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Battling Patent Laws: The Glivec Case

Novartis has lost its case challenging the constitutional validity of Section 3(d) of the Indian Patents Act 1970, but the celebratory air needs to be tempered. The issue of what constitutes enhanced efficacy of a drug is not in general settled. But, more importantly, from the perspective of making the right to heathcare a reality, there is a strong case for certain therapeutic classes of drugs important for public health being taken outside the purview of legal disputation.

Commentary

Battling Patent Laws:The Glivec Case

Novartis has lost its case challenging the constitutional validity of Section 3(d) of the Indian Patents Act 1970, but the celebratory air needs to be tempered. The issue of what constitutes enhanced efficacy of a drug is not in general settled. But, more importantly, from the perspective of making the right to heathcare a reality, there is a strong case for certain therapeutic classes of drugs important for public health being taken outside the purview of

legal disputation.

S SRINIVASAN

N
ovartis, the Swiss pharmaceutical multinational corporation (MNC) (2006 sales: $ 37 billion) has lost the case in the Chennai High Court challenging the constitutional validity of Section 3 (d) of the Indian Patents Act 1970, last amended in April 2005.1 On August 6, 2007 a division bench of the Madras High Court dismissed this challenge. Section 3(d) is the provision that seeks to prevent “evergreening”2 of patents.

Earlier in January 2006, Novartis’ application for a patent on the beta crystalline form of imatinib mesylate, marketed by the company under the brand name of Glivec/Gleevec in several countries, was rejected by the Chennai Patents office. The patent was rejected on the grounds that the drug imatinib mesylate was a new form of an old drug, and therefore was not patentable under Indian law. Novartis’ appeal against the Chennai Patents office order will be now heard by the Intellectual Property Appellate Board (IPAB), the first of whose hearings is scheduled on September 10, 2007.3 In principle the earlier decision of the Chennai Patents office can be reversed by the IPAB – even as the IPAB is not the final arbiter on the matter. Some background to the case is in order.

The Glivec Case: Some Milestones

Over 30,000 cases of chronic myeloid leukemia (CML), a form of cancer of the blood cells, are reported in India every year. In 2001, Novartis introduced Glivec (imatinib mesylate) in India, a really useful drug producing remission in over 90 per cent of CML patients. Glivec is to be taken lifelong. Treatment with Glivec, the version manufactured and marketed by Novartis, costs Rs 1.2 lakh a month, whereas Indian companies, nine of them, were making and marketing it at a price of about Rs 8,000 per month. It costs about Rs 1,000 or less for the manufacturers to make the monthly quota. So Indian companies too are deriving high profit margins from imatinib mesylate, albeit less than Novartis’ margins.

The pricing of Glivec puts it out of reach for nearly everyone in India. If a patent were to be granted to Novartis for imatinib mesylate, Indian companies cannot produce the drug and at a treatment cost of Rs 1,20,000 per month, over 99 per cent of patients requiring the drug would find the drug unaffordable and hence be denied access. Glivec is a classic illustration of how a patent-enabled drug monopoly can be and is harmful to the majority but good for the company’s bottom line. Novartis sold globally in 2006 $ 2.6 billion worth of Glivec.

In 1998, Novartis applied in India for a patent for Glivec and was granted an exclusive marketing right (EMR) in January 2003.4 As a result, Indian courts forbade six out of nine generic producers to market imatinib mesylate. Three of the remaining generic companies could not cover the entire country and, according to the Cancer Patients Aid Association (CPAA), thousands of CML patients suffered and many became bankrupt as they tried to buy Glivec; many even died.5 CPAA went to the Supreme Court of India against granting of EMR to Novartis.

In April 2005, India’s Parliament amended the Indian Patents Act 1970: medicines could now be product patented in India. However, Section 3(d) of the amended Act specifies that new forms of known substances do not deserve patents. (Section 3(d) says: “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or 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. Explanation: 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 be the same substance, unless they differ significantly in properties with regard to efficacy.”)6

The amended patents law also provides for pre-grant opposition of patents. In 2005, the CPAA and the other generic Indian companies filed a pre-grant opposition against Novartis’ patent application for beta crystalline form of imatinib mesylate, claiming, among other things, that Novartis’ alleged “invention” lacked novelty, 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 substance’s efficacy, and was thus not patentable under Section 3(d) of the Patents Act. Novartis had already been granted a patent in 1993 for the active molecule, imatinib, and that the present application only concerned a specific crystalline form of the salt form of that compound.

In January 2006, the Chennai office of the Controller General of Patents and Designs rejected the patent application of Novartis for Glivec on the grounds that it is simply a new form of a known substance. The Assistant Patents Controller at Chennai held that the 1993 patent claimed all salts related to the free base that was being patented. Since Glivec was

Economic and Political Weekly September 15, 2007

a salt of that free base, and was obtained in the customary manner and was the form that the salt normally exists in, Glivec was a known salt and could not be patented. Since Glivec’s salt form was the most thermodynamically stable and also the form that the salt normally assumes, it was obvious. The application only claims a new form of a known substance and in view of Section 3(d) of the Patent Act must show enhancement of efficacy. The base substance known at the time of application was not imatinib but imatinib mesylate thus Glivec being only a beta-crystalline form of imatinib mesylate was deemed to be only a new form of a known substance and not an enhancement of efficacy. Rejecting Novartis’s argument that it was 30 per cent more bio available in rats, the controller held that there had been no enhancement of efficacy.

The patent was therefore denied. As a result, once again, generic versions of Glivec were available in the Indian market at somewhat affordable prices.

Before the Chennai High Court

In May 2006, Novartis appealed in the Chennai High Court against the decision of the Patents Controller at Chennai and also filed a case against the Indian Patents Act, 1970. Respondents included several interested drug companies as well as the CPAA. Novartis’ position was argued by Shanti Bhushan and Soli Sorabjee.7

Counsel for Novartis contended before the Chennai High Court division bench that the amended Section 3(d) was not TRIPS compliant. And that Section 3(d) because of its inherent ambiguity, vagueness and arbitrariness conferred un-canalised powers on the Statutory Authority (in this case the Patents Controller) and therefore violated Article 14 (right to trade) of the Indian Constitution. In its detailed response, the Chennai High Court felt the first issue was outside the jurisdiction of the court, it being inter alia an international treaty among WTO member countries, and there was a settled mechanism, under Article 64 of TRIPS, namely the Dispute Settlement Body, to deal with such issues. For the same reason, the honourable court did not deem it fit to decide on the issue as to whether the amended Section 3(d) is compatible with TRIPS. On the latter issue, the court, after examining in detail relevant case law, held that the amended Section 3(d) is not in violation of Article 14 of the Constitution of India and accordingly dismissed the petitions by Novartis AG and its Indian subsidiary. The Swiss government as the member country where Novartis has its headquarters has since confirmed that it has no intention of taking the issue to the WTO’s Dispute Settlement Body.

Issues Emerging

There is a celebratory air among anti-Novartis protagonists in India and elsewhere. These may need to be tempered. The decision that Glivec was not really a drug deserving to be patented may get upturned anytime given the nature of the judicial process and the long journey of appeals that Novartis is entitled to. However Novartis may be reluctant to appeal further because of the bad publicity it will create and may resort to other tactics which include bad mouthing India’s “unfavourable” IP atmosphere. Secondly, inasmuch as such cases add to the compendium of case law, the text of the judgment does not per se inhibit any future appeals on similar drugs by other companies and that will definitely include home-grown companies straining at the leash to join the big boys of inter national pharma. The issue of what constitutes enhanced efficacy of a drug is not in general settled, we need to respectfully submit. Nor the means to establish the validity of a claim for enhanced efficacy. Is it bioequivalence or bioavailability? Or safety and toxicity, side-effects, adverse effects, contra-indications? How much difference should be there in each to show that “they significantly differ in properties with regard to efficacy”? What indeed is the definition of efficacy? Since this issue is not settled judicially (whether can it ever be settled scientifically is a different debate) – we are in for a long haul. Until such settlement, each new drug contested will need to be argued case by case, although hopefully with increasing ease.

The problem arises because the intent of Section 3(d) is to prevent evergreening and ensure affordable access to medicines to the Indian public. Section 3(d) should be read as such. Section 3(d) should not be read as primarily a scientific subtext that says that there is little chance that new forms of a known substance cannot/ can have better efficacy, howsoever defined. Therein lies the route to legal quagmire. Different forms of a drug are known to have differential effects, some more and some not so dramatic. The issue is ripe for endless contestation. Add on to these, issues like obviousness (lies in the mind of the beholder?). Jurisprudence over the years may raise/lower the yardstick for what constitutes obviousness,8 efficacy, significantly different, etc, depending on matter presented to them and let us admit depending on the world view of the judge (s) regarding patents, intellectual property, etc.9 The ordinary people of India are in for an even longer haul.

We mentioned the intent of Section 3(d). Unfortunately the ruling dispensations at the centre do not seem to show any inclination to take this understanding in other multiple ways so as to really make the right to healthcare a reality. On the contrary, our ruling elites in their neo-liberal wisdom are keen to integrate with the rest of the world – specifically the Western world from which the likes of Novartis spring. Such integration howsoever welcome comes with a price and one price is that intellectual property of MNC drug companies, such as it is, will have to be protected and seen to be protected with “seriousness”, what with India’s leading business media siding with them – not infrequently the pink papers of India strive to demonstrate how India is not an “IP pariah” as compared to say poor China. Even as Novartis battles over its image10 and over Glivec, Swiss pharma manufacturer Roche, no saint that, received last year India’s first product patent for its hepatitis treatment drug Pegasys and now in the last few weeks has been granted four more product patents. Roche has obtained product patents for its latest drug Mircera, which is an advanced form of drug Erythro poetin used in organ transplant, for Tarceva, the drug it launched last year for treatment of lung cancer, for its anti-viral brand Valgancyclovir and for its breast cancer drug Herceptin.11

A better touchstone therefore is to look at these issues from the point of public health and Article 21 of India’s Constitution (Right to Life). A drug MNC with deep pockets can interminably drag the issue. Neither do well-intentioned publicspirited lawyers nor activists have enough resources to counter the rate at which drug patents are/will be issued – or even to examine a strategic sample of them. Indeed, there is a strong case for certain therapeutic classes of drugs important for public health, and therefore national security, to be made outside the purview

Economic and Political Weekly September 15, 2007 of legal disputation. This could include either of the following: (a) no patents on drugs important for public health or (b) automatic compulsory licensing of drugs for public health.12 Even now the government of India can issue a compulsory licence for imatinib besylate to begin with. It will be complementary, and a more efficient use of public money, to government’s attempts to set up a Cancer Patients Treatment Fund. And what is more, it will be TRIPS and Doha compliant.13

Let us conclude from quoting an extract from the executive summary of Inte grating Intellectual Property Rights and Development Policy. Report of the Commission on Intellectual Property Rights, London, 2002, of which the redoubtable Dr Mashelkar was a concurring member:14

... For the most part IP rights are nowadays generally treated as economic and commercial rights, as is the case in TRIPS, and are more often held by companies rather than individual inventors. But describing them as “rights” should not be allowed to conceal the very real dilemmas raised by their application in developing countries, where the extra costs they impose may be at the expense of the necessities of life for poor people. We believe policymakers need to consider the available evidence, imperfect as it may be, before further extending IP rights. Too often, the interests of the “producer” dominate in the evolution of IP policy, and those of the ultimate consumer are either not heard or heeded. In IPR discussions between developed and developing countries, a similar imbalance exists. Developing countries negotiate from a position of relative weakness. The difficulty is that they are “second comers” in a world that has been shaped by the “first comers”. The question is how they can mould their IP systems to suit their own economic, social, and technological conditions, as developed countries did in the past. Intellectual property systems may, if we are not careful, introduce distortions that are detrimental to the interests of developing countries. Developed countries should pay more attention to reconciling their commercial self-interest with the need to reduce poverty in developing countries, which is in every one’s interest. Higher IP standards should not be pressed on developing countries without a serious and objective assessment of their impact on development and poor people. We need to ensure that the global IP system evolves so that the needs of developing countries are incorporated and, most importantly, so that it contributes to the reduction of poverty in developing countries by stimulating innovation and technology transfer relevant to them, while also making available the products of technology at the most competitive prices possible…

EPW

Email: sahajbrc@youtele.com

Notes

[The author is grateful for information at the following links: web sites of the Cancer Patients Aid Association at http://www.cpaaindia.org/ aboutus/PublicEyeAwards.htm; and the Affordable Medicines Treatment Campaign at http://www. lawyerscollective.org/^amtc/^Patent_Oppositions/ gleevec.asp. Some exchanges with Anand Grover, counsel for CPAA, helped as also the educative blogs at http://www.patentlyo.com/ and http:// spicyipindia.blogspot.com. Last accessed September 5, 2007. The usual disclaimers apply.]

1 The bill for the Patents (Amendment) Act, 2005 was introduced in March 2005 and finally passed in April 2005 by Parliament. One finds both dates quoted, interchangeably, by commentators as the date of the amendment. Novartis filed the case in the Chennai High Court in May 2006.

2 “Evergreening” is the process of interminably extending the life of a patent – 20 years according to Indian law for product patents on drugs – by inventing new uses, indications or even dosages and/or by trivially modifying the structure of the drug. US FDA has been more liberal with respect to evergreening but the record of US courts is mixed. A recent US Federal Circuit judgment in Pfizer vs Apotex supports the ruling of the Chennai Patents Controller’s office, and therefore probably Pfizer should accuse US law for not being TRIPS compliant enough! In the American case, Pfizer, the pharmaceutical giant filed a suit against Apotex, a generic drug maker for infringing its patent on Norvasc, antihypertensive and anti-anginal. The active ingredient in Norvasc is amlodipine besylate. Besylate is referred interchangeably in the literature as benzene sulphonate, benzenesulphonate, or benzene sulfonate. Pfizer acquired a patent bearing number 48,79,303 over amlodipine besylate in 1989. Pfizer sued Apotex for infringement; Apotex alleged that Pfizer’s patent is invalid because the invention was obvious from Pfizer’s own previous patent on amlodipine. Apotex pointed out that Pfizer was the patent owner over amlodipine (US Patent No 45,72,909) which was issued in 1986. Amlodipine besylates, Apotex argued, are just the salt form of amlodipine and hence, are just obvious improvements. The Federal Circuit concurred with Apotex and held that amlodipine besylate was prima facie obvious over amlodipine. It is notable that there was no significant or enhanced utility in the besylate form. The Federal Circuit ruling reinforces the idea that salts of known compounds are deemed to be obvious unless there is an unexpected utility or improvement or efficacy. (For the full

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Economic and Political Weekly September 15, 2007

judgment, see http://www.fedcir.gov/ opinions/06-1261.pdf.)

3 There is a twist to the tale. In April 2007, Novartis’ appeal against the order of the Patent Controller rejecting its patent application for Glivec (imatinib mesylate) initially filed in the Madras High Court was transferred to the IPAB, following a notification in April 2007 by the government of India. When the matter was to be heard by IPAB, comprising justice Ansari and Chandrasekaran (technical member), on June 18, 2007, Novartis filed a miscellaneous petition seeking the removal of Chandrasekaran (former patent controller) from the IPAB for the current appeal on the ground of bias: the bias alleged was that Chandrasekaran is the deponent (signatory) who signed on the government’s reply affidavit in the appeal pending before the IPAB, which was formerly before the Madras High Court and therefore was not likely to be impartial. The IPAB dismissed this too taking recourse to the doctrine of necessity: under this doctrine, in case of bias, where there is no other person who is competent or authorised to be an adjudicator or if a quorum cannot be formed or no other competent tribunal can be constituted, the law would permit certain things to be done which it would otherwise not allow. Meaning in the extant circumstances there was no replacement possible other than Chandrasekaran as technical member who also meets the prerequisites laid down under law for a technical member. To this writer the IPAB’s disposal of the further issue of how whether the technical member was not capable of bias in his new capacity reeks of a double-edged sword that can cut either way – although the outcome was favourable in the current case from the point of clipping Novartis’ wings.

4 Much of the research and development of Glivec was carried out by Brian Druker of the Oregon Health and Science University. His lab, working in a partnership with a scientist working for Novartis, identified the compound STI 571. They first used the compound to cure cancer in mice. Druker oversaw the first clinical trial, and other early Phase I clinical trials. He also participated in each of the clinical trials cited in the FDA approval of the drug for treatment of Chronic Myeloid Leukemia. While he was developing the drug his laboratory’s funding sources were

  • 50 per cent – National Cancer Institute
  • 30 per cent – Leukemia and Lymphoma Society
  • 10 per cent – Novartis
  • 10 per cent – Oregon Health and Science University (Source: Brian Druker quoted in ‘A Note on Dr Brian Druker’s Involvement in the Research and Development of Gleevec’ at http://www.cptech.org/ip/health/gleevec/ drucker.html): Elsewhere Druker is quoted in e-drug forum as saying: “....the price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive
  • rights by excessive prices and seeking patents over minor changes to extend mono poly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible. ...... Without access medical research becomes a luxury good. Most of my colleagues would be very uncomfortable if we felt that this would be the result of our decades of effort.”

    5 Novartis claims that all those cancer patients in India needing Glivec are/were provided the drug free by the company. However, CPAA chairperson Y K Sapru has this to say: “The Novartis claim that all poor CML patients who needed Glivec since 2002 till today have had an access to free Glivec through Glivec International Patient Assistance Programme (GIPAP) is not true. This is obvious from Novartis’ own claim of having given Glivec free to around 7,000 CML patients from 2002 to 2007. Does it mean that in this five-year span, out of 30,000 CML patients detected every year, i e, 1,50,000 CML patients in five years in India, only 7,000 poor CML patients needed Glivec? ...The reality is that Glivec is available free to only a few selected patients recommended by doctors chosen by Novartis while thousands of others are treated by generic versions of Glivec manufactured by nine Indian generic manufacturing companies”(quoted in the Times of India, Sunday Mailbox, April 22, 2007).

    6 For a better understanding, the un-amended sections read: Un-amended Section 3(d): The mere discovery of any new property or new use of 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. Amendment to Section 3(d) under Ordinance 7/2004: The mere discovery of any new property or mere new use of 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.

    7 The All-India Drug Action Network (AIDAN) sent letters to both counsels requesting them to desist from arguing for Novartis. See mfc bulletin, April-May 2007, p 24. at www. mfcindia.org. Their letter concludes: “... On whose side will you stand Bhushan/ Sorabjee? On the side of your people and their distress or the balance sheet of a multinational company? Is the cause you now represent, in line with what you championed not so remotely in the past? Another illustrious lawyer of this land stood on the side on a company responsible for one of the worst industrial disasters in history for which thousands have paid the price. We appeal to you to stop representing Novartis in this vital case and assure you that your example shall long be remembered by both lawyers and the people of this vast and suffering nation. In our appeal we are only reminding you of the words of one of the most illustrious lawyers this country has produced, ‘There is a higher court than courts of justice and that is the court of conscience. It supersedes all

    other courts.’ The lawyer was M K Gandhi.”

    8 In a recent unanimous decision, in KSR Int’l vs Teleflex, Inc, No 04 – 1350, April 30, 2007, the US Supreme Court rejected any notion that the concept of obviousness in patent law can be rigidly or narrowly defined

    – holding that “the obviousness analysis cannot be confined by a formalistic conception”. This judgment is viewed as raising the bar on non-obviousness and has sparked off furious comment in the American IP community. See for full judgment http://www. patentlyo.com/patent/files/KSRvTeleflexOpinion.pdf.

    9 The same Federal Circuit Court, quoted approvingly by us in fn 2 above, took a totally contrary stand regarding obviousness in cases relating to Lipitor and Plavix: Plavix was about selecting a salt from about 50 salts; and Lipitor was about selecting an enantiomer, (a mirror image, like left and right hand) from a racemate (optically inactive mixture of “left” and “right” enantiomers) – both cases were held non-obvious. Enantiomers are obvious in principle, but not obvious to generate, but they can have significantly different pharmacological properties.

    Thalidomide is an example of a racemic drug, in which one enantiomer produces a desirable antiemetic (against nausea, vomit, etc) effect, whereas the other is toxic and produces a teratogenic (can result in malformation of foetus) side-effect.

    10 “On the opening day of the World Economic Forum in Davos, Switzerland, the Public Eye Swiss Award 2007 for irresponsible corporate behaviour was given to Novartis on the basis of a nomination made by the Cancer Patients Aid Association (CPAA). The Berne Declaration and Pro Natura, Switzerland, have given out this negative award for the last three years.” (Source: http:// www.cpaaindia.org/aboutus/PublicEye Awards.htm).

    11 “It’s raining patents for Roche” quoted at http://www.moneycontrol.com/india/news/ business/its-raining-patents-forroche/20/24/297329, accessed on September 5, 2007.

    12 Lest this is thought to be an impractical suggestion, Thailand considered more “beholden” to the US than India has taken the courageous step to introduce compulsory licenses (CLs) for three drugs that were unaffordable for the majority of its people. India can learn from Thailand how to use the flexibilities in the TRIPS/Doha Agreement and our own amended Patents Act 1970. “The main objective of announcing and implementing the Government use of patent is to increase the access to essential medicines among the Thai people. The government does not save any budget and in some cases has to spend more. For those ARVs which have limited coverage, like Efavirenz and Lopinavir+Ritonavir, many more people will have access to the drugs with the same budget level. In the case of Clopidogrel, the patients under the National Public Health Insurance Plan had no or very little access before, and the government had to pay an additional amount to allow access to the lower priced generic version of Clopidogrel. It should be reiterated that drugs

    Economic and Political Weekly September 15, 2007

    derived from the implementation of the three Government Use of patent will be distributed only to those patients under any of the three public health insurance plans paid by the government.” [Source: Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand. Document to Support Strengthening of Social Wisdom on the Issue of Drug Patent by the Ministry of Public Health and the National Health Security Office, Thailand, February 2007. Also at http:// www.moph.go.th/hot/White%20Paper%20 CL-EN.pdf].

    13 The Doha Declaration para 4 states “We agree that the TRIPS Agreement does not and should not prevent Members from taking measure to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose”.

    14 Full report available at http://www. iprcommission.org/papers/pdfs/final_report/ CIPfullfinal.pdf

    Economic and Political Weekly September 15, 2007

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