cure ofdisease. Therefore, the process relating to therapy is also not patentable as heldin Unilever Limited (Davis') Application, [1983] RPC 219. Although some medicaldictionaries pointed towards a narrow interpretation of the term, other works ofreference, including non-specialist dictionaries, indicated a more generalmeaning; this was preferred in this case, following the principle that words instatutes dealing with matters relating to the general public are presumed to beused in their popular, rather than their narrowly legal or technical, sense.However, for a treatment to constitute therapy, there must be a direct linkbetween the treatment and disease state being cured, prevented or alleviated,(BL O/248/04). It appears that any medical treatment of a disease, ailment, injuryor disability, i.e., anything that is wrong with a patient and for which he wouldconsult a doctor, as well as prophylactic treatments such as vaccination andinoculation, is to be regarded as therapy. The same considerations apply foranimals as for human patients, so that for example prophylaxis andimmunotherapy in animals are regarded as therapy[T 24/91] 4.9.5 Prophylactictreatment, aimed at maintaining health by preventing ill effects that wouldotherwise arise, amounts to a method for treatment by therapy. Both prophylacticand curative methods of treating disease are covered by the word therapy, sinceboth are directed to the maintenance or restoration of health The sameconsideration applies for animals as well as for human beings. For example,prophylatic immuno-therapy in animals are regarded as therapy.

4.9.6 An application of substance to human body purely for cosmetic purposes isnot a treatment or therapy. On the other hand, the application to the skin of anointment designed to be effective to remove keratoges from the skin would be



the instance of medical treatment. Here, “Treatment” in relevant senses meansthat the purpose of application of a process or substance to the body must be toarrest or cure of a disease or diseased condition or correcting some malfunctionor amelioration of some incapacity or disability (Joos v. Commissioner of Patent(1973) RPC 59).

4.9.7 Application of substances to the body for purely cosmetic purposes is nottherapy. In allowing claims to a process for improving the strength and elasticityof human hair and finger nails, the High Court of Australia observed that, while aprocess for the treatment of the human body as a means of curing or preventinga disease or other disorder was not patentable, those who apply chemicalpreparations to the skin to prevent sunburn in climates which enjoy sunshine andmoderate air temperatures can scarcely be regarded either as, in a relevantsense, treating their bodies or as undergoing treatment. On the other hand, theapplication to the skin of an ointment designed and effective to remove keratogesfrom the skin would be an instance of medical treatment. To be treatment in therelevant sense, it seems to me that the purpose of the application to the bodywhether of a substance or a process must be the arrest or cure of a disease ordiseased condition or the correction of some malfunction or the amelioration ofsome incapacity or disability (Joos v. Commissioner of Patents, [1973] RPC 59).

4.9.8 It was held in Lee Pharmaceuticals application [(1978) RPC 51] that, sinceone of the reasons of grinding pits and fissures in teeth was to prevent the onsetof dental decay, the purpose of the treatment was therapeutic rather thancosmetic. 4.9.9 Patent may however be obtained for surgical, therapeutic ordiagnostic instrument or apparatus. Also the manufacture of prostheses orartificial limbs and taking measurements therefor on the human body arepatentable.

4.9.10 In Oral Health Products Inc (Halstead's) Application, [1977] RPC 612,claims to a method of removing dental plaque and/or caries were refused as wasa claim to a method of cleaning teeth which embraced both curative andcosmetic effects. This decision has been followed under the 1977 Act in ICI Ltd'sApplication No 7827383 (BL O/73/82), where a claim was refused to a method ofcleaning teeth which removed both plaque and stains. It was argued that whenapplied to perfectly healthy teeth the method was purely cosmetic, but thehearing officer observed that practically all medical treatments which arepreventative in nature (such as vaccination) must at times be applied to peoplewho would have remained healthy anyway, but they remained medicaltreatments

4.9.11 In T 290/86 the Board held that the use of a lanthanum-containingcompositionfor cleaning plaque and/or stains from human teeth...will always inevitably have atherapeutic effect (at least in the prophylactic sense) as well as a cosmetic effect.Thus the invention as here claimed is not directed solely to a cosmetic effect, butis also necessarily defining a treatment of the human body by therapy and henceexcluded from patentability.



4.9.12 Methods of treatment of the human or animal body by surgery areexcluded.‘Surgery’ is defined as the treatment of disease or injury by operation ormanipulation. It is not limited to cutting the body but includes manipulation suchas the setting of broken bones or relocating dislocated joints (sometimes called"closed surgery"), and also dental surgery. In general, any operation on the body,which required the skill and knowledge of a surgeon, would be regarded assurgery and includes non-curative treatments such as cosmetic treatment, thetermination of pregnancy, castration, sterilization, artificial insemination, embryotransplants, treatments for experimental and research purposes and the removalof organs, skin or bone marrow from a living donorare, if carried out by surgery, regarded as surgical treatments. Once it has beendecided that a method constitutes surgery, therapy or diagnosis practiced on thehuman or animal body, it is necessarily non-patentable. For example, methods ofabortion, induction of labour, control of oestrus or menstrual regulation arealways therapy, irrespective of the reason for the treatment.

4.9.13 In Unilever Limited (Davis1) Application, [1983] RPC 219, it was observedthat any method of surgical treatment, whether curative, prophylactic or cosmetic,is not patentable. This view was upheld in an another case also, while refusing toallow claims to a method of implanting an embryo transplant from a donormammal into the uterus of a recipient mammal, since the method wouldnecessarily have to be carried out by a surgeon or veterinary surgeon.

4.9.14 Methods of diagnosis practised on the human or animal body areexcluded. Methods of diagnosis performed on tissues or fluids, which have beenpermanently removed from the body are, therefore, not excluded frompatentability.

4.9.15 Diagnosis is the identification of the nature of a medical illness, usually byinvestigating its history and symptoms and by applying tests. Determination ofthe general physical state of an individual (e.g. a fitness test) is not considered tobe diagnostic if it is not intended to identify or uncover a pathology. Sectionrelates to methods of diagnosis practised on the human or animal body;diagnosis in itself is a method of performing a mental act and is excluded frompatentability. Typically, the process of diagnosis involves a number of stepsleading towards identification of a condition. For a claim to fall under thisprohibition, it must include both the deductive step of making the diagnosis andpreceding steps constructive for making that diagnosis involving specificinteractions of a technical nature with the human or animal body. The exclusionis therefore a narrow one, and also requires all the method steps of a technicalnature to be practised on the body. In determining whether or not a method is adiagnostic, the Board held that it is irrelevant whether it is necessary for amedical or veterinary practitioner to be involved. Furthermore, a method is“practised on the human or animal body” if it involves any interaction whichnecessitates the presence of the patient, so will include both invasive and non-invasive methods. Methods of diagnosis performed on tissues or fluids whichhave been permanently removed from the body are not excluded. "Body" shouldbe taken to mean living body, and a method practised on a dead body, forexample in order to determine the cause of death, would not be exclude.



4.9.16 Methods of therapy carried out on materials temporarily removed from thebody, for example, when blood is circulated through an apparatus whileremaining in living communication with the body, are not patentable (cf CalmicEngineering Co Ltd's Application, [1973] RPC 684).

4.9.17 In Ciba-Geigy AG's Application, (BL 0/30/85) the objection was raised tocertain claims for a method of controlling parasitic helminthes (worms which maydevelop in the animal body, for example, in the intestinal tract of animals such assheep) by the use of a particular (novel and inventive) antihelmintic composition,The applicants contended that the composition when administered to an animalwould prevent the reproduction of the helminthes and kill them should they infestthe animal, but without affecting the animal's body, and that its use was thereforenot "therapy". However, the applicants' specification made it clear that aninfestation of helminthes worms can result in restricted growth, damage to theanimals and even death, if not properly treated. Moreover, the application madeno mention of controlling helminthes by the use of thecomposition in any environment other than the animal body. The hearing officerconsidered that such an infestation was therefore a disease requiring medicaltreatment of the animal and that such treatment, whether curative orpreventative, constituted therapy practiced on the animal body and consequentlyheld that the claims in question were not allowable.

4.9.18 In the case of M/s. AGA Medical Corporation, USA [Patent ApplicationNo.1283/DEL/2004], the Controller held that “The purpose of the invention is toprovide a method for determining the nominal or stretched diameter of an internalopening or defect with in a patient and particularly determining the stretcheddiameter of a septal defect within the heart of a patient is inseparably connectedwith the method of treatment” and, therefore, it is not patentable under section3(i) of the Patent Act 1970.

4.9.19 In an application No. 1377/Del/1999 the claimed invention was related to amethod for in vitro production of isolated langerhans islets endocrine cells freefrom fibroblasts so as to be suitable for transplantation. The process disclosesthe steps of culturing and proliferating the cells and back and forth aspiration toseparate fibroblast from the cells, which will be capable of differentiating intoinsulin producing cells. The applicant argued that (1)the process is novel and hasutility as fibroblast free langerhans islets are useful in the enhanced productionof insulin, to control diabetes,(2) Calcutta High Court has already allowedpatenting of a substance containing living organisms, and(3)Indian Patent lawdoes not bar the grant patent for such invention. However theController refused the application under section 15 on the grounds that theinvention claimed is not patentable under section 3(i) as a method of treatment ofhuman being, since langerhans islets are freshly taken from the body of patient inorder to treat them to remove fibroblast so as to increase secretion of insulin. Theend product of the process is nothing but a cluster of cells or piece of tissues ofhuman body. The principles laid down in Calcutta High Court are not applicableas the end product of the process of present invention is not commercial entityand cannot be passed on from one person to another upon the transaction ofpurchase or sale.



For Section 3(j)” Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biologicalprocesses for production or propagation of plants and animals”

4.10.1 As per this sub-section, while plants and animals or any part of the plantor animal is not patentable, an exception is made in the case of micro-organisms.However, any discovered micro-organism from the nature is not patentable.4.10.2 In Dimminaco – A.G v. Controller of Patents & Designs and others (AIDNo.1 of 2001)the issue involved was the patenting of the process for preparationof infectious bursitis vaccine, which is invented for protecting poultry againstinfectious bursitis. The Controller held that the process of separation of thevaccine which has living entity cannot be considered a manufacture and hencenot patentable under section 2(1)(j)of the Patents Act. He also held that since thevaccine contains living organism it cannot be patented. The court held that thematter involved is of a new process of preparation of vaccine under specificscientific conditions and the said vaccine is useful for protecting poultry againstcontagious bursitis infection and there is no statuary bar to accept a manner ofmanufacture as a patentable even if the end products contain living organism.4.10.3 Plant varieties are provided protection in India under the provisions of theProtection of Plant Varieties and Farmers’ Rights Act, 2002.

INTERNATIONAL PROVISIONS: WTODOHA WTO MINISTERIAL 2001: TRIPS

WT/MIN(01)/DEC/2, 20 Nov 2001

Declaration on the TRIPS agreements and public health8, Adopted on 14 No.2001

8 http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm



1. We recognize the gravity of the public health problems afflicting many developing andleast-developed countries, especially those resulting from HIV/AIDS, tuberculosis,malaria and other epidemics.

2. We stress the need for the WTO Agreement on Trade-Related Aspects of IntellectualProperty Rights (TRIPS Agreement) to be part of the wider national and internationalaction to address these problems.

3. We recognize that intellectual property protection is important for the development ofnew medicines. We also recognize the concerns about its effects on prices.

4. We agree that the TRIPS Agreement does not and should not preventmembers from taking measures to protect public health. Accordingly, whilereiterating our commitment to the TRIPS Agreement, we affirm that theAgreement can and should be interpreted and implemented in a mannersupportive of WTO members' right to protect public health and, in particular, topromote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, theprovisions in the TRIPS Agreement, which provide flexibility for this purpose.

5. Accordingly and in the light of paragraph 4 above, while maintaining our commitmentsin the TRIPS Agreement, we recognize that these flexibilities include:

a. In applying the customary rules of interpretation of public international law, eachprovision of the TRIPS Agreement shall be read in the light of the object andpurpose of the Agreement as expressed, in particular, in its objectives andprinciples.

b. Each member has the right to grant compulsory licences and the freedom todetermine the grounds upon which such licences are granted.

c. Each member has the right to determine what constitutes a national emergencyor other circumstances of extreme urgency, it being understood that public healthcrises, including those relating to HIV/AIDS, tuberculosis, malaria and otherepidemics, can represent a national emergency or other circumstances ofextreme urgency.

d. The effect of the provisions in the TRIPS Agreement that are relevant to theexhaustion of intellectual property rights is to leave each member free toestablish its own regime for such exhaustion without challenge, subject to theMFN and national treatment provisions of Articles 3 and 4.

6. We recognize that WTO members with insufficient or no manufacturing capacities inthe pharmaceutical sector could face difficulties in making effective use of compulsorylicensing under the TRIPS Agreement. We instruct the Council for TRIPS to find anexpeditious solution to this problem and to report to the General Council before the endof 2002.

7. We reaffirm the commitment of developed-country members to provide incentives totheir enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products,to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforcerights provided for under these Sections until 1 January 2016, without prejudice to theright of least-developed country members to seek other extensions of the transition



periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Councilfor TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of theTRIPS Agreement.

URUGUAY ROUND AGREEMENT: TRIPS

PART I General Provisions and Basic Principles9:

Article 8 Principles

1. Members may, in formulating or amending their laws and regulations, adoptmeasures necessary to protect public health and nutrition, and to promote the publicinterest in sectors of vital importance to their socio-economic and technologicaldevelopment, provided that such measures are consistent with the provisions of thisAgreement.

2. Appropriate measures, provided that they are consistent with the provisions ofthis Agreement, may be needed to prevent the abuse of intellectual property rights byright holders or the resort to practices which unreasonably restrain trade or adverselyaffect the international transfer of technology.

PART II Standards Concerning the Availability, Scope and Use of IntellectualProperty Rights, Section 5: Patents10.

2 Article 27 Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available forany inventions, whether products or processes, in all fields of technology, provided thatthey are new, involve an inventive step and are capable of industrial application.11

Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of thisArticle, patents shall be available and patent rights enjoyable without discrimination as tothe place of invention, the field of technology and whether products are imported orlocally produced.

2. Members may exclude from patentability inventions, the prevention within theirterritory of the commercial exploitation of which is necessary to protect ordre public ormorality, including to protect human, animal or plant life or health or to avoid seriousprejudice to the environment, provided that such exclusion is not made merely becausethe exploitation is prohibited by their law.

3. Members may also exclude from patentability:

9 http://www.wto.org/english/docs_e/legal_e/27-trips_03_e.htm10 http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm#511 For the purposes of this Article, the terms "inventive step" and "capable of industrial

application" may be deemed by a Member to be synonymous with the terms "non-obvious" and"useful" respectively.



(a) diagnostic, therapeutic and surgical methods for the treatment of humansor animals;

(b) plants and animals other than micro-organisms, and essentially biologicalprocesses for the production of plants or animals other than non-biological and microbiological processes. However, Members shallprovide for the protection of plant varieties either by patents or by aneffective sui generis system or by any combination thereof. Theprovisions of this subparagraph shall be reviewed four years after thedate of entry into force of the WTO Agreement.

======= End of Chapter III ===========

CHAPTER IV

PHARMACUTICAL INDUSTRIES - JAPAN

Introduction:



Japanese pharmaceutical market supposed to be the second largest individualmarket in the world. With sales of $60 billion it constitutes approximately 11% of theworld market12.

13The total production amount of final pharmaceutical products in Japan in 2008was 6.6201 trillion yen; the import amount from abroad was 1.8594 trillion yen; and thus,the total sales amount was 8.4795 trillion yen.

In contrast, the total domestic shipping amount was 8.1800 trillion yen and thetotal export amount to foreign countries was 162.6 billion yen.

1. Production of pharmaceuticals

(1) The total production amount of final pharmaceutical products in 2008 was 6.6201trillion yen, increase of 167.9 billion yen (2.6%) compared to that of 6.4522 trillion yen inthe previous year. As for the total production amount in past 10 years, it was increasedby 7.7% in 1999, decreased by 1.9% in 2000, increased by 4.5% in 2001, decreased by0.8% in 2002, increased by 0.5% in 2003, decreased by 0.8% in 2004, increased by4.4% in 2005, increase of 0.7% in 2006, increased by 0.2% in 2007, and increased by2.6% in 2008. The total production amount often declined in the year of revision of drugprice standard, but it was increased by 0.7% and 2.6% in years 2006 and 2008, althoughthe drug price standard was revised in these years. The drug price standard wasrevised after 2000 in 2000 (-7.0%), 2002 (-6.3%), 2004 (-4.2%), 2006 (-6.7%) and 2008(-5.2%)) (increase/decrease, based on medicinal price).

(2) Production facilities by scale

The number of drug production facilities, as classified by scale, and theproduction amounts thereof are summarized in Table 25. The number of productionfacilities with a production amount (both in-house and contracted) of less than 100million yen per month is 1,482 (81.6%), but the production amount is 152.2 billion yen,which is only 3.1% of the total of in-house and contracted production. In contrast, thenumber of production facilities with a production amount of 100 million or more is 336(18.4%), but the production amount is as high as 4.6758 trillion yen (96.8%).

(1) Export

As shown in Table 26, the total export amount of pharmaceuticals in 2008 is162.6 billion yen, increase of 18.6 billion yen (12.9%), compared to that of 144.0 billionyen in the previous year.

Change in the export amount by area is summarized in Table 27. The exportamounts to North America, Asia and Europe are larger in that order, respectively at 84.6billion yen (52.0%), 52.7 billion yen (32.4%) and 18.7 billion (11.5%).

12 http://en.wikipedia.org/wiki/Manufacturing_industries_of_Japan#cite_note-1 13 Extract from The Annual Report of Japanese Pharmaceutical Industry 2008 by the Ministry ofHealth, Labor and Welfare Japan (Translation done from Japanese version)



(2) Import

As shown in Table 30, the total import amount of pharmaceuticals in 2008 was1.8594 trillion yen, increase by 151.0 billion yen (8.8%) from that of 1.7084 trillion yen inthe previous year.

The import amounts by area are summarized in Table 31, and the importamounts from Europe, North America and Asia are larger in that order, respectively at1.4178 trillion yen (76.2%), 377.0 billion yen (20.3%) and 46.4 billion yen (2.5%).

How the Japanese Pharmaceutical Industry Operates14

The Japanese Pharmaceutical Industry and Laws are very particular. They areruled by The Ministry of Health, Labor, and Welfare which was established by a mergerof the Ministry of Health and Welfare and the Ministry of Labor, on January 6, 2001 aspart of the Japanese government program for re-organizing government ministries. 15

The Ministry of Health, Labor, and Welfare (MHLW)16 is in charge ofpharmaceutical regulatory affairs in Japan and the Pharmaceutical and Food SafetyBureau (PFSB), undertaking duties and functions of the Ministry. It handles clinicalstudies, approval reviews and post-marketing safety measures. The Health PolicyBureau handles promotion of R&D, and production and distribution policies, includingfunctions relating to pharmaceutical companies. The Pharmaceuticals and MedicalDevices Evaluation Center in the National Institute of Health Sciences was establishedto strengthen approval reviews on July 1, 1997. To confirm the reliability of reviews andapplication data, the Organization for Pharmaceutical Safety and Research (OPSR)conducted compliance reviews on application data, OPSR also began offeringconsultation services on protocols at the clinical trial stage.

This was followed by the integration of the Evaluation Center, OPSR and part ofthe Medical Devices Center on April 1, 2004, to form a new independent administrativeorganization, the Pharmaceutical and Medical Devices Agency (PMDA). The role of thePMDA is to provide consultations concerning the clinical trials of new drugs and medicaldevices, and to conduct approval reviews and surveys of the reliability of applicationdata.

The Pharmaceutical and Food Safety Bureau (PFSB) is one of the 11 bureaus ofthe MHLW. In addition to polices to assure the efficacy and safety of drugs, quasi-drugs,cosmetics and medical devices, and policies for safety in medical institutions, the PFSBtackles problems directly related to the lives and heath of the general public includingpolicies related to blood supplies and blood products, narcotics and stimulant drugs. Thisnew bureau consists of a Secretary-General, Councilor in charge of drugs, five divisions,and one office.

These divisions have the following functions:

14 http://www.asia-manufacturing.com/PerspectiveArticle-6.html15 http://en.wikipedia.org/wiki/Manufacturing_industries_of_Japan#cite_note-216 http://www.mhlw.go.jp/english/index.html



1. The General Affairs Division:1.1 Evaluation and Licensing Division1.2 Safety Division1.3 Compliance and Narcotics Division1.4 Blood and Blood Products Division

2. Health Policy Bureau2.1 Economic Affairs Division2.2 Research and Development Division

3. National Institute of Health Sciences4. Pharmaceuticals and Medical Devices Agency (PMDA), OTC and Generics

4.1 Office of Medical Devices4.2 Office of New Drug I4.3 Office of New Drug II4.4 Office of New Drug III4.5 Office of Biologics4.6 Office4.7 Office of Safety

5. The National Institute of Biomedical Innovation Independent Administrative Agency6. Pharmaceutical Affairs and Food Sanitation Council (PAFSC)7. National Institute of Infectious Diseases

Japanese Pharmaceutical Law and Regulations17

Pharmaceutical administration in Japan is based on various laws andregulations, consisting mainly of, Pharmaceutical Affairs Law, Pharmacists Law, LawConcerning the establishment for Pharmaceuticals and Medical Devices Organization,Law Concerning Securing a Stable Supply of Blood Products, Poisonous andDeleterious Substances Control Law, Narcotics and Psychotropics Control Law,Cannabis Control Law, Opium Law, and Stimulants Control Law. For the enforcementand management of these laws, detailed regulations are prepared by the government inthe form of ministerial ordinances and notices, such as the Enforcement Ordinance andthe Enforcement Regulations of the Pharmaceutical Affairs Law, and notifications issuedby the Director General of the bureau or the directors of the Divisions in charge in theMinistry of Health, Labor, and Welfare.

Modern pharmaceutical legislation originated in Japan with the enactment of theRegulations on Handling and Sales of Medicines in 1889. The Pharmaceutical AffairsLaw was enacted in 1943 and has been revised several times since then. The currentPharmaceutical Affairs Law is the result of complete revisions (Law No. 145) in 1948 and1960. Subsequent revisions have included that the re-examination of new drugs, the re-evaluation of drugs, notification of clinical study protocols, and items required forsponsoring clinical studies in 1979, that related to direct manufacturing approvalapplications by overseas pharmaceutical manufacturers, and the transfer ofmanufacturing or import approvals in 1983, relating to promotion of R&D of orphan drugsand priority reviews for such drugs in 1993.

In 2002, the Pharmaceutical Affairs Law was revised (Law No. 96, July 31, 2002)based on demands for augmentation of safety assurance in keeping with the age of

17 News abstract > http://www.asia-manufacturing.com/PerspectiveArticle-6.html



biotechnology and genomics, augmentation of post-marketing surveillance policies,revision of the approval and licensing system (clarification of the responsibility ofcompanies for safety measures and revision of the manufacturing approval system inaccordance with international coordination) and a radical revision of safety policies formedical devices.

In the revised Law, provisions on the enhancement of safety measures forbiological products, investigator-initiated clinical trials and safety reports from medicalinstitutions came into effect on July 30, 2003 (Cabinet Order No. 212, April 23, 2003),and law to establish the PMDA was enacted on April 1, 2004 to revitalize the reviewsystem. Provisions related to the manufacturing / distribution approval system,manufacturing / distribution businesses and manufacturing businesses, as well asprovisions related to medical devices came into effect on April 1, 2005.

Person wishing to start a manufacturing or distribution business for drugs, quasi-drugs, cosmetics or medical devices must obtain a manufacturing / distribution businesslicense depending on the type of business. These licenses are of the following seventypes:

1. Type 1 drug manufacturing, distribution business license:manufacturing/distribution of prescription drugs2. Type 2 drug manufacturing, distribution business license:manufacturing, distribution of drugs other than prescription drugs3. Quasi-drug drug manufacturing, distribution business license:manufacturing, distribution of quasi-drugs4. Cosmetic drug manufacturing, distribution business license:manufacturing, distribution of cosmetics5. Type 1 medical device manufacturing/distribution business license:manufacturing,distribution of specially controlled medical devices6. Type 2 medical device manufacturing/distribution business license:manufacturing, istribution of controlled medical devices7. Type 3 medical device manufacturing/distribution business license:manufacturing,distribution of general medical devices

The licensing requirements for drug manufacturing / distribution businessesinclude the appointment of a manufacturing / distribution secretary-general who is apharmacists, and compliance with manufacturing and quality control standards (GQP)and Good Vigilance Practice (GVP).

The manufacturing / distribution secretary-general, the quality assurancesupervisor of the quality assurance unit in charge of GQP and the safety managementsupervisor of the general safety management division in charge of GVP are known asthe 'manufacturing / distribution triumvirate' and are at the center of the manufacturing /distribution system. Persons wishing to establish a business for the manufacture ofdrugs, quasi-drugs, cosmetics or medical devices must obtain a manufacturing businesslicense in accordance with the manufacturing category as specified by MHLW ordinance.

GMP specifies that compliance with the Regulations for Buildings and Equipmentof Pharmacies, that specify standards for structures and equipment in manufacturingplants for each manufacturing category without relation to the products manufactured is



a requirement for a manufacturing business license. Compliance with the GMPordinance that specifies standards for structures and equipment required for the productconcerned as well as standards for manufacturing control and quality control for eachmanufactured product is a condition for approval of the drug concerned.

The drug master file system aims at protecting intellectual property of relevantinformation and facilitating review work by allowing a registrant (master file registrant)other than an applicant to separately submit information on quality and themanufacturing method at the time of approval reviews of drug substances to be used indrug products. The range of the drug master file covers drug substances andintermediates for prescription drugs, product raw materials for special formulations ofbulk chemicals, new additives and premixes, raw materials for medical devices, andcontainer and packaging materials.

All ingredients used as excipients must be included in the package inserts ofprescription and non-prescription drugs. Entries in the package inserts of biologicalproducts are specified in Notification No. 0515005 of the PFSB dated May 15, 2003 andlabeling on the immediate container or packaging of biological products is specified inNotification No. 0515017 of the PFSB dated May 15, 2003. These specifications cameinto effect from July 30, 2003. According to the Pharmaceutical Affairs Law amended onApril 1, 2005, a new regulatory category for prescription drug labeling “Caution: use onlywith a prescription from a physician” and a labeling item for manufacturer / distributorbusiness instead of manufacturer or importer were added.

Japan Pharmaceutical Market18

The Japanese market remains the second largest domestic pharmaceuticalmarket in the world, with total sales of prescription drugs of $47.5 billion in 2001, onlyslightly less the total sales in the five leading EU countries. Commensurate with thisstatus the R&D spend of the Japanese pharmaceutical industry is greater than that ofany European country accounting for 15.4% of global R&D spending.

This market thus provides a major source of revenue for the pharmaceuticalindustry that continues to be dominated by domestic pharmaceutical companies.However, the recent problems of the Japanese economy and a failure to penetrateWestern markets have led to a relative decline in the global status of Japanesepharmaceutical companies with only Takeda now ranking in the world's top 20pharmaceutical companies.

Despite such problems the Japanese pharmaceutical industry continues to be amajor source of innovation and the leading Japanese companies dominate theirdomestic market. In consequence these companies have significant R&D pipelines.Most lack significant market capabilities in the USA or Europe and are reliant on co-marketing or licensing deals to reap the full commercial benefits from their R&Dinvestment.

18 http://www.marketresearch.com/product/display.asp?productid=922895



Japanese pharmaceutical market is evolving, as regulatory changes stimulatedirect western competition and generic penetration, and government cost containmentmeasures restrict the market. The unique pricing policy currently in place in Japan thatputs a premium on new drugs, and progressively reduces reimbursement rates for olderdrugs, demonstrates the need for companies to maintain full development pipelines tosustain their domestic revenues.



Financial Profile of Leading Pharmaceutical Companies in Japan 2009

Company Net sales * Grossprofit*

R&Dexpenses*

Operatingincome*

1 Takeda 14660 4.202(Year 2010)2 Astellas 9748.77 685,637 195,570 186,407

3 Daiichi Sankyo 9521 1968 9554 Pfizer 334.72 B US $5 Roche -Chugai 4166 Eisai 8.032 6424 1791 8647 Dainippon

Sumitomo2.264 398 528 311

8 Novartis 2.977 3.4699 Taisho 2.584 1667 2.812 6.184

10 Mitsubishi TanabePharma

4.047

*In Billions of Yen

Patenting Profile of Leading Pharmaceutical Companies in Japan

(19Filing of Patent Application and Grant of Patent at Patent Office India )

Takeda Astellas DaichiSankyo

Roche -Chugai

Eisai DainipponSumitomo

PatentApplicationFiled#

90 106 89 42 120 30

PatentGranted* 100 45 124 12 33 35

# (Since 1995) * (Including filing prior to 1995)

19 www.ipindia.nic.in



======= End of Chapter IV ===========

CHAPTER V

PHARMACUTICAL INDUSTRIES - INDIA

Introduction20:

Drugs and pharmaceutical industry plays a vital role in the economicdevelopment of a nation. It is one of the largest and most advanced sectors in the world,acting as a source for various drugs, medicines and their intermediates as well as otherpharmaceutical formulations. Being the intense knowledge-driven industry, it offersinnumerable business opportunities for the investors/ corporate the world over. Theexistence of well-defined and strong pharmaceutical industry is important for promotingand sustaining research and developmental (R&D) efforts and initiatives in an economyas well as making available the quality medicines to all at affordable prices. That is, it isessential to improve the health status of the individuals as well as the society as awhole, so that positive contributions could be made to the economic growth and regionaldevelopment of a country.

The Indian drugs and pharmaceutical industry, over the years, has showntremendous progress in terms of infrastructure development, technology base creationas well as product usage. On the global platform, India holds fourth position in terms ofvolume and thirteenth position in terms of value of production in pharmaceuticals. Thepharmaceutical industry has been producing bulk drugs belonging to all majortherapeutic groups requiring complicated manufacturing processes as well as a widerange of pharma machinery and equipments. It has also developed excellent 'goodmanufacturing practices' (GMP) compliant facilities for the production of different dosageforms. Besides, the amendment to the Patents Act, 1970 [enactment of Patents(Amendment) Act, 2005], has opened up new avenues for the sector. The new patentregime has ushered in the era of product patents for the pharmaceutical sector, in linewith the obligations under the World Trade Organisation (WTO) and Trade-RelatedAspects of Intellectual Property Rights (TRIPS) Agreement. As a result, the Indianpharmaceutical industry has become self-reliant in several areas and has developed amore sound and technologically advanced R&D segment.

The industry offers several opportunities for investments and trade owing to thefollowing advantageous features:-

� Self-reliance displayed by the production of 70 per cent of bulk drugs and almostthe entire requirement of formulations within the country;

� Low cost of production of quality bulk drugs and formulations� Low R&D costs

20Report from Business Portal of India: http://business.gov.in/Industry_services/drugs.php



� Strong scientific, innovative and technical manpower� Excellent and world-class national laboratories specialising in process

development and development of cost effective technologies� Increasing balance of trade in pharma sector� Efficient and cost effective source for procuring generic drugs, especially the

drugs going off patent in the next few years� Excellent centre for clinical trials in view of the diversity in population� Fast growing biotech industry which has great potential in the international

market� Apart from its strengths in manufacturing and exporting allopathic medicines, the

systems of medicines like Ayurveda, Unani, Siddha, Yoga, Naturopathy andHomeopathy are also prevalent in the country.

Driven by all such factors, India has been recognized as one of the leading globalplayers in pharmaceuticals. The annual turnover of the industry is estimated to be aboutUS $ 17 billion (over Rs.68,000 crores) during 2006-07. Indian exports are destined tomore than 200 countries around the globe including highly regulated markets of US,Europe, Japan and Australia. The value of exports of drugs and pharmaceuticals hasincreased to Rs. 24,942 crores in 2006- 07 from around Rs. 22,216 crores in 2005-06.While, the imports of medicinal and pharmaceutical products have been aroundRs.5867.3 crores (provisional) in the year 2006-07. It is estimated that by the year 2010,the industry has the potential to achieve over Rs. 1,00,000 crores in formulations andbulk drug production. Moreover, increasing number of Indian pharmaceutical companieshave been getting international regulatory approvals for their plants from agencies likeUSFDA (USA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada, etc.India has the largest number of USFDA approved plants for generic manufacture.Leading Indian companies are now seeking more Abbreviated New Drug Approvals(ANDAs) in USA in specialized segments like anti infectives, cardiovasculars and centralnervous system groups.

The concerned authority in India is the Department of Chemicals and Petro-Chemicals21, under the Ministry of Chemicals and Fertilizers, which is responsible forplanning, developing and regulating the drugs and pharmaceuticals industry. TheDepartment seeks to ensure abundant supply of good quality essential pharmaceuticals/drugs for mass consumption and at reasonable prices within the country. It aims toformulate and implement policies and programming of the Chemicals22,

21 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in22 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/chem1.htm23 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/petro1.htm24 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/pharma1.htm25 http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/26 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/pharma5.htm27 http://business.gov.in/outerwin.php?id=http://indiacode.nic.in/rspaging.asp?tfnm=19551028 http://business.gov.in/outerwin.php?id=http://www.idpl.gov.in/29 http://business.gov.in/outerwin.php?id=http://hindantibiotics.gov.in/30 http://business.gov.in/outerwin.php?id=http://www.bengalchemicals.com/31 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/pharma_bil.htm#bil32 http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/pharma_sspl.htm33 http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/drug_pol86/txt1.html34 http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/may-2002/policy-02.html



Petrochemicals23 and Drugs and Pharmaceutical24 sectors in the economy.

The major activities handled in the Pharmaceutical division of the Departmentrelate to the development of the pharmaceutical industry, that is, its production, exports,imports, R&D, pricing, duty matters, etc. There is a 'Export Promotion Cell' in the divisionwhich acts as a nodal agency in the matters related to export of pharmaceuticals. TheCell collects statistical data on export and import of pharmaceuticals in the country aswell as undertakes promotional activities for the acceleration of their exports.

There is an attached office of the Division, known as National PharmaceuticalPricing Authority (NPPA)25, which looks after price fixation/revision of pharmaceuticaland other related matters. That is, it aims to fix/ revise the prices of controlled bulk drugsand formulations as well as enforce prices and availability of the medicines in thecountry. It also monitors the prices of decontrolled drugs and formulations in order tokeep them at reasonable levels and oversees the implementation of various provisionsof the Drug Prices Control Order 199526. This order has been issued by theGovernment of India under Section 3 of Essential Commodities Act, 195527 forregulating the prices of drugs. It includes the list of price controlled drugs, procedures forfixation of prices of drugs, method of implementation of prices fixed by Government,penalties for contravention of provisions, etc.

Broadly, the functions of NPPA are to:-

� Implement and enforce the provisions of the Drugs (Prices Control) Order inaccordance with the powers delegated to it

� Deal with all legal matters arising out of the decisions of the Authority� Monitor the availability of drugs, identify shortages, if any, and to take remedial

steps� Collect/ maintain data on production, exports and imports, market share of

individual companies, profitability of companies, etc. for bulk drugs andformulations

� Undertake and/ or sponsor relevant studies in respect of pricing of drugs/pharmaceuticals

� Recruit/ appoint the officers and other staff members of the Authority, as perrules and procedures laid down by the Government

� Render advice to the Central Government on changes/ revisions in the drugpolicy and

� Render assistance to the Central Government in the parliamentary mattersrelating to the drug pricing.

There are five public sector undertakings (PSUs) in the pharmaceutical sector, namely:-

� Indian Drugs and Pharmaceuticals Ltd. (IDPL)28

� Hindustan Antibiotics Ltd. (HAL)29

� Bengal Chemicals and Pharmaceuticals Ltd. (BCPL)30

� Bengal Immunity Ltd. (BIL)31

� Smith Stanisteet Pharmaceuticals Ltd.(SSPL)32

With liberalization, globalisation and new obligations undertaken by India under the WTO



Agreements, the drug and pharmaceutical industry in the country has been facing manynew challenges. Accordingly, the Department has undertaken several policy initiatives inorder to improve R&D conditions in the industry.

The major policy being the Drug Policy33, which has been announced and modified,from time to time, with the aim of achieving the following objectives:-

� Ensuring abundant availability, at reasonable prices, of essential life saving andprophylactic medicines of good quality

� Strengthening the system of quality control over drug and pharmaceuticalproduction and distribution as well as promoting their rational use

� Encouraging R&D in the pharmaceutical sector in a manner compatible with thecountry’s needs and with particular focus on diseases endemic or relevant toIndia

� Strengthening the indigenous capability for cost effective quality production andexports of pharmaceuticals by reducing barriers to trade in the sector and

� Creating an environment conducive to channelising new investments into thepharmaceutical industry and to introducing new technologies and drugs.

Similarly, in order to achieve such objectives, another policy has also been framednamely the Pharmaceutical Policy34 in 2002, which aims to bring new incentives intothe sector beyond those enumerated in the drug Policy, so that policy inputs are directedmore towards promoting accelerated growth of the pharmaceutical industry and towardsmaking it more internationally competitive. Some of the salient features of this policyare:-

� Abolition of Industrial licensing for all bulk drugs cleared by Drug ControllerGeneral (India), all their intermediates and formulations, subject to stipulationslaid down from time to time in the Industrial Policy, except in the cases of:-

I. Bulk drugs produced by the use of recombinant DNA technologyII. Bulk drugs requiring in-vivo use of nucleic acids as the active principles

andIII. Specific cell/tissue targeted formulations.

� Permission of foreign investment up to 100 per cent, subject to stipulations laiddown from time to time in the Industrial Policy, through the automatic route in thecase of all bulk drugs cleared by Drug Controller General (India), all theirintermediates and formulations, except those referred in the above point, keptunder industrial licensing.

� Availability of automatic approval for 'Foreign Technology Agreements' in thecase of all bulk drugs cleared by Drug Controller General (India), all theirintermediates and formulations, except those referred in the first point, keptunder industrial licensing for which a special procedure prescribed by theGovernment would be followed.

� Measures to give impetus to R&D in the drugs sector are as follows:-

I. Constitution of the Pharmaceutical Research and Development SupportFund (PRDSF) and the Drug Development Promotion Board (DDPB)

II. A manufacturer producing a new drug patented under the Indian Patent



Act, 1970, and not produced elsewhere, if developed through indigenousR&D, would be eligible for exemption from price control in respect of thatdrug for a period of 15 years from the date of the commencement of itscommercial production in the country

III. A manufacturer producing a drug in the country by a process developedthrough indigenous R&D and patented under the Indian Patent Act, 1970,would be eligible for exemption from price control in respect of that drugtill the expiry of the patent from the date of the commencement of itscommercial production in the country by the new patented process etc.

� The system of the price control would be operated through a single list of pricecontrolled drugs selected on the basis of criteria as laid down in the policy andformulations based thereon, with a Maximum Allowable Post-manufacturingExpenses (MAPE) of 100% for indigenous formulations and margin upto 50% forimported formulations.

� Ceiling prices may be fixed for any formulation, from time to time, and it would beobligatory for all, including small scale units or those marketing under genericname, to follow the price so fixed.

� Setting up of the 'National Institute of Pharmaceutical Education andResearch (NIPER)' as an institute of national importance in order to achieveexcellence in pharmaceutical sciences and technologies, education and training.Besides tackling problems of human resources development for academia andthe indigenous pharmaceutical industry, the institute seeks to make efforts tomaximize collaborative research with the industry and other technical institutes inthe area of drug discovery and pharma technology development.

Due to various policy measures taken by the Government in recent past, researchand development (R&D) activities in this sector has not only increased quantitatively butalso qualitatively. Presently, atleast 10 leading Indian pharma companies are into newdrug discovery and some of them have increased their R&D spending by over 5 per centof their respective sales turnover. There are other efforts like providing fiscal incentivesto R&D units in pharma sector as well as streamlining procedures related todevelopment of new drug molecules, clinical research and new drug delivery systems.As a result, India is emerging as an alliance and outsourcing destination of choice forglobal pharma companies across the value chain.

Hence, the drugs and pharmaceutical is one of the most diversified of all the industrialsectors. The accumulated knowledge of traditional medicinal system and large bio-diversity of India offers great advantage to the drug industry. The rapidly changingeconomic, trade and intellectual property scenario, nationally and internationally, posesmany challenges to it, including the challenge of becoming leaders and competitorsglobally. This necessitates a shift in the approach of the industry that is, moving awayfrom manufacturing only known drugs to discovering and commercializing newmolecules through innovative process routes. It would mean that the Indian pharmaindustry has to focus more on R&D, so as to enable India to maintain its status in theworld pharma market and move ahead to become a global leader. In other words, thestrength of the industry lies in leveraging the country’s power in organic synthesis andprocess engineering as well as developing cost-effective technologies in the shortestpossible time for drug intermediates and bulk activities, without compromising on quality.



Related Links:

Department of Chemicals and Petrochemicals

http://business.gov.in/outerwin.php?id=http://chemicals.nic.in

Government Policies of the Department of Chemicals & Petrochemicals

http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/policy.htm

Drug Policy 1986

http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/drug_pol86/txt1.html

Modifications in Drug Policy 1986

http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/drug_pol86/modif86/mod1.html

Drugs (Prices Control) Order 1995

http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/drug_price95/txt1.html

Pharmaceutical Policy 2002

http://business.gov.in/outerwin.php?id=http://nppaindia.nic.in/may-2002/policy-02.html

FAQs about Chemical Weapons Convention (CWC)

http://business.gov.in/outerwin.php?id=http://chemicals.nic.in/faq-cwc.pdf

Pharmaceutical Export Promotion Council (Pharmexcil)

http://business.gov.in/outerwin.php?id=http://www.pharmexcil.com/v1/aspx/default.aspx



PHARMACEUTICAL ASSOCIATIONS IN INDIA35:

35 http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-associations/

1 Indian Drug Manufacturers’ Association (IDMA)

Indian Drug Manufacturers’ Association (IDMA), formed in1961, works for Indian drug manufacturers' interests apart fromprotecting the interest of Indian consumer. It takes up policyissues related to implementation of the Drugs Cosmetics Ruleswith Central or State levels authorities. It has a membership ofover 600 Indian pharmaceutical companies. It has manypublications including IDMA Bulletin; Indian Drugs; IDMAAnnual Publication; Indian Herbal Pharmacopoeia; IDMA-APAForum - for professional Pharmaceutical Analysts; IDMA-PEGNewsletter - for Pharmaceutical Engineers; and TechnicalMonographs - Guidelines on standards in manufacture. IDMAhas also instituted many awards for excellence in various fieldsof pharmaceuticals including patents, research andoutstanding and young

Contact Address: 102-B, PoonamChambers, Dr.A.B.Road Worli,Mumbai - 400 018.Phone: +91 - 22 - 2494 4624 / 24974308Fax: +91 - 22 - 24950723E mail: [email protected],[email protected] : http://www.idma-assn.org/

2 The Organisation of Pharmaceutical Producers ofIndia (OPPI)The Organisation of Pharmaceutical Producers of India (OPPI)was established in 1965 as a premier association of researchbased international and large pharmaceutical companies inIndia. It is also a scientific and professional body. The missionof OPPI is to contribute towards achieving health careobjectives of the nation while professionally addressing thecollective interests of its members and encouraging innovationfor inclusive growth. It caters to the needs of Research basedPharmaceutical Industry. OPPI is an active member ofInternational Federation of Pharmaceutical ManufacturersAssociations (IFPMA), Geneva. It has many publicationsincluding reports, codes, guidelines on pharmaceuticalproducts and specific subject based publications like'Outsourcing Opportunities in Indian Pharmaceutical Industry,''Corporate Social Responsibility of Pharmaceutical Companiesin India' etc

Contact Address: PeninsulaChambers, Ground Floor, GanpatraoKadam Marg, Lower Parel, Mumbai400 013.Phone: +91 22 24918123,24912486, 66627007Fax: +91 22 24915168E mail: [email protected] : http://www.indiaoppi.com/

3 The Bulk Drug Manufacturers Association (BDMA)The Bulk Drug Manufacturers Association (India), formed in1991, is an all India body representing all the Bulk DrugManufacturers of India. BDMA is a catalyst between thegovernment and the industry on various issues for the growthof pharmaceutical drugs industry. It conducts periodicalseminars on current technical topics; provides a platform fordiscussion among the member industries on various subjectsconcerning the Bulk Drug Industry; encourages innovationsand make known the nature and merits of inventions;

Contact Address: C-25, IndustrialEstate, Sanath Nagar, Hyderabad500018Phone: 040 - 23703910/23706718



formulates methods for developing indigenous as well asexport market for Bulk Drugs manufactured in India. BDMApublishes a monthly newsletter with information on day to daymatters, articles from the eminent personalities, gadgetnotifications and other important information pertaining topharmaceutical industry.

Fax: 040-23704804E mail: [email protected] : http://www.bdmai.org/index.html

4 The Confederation of Indian PharmaceuticalIndustry (SSI)The Confederation of Indian Pharmaceutical Industry (SSI) isthe apex body of small scale manufacturers of drugs andpharmaceuticals in India. Its federating members include all themajor State level associations of the pharmaceuticalmanufacturers. The Confederation aims to bring together themembers of Industry Associations into a body and to form aforum for representation to the Government or the other PublicAuthorities, Mercantile and Public bodies in India andelsewhere. It protects the general, commercial and businessinterest of the members and takes steps to advise themwhenever required.

Contact Address: A-3/314, FirstFloor, Paschim Vihar, New Delhi –110 063Phone: 011-25275471Fax: 011-28538801E mail: [email protected] : http://www.cipi.in/

5 Indian Pharmaceutical Association (IPA)Indian Pharmaceutical Association (IPA) is the professionalassociation of pharmacists in India with a membership of over10,000. It has 17 state branches and more than 33 localbranches. It also manages several academic programmes andis affiliated with international pharma associations like FIP,FAPA, CPA, AAPS, AAiPS, IPSF & WHO. It has manyimportant pharmaceutical publications to its credit including'Indian Journal of Pharmaceutical Sciences' which is a bi-monthly scientific publication containing original research workin the areas of Pharmaceutical Sciences. Its anotherpublication, 'Pharma Times' is a news magazine and ascientific journal featuring articles of professional interest.

Contact Address: Kalina, Santacruz(E), Mumbai - 400 098.Phone: 91-22-2667 1072Fax: 91-22-2667 0744E mail: [email protected] :http://www.ipapharma.org/Home.aspx

6 Association of Pharmaceutical Teachers of IndiaAssociation of Pharmaceutical Teachers of India, establishedin 1966, aims at providing a common platform to discussvarious issues of Pharmacy Education. Its objectives includeidentifying current needs of pharma industry and adapt thesyllabus pattern as per the needs; honoring PharmacyEducators and Researchers.; imparting Continuing PharmacyEducation (CPE).; establishing a novel pharmacy teachers'training institute.; and arranging for lectures, exhibitions, etc, tofocus on pharmacy profession through publications

Contact Address: H.Q: Al-AmeenCollege of Pharmacy, Opp. LalbaghMain gate, Hosur Main Road,Bangalore - 560027 INDIAPhone: 080 - 22234619Fax: 22225834E mail: [email protected] : http://www.aptiindia.org/



Key Players in Pharmaceutical Industry36

There are several national and international pharmaceutical companies that operatein India. Most of the country's requirements for pharmaceutical products are met bythese companies. Some of them are briefly described below:

• Ranbaxy Laboratories Limited is the biggest pharmaceutical manufacturingcompany in India. The company is ranked at the 8th position among the globalgeneric pharmaceutical companies and has presence in 48 countries includingworld class manufacturing facilities in 10 countries and serves to customers fromover 125 countries. Ranbaxy Laboratories 2009-2010 Q3 Net Profit Results showeda profit of Rs 116.6 crore as compared to Rs 394.5 crore deficit, recorded during thecorresponding period last fiscal.

• Dr. Reddy's Laboratories manufactures and markets a wide range ofpharmaceuticals both in India and abroad. The company has 60 activepharmaceutical ingredients to manufacture drugs, critical care products, diagnostickits and biotechnology products. The company has 6 FDA plants that produceactive pharma ingredients and 7 FDA inspected and ISO 9001 and ISO 14001certified plants. Dr. Reddy's Q1 FY10 result shows the revenues of the company atRs. 18,189 million which is up by 21%. During this quarter the company introduced24 new generic products, applied for 22 new generic product registrations and filed4 DMFs.

• Cipla is an Indian pharmaceutical company renowned for the manufacture of lowcost anti AIDS drugs. The company's product range comprises of anthelmintics,oncology, anti-bacterials, cardiovascular drugs, antibiotics, nutritional supplements,anti-ulcerants, anti-asthmatics and corticosteroids. Cipla also offers other serviceslike quality control, engineering, project appraisal, plant supply, consulting,commissioning and know-how transfer, support. For the financial year 2008-09 thecompany registered an increase of 22% in sales and other income over theprevious year.

• Nicholas Piramal is the second largest pharmaceutical healthcare company inIndia. The brands manufactured by the company include Gardenal, Ismo, Stemetil,Rejoint, Supradyn, Phensedyl and Haemaccel. Nicholas Piramal has entered intojoin ventures and alliances with several international corporations like Cheissi, Italy;IVAX Corp; UK, F. Hoffmann-La Roche Ltd., Allergan Inc., USA etc.

• Glaxo Smithkline (GSK) is a United Kingdom based pharma company; it is theworld's second largest pharmaceutical company. The company's portfolio of pharmaproducts consist of central nervous system, respiratory, oncology, vaccines, anti-infectives and gastro-intestinal/metabolic products among others. On November2009, the FDA had announced that the H1N1 vaccine manufactured by GSK wouldjoin the list of the four vaccines approved.

• Zydus Cadila also known as Cadila Healthcare is an Indian pharmaceuticalcompany located in Gujarat. The company's 1QFY2010 results show the net salesat Rs880.3cr which is higher than the estimated Rs773cr. The net profit wasRs124.8cr which was increase of 39%; the increase was on account of higher salesand improvement in the OPM.

36 http://business.mapsofindia.com/pharmaceutical/



Future Scenario

With several companies slated to make investments in India, the future scenario ofthe pharmaceutical industry in looks well promising. The country's pharmaceuticalindustry has tremendous potential of growth considering all the projects that are in thepipeline. Some of the future initiatives are:

• According to a study by FICCI-Ernst & Young India will open a probable US$ 8billion market for MNCs selling expensive drugs by 2015

• The study also says that the domestic pharma market is likely to reach US$ 20billion by 2015

• The Minister of Commerce estimates that US$ 6.31 billion will be invested in thedomestic pharmaceutical sector

• Public spending on healthcare is likely to raise from 7 per cent of GDP in 2007 to13 per cent of GDP by 2015

• Dr Reddy's Laboratories has tied up with GlaxoSmithKline to develop and marketgenerics and formulations in upcoming markets overseas

• Lupin, a Mumbai based pharmaceutical company is looking to tap opportunitiesof about US$ 200 million in the US oral contraceptives market

• Due to the low cost of R&D, the Indian pharmaceutical off-shoring industry isdesignated to turn out to be a US$ 2.5 billion opportunity by 2012

37Various export promotion activities have been undertaken as per ForeignTrade Policy for increasing the exports of drug and pharmaceuticals as is evident fromthe growth rate indicated above.

Government provides assistance under Market Development Scheme (MDA) andMarket Access Initiative (MAI) Scheme to all Indian exporters, including exporters ofPharmaceutical products. Besides this, incentives to Pharmaceutical industry areavailable in various trade promotion schemes like Focus Market Scheme, Market LinkedFocus Product Scheme etc. in the Foreign Trade Policy (FTP) 2009-14.

A Government constituted Task Force in its report has made wide rangingrecommendations for increasing the production and exports of pharmaceutical productsfrom India. These recommendations have been conveyed to the concernedMinistries/Departments.

37 http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=2564



Indian Domestic Pharmaceutical Market:

Source : http://business.mapsofindia.com/pharmaceutical/



SIGNIFICANT STATISTICS:

Annual growth of exports, imports, sales and domestic consumption:

Indicator 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09

Exports Value 15213.2 17857.8 22115.7 26895.2 30759.6 39537.7

Imports Value 2958 3169.3 4550.9 5851.6 6712.9 8617.6

Sales Value 40800 42500 49500 61000 70000 75500

Market Size(Value)

43758 45669.3 54050.9 66851.6 76712.9 84117.6

DomesticConsumption(Value)

28544.8 27811.5 31935.1 39956.5 45953.3 44579.9

DomesticConsumptionGrowth

-3% 15% 25% 15% -3%

Source: CMIE data Base, Reference taken from Discussion Paper by DIPP38

Top 5 commodities exported from India39:

Department of CommerceSystem on Foreign Trade Performance Analysis (FTPA)

Top 5 Commodities of Export Dated: 23/8/2010 Values in Rs. Crores(P) Provisional

Rank Commodity Apr-Mar2009

Apr-Mar2010(P) %Growth %Share

1 GEMS & JEWELLARY 128,575.19 137,200.31 6.71 16.232 PETROLEUM (CRUDE &

PRODUCTS)123,397.91 132,616.10 7.47 15.69

3 TRANSPORTEQUIPMENTS

51,297.79 47,193.05 8.00 5.58

4 MACHINERY ANDINSTRUMENTS

50,341.86 45,325.81 -9.96 5.36

5 DRUGS,PHRMCUTES &FINE CHEMLS

40,421.71 42,091.90 4.13 4.98

Total 840,755.05 845,125.20 0.52 100.00

Data Source: DGCIS, Kolkata DOC-NIC

38 http://www.dipp.nic.in/CL-DraftDiscussion.doc

39 http://commerce.nic.in/ftpa/com.asp



Turn over of Drugs and Pharmaceutical Companies:

Year Sales %SalesGrowth

Exports %ExportGrowth

%ofExports

Domesticsales

% growthofDomesticSales

1994-95 14181 2512 18% 116691995-96 16831 19% 3409 36% 20% 13423 15%1996-97 22553 34% 4342 27% 19% 18211 36%1997-98 22390 -1% 5419 25% 24% 16971 -7%1998-99 26000 16% 6256 15% 24% 19744 16%1999-00 27700 7% 7230 16% 26% 20470 4%2000-01 31300 13% 8758 21% 28% 22543 10%2001-02 33200 6% 9835 12% 30% 23365 4%2002-03 37300 12% 12826 30% 34% 24474 5%2003-04 40800 9% 15213 19% 37% 25587 5%2004-05 42500 4% 17858 17% 42% 24642 -4%2005-06 49500 16% 22116 24% 45% 27384 11%2006-07 61000 23% 26895 22% 44% 34105 25%2007-08 70000 15% 30760 14% 44% 39240 15%2008-09 75500 8% 39538 29% 52% 35962 -8%Source CMIE: Economic Intelligence Service (EIS)Rs. In Crores

Drugs & pharmaceuticals Sales in 2008-2009

Cipla 4807.67Ranbaxy Laboratories 4755.76Dr. Reddy's Laboratories 4394.9Lupin 2934.25Sun Pharmaceutical Inds. 2830.86Aurobindo Pharma 2730.75Cadila Healthcare 1765.4Glaxosmithkline Pharmaceuticals 1668.08Piramal Healthcare 1565.42Wockhardt 1448.87Source CMIE: Economic Intelligence Service (EIS) Rs in Crores



Top 10 Major Indian Applicants for patents from Pharmaceutical Industry:

Sl.No.

Name of Pharmaceutical Industry Applicationsfiled

1. Dr Reddy’s Laboratories 147

2 Ranbaxy Laboratories Limited 101

3 Avesthagen Limited 66

4 Cadila Healthcare Ltd 57

5 Matrix Laboratories Ltd 54

6 Orchid Chemicals & Pharmaceutical Limited 22

7 Aurobindo Pharma Limited 22

8 Jubilant Organosys Ltd 21

9 Ind-Swift Laboratories Ltd 19

10 Panacea Biotech Limited 15

Source: Page No 9 Annual Report 2008-09 CGPDTM India40

40 http://ipindia.gov.in/cgpdtm/AnnualReport_English_2008_2009.pdf



GOVERNMENT INITIATIVES TO PROMOTE PHARMACEUTICAL INDUSTRIES41:

Recognizing the profound influence of R&D on the prospects and opportunities forthe growth of the Indian Drug Industry, Department of Science and Technology (DST),Government of India mounted the programme on drug development during 1994-95 forpromoting collaborative R&D in drugs and pharmaceuticals sector with the followingspecific objectives:

o To synergise the strengths of publicly funded R&D institutions and IndianPharmaceutical Industry.

o To create an enabling infrastructure, mechanisms and linkages to facilitate newdrug development.

o To stimulate skill development of human resources in R&D for drugs andpharmaceuticals; and

o To enhance the nation's self-reliance in drugs and pharmaceuticals especially inareas critical to national health requirements.

During January 2004, Government of India established Drug DevelopmentPromotion Board (DDPB) http://chemicals.nic.in/pharma10_f2.htm under theadministrative control of DST for supporting R&D projects jointly proposed by industryand academic institutions/ laboratories and to extend soft loan for R&D to drug industry.

Collaborative R&D Projects

o supports research in all systems of medicines including setting up of facilities

o supports joint research projects of industry and institution

o normally 50 : 50 sharing of financial requirements between industry andinstitution

o research undertaken by industry is funded 100% by industry

o institution share is supported jointly by government and industry. Capitalexpenditure: 100% by government, recurring expenditure: 70% by governmentand 30% by industry

o DSIR recognition is desirable

41 http://www.dst.gov.in/scientific-programme/td-drugs.htm



Soft Loan for Pharma Industrial R&D Projects

o Loan amount upto 70% of the project cost.

o Loan will be an unsecured one carrying a simple interest of 3% on reducingamount.

o Repayment of the loan will be in 10 annual equal instalments after the projectperiod.

o Interest during the implementation period will be amortized and will be payable inmaximum of 5 instalments after the project period along with the instalment ofprincipal amount.

Grant-in-aid to Industry for Clinical trials for developing drugs for neglected diseases:Any Indian Pharma Industry including new and small for R & D projects involving clinicaltrials (phase-I, II and II) of developing drugs for neglected diseases like tuberculosis,malaria, kala-azar, filariasis, etc.

Coverage

The programme supports both human and veterinary drug development for all types ofmedicinal systems, be it traditional Indian medicinal system or the modern one. Theprogramme employs a two pronged approach involving exploratory drug design anddrug development on candidate molecules already identified on one hand and providinga cutting edge to Indian Industry through innovative process for known/generic drugs aswell as crucial intermediates on the other. Some of the areas where support could beconsidered are:

(a) any component/stage in the innovation chain of new drug development(b) innovative/cleaner process technology for known drugs/key intermediates,where India has a competitive advantage(c) chiral synthesis of drugs(d) resolution of racemic drugs(e) clinical studies(f) development of new formulations and standardization

Significant Achievements42

Clinical Trials : A peptide based anti-cancer drug for the treatment of colorectal cancerby Dabur Research Foundation under Phase-II of clinical trial.

Patents - Product Patents: Six product patent applications based on three projects havebeen filed:

42 http://www.dst.gov.in/scientific-programme/td-achievement.htm



o "A new drug for the treatment of cancer" - India, USA, Australia, Canada,Europe, Israel and Japan

o "Novel peptide analogs for the treatment of cancer" - India

o "A novel oligospirostanoside from Asparagus racemosus" - India

o Cyclopentenone derivatives for cancer therapy - India and USA(PCT)

o Flavopereirine derivates for cancer therapy - PCT

o Hydroanthracene based compounds as anticancer agents (PCT)

Completed Collaborative Projects

(A) New Chemical Entities:

o New drug studies for development of peptides based anti-cancer agent

o Synthesis and biological evaluation of Camptothecin and Podophyllotoxinanalogues

o Synthesis and screening of newer analogues of Quinolone Carboxylic acid asanti-infective agents with special emphasis on activity against multi drug resistantbacterial, Mycobacterial and fungal pathogens

o Sugar and heterocycle modified Nucleosides : Section A - Synthesis of NewPotential Antivirals. Section B - Development of cost effective processes forantiviral drugs

o Novel hypocholesterolemic agents : synthesis and biological evaluation ofsqualene epoxidase inhibitors

o Discovery of Novel peptidomimetics as endo-thelin receptor antagonists: denovosynthesis using b-Dehydro and b-Amino Acids and crystallographic studiesutilising cloned receptor.

o Synthesis and screening of new Antimycotic agents.

o Synthesis of structurally unique anti-Cancer agents and their biologicalevaluation

o Rational design and synthesis of novel antibacterial agents.

o Novel monosaccharide and disaccharide derivatives as anti-inflammatory andanti-proliferative agents.

o Synthesis of selective Cyclooxygenase-2 inhibitors and novel symbiotic approachto anti-inflammatory and immunomodulatory therapy.

o Lead optimisation and development of new gastric proton pump inhibitor.

o Rational design, synthesis and screening of new antimicrobial macrolides

o New anti-cancer compounds : design, synthesis, screening and optimisationthrough QSAR.



o Design synthesis and bioactivity determination of antagonist analogues andmimetics of vasoactive intestinal peptide (VIP) for cancer therapy

o Design, synthesis and biological evaluation of new antitubercular compounds.

o Structure based drug design, synthesis, SAR studies and screening of novel anti-tubercular and anti-bacterial compounds

o Identification and development of novel anti-cancer agents.

o Synthesis of selective b-3 adrenergic receptor as a novel therapy for obesity.

On-Going Collaborative Projects:

(a) Herbal Drugs - Indian System of Medicine (On-Going):

o Process and product standardisation of classical Ayurvedic drugs with specialreference to Rheumatism.

o Screening of cancers manifesting altered histone acetyltransferases (HATs) anddeacetylases (HDACs) function and search for inhibitors of these enzymes innatural products as therapeutic agents.

o Study of the identified plant based immunostimulators as potential adjuvants forvaccines

o Scientific evaluation of safety and efficacy profile of Herbal Siddha formulation inthe management of rheumatoid arthritis

o Efficacy and safety evaluation of Siddha medicine HIVS-2004 for HIV/AIDS

o Development and Standardisation of therapeutic herbal formulations for themanagement of alopecia and skin disorder

o Development of Herbomineral (Ayurvedic) and Plant based disease orientedimmunomodulator formulation

o Scientific evaluation of safety and efficacy profile of Siddha formulation in themanagement of leucoderma

o Standarisation and modernization of Ayurvedic Herbal formulations using moderntechniques

o Development and standardization of herbal anti-malarial drug

o Development of drugs for the medical therapy of Glaucoma using naturalproducts

o Clinical and experimental evaluation of Reno Protective Effect of Maha NimbRhubarb and Herbal Compound (Ayurvedic)

o Quality assurance and validation of some Ayurvedic formulations for Lifestylerelated and gynaecological disorders

(b) New Chemical Entities (On-Going):



o Design synthesis and testing of new chemical entities as potential anti-fungalagents

o Computer aided design synthesis and biological evaluation of novelphosphodiesterase-4 inhibitors

o Identification and optimization of Lead Molecules for Development as anticanceragents

o Lead Optimisation and development of new orally active anti-malarial peroxides

Industry/Institutional Alliances:

Under this programme, so far 50 industry-institutional alliances have taken place amongthe following:

Industries

o SPIC Pharma, SPIC Centre , 97, Mount Road, Guindy Campus, Chennai - 600032

o Dr. Reddy's Foundation, 7-1-27, Ameerpet, Miyapur, Hyderabad - 500 016

o Ranbaxy Laboratories Ltd., Sector 8, Udyog Vihar, Gurgaon - 122 001

o Dabur Research Foundation, 22, site-IV, Sahibabad, Ghaziabad - 202 010

o Zandu Pharmaceuticals Works Ltd., Gokhale Road, South Dadar, Mumbai - 400025

o Recon Ltd.,Kalana Agrahara Village, Bannerghatta Road, Bangalore - 560 076

o Bharat Biotech International Ltd., 726, Road .3, Banjara Hills, Hyderabad - 500034.

o Cadila Healthcare Ltd., Surkhej Bawla Highway, Ahmedabad - 382 210

o Indian Herbs Research and Supply Co.Ltd., Sharda Nagar, Saharanpur-247001

o Arya Vaidya Sala, Kottakkal - 676 503 (Kerala)

o Cadila Pharmaceuticals Ltd., B.D.Patel House, Naranpura, Ahmedabad - 380014

o Glenmark Pharmaceuticals Ltd., B/2 Mahalaxmi Chambers, Mumbai - 400 026

o Alembic Ltd., Alembic road, Vadodara - 390 003

o Lupin Laboratories Ltd., 159-CST Road, Kalina Santacruz(E) Mumbai - 400 098

o Dey's Medical Stores Mfg. Ltd., 6/D, Lindsay Street, Kolkata - 700 017

o Life Pharmaceuticals Pvt. Ltd, 3/2B, Orient Row, Kolkata - 700 017

o Herbochem Remedies India (P) Ltd, Narendrapur, 10, Musalman Para Road,Distt. 24, Parganas (South), West Bengal - 743508



o FDC Ltd., Mumbai

o Lifecare Innovations Pvt. Ltd., Gurgaon

o Vedic Drugs Pvt. Ltd., Bangalore

o Indian Medicines Pharmaceuticals Corporation Ltd., Mohan, Uttaranchal

o Nagarjuna Herbal Concentrates Ltd., Idukki, Kerala

o Shree Dhootapapeshwar Ltd., Panvel, Maharashtra

o Marico Industries Ltd., Mumbai

o Citadel Fine Pharmaceuticals Ltd., Chennai

o Sami Labs Ltd., Bangalore

o Natural Remedies Pvt. Ltd., Bangalore

o Petlad Mahal Arogya Mandal Pharmacy, Nadiad, Gujarat

o Ipca Laboratories Ltd., Mumbai

o Promed Exports Pvt. Ltd., New Delhi

o Emmellen Biotech Pharmaceuticals Ltd., Mumbai

o Serum Institute of India Ltd., Pune

o Surya Pharmaceuticals Ltd., Varanasi

Institutions :

o Indian Institute of Chemical Technology (IICT), Uppal Road, Hyderabad - 500007

o Central Drug Research Institute (CDRI), Chattar Manzil Palace, Lucknow - 226001

o Centre for Biochemical Technology (CBT), University Campus, Delhi -110 007

o Regional Research Laboratory(RRL), Canal Road, Jammu - 180 001

o Regional Research Laboratory(RRL), Indl. Estate, Thiruvananthapuram - 695019

o National Chemical laboratory(NCL), Pashan road, Pune - 411 008

o Indian Institute of Chemical Biology(IICB), Jadavpur, Calcutta - 700 032

o Centre for Cellular & Molecular biology(CCMB), Uppal Road, Hyderabad - 500007

o Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Jakkur,Bangalore - 560 064.

o Central Institute for Research on Goats (CIRG), Mathura

o Central Leather Research Institute (CLRI), Chennai

Academia:



o Indian Institute of Science(IISc.), Bangalore - 560 012

o University of Hyderabad, Hyderabad - 500 046

o University Department of Chemical Technology(UDCT), Mumbai - 400 019

o All India Institute of Medical Sciences(AIIMS), New Delhi - 110 029

o Tamil Nadu Veterinary & Animal Sc. University (TANUVAS), Chennai - 600 051

o Delhi University, South Campus, New Delhi - 110 021

o Indian Institute of Technology, Kanpur - 208 016

o Indian Institute of Technology, Mumbai

o Seth G.S. Medical College & KEM Hospital, Parel, Mumbai - 400 012

o Saurashtra University, Rajkot - 360005

o Post Graduate Institute of Medical Education and Research (PGI), Chandigarh

o National Institute for Pharmaceutical Education and Research (NIPER),Chandigarh

o Sastra Deemed University, Thanjavur (TN)

o JSS College of Pharmacy, Ootacamund (TN)

o SP Mandali's Ramnarain Ruia College, Mumbai

o BYL Nair Hospital and Medical College, Mumbai

o Sree Chitra Tirunal Institute for Medical Science & Technology,Thiruvananthapuram

o Sardar Patel University, Vallabh Vidyanagar, Gujarat

o Veer Narmad South Gujarat University, Surat, Gujarat

o Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New Delhi

o University of Pune, Pune

o Banaras Hindu University, Varanasi

Open Source Drug Discovery in Pharmaceutical Innovation43

OSDD is a CSIR Team India Consortium with Global Partnership with a vision to

provide affordable healthcare to the developing world by providing a global platform

where the best minds can collaborate & collectively endeavor to solve the complex

problems associated with discovering novel therapies for neglected tropical diseases like

Malaria, Tuberculosis, Leshmaniasis, etc. It is a concept to collaboratively aggregate the

biological and genetic information available to scientists in order to use it to hasten the

discovery of drugs. This will provide a unique opportunity for scientists, doctors,

43 http://www.osdd.net/



technocrats, students and others with diverse expertise to work for a common cause.

The success of Open Source models in Information Technology (For e.g., Web

Technology, The Linux Operating System and Biotechnology (For e.g., Human Genome

Sequencing) sectors highlights the urgent need to initiate a similar model in healthcare.

Funding source - The Government of India has committed Rs. 150 crores (US $38

million) towards this project. An equivalent amount of funding would be raised from

international agencies and philanthropists. About 46 crores (US $12 million) has been

already released by the Government of India.

How does OSDD work

THE PROTECTION AND UTILIZATION OF PUBLIC FUNDED INTELLECTUALPROPERTY BILL, 2008

The Government of India plans to introduce a Public Funded R&D Projects(Protection of Intellectual Property) Bill in the upcoming legislative session. The Bill, ifenacted, would enable and encourage recipients of government-funding to patent andlicense the results of their research. This, in turn, would provide incentives for thoserecipients to work with industry players to commercialize the basic research, turning itinto products and services that benefit the population at large, driving economic

The Bill, if enacted, will spur economic development in the technology sector bycreating a system that facilitates commercialization of government funded research,leading to new products and services for consumers and businesses and resultingeconomic growth. It does so by establishing the general rule that recipients ofgovernment funding can patent resulting inventions, and licenses them to businesses.Without this basic legal foundation permitting patenting of inventions arising out of



government-funded research, commercialization of that research will lag. growth,employment, foreign direct investment, and tax revenues.

======= End of Chapter V ===========

CHAPTER VI

PARTICIPATION IN TRAINING COURSES, INDUSTRY VISITS & MEETINGS

During this study program, I have been a very good opportunities to be inenlightened through deliberations by expert of the subjects on various issues related tointellectual Property in training programs organized by AOTS and APIC during end ofJune and through July 2010.

Following deliberations were attended :

1. FY 2010 JPO/IPR Training Course for Lawyers-June 28th - July,16th 2010

2. FY 2010 the 5th JPO/IPR Training Course for Patent Experts-July,12th - July 30th

3. Factory Visit: Nihon Tetra Pak Co. Ltd. -6th July, 2010.

4. Factory Visit: Ajnomoto Co Inc. -9th July, 2010.

5. Visit to Intellectual Property High Court- 12th July, 2010.

6. Factory Visit to Toppon Printing Co. Ltd (Printing Museum) and Mint House -20th

July, 2010.

7. Factory Visit to Fuji Xerox on 3rd September, 2010

FY 2010 JPO/IPR Training Course for Lawyers-June 28th to July,16th 2010

SN

Date Topic Delivered By

1 June28th

IP System within Japan’s LegalSystem

Mr. Masayoshi SUMIDA,Professor of Intellectual PropertyLaw, Tokai University Law School

2 June30th

The Current Status and FutureDirection of Japanese IndustrialProperty Administration

Mr. Ryouetsu HARIMA,Senior Specialist for IndustrialProperty Rights, InformationDissemination and Policy PromotionDivision, JPO



3 July1st

AM

IP Rights System��Introductionto Patent Law

Masanori Fushimoto,Director,Study and Research Group,Intellectual Property ResearchCenter JIII

4 July1st PM

IP Rights System ExaminationGuidelines industrially applicableinventions, novelty & inventive step

Mr. Akinori YAMAGUCHI,Vice President, Patent Attorney,Itoh International Patent Office

5 July5th

AM

IP Rights System Introduction toDesign Law

Mr. Mamoru MORITA,Professor, Department of ProductDesign, Nagaoka Institute of Design

6 July5th

PM

International Trends in IntellectualProperty Rights(includingrelationships between developedand developing countries)

Mr. Shinjiro ONO,Senior Partner, Head of PatentDivision, YUASA AND HARA

7 July6th

Current State of Intellectual PropertyRights: Management at Tetra PakCo.,Ltd.

Nihon Tetra Pak Co.,Ltd.

8 July9th

Current State of Intellectual PropertyRights: Management at AjinomotoCo., Inc.

Ajinomoto Co., Inc.

9 July

12th

Visit to the IP High Court

10 Case Study Patent RightInfringement Cases

Mr. Seiji OHNO,Managing Partner, Attorney-at-Law,Patent Department, OHNO &PARTNERS

FY 2010 the 5th JPO/IPR Training Course for Advanced IP Practitioners-July,12-30

SN

Date Topic Delivered By

1 July15th

Overview of Patent Management Mr. Isamu SOJYO, SpeciallyAppointed Professor, Office ofSociety-Academia Collaboration for



AM Invention Kyoto Univ.

2 July15th

PM

Invention ManagementUnderstanding Inventions and PriorArt Searches)

Mr. Nobuyuki TANIGUCHI, PatentAttorney, NAKAMURA &PARTNERS

3 July16th

Patent Application Practices(Writing Patent Specifications)

4 Procedural Flow on Examinationand Appeal System for Patents

Ms. Junko SUGIMURA

Patent Attorney, SUGIMURA,TAMURA & PARTNERS.International Patent & Trade MarkOffice

5 July20th

Current State of IntellectualProperty Rights: Management atToppan Printing Co., Ltd.

Mr. Nobumasa YAMAZAKI, SeniorManager, Intellectual Property Dept.Toppan Printing Co., Ltd. (PrintingMuseum, Tokyo)

6 July21stAM

IP Management - IndustrialProperty Information and Searches

7 PM IP Management - Patent Maps

Ms. Yoshiko SUGAWARA, Director,Intelligence and Information CenterUnit Intellectual Property Division,Mitsui Chemicals, Inc.

8 July22nd

AM

Utilization of Patent Rights Mr. Kiyotaka KANEKO, GeneralManager, Intellectual PropertyTechnology Div. IP Div. R&DManagement HQ.,FUJIFILM Corpn.

9 PM Patent Right Infringement Mr. Kazuhiro MATSUDA, Professor,Graduate School of Law, KyotoUniversity

10 July26th

AM

Design System Overview Ms. Minako MIZUNO,DepartmentHead, Registered Patent Attorney,Seiwa Patent & Law

11 July28th

AM

IP Management - Corporate Case

(Pharmaceutical Company)

Mr. Kazuo SATO, Manager, PatentGroup �, Intellectual Property Dept,DAIICHI SANKYO CO., LTD.

12 July28th

PM

IP Management -Corporate Case(Automobile and MachineryCorporation)

Mr. Koichi TAKEUCHI, ProjectManager, Intellectual PropertyDivisionToyota Motor Corporation

13 July29th

IP Management - Universities(Industry-University Cooperation)

Ms. Yuko HAYASHI,LiaisonCoordinator, Office of Liaison Tokyo



AM Institute of Technology

14 PM IP Management - Small andMedium Enterprises

Mr. Yoshikazu MURAMATSU,Leader of Legal IP Team, MaterialsDept. Honda Electronics Co. Ltd.

Meeting with the Officers from Information Technology Planning Office,Japan Patent Office with regard to experiences in electronic filing:

There was an informal meeting with JPO officials on 22nd Aug.2010 toput some light on experiences and utilization of e-filing in Japan Patent Officeand to learn for application in case of India.

SNo

Subject Result of Discussion

1 What is the progressive experienceof JPO in case of e-filing of Patentapplications?

JPO has started this journey in 1990, e-filing ofPatent,Utility model via a special terminal or FD. In1998 such filing provided by PC. In Jan 2000 e-filing ofDesign,Trade Marks and PCT-DO via PC started. InApril 2004, e-filing of PCT-RO via PC resumed. In Oct2005, e-filing of Patent, Utility Model, Design, TradeMark and PCT-DO via Internet started. In Jan 2007, e-filing of PCT-RO via Internet. JPO adopted xml formatsince July 2003 onwards.

2 What strategies JPO adopted forpromoting the e-filing in Patents?

As above

3 Does JPO have any feesconcessions for e-filing?

JPO charges Basic Fee @1200 Yen and Per page @700 Yen for over the counter filing of IP applications asdigitization charges. So online filing results in a goodfinancial benefit to the applicant as digitization at thatend is economic.

4 How JPO is processing patentapplications filed by e-filing? I meanthe difference between filing overthe counter and e-filing.

JPO receiving IP applications mostly through onlinefiling. ( 97% Patents,92% Design,81% TM and 99%Appeal). Over the counter filing is not popular.

5 How JPO observe/determine thetime difference globally?

Timings and dating of application is as per Japanstandard time.

6 Do JPO require any documents inthe form of hard copy? If yes whatare those documents?

Not required.

7 What are the format files uploadedby the applicants?

xml



8 Is all proceedings of patents areonline? Like filing, first and furthercommunications, filing response bythe applicant, decision of grant ofpatent and renewal of patent?

Yes, accept appeal and International Trade Marksapplications.

9 Whether digital signature iscompulsorily required or there isany alternative to digital signature?

Yes, digital signature is compulsory.

10 Is there any software provided byJPO that helps in preparingdocuments for e-filing like our?

Yes but not by JPO it is a separate out agency INPIT.http://www.inpit.go.jp/english/distri/exchange/news.htmlThis can be used in Windows, Mac OS X and Linux.This software has functions such as document formatcheck, file format conversion, fee calculation etc.Applicant can submit application document at office orhome.

11 What are the different modes ofPayment? i.e. Net banking/CreditCard/Account with JPO

Deposite a/c, Cash Payment at Bank, Online CashPayment and Transfer form bank a/c.

12 How the documents filed by e–filingintegrated to the JPO System?

Automatic process.

13 How many forms/entries areaccepted through e-filing? i.e.Application/Renewals/Amendmentsin Application(like Form13 of IPO)etc

Applicant to JPO > 400 FormsJPO-Applicant > 200 FormsJPO-JPO > 100 Forms

14 Whether anyone in the world canuse the e-filing or is it restrictedthrough agents or to the citizen ofJapan?

This is subjected to the provisions of the Law. Art 8 ( 1)and Art. 9

15 Whether date is accorded uponevent of payment or anyuploading?

On uploading documents. In case of no fees,communication to applicant in formal checking.Application date does not affect on delay in payment.

16 How many sections and manpoweris involved in processing/support ofe-filing?

Only 4 to 5 persons in JPO and rest at the out sourcedINPIT staff.



SALIENT FEATURES:

1. Decision of grant is to be taken by the examiner. [Article 51]

2. Statutory time lines for filing response to the first communication of examiner isflexible and states adequate time limit which in all less that 12 months asprovided in Indian Patent Act (in practice 2 to 3 months with some extensionpossible).

3. Time limit for request for examination id 36 months while in India it is 48 months.For divisional application only 30 days extension possible. [Article 48(2) to 48 (5)]

4. For various timelines Japan Patent Law mentions word “adequate time limit”.Throughout the text of Japan Patent Law it appears at about 20 places forvarious procedures. I have discussed with JPO officials, how they observe thistimelines, it is submitted that in general they give 2 months time and may extendfor one month or little more.

5. Japan Patent Law specifically mentions about the Employees inventions which inturn may be healthy for generation of invention. [Article 35]

6. Provision for Preferential examination44. [Article(48-6)]

7. Second medical use considered as inventive step. [Examination Guidelines ]

8. The Patent Prosecution Highway (PPH) is good way for speedy disposal andensuring quality of examination.

9. Extension of Patent Term for medicines is possible for 5 years. [Article 67(2)]

10. Working of invention is not compulsory.

11. Penal provisions in Japan Patent Law. Provision for imprisonment with labor ispossible in several IP related issues. [ Art. 196 to 204 ]

12. Provision for refund of fees45 if applicant withdraws application results positivelyin handling with backlog.

44 http://www.jpo.go.jp/cgi/linke.cgi?url=/torikumi_e/t_torikumi_e/outline_accelerated.htm45 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/ryoukin_e/half_refund_system.htm



13. Filing and getting Patent is costly in Japan.46

Govt. of Japan Efforts Related to Patents-200947

1. Promotion of Acceleration of Patent Examination(1) Expansion in Volume of the Outsourcing of Prior Art DocumentSearches.(2) Securing a Necessary Number of Examiners

2. Promotion of Quality Management of Patent Examination

(1) Trends in the Quality of Patent Examination(2) Measures for Maintaining and Improving the Quality of PatentExamination

1) Quality control of examination for each patent application2) The Cross-sectional “Quality Management”

3. Efforts to Realize Patent Examinations that Meet the Needs of Applicants(1) Promotion of Use of the Accelerated Examination System(2) Commencement of the trial of the Super Accelerated ExaminationSystem(3) Promotion of Interview Examination(4) Steady Implementation of Consolidated Examination Program forRelevant Applications(5) Provision of Predicted Period for Starting Patent Examination(6) Submission of Information by Third Parties

4. Promotion of International Cooperation for Patent Examination(1) International Work Sharing in Patent Examination

1) Patent Prosecution Highway (PPH)2) JP-FIRST (JP-Fast Information Release STrategy)3) Triway4) Simultaneous Processing of International Search and NationalExamination of PCT Applications

(2) Efforts for Promoting Work Sharing of Patent Examination1) International Examiner Exchange Program2) Comparative Study on Examination Practice3) Cooperation for Enhancement of Quality of Patent Examination4) Improvement of the Dossier Access System

46 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/ryoukin_e/ryokine.htm47 Annual Report JPO 2009 Part 2 Chapter 2http://www.jpo.go.jp/shiryou_e/toushin_e/kenkyukai_e/pdf/annual_report2009/part2.pdf



About Patent Prosecution Highway (PPH) 48,49

The Patent Prosecution Highway (PPH) is a framework for allowing, on request by theapplicant, accelerated examination in the Office of Second Filing with simplified procedures, withrespect to the application whose claims are determined to be patentable in the Office of FirstFiling. This framework supports an efficient acquisition of a stable and strong patent right inmultiple Offices through the making use at the above level (c), that is, the making use of allexamination results including the final decision in the Office of Second Filing.

About JP-FIRST (JP-Fast Information Release STrategy)

JP-FIRST has been implemented since April 2008 in order to solve the above problem, takinginto consideration the patent system of the JPO such as the examination request system and aframework of PCT for conducting the international search.

JP-FIRST is a framework in which:- The JPO prioritizes the examination of the patent application for which the examinationhas been requested within 2 years from the filing date among the patent applicationswhich are the bases for priority under the Paris Convention (with the proviso that theapplications which are the bases for the PCT application are not subject to JP-FIRST).- The JPO conducts the examination in principle within 6 months from the later date ofthe examination request date and the publication date that is no later than 30 monthsafter the filing date.

It is expected to support an appropriate patent acquisition in the foreign Offices and toalleviate the whole examination load in various Offices as a whole by providing the results of thefirst action of the JPO at an early stage to promote the utilization of these results in the foreignOffices.

48 http://www.jpo.go.jp/cgi/linke.cgi?url=/torikumi_e/t_torikumi_e/patent_highway_e.htm49 http://www.jpo.go.jp/cgi/linke.cgi?url=/ppph-portal/index.htm



References:

(Notification concerning information on invention described in publications)Article 48septies(48-7). — Where the examiner finds that the application does notcomply with Section 36(4)(ii), he may notify the applicant to that effect and give him anopportunity to submit a statement of argument, designating an adequate time limit.

(Examiner’s decision of refusal)Article 49. — The examiner shall make a decision that a patent application is to berefused where it falls under any of the following paragraphs:(i) the amendment to the description, patent claim(s) or drawing(s) attached to therequest does not comply with Section 17bis(17-2)(3);(ii) the invention claimed in the patent application is not patentable under Section 25,

29, 29bis(29-2), 32, 38 or 39(1) to (4);



(iii) the invention claimed in the patent application is not patentable in accordance with atreaty;(iv) the patent application does not comply with Section 36(4)(i) or (6), or 37;(v) the application does not yet comply with Section 36(4)(ii), where the notification wasmade under Section 48septies(48-7), and where amendment to the description or thesubmission of the statement of arguments of applicant was made;(vi) the features disclosed in the description, patent claim(s) or drawing(s) attached tothe request of the patent application do not remain within the scope of the featuresdisclosed in the foreign language document, when the patent application concerned is aforeign language file application;(vii) the applicant for patent who is not the inventor has not succeeded to the right toobtain a patent for the invention concerned.

(Notification of reasons for refusal)Article 50. — When the examiner intends to render a decision that an application is tobe refused, he shall notify the applicant for the patent of the reasons for refusal and givehim an opportunity to submit a statement of his arguments, designating an adequatetime limit. However, in the case of Section 17bis(17-2)(1)(iii), this provision shall notapply to the case of a ruling to decline an application under Section 53(1).

(Examiner’s decision that a patent is to be granted)Article 51. — When the examiner finds no reasons for refusal with respect to the patentapplication, he shall render a decision that a patent is to be granted.

(Formal requirements of decision)Article 52. — (1) The examiner’s decision shall be in writing and shall state the reasonstherefor.(2) When the examiner’s decision has been rendered, the Commissioner of the PatentOffice shall transmit a copy of the decision to the applicant.

(Employees’ inventions)Article 35. — (1) An employer, a legal entity or a state or local public entity (hereinafterreferred to as the “employer, etc.”) shall have a non-exclusive license on the patent rightconcerned, where an employee, an executive officer of a legal entity or a national orlocal public official (hereinafter referred to as the “employee, etc.”) has obtained a patentfor an invention which by reason of its nature falls within the scope of the business of theemployer, etc. and an act or acts resulting in the invention were part of the present orpast duties of the employee, etc. performed on behalf of the employer, etc. (hereinafterreferred to as an “employee’s invention”) or where a successor in title to the right toobtain a patent for an employee’s invention has obtained a patent therefor.

(2) In the case of an employee’s invention made by an employee, etc. which is not anemployee’s invention, any contractual provision, service regulation or other stipulationproviding in advance that the right to obtain a patent or the patent right shall pass to the



employer, etc. or that he shall have an exclusive license on such invention shall be nulland void.

(3) The employee, etc. shall have the right to a reasonable remuneration when he hasenabled the right to obtain a patent or the patent right with respect to an employee’sinvention to pass to the employer, etc. or has given the employer, etc. an exclusive rightto such invention in accordance with the contract, service regulation or other stipulation.

(4) The payment of the remuneration in the preceding subsection, as provided for inthe contract, service regulation or other stipulation shall not be considered to beunreasonable, in view of the situation under which a negotiation is carried out betweenemployer, etc. and employee, etc. in the course of establishing the criteria fordetermining the remuneration, the situation under which the criteria established aredisclosed, and the situation under which the views of employee, etc. are heard forcalculating the amount of the remuneration, etc.

(5) Where there is no stipulation with respect to remuneration referred to in thepreceding subsection or where the payment of the remuneration determined therebyshall be considered to be unreasonable, the amount of the remuneration referred to insubsection (3) shall be determined, taking into consideration the amount of profits thatthe employer, etc. will make from the invention, the burden assumed and contributionmade by the employer, etc. in connection with the invention, and the treatment upon theemployee, etc. and other circumstances.

(Preferential examination)Article 48 sexies (48-6). — When the Commissioner of the Patent Office recognizesthat a person other than the applicant is commercially working the invention claimed in apatent application after the laying open of the application, he may, if

(Offense of infringement)Article 196. — Any person who has infringed a patent right or an exclusive license

shall be liable to imprisonment with labor not exceeding five years or to a fine notexceeding 5,000,000 yen.

(Offense of fraud)Article 197. — Any person who has obtained a patent, a registration of an extension

of the term of a patent right, a ruling on the opposition to the patent, or a trial decision bymeans of a fraudulent act shall be liable to imprisonment with labor not exceeding threeyears or to a fine not exceeding 3,000,000 yen.

(Offense of false marking)Article 198. — Any person infringing Section 188 shall be liable to imprisonment with

labor not exceeding three years or to a fine not exceeding 3,000,000 yen.

(Offense of perjury, etc.)Article 199. — (1) A witness, expert witness or interpreter who, having taken an oath

under this Law, has made a false statement or has given a false expert opinion or hasinterpreted falsely before the Patent Office or a court commissioned thereby shall be



liable to imprisonment with labor for a term not less than three months nor more than tenyears.

(2) Where a person committing the offense in the preceding subsection has made avoluntary confession before the certified copy of the interpretation is transmitted or theruling on the opposition to the patent or trial decision concerning the case has becomefinal and conclusive, his sentence may be reduced or suppressed.

(Offense of divulging secrets)Article 200. — Where any present or former official of the Patent Office has divulged

or made surreptitious use of the secrets relating to an invention in a patent application towhich he had access in the course of his duties, he shall be liable to imprisonment withlabor not exceeding one year or a fine not exceeding 500,000 yen.

(Offense of Secrecy Order violation)Article 200bis(200-2). — (1) Any person violating the Secrecy Order shall be liable to

imprisonment with labor not exceeding three years or to a fine not exceeding 3,000,000yen.

(2) The offence under the preceding subsection shall be prosecuted upon complaint.

(Dual liability)Article 201. — Where an officer representing a legal entity or a representative,

employee or any other worker of a legal entity or of a natural person has committed anact in violation of any of the provisions prescribed in the following paragraphs withregard to the business of the legal entity or such natural person, the legal entity shall, inaddition to the offender, be liable to the fine prescribed in the following paragraphs, andsuch natural person shall, in addition to the offender, be liable to the fine prescribed inthe Sections referred to in the following paragraphs:

(i) Section 196, a fine not exceeding 150 million yen;(ii) Section 197, 198 or 200bis(200-2)(1), a fine not exceeding 100 million yen.(2) In the case of subsection (1), a complaint lodged against an offender under

Section 200bis(200-2)(2) shall be effective also with respect to the legal entity or thenatural person concerned, and a complaint lodged against a legal entity or a naturalperson shall be effective also with respect to the offender concerned.

(Administrative penalties)Article 202. — Where a person who has taken an oath under Section 207(1) of the

Code of Civil Procedure as applied under Section 151 (including its application underSections 71(3) and 174(1) to (3) of this Law) has made a false statement before thePatent Office or a court commissioned thereby, he shall be liable to an administrativepenalty not exceeding 100,000 yen.

Article 203. — Where a person who has been summoned by the Patent Office or acourt commissioned thereby in accordance with this Law has failed to appear or hasrefused to take an oath, to make a statement, to testify, to give an expert opinion or to



interpret, without a legitimate reason, he shall be liable to an administrative penalty notexceeding 100,000 yen.

Article 204. — Where a person who has been ordered by the Patent Office or a courtcommissioned thereby to produce or show documents or other evidence in accordancewith this Law relating to the examination or preservation of evidence has failed to complywith the order, without a legitimate reason, he shall be liable to an administrative penaltynot exceeding 100,000 yen.

======= End of Chapter VI ===========

CHAPTER VII

STUDIES ON PATENTING TRENDS IN INDIA and JAPAN

STUDY NO. 1

COMPARATIVE STUDY IN GRANTED PATENTS

Trend in Type of Applicants, and Type of Claims, ( product, method,

composition and use ) Claimed by Domestic vs. Foreign applicants.



Objective of Study No. 1:

The objective of this study is to understand the trend of applicants, domestic vs.foreign and the trend of the type of claims granted (product, method, composition anduse) in this specific field of technology for medical inventions by Japan Patent Office andPatent Office India. This study may reflect some significant difference between the twocountries

Methodology of Study No 1:

Studies of the subject matter for Japan were made with the help official websiteof JPO for data search, i.e. IPDL50. Sample data were taken for “Date of Publication ofPatent Registration” [9th from bottom of dropdown box of “Select Search Item”] in JPOduring 201001001 and 20100331 for specific technical field of inventions in InternationalPatent Classification (IPC) subgroup A61K31/?. As the search for such information wasnot available in English version, language barrier overcomes with the help of APIC andJPO officials for this purpose. International Patent Classification Subgroup, A61K31/? isassigned for the inventions in the field of “Medicinal preparations containing organicactive ingredients”. Total 564 patents have been found to be granted during this timeperiod for such particular IPC. Analysis for type of claims was made on first 100applications; however the study for type of applicant has been done on all 564applications. Segregation for type of applicant has been done based on thetranscriptions used in Japanese language, like kanji (��), (Chinese characters used inJapanese language) considered as indication of domestic applicants and Katakana(��) is considered as indication for foreign applicants. Type of claims has beenstudied by referring first claim of each patent. 100 patents have been referred for thispurpose.

Similarly, studies of the subject matter for India were made from official websiteof Patent Office of India, i.e. IPAIRS51. Sample data were taken for granted patents ason 26th May, 2010 for specific IPC subgroup A61K31/00 of inventions. It was notpossible to have data for any time range as in case of Japan. Search made by using“Quick Search” for Key word A61k31/00 in “Search Condition” and selecting box for IPC.Total 217 hits displayed as a result of search. There was some duplication in displayedresults, on filtering duplicates total 173 patents have been found to be granted by thisdate for such particular IPC. Analysis for type of claims and type of applicants was madeon all the 173 applications. Segregation for type of applicant type has been done basedon the knowledge of reporter. Type of claims has been studied by reading first claim ofeach patent. All 173 patents have been referred for this purpose.

Result and Discussion of Study No 1:

Results>

50 http://www.ipdl.inpit.go.jp/homepg_e.ipdl51 http://ipindia.nic.in/ipirs1/patentsearch.htm



(A) Patents Registered in Japan Patent Office: 20100101–20100131 for IPCA61K31/?

Type of Applicants (Domestic/Foreign):

Applicant Type Nos. PercentDomestic 231 41%Foreign 333 59%Total Patents 564

Type of Claims to Domestic Applicants:

First Claim Type PercentageProduct 44.76%Method 10.52%Composition 42.10%Use 2.60%



Type of Claims to Foreign Applicants

(B) Patents Registered in Indian Patent Office: 26th May 2010 for IPC A61K31/00:

Type of Applicants (Domestic/Foreign) :

First Claim Type PercentageProduct 75.80%

Method 12.90%Composition 11.29%Use 0%



Applicant Type Nos. PercentageDomestic 105 61%Foreign 68 39%Total 173

Type of Claims to Domestic Applicants:

First Claim Type PercentageProduct 16.20%Method 63.80%Composition 20.00%



Use 0.00%

Type of Claims to Foreign Applicants:

First Claim Type PercentageProduct 19.11%Method 38.23%Composition 42.64%Use 0%

Search Results for Registered Patents Jan.2010 to March 2010 for IPCA61K31/?“For Medicinal preparations containing organic active ingredients” - Type of Applicants�� 564 � Cases hits 564

Publication Title of invention The applicant Type



number�� US��

1 ��4444908 ��

�� D

2 ��4444721 �� D3 ��4444659 �� F

4 ��4444651 ��…

� �� F

5 ��4444626 �� D6 ��4444591 �� D

7 ��4444492 ��…..

�� ….. F

8 ��4444385 �� D9 ��4444375 ��

��..�� F

…. …so on. ……………………………. ……………………………….. ……….

563

��4392481 ��

F

564

��4392473 ��

F

Note : Out of Total 564 : Domestic 231 >41%:Foreigner 333 >59% ;

D=Domestic Applicant ; F= Foreign Applicant

Discussion>

On analysis of the result for type of applicant in Japan, 60% for foreign applicantsand 40% for domestic applicants it can be understood that domestic applicants are lessin proportion to the foreign applicants.

On analysis of the result for type of claims in Japanese Patents, 44% for productand 42% for composition, it has been noted that domestic applicants are almost



proportionately equally involved in generation of both the type of inventions. It may beunderstood that there is strong platform in Japan for generation of product, method andcomposition inventions. Proportionate balance between product and compositioninvention gives an idea of good platform for the two basic fields of inventions formedicines.

On analysis of the result for type of applicant in India it can be understoodthat in foreign applicant are less (39%) in proportion to that of domestic applicants. Onereason for this may be that this sample data mostly including the process patentapplications, generated by domestic industries/inventors in India. Another reason maybe the lack of confidence in foreign applicants with regard to patenting in India. As thepresence of foreign applicants is very significant in global economy and technologytransfer, this needs attention for the policy makers. Recently there has been someconfusion among oversea applicants over the patentability criteria in India, specificallySection 3(d). However, the presence of more domestic applicants (61%) could beunderstood as good presence of domestic inventors in this particular field of technologyas a good sign for better future of pharmaceutical industries.

On analysis of the result for type of claims in Indian Patents, it has been notedthat larger proportion of the inventions are generating as method of preparations andthen for composition of and few in the field of product / basic molecule. This situationalarms towards the present need of India to improve product inventions. This is the needof the hour and latest challenge to Indian Pharmaceutical industries in post productpatent regime

Concluding Remarks Study No. 1:

India needs for looking in to the motivation for domestic source of inventionsfor generating more product/basic molecules drug inventions and also maintaining thepace of composition inventions which generally lead to creation of new medicine in theform of generic medicines. There is need to assess and attend the concern of overseaapplicants.

STUDY NO.2

COMPARATIVE STUDY OF PATENT ON SAME PCT APPLICATIONS:

Objective of Study No. 2:



The objective of this study is to understand the trend in structuring the claims ofPatents granted in both the Patent Offices for substantively same application/invention.This study is being done to extract any difference in the practice of two different PatentOffices and also the strategy of applicant with respect to different countries. If there isany change observed, same may be correlated with the provisions in nationalLegislations or any business strategy of applicants.

Methodology of Study No. 2:

Studies made with the help of official website of IPO India, www.ipindia.gov.in -.IPAIRS, JPO Japan-IPDL http://www.ipdl.inpit.go.jp/homepg_e.ipdl, and WIPO -PATENTSCOPE http://wipo.int/pctdb/en/index.jsp . Sample data were taken fromgranted patents at IPO India by Key word search for “A61K31/00” and then searchingthe status at IPDL Japanese edition for same PCT application No. with the help of APICand JPO officials. In most of the application it was not possible to assess the status inJapan. However there were few successes in this efforts and some application numbersprocured from local company, Daiichi Sankyo Pharmaceuticals for this study purpose.

Result and Discussion of Study No. 2: ………….Next Page

Result and Discussion of Study No. 2:

Results>



SNo

Key Attributes Remarks

1

PCT/JP2001/002041 WO/2001/068660

Title : GLUCOPYRANOSYLOXYBENZYLBENZENE DERIVATIVES, MEDICINALCOMPOSITIONS CONTAINING THE SAME ANDINTERMEDIATES FOR THE PREPARATION OFTHE DERIVATIVES

Applicant: KISSEI PHARMACEUTICAL CO., LTD.

IN 210799

Total Claims=3 ; Product- 2,Composition-1

JP,3773450,B

Total Claims=8; Product- 4,Composition-4

However the type ofclaims granted in both thecountries are of the similartype. Principle claim asgranted in India and Japanhave little languagedifference, substantivelythey are same.Composition claim asgranted in is havingpercentage range of theactive ingredients whilethe claim in JPO mentionsthe name of differentdiseases where inventioncan be used.

2

PCT/JP2000/005678 WO/2001/016147)

Title: GLUCOPYRANOSYLOXYPYRAZOLEDERIVATIVES, MEDICINAL COMPOSITIONSCONTAINING THE SAME AND INTERMEDIATES INTHE PRODUCTION THEREOF

Applicant: KISSEI PHARMACEUTICAL CO., LTD

IN226624 Total Claims=4:Product-3,Composition-1

JP,3989730,B Total Claims=10:Product-6,Comp-4

Substantively both thepatents are same, littlelanguage difference. Useclaim as granted in India isa single application claimwhile the claims in JPOare multiple for use indifferent diseases.



3

PCT/JP2003/008860 WO 2004/007471

Title: "N-PHENYL-(2R, 5S) DIMETHYLPIPERAZINEDERIVATIVE"

Applicant: YAMANOUCHI PHARMACEUTICAL CO.,LTD.

IN235798

Total Claims=3; Product=3

JP,4449746,B

Total Claims=8;Product= 6, Composition-1,Treatmentagent= 1

However the scope ofclaim for basic compoundin both the countries aresame under singleinventive concept but theother two claims differ indrafting language as pernational law In Japan oneuse claim as prostate-cancer-treatment agenthas been allowed inaddition.

4

PCT/JP1996/001145 WO/1996/033998

Title : PENTACYCLIC COMPOUNDS

Applicant: DAIICHI PHARMACEUTICAL CO., LTD.TERASAWA, Hirofumi SOGA, Tsunehiko ISHIYAMA,Takashi

IN 206962

Total Claims=26 ; All Compound and their salts

JP,03746563,B

Total Claims=24; All Compound and their salts

Broadly no differenceworth mention.

5 PCT/JP2001/010086 WO/2002/04047

Title : DEHALOGENO COMPOUNDS

Applicant: DAIICHI PHARMACEUTICAL CO., LTD.

IN 223158

Total Claims=34 ; Compound-33 Composition-1

JP,003711108,B

Total Claims=33; All Compound

Broadly no differenceworth mention.



6

PCT/JP2003/016783 WO/2004/058715

Title : DIAMINE DERIVATIVES

Applicant: DAIICHI PHARMACEUTICAL CO., LTD.

IN 220513

Total Claims=12 ; Compound-11 Composition-1

JP,04109288,B

Total Claims=24;Compound-20, composition-4

Broadly no difference.

In JPO claims specificcompound are mentionedwhile in India generalcompound name arementioned.

7

PCT/JP2002/01500 WO/2002/066465

Title : WATER-SOLUBLE TRIAZOLE FUNGICIDE

Applicant: SANKYO COMPANY, LIMITED.

IN 225491

Total Claims=31 ; All Compound and their salts

JP,03708884,B

Total Claims=31; All Compound and their salts

No difference as grated inJapan and India

8

PCT/JP2004/003048 WO/2004/081050

Title : ANTIBODY AGAINST TUMOR SPECIFICANTIGEN AS TARGET

Applicant: SANKYO COMPANY LIMITED

IN 228743

Total Claims=14 ; Compound-14, Composition-1

JP,0446294,B

Total Claims=24;Compound-20, composition-4

There is difference inclaims according tonational provisions. Claimsfor diagnostic methods arenot there in Indian Patent.



Discussion>

In general structure of claims claimed and granted in India and Japan is more orless similar except where the national provisions limit the invention. In few cases inIndia, it has been noted that composition claims have disclosure of percentage ofconstituents also. Use claims as in India are generally for single use of substance asmedicine while in Japan they are related with the different use of medicine for aparticular or different disease as the case may be. As usual in both the county, mostcase products are claimed with composition and method for preparation of such product.

Concluding Remarks of Study No. 2: There is no significant difference in claimsstructure and grant in both the country.



STUDY NO. 3

COMPARATIVE STUDY IN PUBLISHED PATENT APPLICATIONS

Analysis of Published Patent Application in Patent Office India: broadly twodifferent significant fields of inventions;

� For medical preparations containing organic ingredients, IPC Subclass A61K 31/00.

� For medical preparations containing of undetermined constitution containingmaterial from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditionalherbal medicines IPC Subclass A61K35/00,78 and 36/00

Objective of Study No 3:

The objective of this study is to understand the comparative trend of applicants,domestic vs. foreign in these two specific class of medical inventions by Indian PatentOffice and Japan Patent Office. This study may reflect any significant difference betweenthe two classes of inventions in medicines.


Sample data for India were taken from official website www.ipindia.gov.in IPAIRSfor published patent applications in the IPC field A61K31/00 as on 31st May 2010. Total463 applications were found to be published (18 month publication) in this IPC filed tillthis date. Similarly Search made for IPC A61K35/00, A61K35/78, and A61K36/00 andcombined the result obtained. Search results were copied in excel sheet to make studyeasy. Results were segregated for applicant’s type by recognizing on the basis ofknowledge and understanding of the researcher. There was no date range in case ofstudy from IPAIRS India Patent Office as the same could not be possible.

Sample data for Japan were taken from official website IPDL for published patentapplications in the IPC field A61K31/?from 1st January 2010 to 15th June 2010. Sampleshave been taken for this period as for larger period the results becomes more than 1000and IPDL does not displays the list in such case so as to provide other details like,publication no., title of application and applicant name. Total 949 numbers of patentapplications were found to be filed in this IPC filed in this period. List copied in excelsheet and analyzed for study of type of applicants as domestic and foreign. Similarly,search made for IPC A61K35/? and A61K36/? and combined the result obtained for thissecond kind of inventions. Search was done in IPDL Japanese version with the help oflocal people and Google translator. Step 1.> Select box ”Patent & Utility Model search”having picture of bulb and subsequent 3rd option for “Text Search” ; Step 2.>Nowselect(tick) first box for “Publication of patent applications (published, released, re-released)” on top and then in subsequent option for IPC in one of the “Select Search



Item �� and input the required IPC and then select option for “Publication date”��(17th from top) in second option and input date range 20100101:20100615.


Results> INDIA

(A) For medical preparations containing organic ingredients, IPCSubclass A61K 31/00.

(B) For Medicinal preparations of undetermined constitution containingmaterial from algae, lichens, fungi or plants, or derivatives thereof, e.g.traditional herbal medicines. A61K 35/00,78 and 36/00

(C) Overall ratio between filing in IPC A61K31/00 and A61K 35/00,78 and36/00.

Applicant Type Nos. % ageDomestic 241 52.05%Foreign 222 47.94%Total 463


IPC Nos % age

A61K31/00 463 56.40%

A61K 35/00,78 & 36/00 358 43.60%

Total 821



Results> JAPAN

(A) For medical preparations containing organic ingredients, IPCSubclass A61K 31/? “Publication Date” (20100101-20100615).

(B) For Medicinal preparations of undetermined constitutioncontaining material from algae, lichens, fungi or plants, or derivativesthereof, e.g. traditional herbal medicines. A61K 35/? and 36/?“Publication Date” (20100101-20100615).

(C) Overall ratio between filing in IPC A61K31/00 and A61K 35/? & 36/?.


Applicant Type Nos. % ageDomestic 370 80.0%Foreign 92 20.0%

Total462

(182+280)

IPC Nos. % ageA61K31/? 949 67.30%

A61K 35/?,36/? 462 32.70%

Total 1411



Discussion>

Results from India Patent office for type of applicant in medicines of organicingredients or say synthetic medicines for domestic and foreign applicants is 52% and42 % respectively. On analysis, it is observed that the proportion in domestic to foreignapplicant in IPC A61K31/00 is almost 1 : 1 and having small shift to domestic applicant.This equal presence of applicant and shift towards domestic applicant shows the goodpresence of domestic applicants in India.

Results for the medicines originated from natural products, traditional medicinesi.e., in case of invention for IPC A61K 35/00,78 and 36/00 from domestic and foreignapplicants is 72% and 28 % respectively. On analysis, it is observed that there is largerdifference in the proportion for domestic and foreign applicants i.e. 3 : 1. This positiveshift towards domestic applicants shows that in Indian domestic inventors are moreinclined towards traditional herbal medicines.

Overall proportion of these two types of inventions in medicine is 56% and 44%which is almost 1 : 1.

On analysis of results from Japan Patent office for type of applicant in medicinesof organic ingredients or say synthetic medicines for domestic and foreign applicants is60% and 40 % respectively. On analysis, it is observed that the proportion in domestic toforeign applicant in IPC A61K31/00 is almost 3 : 2.This shows the presence of goodnumber of domestic applicant similar the trend in India.

On analysis of results for the medicines originated from natural products,traditional medicines i.e., in case of invention for IPC A61K 35/? and 36/? fromdomestic and foreign applicants is 80% and 20 % respectively. On analysis it can beunderstood that there is good number of inventions of this kind of invention in Japan bydomestic applicants in comparison to foreign applicants.

Overall proportion of these two types of inventions in medicine is. 67% and 32%is i.e. 2 : 1. On analysis it can be understood that in Japan more and more inventionsare from the field of synthetic organic compounds.

Concluding Remarks of Study No. 3:

In addition to synthetic chemistry and combinatorial chemistry, India should try tocapitalize its natural resources in order to find New Chemical Entities (NCEs) byvalidation of traditional medicines with the help of modern science and creation ofinventions/patents and also research for New Biological Entity (NBEs).



For right balance between NCE and NBE research is probably needed.

As such there is no difference between trend in India and Japan.

STUDY NO. 4

PATENTING IN INDIA BY LEADING JAPANESE PHARMACEUTICAL COMPANIES:


The objective of this study is to understand the trend and presence of domesticindustries of Japan in India.


Sample data for India were taken from official website IPAIRS52 of Patent officeIndia. Published patent applications (18 month publication u/s 11 (A) of Indian PatentAct) and granted patents (Publication u/s 43(2) of Indian Patent Act) were taken bysearch. Company name with starting word Like Mochida, Takeda and Daiichi …so on,were used as Key Word for searching.


Results>

Filing of Patent Application and Grant of Patent at Patent Office India :

Takeda Astellas DaichiSankyo

Roche-Chugai

Eisai DainipponSumitomo

PatentApplicationFiled#

90 106 89 42 120 30

PatentGranted*

100 45 124 12 33 35

# (Since 1995) * (Including filing prior to 1995)

52 www.ipindia.gov.in



Discussion>

All top Japanese pharmaceutical industries are filing a good number of patentapplications in India. This shows the presence and interest of Japanese pharmaceuticalindustries in Indian market.


It is good to have a competitive advantage by the presence of Japanesepharmaceutical industries in India. Presence of foreign companies predicts possibilitiesfor technology transfer and economic development.



STUDY NO. 5

STATISTICAL ANALYSIS OF PHARMA PATENTS GRANTED INDIA:

Post Product Patent in the field of Pharmaceuticals - 2005-2010


The objective of this study is to understand the trend of kind ofpharmaceutical patents granted in India as mentioned in the title of the patentapplications. This study is significant to have some reflections on the existing practicesat Patent Office India with regard to some overseas concerns as to explanations inSec.3 (d).


Sample data were taken from official website of Patent Office India, linkfor “Revised list of Pharma Patens”53, posted on 28th July 2010 (Total= 3488). Copiedpdf file was searched by “open full Reader Search” option for various key words asindicated in results.


Results>

53 http://www.ipindia.gov.in/iponew/Patent_PharmaProduct_2005_06_2009_10.pdf



Types of Applicants:

S No Applicant Patents Granted Percent

1 Foreign 2654 76 %

2 Domestic834

(Total 3488- Foreign 2654)24 %

Major Field of Inventions as mentioned in Title:

SNo

Field of InventionNumber of Patents

GrantedRemarks

1 Composition/Formulation 1248 <975 +173 >>

2 Compound/Product 746 <732+14 >

3Formula (Includes.compound)

422

4Process + Method ofManufacture

491<314+177 > Includes

derivative ,formula,composition and compound)

Various Aspects/Forms of inventions as in Title:

SNo

Type Patent S No Type Patent

1 Polymorph 13 9 Derivative 605

2 Salts 88 10 Complex 15

3 Ester 11 11 Use as application 263



4 Ether 16 12 Treatment as application 181

5 Pure Form 4 13 Cancer related 48

6 Isomer 6 14 HIV related 21

7

Particle size 13

15Herbalproduct/composition

59 (64%Indian

Individuals)

8 Mixture 7

Discussion>

It seems that good number of product patents (746) have been granted since2005, the year of implementation of provision for product patent in the field of medicinein Indian Patent Act. Also patent are being granted in various forms, salts andpolymorphs as explained in Section 3(d) India for patentability.

Concluding Remarks of Study No.5:

Patents are being well granted in India on the subject matter asmentioned in section 3(d) for patentability of “new form of known substance” andexplanation part of section 3 (d) for same substance, fulfilling the requirements of the Act



STUDY NO. 6

PATENTS GRANTED EXTENSION OF PATENT TERM IN JAPAN:

(Article 67(2) of Japan Patent Law)


The objective of this study is to understand the trend and utilization of theprovision for extension of patent term by Japan pharmaceutical industries.


Studies of the subject matter for Japan were made with the help official websiteof JPO for data search, i.e. IPDL54. Sample data were taken for Patents grantedextension in the year 2009 and July 2010.Japanese version of IPDL used for thispurpose. Proceeded first to main window and selected the option horizontally 3rd, justbelow the box having picture of electric bulb and select no.2 in subsequent dropdownoption. Further in succeeding window selected 8th option from top in first drop down box> Now inputted the dates for any particular one month YYYYMMDD and then click thebutton below the date window. We got the number of hits displayed on top, by clicking

54 http://www.ipdl.inpit.go.jp/homepg_e.ipdl



adjacent button to numerical of hits , the details displayed for patent applications grantedextension of patent term in that particular month. Likewise studies done for all themonths and total numbers collected. Further studies can be done by taking no. ofapplication and patent no. from these results.


Results> Data for the Year 2009 and 2010 May are given below.

Year No of Patents Year No of Patents

Jan 2009 8 Jan 2010 38

Feb 2009 6 Feb 2010 11

March 2009 13 March 2010 7

April 2009 15 April 2010 24

May 2009 8 May 2010 0

June2009 5 June2010 0

July 2009 36 July 2010 0

Aug 2009 3

Sep 2009 10

Oct2009 30

Nov 2009 9

Dec2009 20

Total 2009 163



Discussion>

There are several instances where patent applicants have made request andsubsequently granted extension of patent term in pharmaceutical patents.


The extension of patent term is well in practice among Japanese InnovatorPharmaceutical Industries.

India may consider the provision for Patent Term Extension as motivation toInnovator Pharmaceutical Industries.

STUDY NO. 7

WEB SEARCH FOR NEW CHEMICAL ENTITIES INTRODUCE BY INDIAPHARMACEUTICAL INDUSTRIES:


The objective of this study is to understand the trend in creation of productinvention as New Chemical Entities (NCE) by India pharmaceutical industries.


Simple web search was done for various possible key words like “NCE by India” ,New Chemical Entities from India,(by India)”,”New drugs/medicine from India” so on.

Results and Discussion of Study No 7:

Result> Followings are the compilation of useful result of studies:

SN

Company Compound Brief Reference

1 Ranbaxy(Daiichi-Ranbaxy)

Jan 2010

Lulifin(Luliconazole)

Dermatological segment

Ranbaxy Laboratories Limited (Ranbaxy)announced today that the Company haslaunched a New Chemical Entity (NCE),Lulifin (Luliconazole), in the IndianDermatology market. This follows a strategicin-licensing agreement with SummitPharmaceuticals International Corporation,Japan (SPI) allowing Ranbaxy, exclusivemarketing rights, for India, The introduction ofthis NCE, significantly strengthens Ranbaxy’’s

http://www.dancewithshadows.com/pillscribe/ranbaxy-bolsters-dermatology-portfolio-by-launching-mycoses-anti-fungal-



presence in the Dermatological segment,Mr. Sanjeev Dani, Si”. Viet President &Regional Director –Asia, CIS & Africa,Ranbaxy, said, ‘’it is well recognized that inthe post product patent era, licensing wouldbe the key strategy to bring New ChemicalEntities to India, “We would be manufacturingthe product in India under licence from SPI,Japan.”http://www.asia-manufacturing.com/press-627-ranbaxy-nce-summitpharmaceuticals-dermatologicalsegment-press5.html

luliconazole-lulifin-in-india/

2 NicholasPiramal Ltd

March 2010

Tinefcon,


Remedy forPsoriasis

Piramal Life Sciences scientists discoveredthe efficacy of Tinefcon against psoriasis fromas part of its ongoing phytopharmaceuticaland NCE development programme.

Plant based compoundhttp://www.dancewithshadows.com/pillscribe/plant-based-psoriasis-drug-tinefcon-safe-in-human-trials-says-piramal-life-sciences/

http://www.tinefcon.com/

3 Biocon

Nov. 2010

INSUGENTM

a bio-insulinfirstrecombinanthuman (r-DNA) insulin

INSUGENTM, the new generation bio-insulinwas launched by Biocon Limited, India’s premier Biotechnology company onNovember 10, 2004.

http://www.biocon.com/insugen/insugen.html

4 CadilaPharmaceuticals Ltd

Oct 2009

Risorine

Tuberculosis

Prime Minister Manmohan Singh will unveil anew anti-tuberculosis (TB) drug developed byIndian scientists next week. The drug, knownto be more effective than existing therapies,has been developed by Indian Institute ofIntegrative Medicine (IIIM), Jammu, after 12years of research. Ahmedabad-based CadilaPharmaceuticals will market the medicineunder the brand name “Risorine”.

http://sify.com/topics/Risorine-1.html

http://www.orissatv.com/NewsDetail.asp?newsId=NS12002

5 Dr. Reddy’sReasearchFoundation

April-May2007

Reditux™(Rituximab) –World’s firstbiosimilar of amonoclonalantibody

Dr Reddy’s Laboratories has announced thelaunch of Reditux (its brand of rituximab), amonoclonal antibody (Mab) used in thetreatment of non-hodgkin’s lymphoma.Reditux is the second product from thecompany’s biologics division and isapproximately priced at half the originator’sprice. Product availability is planned atcompany’s C&F agents and at all majorhospitals in the country.http://www.pharmabiz.com/article/detnews.asp?Arch=&articleid=38634&sectionid=45

http://findarticles.com/p/articles/mi_m0EIN/is_2007_April_30/ai_n19041663/

6 Dr Reddy’sReasearchFoundation

Aug 2007

Blaglitazone(DRF 2593) –

India’s mostadvancedNCE

Dr.Reddy’s Lab. Out licensed Balaglitazone toDanish Pharma major Nova Nordisk in 1997to subside risk as well as cost involved in it.But immediately after out licensingBalaglitazone, Dr.Reddy’s lab came up withanother superior lead molecule in the same

http://www.pharmainfo.net/abhi271183/story-balaglitazone-



Anti-diabeticsegment

category i.e. Ragaglitazone, which waslooking more promising than Balaglitazone ashaving similar action to Balaglitazone inaddition to lipid reducing capacity

How Dr Reddy’s chased diabetes moleculedream9 Aug, 2007, 0545 hrs IST,Noemie Bisserbe,TNN

Last week’s announcement by Dr Reddy’sLaboratories (DRL) that its anti-diabetesmolecule Balaglitazone has entered the finalphase of clinical development is not just amilestone in an Indian company’s journey tobecome a drug innovator, but also a strongcomeback for a molecule that often stood atthe doorstep of obscurity.

india%E2%80%99s-first-nce

http://www.diabetesforums.com/forum/type-2-diabetes/20915-balaglitazone-and-ragaglitazone.html

7 Wockhardt

1998

Mitotax(Paclitaxel)

Anti-cancer

Dr. Reddy’s Laboratories (DRL) has launchedits first anti-cancer drug Mitotax (Paclitaxel).The product is produced in-house atDr.Reddy’s Research Foundation (DRF) fromthe extracts of the yew tree and formulated ina dedicated facility in Hyderabad.

http://www.moneycontrol.com/stocks/company_info/company_history.php?sc_did=DRL

8 Wockhardt WCK 771- is abroad-spectrumantibiotic,which hasproveneffective intreatingdiversestaphylococcal infectionslike MRSAand VISA.

The New Drug Discovery team atWockhardt has developed a number of leadmolecules mainly in the anti-infective field,that are currently in various stages ofdevelopment.

The most advanced of these New ChemicalEntities (NCEs) is WCK 771 that hascommenced Phase II human clinical trials.WCK 771 is a broad-spectrum antibiotic,which has proven effective in treatingdiverse staphylococcal infections like MRSAand VISA.

http://www.wockhardtin.com/new_drug.html

9 Wockhardt WCK 1152, toRespiratorytractinfections,includinghospital-acquiredinfections.

WCK 1152, a promising lead molecule to treatrespiratory tract infections, including hospital-acquired infections, is undergoing Phase Iclinical trials.

http://www.wockhardtin.com/new_drug.html

9 NicholasPiramal Ltd

March 2010

Tinefcon,


Piramal Life Sciences scientists discoveredthe efficacy of Tinefcon against psoriasis fromas part of its ongoing phytopharmaceuticaland NCE development programme.Plant based compoundhttp://www.dancewithshadows.com/pillscribe/

http://www.tinefcon.com/



Remedy forPsoriasis

plant-based-psoriasis-drug-tinefcon-safe-in-human-trials-says-piramal-life-sciences/

Discussion>

There are instances of introduction of NCE in India by domestic industries.

Conclusion of Study No 7:

Indian pharmaceutical industries have capability and interest in creation of NewChemical Entities (NCE)

STUDY NO. 8

MEETING WITH THE PHARMACEUTICAL ASSOCIATION:

THE JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION (JPMA)55:


This study has been made with the objective of understanding the concern ofJapanese pharmaceutical Industries and any other topical issue in this field.


There was an informal meeting with the members of The Japan PharmaceuticalManufacturers Association (JPMA), Tori Nihonbashi Building, 3-4-1 Nihonbashi-Honcho,Chuo-Ku, Tokyo on 2nd July 2010Mr. Yuji WATANABE, Ph. D. Chairman, IntellectualProperty Committee, JPMA

Director of Intellectual Property, JPMA and Director of International AffairsDepartment, JPMA participated in discussion.


55 http://www.jpma.or.jp/english/



� Specific concern of Japan’s pharmaceutical industry with respect to practicingThe Indian Patent Act by Indian Patent Office.

• Section 3(d), 25(1), 107(A) and Section 14 of The Patent Act, 1970 of Indiawere the main provisions raised in this discussion.

• It was mentioned that IP practitioners of Japan are not very clear about theobservation of Section 3(d) and how the efficacy is being assessed by Indianexaminers in the patent specification.

• As Novartis patent on new form of Glivec is granted in Japan and rejected inIndia JP IP practictioners observe it as the difference between the two offices.

• Necessity for incorporation of some typical examples in examinationguidelines is felt for making the issue more clearly to IP practitioners.

• Issue regarding the delay in disposal of pre-grant opposition u/s 25(1) ofIndian Patent Act discussed.

• In Section 107(A) (b), excluding the act of “importation of patented productsby any person from a person who is duly authorized under the law to produceand sell or distribute the product” from the ground of infringement is creatinga fear/doubt in the mind of IP practitioner of Japan for strongly enforcing theirpatent rights in India. It is submitted that they are not sure about the term“under the law”.

• Provisions provided in Section 14 and 15 for providing hearing andreasonable order is not always strictly practiced uniformly.

• Use claims as second medical use should be recognized as inventive step inIndia.

• There should be provision for patent term extension for medical inventionrequiring introduction of new drugs in the market.


There are few issues with the Japan Pharmaceutical Industries whichrequires attention by Indian authorities.



STUDY NO. 9

MEETING WITH THE PHARMACEUTICAL INDUSTRIES:

DAIICHI SANKYO CO., LTD.56


This study has been made with the objective of understanding the concern ofthe applicant as Japanese pharmaceutical Industries on this topical issue.


There was an informal held on after noon 18th Aug., 2010 at Daiichi Sankyo Co.Ltd., Kasai R & D Center, Edogawa-ku Tokyo Japan. The General Manager, IntellectualProperty of Daaichi Sankyo has participated in the meeting with some other colleguefrom Lead Discovery & Optimization Research Laboratory.


56 http://www.daiichisankyo.com/



Situation of Daiichi Sankyo Pharmaceuticals Ltd. with respect to status of PatentApplications in India in comparisons to others countries:

Patent Granted /Rejected/Withdrawn:

India JapanType

Grant Rej/AbdTotal

Grant Rej/Abd PendTotal

Compound 12 2 14 10 1 3

Use 2 2 2

Salt 1 1 1

Crystal 3 3 2 1

Composition 2 2 1 1

Formulation 3 1 4 3 1

Micro body 0

Bioproduct 0

Others 8 8 6 2

Total 28 6 34 9

US EP TotalType

Grant Rej/Abd Pend

Total

Grant Rej/Abd Pend

Compound 10 2 2 14 7 1 6

Use 1 1 2

Salt 1 1 1

Crystal 3 1 3 1 2

Composition 1 2 3 2

Formulation 1 1 2 3 1

Micro body 0

Bioproduct 0

Others 8 8 5 3

Total 25 3 5 32 21 1 12



Reason for Rejection/Withdrawn:

Type 2-l 2-j 3-c 3-d 3-e others Total

Compound 1 1 1 1 4

Use 1 1 1 1 4

Salt 0

Crystal 0

Composition 0

Formulation 0

Micro body 0

Bioproduct 0

Others 0

Total 0 2 2 2 2 8

• Daiichi has very strong history of discoveries by Dr. Jokichi Takamine, ofdigestive enzyme Taka-Diastase in 1899 and Dr. Umetaro Suzuki of VitaminB1from rice bran in 1910, Daiichi is committed to realization of its goal to become“Global Pharma Innovator” in near future.

• Daiichi has state of art laboratory in the field of Lead Discovery & OptimizationResearch and Structure Based Drug Design” (SBDD) activity.

• As discussed with the general Manager, IP Daiichi Sankyo, there is no specificissue with regard to practicing Patent Act,1970 of India by IPO India.

• However concern shown over the uncertainty in disposal of pre-grant oppositionu/s 25(1) of The Patent Act, 1970, of India.

• Situation of Daiichi Sankyo Pharmaceuticals Ltd. with respect to status of PatentApplications in India in comparisons to others countries was discussed andunderstood.




There is no significant practical problem from the pharmaceutical industries withregard to practicing the “The Patent Act, 1970 As Amended” by IPO India. Someconcerns are there which are related to the provisions in the Act not with the practicingthe existing Act.

STUDY NO. 10

PATENTING TREND IN NOVEL DRUG DELIVERY SYSTEM IN INDIA


This study has been made with the objective of understanding the trend in thisnew and emerging field of technology related with the medicines.


Sample data for this study were taken from official website IPAIRS57 of Patentoffice India. Published patent applications (18 month publication u/s 11 (A) of IndianPatent Act) and granted patents (Publication u/s 43(2) of Indian Patent Act) were takenby searching with the key word ”drug delivery”.


57 www.ipindia.gov.in



.

Novel Drug Delivery System (NDDS) seems as definitely viable, cost effectiveand takes shorter time to achieve goal, is an immediate option for larger Indiancompanies than NCE development with its long-term gestation. As in India and otherdeveloping countries a large number of diseases are still prevailing which needs a longterm and controlled medication therapy and hence there is an immense need to developsafe and effective drug delivery system for such diseases. NDDS in conventional dosageforms like controlled and predictable release, lesser chances of dose dumping, reductionin frequency of administration, have greater advantage in minimization of side effects,etc.

Concluding Remarks Study No. 10:

There is a need for improved interaction among industry, academy, medicalprofession, and government for India to be one of the leading countries in NDDS.

======= End of Chapter VII ===========

CHAPTER VIII

CONCLUSIONS AND RCOMMONDATIONS

Conclusions:–

In the light of the studies of legislative provisions and analysis of varioussignificant developments of patenting in the field of pharmaceuticals made, it can beconcluded that the hypothesis made proves truth.

“The Transformation of the national patent regime in the field of pharmaceuticalshas catalyzed the domestic research and development in medicine and public healthcare and new molecules are coming-up keeping the pace for generic drug manufacturingand there is larger scope of business relation in this field of pharmaceuticals betweenIndia and Japan.”

Patent Application Domestic Foreign Total

Published 102 (38%) 167 (62%) 269

Granted 28 (45%) 34 (55%) 62



Summary:– • In general claims granted in India and Japan are more or less similar except

where the national provisions limits the invention.• Product invention in medicines is good in Japan and requires improvement in

India.• As usual in the practice most case products are claimed with composition and

method for preparation of such product.• In Japan dependent claims include various salts of basic compound. In India

product claims usually include wording are like “and pharmaceutical acceptablesalts”. JP4443928 B

• In some patents composition is more definitive as granted in India.• In Japan dosage form are claimed JP, 4444375,B which is not a practice in

India.• In Japan use of invention is claimed as to treatments of specific or different

diseases is claimed. JP,4444290,B. In India such claims are not granted, anormally single use claim which is not so specified is noted.

• In Japan method of treatment of disease is also noticed. JP4443935,B

Suggestions and Future Work:–

� India needs to strive hard to secure the necessary progress in the area of drug

discovery and development by domestic industries/institutions. It has to be

realized that drug discovery and development is a highly specialized and

multidisciplinary activity and requires vigilant positive policy decisions.

� There is a need for the data protection of information provided by the innovator

company to the Govt. for approval of drug introduction in the market in India by

making the necessary provisions/regulations for data protection.



� There is a need for linking the marketing approval of new drugs with their patent

status in India. This can be achieved by providing the patent extension term

beyond the normal period in The Patent Act.

� There is need to attend the concerns of oversea users of intellectual property

about few provision of The Patent Act,1970 of India. In Section 3 (d) word

“efficacy” and in Section 107(A)(b) word “under the law” be made more

elaborative.

� There is need for creating suitable IP- Networking between stakeholders, like

academia and research laboratories in Public-Private Universities and highly

skilled professionals and infrastructures in Public-Private Industries for economic

and social development of India.

� This is the best way to utilize the immense potential of India to become

Global Pharmaceuticals Innovator. Proposal of “The Protection and Utilization

of Public Funded Intellectual Property Bill, 2008” is right step towards this goal.

� There is untapped scope in the area of NDDS.There is a need for improvedinteraction among industry, academy, medical profession, and government forIndia to be leaders in NDDS.

======= End of Chapter VIII ===========

Some Other Useful Reference

SN Title Web Link/Publisher

1 Negotiating Health: Intellectual Property andAccess to Medicines, Edited By: PedroRoffe,Geoff Tanse and David Vivas-Eugi

Pub: Earthscan UK

ISBN 1-84407-295-9

www.earthscan.co.uk



2 Patents for Chemicals, Pharmaceuticals andBiotechnology: Fundamentals of Global Law,Practice and Strategy, Vth Edn.By: Philip W.Grubb and Peter R. Thomson

Pub: Oxford Univ PressISBN 978-0-19-957523-7

Industrial Propert in The Bio-Medical AgeChallenges for Asia, Editors: Christopher HeathAnselm Kamperman Sanders

Kluwer Law International

ISBN 90-411-9926-8

Patents on Biotechnological Inventions

>>>>>>>End of the Document (Ovaari)<<<<<

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