IPR

SAURABH

NATASHA

SWATI

PATENTS

COPYRIGHT

TRADEMARKS

INTELLECTUAL PROPERTY

Natural object becomes a resource when it satisfies a human want

A resource possessed and owned becomes a property

Intellectual property is an idea, design, invention and manuscript which ultimately gives rise to useful product/application development such a property as a rule requires intellectual inputs and innovativeness

• Major problem with intellectual properties is they can be copied, imitated or reproduced which minimizes the returns to the original inventor

• The right of an inventor to derive economic benefits from his invention this right is called intellectual property right. The intellectual property right is recognized by governments

PROTECTION OF INTELLECTUAL PROPERTY RIGHTS

Main forms of Intellectual property rights protection are as follows

[1] PATENTS

[2] COPYRIGHTS

[3] TRADEMARKS

PATENTS A Patent is the legal right granted by a government

to an inventor to exclude others from imitating, manufacturing and selling the invention in question for commercial use during specific period

Patents are granted for

[1] INVENTION

[2] INNOVATION

[3] PROCESS/PRODUCT

[4] CONCEPT

PATENT EXPIRES AFTER 20 YEARS AND ONCE THE PATENT IS EXPIRED IT CANNOT BE RENEWED

PATENT REQUIREMENTS

Chief requirements for grant of a patent are as follows

[1] Novelty. The invention should be new and should not be known to the public

[2] Inventiveness. Every invention which requires a patent should represent an innovation

[3] Industrial application and usefulness. Subject matter of the patent must have industrial application, either immediate or in the future, and this application should be useful to the society

[4] PatentabilityThe subject matter of the patent must be patentable under the existing law. According to Indian patent act 1970 no product patents were allowed in Pharmaceuticals, food and agrochemicals but now according to new Indian patent act 1999 it allows product patents  [5] DisclosureInventor is required to describe his invention in sufficient detail so that person of normal skill is able to reproduce it. In case of biological entities already known organisms may be simply named but if it is genetically modified nature and the method of modification should be described fully

Patent Infringement

Making, Using or selling a patented invention (product or process) without the permission from patent owner is Infringement

Infringement suit can be filed only after patent is issued

Relief from infringement includes Fine

Types of patent infringement

DIRECT INFRINGEMENT

It directly states that third party has willfully or intentionally stole the technology from the inventor without his prior permission

It occurs when someone directly makes, uses or sells the patented invention within the united states

INDIRECT INFRINGEMENT

It refers to the unfair practice that does not give the clear indication that the patent is bought and sold in the market

It occurs when a device is claimed in patent and third party supplies a product used to make claimed device

Limitations of patent

Two basic limitations of patents

[1] Limitation of time – A patent is valid for a specific period of time from the date of its award and this period is of twenty years

[2] Limitation of space – A patent is valid only in the country of its award and not valid in other countries

PROCEDURE OF PATENTING [1] An inventor files a properly prepared application with the

patent office of the concerned country

[2] This application is scrutinized and assessed by patent officials , if it is found not suitable for patenting then it is returned to the inventor along with the reason therefor inventor may withdraw the application modify and resubmit it or submit it with an explanation of the objection raised by patent office

[3] If an application is considered suitable for patenting the invention along with the adequate details is published for the information of all concerned in India this is done 18 months after filling the application

CONTINUE [4] Anyone who wishes to challenge the award of

patent can do so within a specific period of time [within four months in India]

[5] When patent application is not challenged the patent is awarded immediately after the expiry of this period and it is sealed

[6] But if a patent is challenged, the argument and counterarguments of both the applicant and the person challenging the application are heard by a competent authority of the patent office and final decision is taken on the award of patent

PATENT CASES

Turmeric patentIn 1995 a patent was granted in USA for use of turmeric in connection with healing of surgical wounds and gastric ulcer In 1997 US to revoked this patent on the ground that use of turmeric in treatment of wounds was part of traditional Indian medical knowledge

Neem patent

Neem tree has multiple uses having medicinal value, food, and pesticide as well as in cosmeticMore than 500 million Indians use neem stick to brush the teeth2000 years old Indians texts describe the several properties of neem In spite of this dozens of patents were filed in USA and EuropeIn Europe patent owned by W.R.Grace & Co, for fungicidal effects of neem oil was revoked on ground of prior art and that it lacked inventive step In USA patent for stable neem formulation obtained by same W.R.Grace & Co was protected

AstraZeneca vs Mylan Omeprazole patent litigation

Omeprazole was difficult to formulate because it is acid labile scientist of AstraZeneca developed a formulation that protects Omeprazole from degradation in the acidic environment of the stomach formulation of AstraZeneca claimed in the US patent includes a core containing Omeprazole and alkaline reacting compound a water soluble coat and outer enteric coating

Mylans product consist of an inert sugar/starch sphere an active coating of omeprazole ,talc and HPMC two sub coatings and enteric coating

ASTRA’S ARGUEMENT Astra argued that talc in Mylans formulation contains carbonates which serves as an alkaline reacting compound

DECISION BY COURTIN court AstraZeneca failed to prove presence of carbonates in Mylans productThe court also determined that the talc cannot satisfy the Alkaline reacting compound limitation. Therefore no infringement

India revokes patent for GSK’s cancer drug

• The patent on lapatinib ditosylate salt marketed by GlaxoSmithKline as Tykerb was revoked as the product was merely a new form of a known substance, said Dominic Alvares, lawyer with S. Majumdar & Co, representing Fresenius.

• The patent-protected period on this revoked salt was to expire in mid-2021, a Fresenius official said.

• Fresenius had challenged both GSK’s patents on lapatinib and its salt before the Intellectual Property Appellate Board. But the challenge on GSK’s base compound, lapatinib, was unsuccessful and so its patent protection continues till it expires in January 2019.

• Explaining the significance of the development, R. Sankaran, Fresenius Kabi’s Vice-President (Intellectual Property Management), said interested generic companies are free to manufacture and distribute this product, but after the patent protection on the basic salt expires in 2019.

DisappointedMeanwhile, GSK said it was studying the IPAB’s decision. Maintaining the inventiveness of lapatinib ditosylate salt, GSK said it would consider taking further steps before the appropriate authorities to validate its product. Shamnad Basheer, an intellectual property expert, said that the decision was fair, and in line with earlier decisions where genuine innovations are protected.

The Tykerb case is the latest in a string of patent-related cases in India

NOVARTIS GLIVEC PATENT

CASE

In a landmark judgement, India’s Supreme Court rejected a patent plea by Swiss drug maker Novartis AG for cancer drug Glivec, boosting the case for cheaper drugs for life-threatening diseases. Glivec was seen as being one of Novartis’ flagship drugs, and a crucial weapon in the fight against cancer.

FACTS ABOUT GLIVEC

Glivec is a medicine discovered and developed by Novartis for the treatment of chronic myeloid leukemia (CML), a cancer of white blood cells and for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor

Glivec is one of the first cancer drugs that validate rational drug design, based on an understanding of how some cancer cells function. These molecularly targeted drugs are different because they target abnormal proteins that are fundamental to the cancer itself

Glivec, used in treating chronic myeloid leukemia and some other cancers, costs a patient about $2,600 (Rs 1,30,000) a month. Its generic version was available in India for around $175 (Rs 8,750) per month, reported Associated Press. The medicine is the lifeline for poor in many developing countries.

Novartis had argued that it needed to new patent to protect its investment in the cancer drug Glivec while activists said the company was trying to use loopholes to make more money out of a drug whose patent had expired

Glivec has been patented in nearly 40 countries but only faced problems in India. The drug was given exclusive marketing right by the Indian patent office in the year 2003, which was for the duration of 5 years. Later, Novartis sued Ranbaxy and Cipla before the High Courts of Madras and Bombay for making the generic versions of Glivec. Novartis has fought a legal battle in India since 2006 for a fresh patent.

COPYRIGHT

"Copyright" is a protection that covers published and unpublished literary, scientific, and artistic works, whatever the form of expression, provided such works are fixed in a tangible or material form.

This means that if you can see it, hear it, and/or touch it-- it is protected.

What can be copyrighted

Anything tangible – in a fixed form Examples

Literary works, including softwareMusical works, including accompanying wordsDramatic works, including accompanying musicPantomimes and choreographic worksPictorial, graphic and sculptural worksMotion pictures and other audiovisual worksSound recordingsArchitectural works

WHAT IS NOT COPYRIGHTED

Works that have not been fixed in a tangible form of expression; for example, improvisational speeches or performances that have not been written or recorded.

Titles, names, short phrases and slogans; familiar symbols or designs; variations of typographic ornamentation, lettering or coloring; listing of ingredients or contents.

Ideal procedures, methods, systems , processes, concepts, principles, discoveries, or devices, as distinguished from a description, explanation or illustration.

COPYRIGHT AND THE INTERNET

Everything on the Internet is copyrighted

World Wide Web pages

Courses

Electronic mail, listservs and newsgroups

The same copyright laws apply to electronic materials as to print materials

RIGHTS COVERED UNDER COPYRIGHT

RIGHTS OF TRANSLATION

RIGHTS OF PERFORMANCE

RIGHTS OF REPRODUCTION

MOTION PICTURE RIGHTS

BROADCASTING RIGHTS

These rights can be transferred,assigned,licensed for economic benefits

INTERNATIONAL COPYRIGHTPROTECTION

Copyright protection rules are fairly similar worldwide, due to several international copyright treaties, the most important of which is the Berne Convention. Under this treaty, all member countries -- and there are more than 100, including virtually all industrialized nations -- must afford copyright protection to authors who are nationals of any member country. This protection must last for at least the life of the author plus 50 years, and must be automatic without the need for the author to take any legal steps to preserve the copyright.

INTERNATIONAL COPYRIGHTS PROTECTION

In addition to the Berne Convention, the GATT (General Agreement on Tariffs and Trade) treaty contains a number of provisions that affect copyright protection in signatory countries. Together, the Berne Copyright Convention and the GATT treaty allow U.S. authors to enforce their copyrights in most industrialized nations, and allow the nationals of those nations to enforce their copyrights in the U.S.

DURATION OF PROTECTION

For books and other works of arts it is 50-70 years after the death of author

For photographic works 25 years from making the work

For cinematic works 50 years after making the work available to public

TRADEMARKS

DEFINE TRADEMARK

A trade-mark is a word, design, number, two-dimensional or three-dimensional form, sound or color, or a combination of two or more of these elements which a trader uses to distinguish his/her products or services from those of his/her competitors and serves to establish goodwill with the consumer.”

IMPORTANCE OF TRADEMARK REGISTRATION

EXCLUSIVE RIGHTS – Registered trade marks owners have exclusive rights to use their marks in trading they also rights to make legal action for infringement under trade mark law against others who use their marks without consent

LEGAL EVIDENCE – Registration certificate issued by registrar office is a prime evidence of trademark ownership . A certificate of registration serves as an important document to establish ownership of goods exported to other countries

DURATION OF REGISTRATION

Trademark registration is valid for ten years from the date of application and may be renewed every ten years

PHARMACEUTICAL TRADEMARK

WHAT PHARMACEUTICAL BRANDS ARE REGISTRABLE IN INDIA

All brands used in the trade are not registrable. The trademark law does not provide for the registration of all brands used in trade and business. Brands those satisfy certain requirements are only registrable.

Therefore a brand which satisfies the prescribed requirements could be registered.

1.The Pharmaceutical brand should be capable of being represented graphically.

2. The Pharmaceutical brand should be capable of distinguishing the goods or services of one from those of others.

3. The Pharmaceutical brand must be used in relation to goods or services for the purpose of indicating or so as to indicate a connection in the course of trade between the goods and services.

BRANDNAME REGISTRATION PROCEDURES

BRAND NAME SEARCH

FILLING OF BRAND NAME REGISTRATION APPLICATION

EXAMINATION OF BRAND NAME REGISTRATION

PUBLICATION OF MARK IN TRADEMARK JOURNAL

TRADEMARK REGISTRATION

Brand nameBrand Name is other name of Trademark. Brand Name Registration in India governed by the Trade Marks Act, 1999 & Trade Marks Rules, 2002 (and amendments thereof). The Trademark Act & Trademark Rules seeks to provide for the registration of Brand Name relating to goods and services in India. The rights granted under the Act, are operative in the whole of India.

The trouble with product trademarks in the pharmaceutical industry, but what would be life without them ?  

• Medication errors

• Consumer choice

• Drug monitoring  

THANKYOU