glivec vs union of india

Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Business

GLIVEC LITIGATION NOVARTIS AG vs. UNION OF INDIA

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Table of ContentsIntroduction.................................................................................................................................................3

History of Glivec in India..............................................................................................................................3

The Glivec Case............................................................................................................................................5

First Phase - Pre-Grant Opposition..........................................................................................................6

Second Phase – Litigation........................................................................................................................6

Third Phase - Appeal in Intellectual Property Appellate Board................................................................6

Definition.....................................................................................................................................................7

Invention.................................................................................................................................................7

Novelty and Obviousness........................................................................................................................8

Efficacy..................................................................................................................................................10

TRIPS..........................................................................................................................................................12

Article 27...............................................................................................................................................12

Article 31...............................................................................................................................................12

The Indian Patents (Amendment) Act 2005..............................................................................................14

Section 3(d)...........................................................................................................................................14

The Judgement..........................................................................................................................................15

The Implications........................................................................................................................................15

Annexure - I...............................................................................................................................................16

Description of α-form............................................................................................................................16

β Modification.......................................................................................................................................17

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IntroductionThe Novartis case can be traced to 1997 when a patent application was filed by Novartis AG for the α-crystalline of imatinib mesylate (brand name Glivec) which was a slightly different version of their 1993 patent, a vital anti-leukaemia drug, filed in the Chennai (Madras) Patent Office.

The petitioner claimed that they had invented the beta crystalline salt from the free base of imatinib. In 2003, Glivec was granted EMR in the Indian market. Novartis obtained orders preventing some of the generic manufacturers from producing the generic equivalents of Glivec in India. Soon, Novartis was selling Gleevec at USD 2666 per patient per year.15 Generic companies had been selling their generic versions at USD 177 to 266 per patient per month.Pre-grant oppositions were filed by Natco Pharma Ltd., M/s Cipla Ltd., M/s Hetro Drugs Ltd., M/s Cancer Patient Aid Association and M/s Ranbaxy Laboratories Ltd., India and in an order dated January 25, 2006, the Assistant Controller of Patents and Designs, Chennai Patent Office rejected the Novartis application.

History of Glivec in India1993: The base compound of Glivec, imatinib, is invented and patented worldwide. There is no patent filed in India at this time, as India does not have patent laws for pharmaceutical products.

1995: India joins the World Trade Organization (WTO) and begins its mandated 10-year transition period to bring its patent laws into alignment with TRIPS.

JULY 1998: Novartis files a mailbox application in India for imatinib mesylate in crystalline form, the active ingredient of Glivec, in accordance with India’s provisions for obtaining patents. DECEMBER 2001: Novartis obtains marketing approval for Glivec in India.

APRIL 2002: Glivec is launched in India.

SEPTEMBER 2002: Novartis launches the Glivec International Patient Assistance Program (GIPAP) in India.

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NOVEMBER 2003: Novartis is awarded Exclusive Marketing Rights (EMR) for Glivec, marking the first time a pharmaceutical firm is granted an EMR in India. The EMR protects the beta crystal form of the drug for five years, or until the review of the mailbox application. Prior to Novartis receiving the EMR, nine Indian companies obtain approval for commercializing copies of Glivec. Novartis asks that the EMR be enforced; three companies are allowed to continue.

APRIL 2005: The Indian Patents Amendment Act of 2005 is enacted, introducing product patents for pharmaceuticals to fulfil India’s obligation to WTO/TRIPS.

JANUARY 2006: Novartis is denied a patent for Glivec under Section 3(d) of the Indian Patents Act 2005, which introduced a new “improved efficacy” hurdle for patentability of new forms of known compounds. The Indian Patent Office contends that Glivec does not satisfy the requirements of novelty and inventiveness. This rejection automatically terminates the EMR. AUGUST 2006: Novartis challenges the January 2006 ruling by the patent office denying its application for Glivec on the grounds that the ruling lacks legal or factual basis and justification. Novartis asks the High Court of Chennai to declare Section 3(d) unconstitutional and in breach of India’s obligation under TRIPS.

DECEMBER 2006: The number of current GIPAP patients in India reaches 6 700, representing 99% of Indian patients taking Glivec.

FEBRUARY 23, 2007: The court agrees with the Novartis request to convert one part of its case – the challenge to the patent office’s decision to not grant a patent for Glivec – from a writ petition to an appeal. This allows the court to review data and evidence about the effectiveness of Glivec. MARCH 5-6, 2007: The court hears matters relating to the conversion of the writ petition into an appeal, and the Chief Justice announces that the Glivec appeal will be heard by the existing bench.

APRIL 2, 2007: The Intellectual Property Appellate Board (IPAB) becomes operational for patent review in India. The newly-appointed technical member of the appellate board is the former Controller General of the Indian Patent Office, who was responsible for the original decision on the Glivec patent in 2006 and is acting as a party in the current Court case.

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of BusinessAPRIL 3, 2007: The High Court in Chennai determined that Novartis’s appeals matter on the Glivec patent should be heard by the newly-operational Intellectual Property Appellate Board (IPAB) in India.

• High Court / Section 3(d) Matter

APRIL 2007: Arguments on the Section 3(d) matter have closed, and the writ petition is still under deliberation in the High Court in Chennai.

AUGUST 6, 2007: The High Court dismisses challenge on constitutionality and defers to WTO to resolve question on compliance with TRIPS.

• IPAB / Glivec patent review

APRIL 2007: Mr. Chandrasekaran – the former Controller General of the patent office – is appointed technical member of the IPAB.

JULY 2007: Novartis petitions the High Court for a new technical member. OCTOBER 2007: Government of India suggests a revised approach consisting of a two-member review panel.

NOVEMBER 13, 2007: High Court accepts the approach put forward by the Government of India. DECEMBER 2007: Natco appeals against decision before the Supreme Court.

NOVEMBER 2008: Glivec case comes for hearing before the IPAB.

JUNE 2009: IPAB rejects application on grounds of price of the product.(affordability is an important concern). Acknowledges the fact that it is otherwise patentable under international law.

JULY 2009: Novartis challenges the IPAB decision on patent as price is not a clause under patents act.

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The Glivec Case

The debate on the policy of not encouraging patent term extension involving Section 3(d) of the Patent Act, 1970 as amended in 2005 formed the crux of the famous patent dispute involving Novartis’s cancer drug ‘Glivec’. The High Court also examined the provision on the constitutionality front as well as studied the same on the issue of defining ‘efficacy’ (Novartis A.G. vs. Union of India W.P. Nos. 24759 and 24760 of 2006).

First Phase - Pre-Grant Opposition

Novartis AG filed a patent application for an invention titled “Crystal Modification of A N – Phenyl – 2 -Pyrimidineamine derivative, processes for its manufacture and its use”. It, in effect, claimed beta crystal of methanesulphonic acid salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridine-3-yl) pyrimidine-2-ylamino)phenyl]-benzamide commercially known as imatinib mesylate. Generic drug manufacturers along with patients association filed representation by way of pre grant opposition on the following issues -

[1] Not an Invention - Anticipation by Prior publication and Obviousness [2] Section 3(d) of the Patents Act

The Assistant Controller refused to proceed with the patent application in view of the findings and circumstances of the case.

Second Phase – Litigation

Novartis approached Madras High Court, through writ petition, challenging the grounds on which the patent was denied, and separately, section 3(d), which Novartis said not only contravenes TRIPS but Article 14 of the Indian Constitution, which ensures equality before the law. A two-judge bench while dismissing the writ petition ruled that Section 3(d) was constitutional and cited lack of jurisdiction in deciding whether the provision of the law in question is compatible with TRIPS or not.

The High Court referred the appeal challenging the grounds used by the Assistant Controller in rejecting the patent, to IPAB (notified to hear patent cases on April 3, 2007).

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Third Phase - Appeal in Intellectual Property Appellate Board

The appeal ran into problem as Novartis filed a writ petition in the Madras High Court to replace the ex-patent controller on the IPAB board. Novartis AG objected over the nomination of S. Chandrasekharan as technical member on IPAB as he was serving as Controller of Patents and Design when Glivec was refused patent. The Madras High Court, on the suggestion of the government, ruled that a two-member bench consisting of a chairman and vice-chairman can hear the appeal instead of the official three-member panel. The court ruled that the chairman could also act as a technical member of the bench. In response, Natco Pharma Ltd petitioned Supreme Court giving the reason that it will be difficult for the board to take a proper decision without a technical expert on the panel since the matter was too technical and complicated prompting Supreme Court to issue a stay order. Later the Supreme Court examining the nature of the dispute appointed Dr. P.C. Chakraborti, Deputy Controller of Patents & Designs.

The IPAB has commenced hearing the appeals filed by Novartis AG challenging the Indian Patent Office's decision to reject its patent application for the beta-crystalline form of imatinib mesylate (Glivec). A special bench of the IPAB comprising Mr. Negi (Judicial Member) and Dr. P. C. Chakraborti (Special Technical Member) is hearing these appeals.

Definition

InventionAn “invention is the act or operation of finding out something new; the process of contriving and producing something not previously known or existing, by the exercise of independent investigation and experiment.”1

The courts have always held the view that a patentable invention, apart from being a new manufacture, must also be useful.”2

The TRIPs Agreement does not specify what an invention is.

National laws can define this concept according to the standards generally applied, that is, the tests of novelty, inventiveness and industrial application. It is also required that patents be available and patent rights enjoyable without discrimination irrespective of the place of invention, whether products are imported or produced locally.

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of BusinessWhile implementing the TRIPs Agreement, each country should carefully consider the economic, legal and ethical aspects involved in the patenting of living materials or certain types thereof.

If a protein is engineered by biotechnological process with human intervention, it is not a mere discovery (subject to other conditions in the Act). It should be considered as an invention, but the question raised in the Novartis case was the patentability of a new form of already known chemical substances.

1 Smith v. Nichols, 88 U.S. (21 Wall.) 112, 22 LED.566; Hollister v. Benedict & Burnham Mfg. Co.,(1885), 113 U.S. 59, 5 S. ct. 717, 28 Led.901.

2 Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444.

Novelty and ObviousnessNovelty is defined as Freshness: originality by virtue of being refreshingly novel.It is the concept that the claims must be totally new. The invention must never have been made public in any way, anywhere, before the date on which the application for a patent is filed. In the Novartis case, the petitioners claimed that they had invented a particular form of methanesulfonic acid addition salt of a particular Pyrimidineamine Derivative (Imatinib Mesylate) in the crystal form. Additionally, it was claimed that the petitioners had invented the substance in two forms – Alpha and Beta- of which the Beta form can be stored easier, is less hygroscopic, easier to process and guarantees a constant quality of the final drug product. The Beta crystalline form of imatinib mesylate also results in higher bio- availability over the 1993 compound and, hence, differs significantly in properties with respect to efficacy.3

The Beta crystalline form of imatinib mesylate was being produced and sold on a commercial scale in India from 2003 after getting Exclusive Marketing Right (EMR).4

The generic manufacturers and civil society organizations alleged that Novartis’ invention lacked novelty, and was obvious to a person skilled in the art, and that it was merely a new form of a known substance that did not enhance the efficacy of

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Businessthe substance, and therefore, it was not patentable. Different crystalline forms of imatinib mesylate did not differ in properties with respect to efficacy, and thus, the various forms of imatinib mesylate must be considered the same substance.

[Mere arrangement or re-arrangement or duplication of a known device or material cannot be patented- Standpick (P) Ltd. v. Oswal Trading Co. Ltd., 1999 PTC (19) 479]

3 See Annexure I for the chemical combination of the α and β-form of imatinib mesylate.

4 The EMR was intended to be in force for a maximum period of 5 years or until grant or rejection ofPetitioner's product patent application (Black Box application) for the said drug whichever was earlier.

The petitioners alleged that the subject compound is two step removed from the prior art as it is a two-fold improvement over the prior art- first, the imatinib free base had been chemically changed into a salt form (the methanesulfonic acid addition salt) and second, a particular crystal form of this salt, i.e., the beta crystal form which had been made through ingenuity and human intervention. Interestingly, the petitioners claimed that even if it were a discovery of a new form of a known substance, they could claim the patent because, it had resulted in the enhancement of the known efficacy of the known substance, i.e., imatinib free base, thereby making the subject compound more efficacious. Since the expression discovery has not been defined in any section of the amended Patents Act, it could be construed in the ordinary meaning.5

In Generics (UK) Ltd. v. H Lundbeck A/S, the court interestingly held that “The first person to find a way of achieving an obviously desirable goal is not permitted to monopolize every other way of doing so.”

Mere obvious extensions of inventions are not patentable under any law, because most of the countries patent law rewards only the inventions that are new, useful and non-obvious advances.

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of BusinessUnless an applicant showed that the prior art compound lacked the property or advantages asserted for the claimed compound, the presumption of unpatentability was not overcome.6

5 In the case of Gopi Lal v. Lakhpat Rai 1923 PC 103, it was held that the use before the date of the patent negates the novelty criteria in the invention. In this case, a letters patent was granted in respect of improvements in the manufacture of a medicinal preparation which was an improvement in the treatment of a substance found in the interior of some bamboos and known as ‘tabakshir’ or ‘bamboo mannah’ for the purpose of refining the same when in the raw state and to convert it into a nutritious and saleable article. The medicinal preparation was named and marketed as “banslochan” and admittedly had sold throughout India for a long time. The letters patent was granted for the improvements alleged to have been discovered by the respondents. This proposition was confirmed in an old case of Patterson v. Gas Light & Coke Co (1887) 3 AC 239, 244. It confirmed this position in Bombay Agrarwal Co., Akola v. Ramchand Diwanchand AIR 1953 Nag 154. Mere arrangement or re-arrangement or duplication of a known device or material cannot be patented- Standpick (P) Ltd. v. Oswal Trading Co. Ltd., 1999 PTC (19) 479. It was very clear that in the present case also, the ‘same’ medicine, whether it was beta or alpha crystal form of imatinib mesylate (Pyrimidineamine Derivatives), which was used for curing the same disease is available in the market from 1993, hence the so called ‘new’ material could not be patented. The mere carrying forward of an original patented thing is like a workman carrying forward old ideas without any innovations Smith v. Nichols, 88 US 112. The novelty criterion is crucial in all patent applications.

6 Elizabeth Verkey, Law of Patents, (Lucknow: Eastern Book Company), p. 45.

It was also held that one cannot have a patent for the new use of an old product unless there is an invention in the adaptation of the old product to the new use.

An increased efficacy of a known compound may not satisfy the novelty and obviousness criteria, but even then it is patentable under Section 3(d) of the Indian Patent Act, 2005. A significant improvement in the activity level may be considered as an increased efficacy level. However, exactly what is the level of improvement required for meeting the efficacy criterion under Section 3(d) is a question of public policy.

EfficacyEfficacy is capacity or power to produce a desired effect.

In the present case, the petitioners held patents for a form of Pyrimidineamine Derivatives which was patented in many countries (Alpha crystal form). Thus, the subject matter of the patent was already in the public domain and had already been published. The petitioners claimed that the new medicine developed from the Beta crystalline form showed a 30 per cent increased bio-availability over the known substance of the 1993 patent.

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Business[Unlike in India, discoveries also can be patented in the US. The patentability criteria are loosely defined in the US law. It provides that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”]

The petitioner also claimed that the present application is for the Beta crystal form that they had invented in 1997 and that the earlier version was the Alpha crystal form. The petitioners claimed that imatinib mesylate exists in several forms including alpha, alpha 2, beta and H1 form. No teaching or suggestion existed in any prior art document to identify and anticipate the favorable properties or characteristics of the beta crystal form of Imatinib mesylate prior to it being invented. It is possible to obtain a patent for the first medical use of a known substance or composition, where this substance or composition was not previously known to have any medical application. However, in the present case, the Imatinib mesylate was used in the manufacture of Glivec and therefore, it was obvious.

The most pertinent question was not whether the patented subject matter was an invention or mere discovery, but about the significantly increased level of efficacy of the new substance. In the case of pharmaceutical substances, the crucial question is with regard to its increased efficacy rather than the new substance. It is true that the standard of efficacy is neither prescribed in Section 3(d) nor under the Rules.

The earlier provision, Section 3(d) in the Patents Act, 1970, provided that “the mere discovery of any new property of new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” It clearly excludes “mere discovery of any new property of new use” from the ambit of patenting. The explanation to Section 3(d) of 1970 Act also excludes derivatives of known substances of esters and salts from patenting unless the new substance significantly differs in properties with regard to efficacy.

Under the new provision, the legislators intended to include the discovery of a known substance which has higher efficacy than the known substance. However, the Act never fixed a standard definition of efficacy for the patenting of such substance.

On a closer look, Section 3(d) not only permits patenting of pharmaceutical products, but also new forms of known substances, provided there is a higher standard of efficacy of the new product. Neither the Act nor international practice gives a clear definition of efficacy. It can be construed that the intention of the

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Businesslegislature, when they re-drafted Section 3(d) in 2005, was to prevent pharmaceutical companies from ever greening their patents by re-combining known substances.7

In India, the therapeutic efficacy, bio-availability studies and bioequivalence data have to be submitted along with the application for marketing approval.

7 In the U.S. also, it is mandatory to submit evidence of effectiveness of clinical trial, effectiveness of the product and dose comparison trials for getting marketing approval of the drug, Centre for Drug Evaluation and Research Guidance Document, U.S. Food and Drug Administration,http://www.fda.gov/cder/guidance/2097fnl.htm, (Last visited on October 6, 2007). Bio-availability and bioequivalence studies in clinical trials of the drug are required for marketing approval, comparing performance of the formulation or dosage form used in clinical trials have to be submitted to the CDER. InIndia, the therapeutic efficacy, bio-availability studies and bioequivalence data have to be submitted along with the application for marketing approval. However, in none of the regulations the standard of efficacy is clearly defined or distinguished.

TRIPS

Article 271. 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, involve an inventive step and are capable of industrial application. Subject to [the transitional provisions relating to developing countries and patent protection for pharmaceutical and agricultural products], 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.

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

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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 provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

Article 31Article 31 of the TRIPS Agreement addresses authorization of third parties to use patents without the consent of patent holders. This authorization is ordinarily understood to refer to the practice of “compulsory licensing”. However, since Article 31 also covers government use of patents for noncommercial purposes, the terminology of Article 31 is not specifically addressed to compulsory licensing.Article 31 does not limit the grounds upon which compulsory licenses may be granted. It provides procedures that should be followed in granting such licenses, and requires that certain minimum obligations be fulfilled:

each licence should be considered on its own merits (Article 31(a)); there should be prior negotiations for a reasonable commercial licence with

the patent holder, except in the case of national zmergency, extreme urgency, or public non-commercial use (Article 31(b));

the patent holder is entitled to adequate remuneration in the circumstances of the case (Article 31(h)):

the licence should be granted predominantly for the supply of the local market (Article 31(f))

the licence should be non-exclusive (Article 31(d)); and there should be opportunity for review by independent authority of the grant

of the licence and the terms of remuneration (Articles 31(i) & (j)).

When a compulsory license is granted to remedy anticompetitive practices, the restriction on predominant supply of the domestic market does not apply, and remuneration may take into account the remedial nature of the licence (Article 31(k)).

In the public health sector, patent protection may restrict access to medicines among a large segment of the population by preventing competition from generic medicines, and it may be antithetical to a wide public interest to permit such a situation to persist. In these cases, compulsory licensing is available to provide an

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Businesseffective remedy. Often, the mere threat of a compulsory licence will cause a patent holder to re-evaluate its access or pricing strategy.

The Doha Declaration on the TRIPS Agreement and Public Health expressly recognized that the TRIPS Agreement does not limit the grounds on which compulsory licences may be granted, and acknowledged the right of each Member to determine when a national emergency or circumstance of extreme urgency exists. It also directed the TRIPS Council to seek an expeditious solution to the problem facing Members with insufficient or no manufacturing capacity for pharmaceuticals. The TRIPS Council is to provide a recommendation to the General Council on this subject before the end of 2002. This is a critical issue for developing Members since the world supply of low price generic medicines will undergo a significant contraction after January 1, 2005 when developing countries are required to implement pharmaceutical patent protection, and when drugs within the so-called “mailbox pipeline” are brought under patent protection.

The Indian Patents (Amendment) Act 2005

Section 3(d)

Section 3(d) of the Indian Patent Act, as mentioned above, aims to prevent evergreening. While acceding to the TRIPS Agreement through amendment to the Indian Patent Act in 2005, the Government of India introduced certain safeguards in the Act so that patent protection is not monopolized unnecessarily. One such safeguard measure was to introduce Section 3(d) in the Patent Act, the primary aim of which was to prevent evergreening and deny patent protection to incremental innovation unless it fulfills the condition of efficacy laid down in Section 3(d). Although incremental innovations are granted patents in U.S.A and in many European Countries, India decided otherwise so that only true and new inventions are protected. The absence of patent products in India prior to 2005 played a crucial role in the development of domestic pharmaceutical industries.

Over the years, Indian pharmaceutical companies proved their potential and became lifeline for global supply of generic drugs. At present, Indian drugs companies supply generic drugs to nearly 211 countries, both developed and developing. The Indian generic industry has reached the world and India is now considered as the hub of pharmaceutical products. India is one of the top ten pharmaceutical producers in the world and drugs manufactured by it are exported to all parts of the world especially to the third world countries. It is in this background the insertion of Section 3(d) in the Patent Act is to be understood. After India decided to amend its patent law to bring it in line with TRIPS Agreement, there was fear among the generic drug makers that extending patent

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Glivec Litigation Novartis AG Vs. Union Of India Legal Aspects of Businessprotection to products will seriously hamper the growth of domestic drugs companies and will also take the essential drugs out of the reach of common people because it was patent-free regime in India before 2005 that was responsible for tremendous growth of the pharmaceutical industries. To allay the fear of the generic manufacturers that the liberal patent regime in India will take the essential drugs out of the reach of common people and considering their significance in the world pharma market, the Government of India introduced Section 3 (d) in the patent Act which provides for strict patent regime and limits the patent protection to real and new inventions and excludes incremental inventions from the purview of patent protection unless they pass through the test of efficacy.

The Judgement1. The Constitutional validity of the section 3(d) of the Patents Act has been

referred to the WTO Dispute settlement body for deliberation.2. The IPAB rejected the patent claim on grounds of the price (Monthly cost of

Glivec Rs 120000 and the generic versions Rs 10000). This is a very flimsy and non constitutional ground for rejecting the patent. Hence it is now being appealed in the Supreme Court.

The ImplicationsIndia has been a pioneer in identifying the clauses in WTO TRIPS and

exploiting them to the best advantage. We have a special interest in the pharmaceutical substances which can be traced back to the Patents Act, 1970. The Patents Act specifically lays down that pharmaceutical substances cannot be patented. This directly resulted in India becoming hub of the global generics production. The industry today is a result of the patent protection provided to these companies. This however had a disadvantage. While most players were augmenting their research capabilities, Indian companies were quite complacent and were able achieve profits by selling cheaper generics. This is currently a major stumbling block as Indian companies have reduced competencies in research and development.

Post TRIPS we have included product patent for pharmaceutical substances also. This prevents Indian companies from manufacturing generics in India. Thisparticular case has to be analysed from various facets

The patient The innovator The generics maker The nonprofit medical organizations.

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The Patient:In this case of Patent Vs Patient, the Indian courts held that the patient’s

health is more important than profit of organizations. The affordability of drugs is being given its due position. In this case India has taken a stand that is varied from what other countries have taken. For example Brazil resorted to compulsory licensing of their medicines for treating AIDS.

The Innovator:This case highlights the responsibility of the innovator to provide medicines

at affordable cost to the general public and in particular in developing and third world countries. Even after years of enforcement of WTO TRIPS, the companies have not reduced the price for drugs like Antiretrovirals and countries in Africa and Latin America are facing very high medical bills owing to proprietary medicines. The evergreening of products to extend patent life is a technique used by companies and Indian law specifically objects to this. But in the pharmaceutical sector, the incremental improvements are the way ahead. Improving efficacy of drugs is a slow and gradual process and hence innovator should be provided some relief. The presences of such ambiguous clauses are not in favour of the innovators and will deter them from entering the market.

The Generic Maker:This judgement sends a strong signal to the generic makers that the

government will protect them until they serve the interests of the country- generate employment and provide medicines at a reasonable cost. However Indian drug makers must invest in R&D and should over the time become innovators. This would improve the competencies of these companies and will improve them in the long run.

The Non Profit Medical Organizations:The non profit organizations like MSF and WHO funding for epidemics like

AIDS and other diseases require drugs at the least expensive price and hence generics are favoured. Even in the Glivec case MSF was a major proponent in favour of not granting the patent as this would set an example for other countries to follow as this would benefit them greatly in terms of the quantity purchased. Also the affordability of the essential drugs will reduce the burden on the government that provides drugs at highly subsidised rates to its population.

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Annexure - I

Description of -formα

Source: fda.govGleevec (imatinib mesylate) film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula, Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O • CH4SO3 and its molecular weight is 589.7. Imatinib mesylate is soluble in aqueous buffers <= pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol and ethanol, but is insoluble in n-octanol, acetone and acetonitrile.

Modificationβ

Source: Novartis Claim PetitionThe β-crystal form of the 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]benzamide.

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glivec vs union of india

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