s.3(d) of patents act, 1970- issues and controversiesaphrdi/2016/11_n… · •all limited in point...

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S.3(d) of Patents Act, 1970- Issues and controversies By Dr.D.T.Mohan Krishna Associate Professor Pendekanti Law College Hyderabad

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S.3(d) of Patents Act, 1970-Issues and controversies

ByDr.D.T.Mohan KrishnaAssociate Professor

Pendekanti Law College Hyderabad

IP Laws as a response to a public goods problem

• Introduction of IPRs transforms the protected subjectmatter from a public good into a private good andthereby enhances the production of technology andother knowledge goods.

• Public goods – non- rivalry and non-excludability in nature

• Non-rivalry means that consumption of a givencommodity bay an additional person does not add anycosts to it provision.

• Non-exclusive means that once provided, nobody can be excluded from their benefits.

Nature of IPRs

• All IPRs are incorporeal in nature

• All IPRs have an in-built sunset (except Trademarkrights)

• All limited in point of time – with variations for each category of rights

• Trademark rights are perpetual in point of timesubject to certain exceptions (genericide &Non-Use)

• IPRs involves creativity except Trademark

• All IPRs are subject to certain limitations andexceptions

Classification ofIntellectual Property

Industrial Property

Industrial Property

Literary Property

Patents

Trademarks

Industrial designs etc.

IPRs Duration of Protection Registration(Private Domain)

• Patent 20 years Compulsory• Plant Protection 18/15 years Compulsory

• Copyright Life & 60 years Optional• Trademark 10 years & renewable Optional• Designs 10+5 years Compulsory• Trade secrets As long as kept No registration• Integrated Circuits 10 years Compulsory• Geographical Indications 10 years + renewal Compulsory

Patents

• Protect inventions

• Inventions-Novel, Useful & Non-obvious

• Term of Protection-20 Years

• Product & Process patents-Indian Position

• Availability-National & International Protection

• Rights-Not absolute

• Tools of business

Inventor/

Investor

Incentives

Public Domain

Invention

Patent

Patent RegimeGive and Take

Progress of Science and

Technology

Invent

Invest

Disclose

Design

Around

INVENTIONS

Subject Matter

Usefulness

Novelty

Non-obviousness

Specification

PATENTS

Kalyan’s Patent

Filter Model

Subject matter of Patent protection & TRIPS Obligations

Article 27: TRIPS Agreement :Patentable Subject Matter(1):1) Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new(3), involve an inventive step(4) and are capable of industrial application(2).

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

Subject matter of Patent protection & TRIPS Obligations

2) Members may exclude from patentability inventions, the preventionwithin their territory of the commercial exploitation of which is necessary toprotect ordre public or morality, including to protect human, animal or plantlife or health or to avoid serious prejudice to the environment, provided thatsuch exclusion is not made merely because the exploitation is prohibited bytheir law.

3) Members may also exclude from patentability:(a) diagnostic, therapeutic and surgical methods for the treatment of

humans or animals;(b) plants and animals other than micro-organisms, and essentially

biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall providefor the protection of plant varieties either by patents or by an effectivesui generis system or by any combination thereof. The provisions of thissubparagraph shall be reviewed four years after the date of entry into forceof the WTO Agreement.

Position under the Patents Act,1970

• "invention" means a new product or processinvolving an inventive step and capable ofindustrial application [Sec.2(1)[(j)]

• "inventive step" means a feature of aninvention that involves technical advance ascompared to the existing knowledge or havingeconomic significance or both and that makesthe invention not obvious to a person skilledin the art [Sec.2(1)(ja) ]

Position under the Patents Act,1970

• "new invention" means any invention or technologywhich has not been anticipated by publication in anydocument or used in the country or elsewhere in theworld before the date of filing of patent applicationwith complete specification, i.e. the subject matterhas not fallen in public domain or that it does notform part of the state of the art [Sec.2(1)(l)]

• "patentee" means the person for the time beingentered on the register as the grantee or proprietorof the patent [Sec.2(1)(p) ]

Exclusions form patentability –S.3

• Frivolous, Obvious or Contrary to Natural laws

• Contrary to public order or morality

• Prejudicial to animal or plant life/health or environment

• Scientific principle or Abstract theory

• Discovery of any living thing or non-living substance occurring in nature

• A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof

Exclusions …… Contd.

• Mere arrangement or rearrangement of known devices each functioning independently of one another in a known way

• A method of agriculture or horticulture

• Plants and animals in whole or any part thereof other than micro-organisms

• Seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

• A mathematical or business method or a computer program per se(as such) or algorithms

Exclusions …… Contd.

• copyrightable works and television productions • A mere scheme or rule or method of performing metal act or

method of playing game

• A presentation of information

• Topography of integrated circuits

• An invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components .

• Any process for the medical, surgical, curative, prophylactic , diagnostic, therapeutic or other treatment of human beings or any process for similar treatment of animals

Section 3 (d)

• The mere discovery of a new form of a known substancewhich does not result in the enhancement of the knownefficacy of that substance or the mere discovery of any newproperty or new use for a known substance or of the mereuse of a known process, machine or apparatus unless suchknown process results in a new product or employs at leastone new reactant.

• Explanation – for the purpose of this clause, salts , esters, ethers , polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Mere Discovery of A New Form of known Substance

• mere discovery of a new property of known substance is not considered patentable. For instance, the paracetamol has antipyretic property. Further discovery of new property of paracetamol as analgesic can not be patented.

• Similarly, methyl alcohol is used as solvent but further discovery of its new property as anti knocking, thereby making it usable as fuel, can not be considered patentable.

Mere Discovery of Any New Use of Known Substance

• For instance, new use of Aspirin for treatment ofthe cardio-vascular disease, which was earlierused for analgesic purpose, is not patentable.However, a new and alternative process forpreparing Aspirin is patentable.

• Similarly, the new use of methyl alcohol asantifreeze in automobiles is not patentable. Theuse of methanol as a solvent is known in the priorart. A new use has been claimed in this claim asantifreeze which is not allowable.

Innovations –Kinds

• Innovation can be classified into three categories-revolutionary, radical and incremental

• Revolutionary innovations are conceptual advances, such as new scientific theories ors principles, which a form the basis for subsequent research.

• For example, a new biological or metabolic pathway can be considered revolutionary.

• Radical innovations are products that put these conceptual advances into practice and set the standard for utilizing an underlying principle. For example, a “first-in-class medicine” (the first medicine of its kind) is normally considered a radical product.

Incremental innovations

• It is marked by improvements in radical products.

• For example, in pharmaceuticals, incremental innovation includes improvements in therapeutic quality, safety and efficacy over existing medicines.

• Incremental innovation advances medicines by ‘expanding therapeutic classes, increasing the number of available dosing options, discovering new physiological interactions of known medicines, and improving other properties of existing medicines.

• Incremental innovation can include reformulating a medicines to encourage compliance with treatment regimens or increasing a medicine’s shelf life and heat stability to ensure that medicine is effective in diverse climates or environments.

Incremental Innovations

• A study conducted in 2007 found that nearly 60% of the medicines enlisted in the WHO Essential Drug List reflect incremental improvements of older drugs.

• The National Knowledge Commission reports that while 37.3% Indian Companies had introduced breakthrough innovation in the recent years , no fewer than 76.4% had introduced incremental innovations.

• Report on “The Value of Incremental Pharmaceutical Innovation: Benefits for Indian Patients and Indian Business”

• Report was funded by the US Chamber of Commerce’s Innovation, Development and Employment Alliance and produced by White & Case LLP and Dua Consulting.

History of Patent law for Pharmaceuticals in India

• Product Patents for medicines in 1911 Act

• Only process Patent Regime for Pharmaceuticals

• Foreign applications decreased from 4248 in 1968 to 1010 in 1970

• It resulted in the rise of generic drug manufacturing industry and a reduction in drug prices in India

• In contrast , the level of domestic research and development investments did not rise.

TRIPs History

• Conventions for patents and copyrights ,WIPO as a nodal agency for implementation for these conventions

• Success of developing and Developed countries in obtaining certain concessions under the conventions like Paris convention and Berne Convention

• Compulsory licenses for accessing patented articles and educational material .

• Lobbying by western Pharma companies and Hollywood• Forum Shifting from WIPO to WTO• Resulting in Agreement on Trade Related Aspects of

Intellectual Property Rights.(TRIPs Agreement)

TRIPs Obligations

• Product patents also for Pharmaceutical products

• Ten years moratorium for shifting to the product patent regime for developing countries like India.

• Mail Box System and Exclusive Marketing Rights facilities for inventors

• Amendments to Patents Act- 1999,2002, 2005

• S.3(d)- of 2005 Amendment Act

Illustrative examples for section 3(d):

• Draft guidelines for Examination of Patent Application in the field of Pharmaceuticals- Office of the Controller General of Patents and Designs and Trademarks.

• The invention relates to a β-crystalline form of methanesulfonic acid addition salt of imatiniband processes for the preparation thereof. The application was filed with the title: Crystal Modification of A N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture And Its Use. The substance claimed was a medicine for the treatment of chronic myeloid leukemia (CML).

Illustrative examples –Contd.

• The specification asserts that the claimed β-form has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystal form of ImatinibMesylate. No experimental data related to efficacy is provided in the specification for β-crystalline form imatinibmesylate or imatinibmesylate.

• Claims: A form of the methanesulfonic acid addition salt of a compound of formula comprising crystals of the β-modification.

Novartis Case- 2013

• The US Patent No. 5,521,184 (the Zimmermann patent) was granted on May 28, 1996.

• Novartis AG has made the application for US patent for beta crystalline form of Imatinib Mesylate about five and a half years later on May 17, 2005 and was granted the patent on 17th May 2005.

• On April 9, 1998, the appellant filed the Investigational New Drug Application (IND # 55,666) for Gleevec and on February 27, 2001, the original New Drug Application (NDA # 21-335) before the Food and Drug Administration (FDA), USA, for Imatinib Mesylate,

• In the patent information furnished in connection with the NDA as required under (US Code) 21 C.F.R. § 314.53, the active ingredient of the drug was stated as Imatinib Mesylate.

• The FDA approval for the drug Gleevec (Imatinib Mesylate) 50 mg and 100 mg capsules was granted vide Letter dated May 10, 2001

Novartis Case- 2013

• Novartis AG made a Patent Term Extension Application for the Zimmermann patent (US Patent No. 5,521,184) under 35 USC § 156(g)(1)(B), for extending the term of the patent for the time taken in the regulatory review for Gleevec.

• A legal notice on behalf of the appellant was given toNATCO Pharma Ltd. on February 13, 2004. The noticestated that the appellant was the proprietor ofEuropean patent EP-A-0 564 409 (the Zimmermannpatent) and that this patent claimed, among otherthings, the compound Imatinib and acid addition saltsof that compound such as the Mesylate salt.

Novartis Case- 2013

• The physical properties of the Free Base and imatinib mesylate differ in that the Free Base is only very slightly soluble in water (0.001 g/100 ml) while imatinib mesylate is very soluble in water (beta crystalline form: 130 g/100 ml).

• Beta form significantly differs from the alpha form:• Physical attributes:• (a) The beta crystal form has substantially more beneficial flow properties

and thus results in better processability than the alpha crystal form.• (b) The beta-crystal form of the methanesulfonic acid addition salt is the

thermodynamically more stable form at room temperature. Greater stability is thus to be expected.

• (c) The beta-crystal form is less hygroscopic than the alpha-crystal form of the methanesulfonic acid addition salt of a compound of formula.

• (d) The lower hygroscopicity is a further advantage for processing and storing the acid addition salt in the beta-crystal form.”

Novartis Case- 2013

• An about 30% improvement in bioavailability was observed for the beta crystalline for of Imatinib mesylate compared to the Free Base in a study conducted in Rats.

• higher solubility of the beta crystalline form of Imatinib Mesylate is being compared not to Imatinib Mesylate but, once again, to Imatinib in free base form.

• Novartis AG obliged to show the enhanced efficacy of the beta crystalline form of Imatinib Mesylate over Imatinib Mesylate (non-crystalline)

Efficacy

• Efficacy, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”.

• “therapeutic efficacy” of a medicine must be judged strictly and narrowly.

• Not all advantageous or beneficial properties are relevant , but only such properties that directly relate to efficacy, which in the case of medicine , is its therapeutic efficacy.

• Physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy.

Invention , a product must satisfy the following tests-

• I t must be ‘new’ that is to say it must not have been anticipated .

• It must be capable of being made or used in an industry

• It must come into being as a result of an invention which has a feature that –

• a) entail technical advance over existing knowledge; or

• B) has an economic significance and

• C) makes the invention not obvious to a person skilled in the art.

Purpose of S. 3 (d) Amendment

• Amendment or addition made in s.3(d) is meantespecially to deal with chemical substances, andmore particularly pharmaceutical products. Theamended portion of S.3(d) clearly sets up asecond tier of qualifying standards for chemicalsubstances/ pharmaceutical products in order toleave the door open for true and genuineinventions but, at the same time,, to check anyattempt at repetitive patenting of extension ofthe patent term on spurious grounds. – SupremeCourt

Comments on S 3 (d)

• The practice of evergreening has anti-competitive effects as it enables the pharmaceutical MNCs to eliminate competition from the generic manufacturers and charge exorbitant prices for their patented drugs over a prolonged period of time.

• Many contend that by reducing the scope of patentability to only those new forms of known substances that increase the efficacy of the original substance and derivatives of known molecules that significantly differ in properties with respect to efficacy, Section 3(d) excludes majority of useful pharmaceutical innovations.

• Some argue that discouragement of incremental inventions in India does affect the research and development incentives of the Indian pharma companies

• Prof chudhuri argues it doesn't matter for companies such as Cipla and Ranbaxy because majority revenues for these companies come from the us and EU markets.

• Novartis decision will discourages Indian and foreign investors from inventing in India and also from making new formulations or drug delivery systems that Indian climate.

Incoherency of S 3(d)

• Therapeutic efficacy is not provided in the Act

• Another contradiction-if drug Y is the new form of drug X which treats another disease which X cannot treat .As compared to X , Y has new use. Under the main text, y will not qualify for patent, as it does not demonstrate “enhancement of known efficacy”.

• Under Explanation drug Y however qualifies for patent because it differs significantly in properties with regard to efficacy.

Other countries Approach

• US-structural similarities between the pharma substances trigger of a presumption of prima facie obviousness.

• It can be rebutted by demonstrating that the invention exhibits “unexpected or surprise results”

• Just like S.3(d) which is a species of the inventive step test ,a new method is broadening the definition of efficacy by creating species of efficacy.

• Varying levels of weight can be put on the properties depending on the specific drug. Therapeutic efficacy is given more preference given over other efficacies like storability and bioavailability.

• Improved version of patent application is another balancing mechanism.

Rights of Patentee

• Product Patent -Exclusive right to prevent third parties (who do not have his consent) from the act of –

• a) making, b) using , c) offering for sale , c) selling , d) importing for those purposes that product

• Process Patent – exclusive right to prevent third parties (who do not have his consent) from the act of-

• A) using that process , from the act of using – b) offering for sale , c) selling or d) importing for those purposes the product obtained directly by that process .

Exceptions to Patent Rights

• Government may make or import the patented article (article made by the patented process ) for the purposes merely of its own use

• Use of patented process by the Government merely of its own use

• Making or using of patented article or use of patented process for the purpose merely of –

• A) experiment b) research including the imparting instructions to pupils .

• Medicines or drugs may be imported by the government for thepurpose merely of its own use or for distribution in any dispensary,hospital or other medical institution maintained by or on behalf of theGovernment or other medical institution as notified in the officialgazette by the government in this behalf .

General principles applicable to working of patented inventions

(S.83)

• (a) that patents are granted to encourage inventions and to secure thatthe inventions are worked in India on a commercial scale and to thefullest extent that is reasonably practicable without undue delay;

• (b) that they are not granted merely to enable patentees to enjoy amonopoly for the importation of the patented article;

• (c) that the protection and enforcement of patent rights contribute tothe promotion of technological innovation and to the transfer anddissemination of technology, to the mutual advantage of producersand users of technological knowledge and in a manner conducive tosocial and economic welfare, and to a balance of rights andobligations;

General principles applicable to working of patented inventions

(S.83)• (d) that patents granted do not impede protection of public health and

nutrition and should act as instrument to promote public interestspecially in sectors of vital importance for socio-economic andtechnological development of India;

• (e) that patents granted do not in any way prohibit CentralGovernment in taking measures to protect public health;

• (f) that the patent right is not abused by the patentee or personderiving title or interest on patent from the patentee, and the patenteeor a person deriving title or interest on patent from the patentee doesnot resort to practices which unreasonably restrain trade or adverselyaffect the international transfer of technology; and

• (g) that patents are granted to make the benefit of the patentedinvention available at reasonably affordable prices to the public.

Compulsory Licences-S.84

• An interested person after the expiry of 3 years from the date of the grant of a patent may make an application to the Controller for grant of compulsory licence on the following grounds, namely, --

• -a) Reasonable requirements of the public with the patented invention have no been satisfied, or

• -b) Patented invention is not available to the public at a reasonably affordable price, or

• -c) Patented invention is not worked in the territory of India.

Factors to be considered in granting the Compulsory Licences

• -Nature of invention. The time which has elapsed since the grant of the patent and the measures already taken by the patentee or licensee to make full use of the in invention.

• -Ability of he applicant to work the invention to the public advantage,

• -The capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted;

• -Whether the applicant has made efforts to obtain a licence from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period (not exceeding 6 months)

Procedure in dealing with applications-S.87

• publish the application in the official journal;• Patentee or any other person desiring to oppose the

application may oppose in the prescribed time and give notice of opposition to the Controller;

• Notice of opposition shall Controller is satisfied that a prima facie case has been made out ,he shall direct the applicant to serve copies of the application upon the patentee and any the interested persons appearing in the register;

• Controller shall contain the grounds on which the application is opposed;

• Notice of opposition shall be notified to the applicant and the parties shall be given an opportunity of hearing.

Power of controller in granting CLs(S.88)

• In the applicant is a licencee , his licence may be converted in to a CL

• When more than two patents are held by the same patentee and grounds of CL exists only for few and the licencee cannot efficiently or satisfactorily work the licence granted to him without infringing the other patents, then the Controller may grant licence in respect of those patents also.

• Controller can revise the term and conditions of the CL on an application by the licensee after he has worked the invention on a commercial for a period of 12 months on the ground the terms and conditions have proved to be more onerous than originally expected and he is incurring losses. No such application is entertained for the second time.

• The power of the Controller Under S.84 shall be exercised with a view to securing that the inventions are on a acommercial scale in India without undue delay to the fullest extent (S.89).

Terms and Conditions

– the patented articles are made available to the public at reasonably affordable prices;

– the licence granted is an non-exclusive licence; – the right of the licensee is non-assignable;– the licence is for the balance term of the patent unless a

shorter term is consistent with public interest;– the licence is granted with a predominant purpose of

supply in the Indian market and that the licensee may also export the patented product, if need be in accordance with s 84(7)(a)(iii);

– in the case of semi-conductor technology, the licence granted is to work the invention for public non-commercial use;

CLs in case of National Emergency(s.92)

• The Central Govt. is satisfied that in circumstances of national emergency or in circumstance of extreme urgency or incase of public non-commercial uses including the public health crisis related to AIDS, HIV, TB, Malaria or other epidemics it is necessary that CLs should be granted, it may make a declaration to that effect by notification.

• This enables the Controller to grant CL o such term and conditions as he thinks fit. He should secure the articles be available to the public la at the lowest prices.

• Controller need not apply the provision of S.87 and he shall inform as soon as practicable , inform the patentee about such application.

Terms and Conditions

– the patented articles are made available to the public at reasonably affordable prices;

– the licence granted is an non-exclusive licence; – the right of the licensee is non-assignable;– the licence is for the balance term of the patent unless a

shorter term is consistent with public interest;– the licence is granted with a predominant purpose of

supply in the Indian market and that the licensee may also export the patented product, if need be in accordance with s 84(7)(a)(iii);

– in the case of semi-conductor technology, the licence granted is to work the invention for public non-commercial use;

Terms and Conditions

– the patented articles are made available to the public at reasonably affordable prices;

– the licence granted is an non-exclusive licence; – the right of the licensee is non-assignable;– the licence is for the balance term of the patent unless a

shorter term is consistent with public interest;– the licence is granted with a predominant purpose of

supply in the Indian market and that the licensee may also export the patented product, if need be in accordance with s 84(7)(a)(iii);

– in the case of semi-conductor technology, the licence granted is to work the invention for public non-commercial use;

Termination of CL and Revocation of Patents

• On an application of a patentee or his assignee a CL may be terminated if the circumstances giving rise to the grant of CL cease to exist.(S.94)

• On an application made by the Central Govt. or any interested person after the expiration of 2 years from the date of the order granting the first CL , the Controller may revoke the patent on the ground that the Circumstances warranting the invocation of S.84 still exist (S. 85)

Mechanism in built in patent law form preventing wrong patenting

• Pre-grant opposition

• Post –grant opposition

• Revocation of patent by the IPAB on an application by the central Government or any interested person - under S. 64

• Revocation of the patent by the High Court on a counter- claim by the defendant in a suit for infringement of patent.

• Grounds for all the stages are almost the same

Grounds for revocation

• Invention does not satisfy the patentability requirements

• Patentee not entitled to apply• Patent was Wrongfully obtained from the person

applying for revocation • Invention is not new with regard to the public

use or public knowledge• Specification does not sufficiently and fairly

describe the invention and the method by which it is performed or does not disclose the best method

Grounds of revocation

• Claim of complete specification is not fairly based on the matter disclose in the provisional specification .

• Patent obtained on false representation

• Invention was used earlier other wise than for reasonably for trial purposes

• Failure to provide information with regard to foreign application of inventions

• Contravening secrecy directions

Revocation grounds

• Leave to amend specification is obtained by fraud

• Specification does not mention or wrongly mentions the geographical origin of the biological material used in the invention

• Invention is anticipated by oral or written traditional knowledge available within any local or indigenous community in India or elsewhere.

Parallel imports

• Patentee will be adopting the differential pricing system in different countries basing on the purchasing capacity of the public in each country. In order to avail the advantage of this system or in order to meet the local demands any person can import the patented articles from foreign country for marketing purposes. This importing has been exempted under the patent law. This is called the parallel imports exception.

• Importer should have purchased lawfully form the patentee of another country .

Bolar Exception

• During the existence of patent term of an invention, no body can use it for any commercial purpose.

• But in order to make oneself ready with all formalities to launch the product after the term of patent comes to an end with regard to that invention, he needs to do certain experiments and obtain the due approvals from the concerned authorities .

• S.107-A(a) of the Patents Act permits any act of making , using , constructing, selling , importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in the force in India or any other country .

• Stock piling of the patented articles will not be allowed under this exception.

Remedies for infringement

• Preventive remedy – Injunction

• Accounts of Profits or Damages at the option of patentee

• The court may order for seizure, forfeiture ordestruction of infringing materials or goods

• - or any implements the predominant use ofwhich is the creation of infringing goods.

Public Interest and Patent cases

• F.Hoffmann-LA Roche Ltd v. Cipla Ltd-2009• In a country like India where question of general public access to life

saving drugs assume great significance, the adverse impact on such access which the grant of injunction in a case like the instant one should not allowed . (Tareeva drug and Evlicip drug )

• Novartis AG V. Cipla Ltd. – 2015• Where the patent is valid , under the guise of public interest an inventor

cannot be rendered rewardless (INDACATEROL drug for chronic Obstructive Pulmonary disease –COPD)

Thank You

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