Novartis firmly put in place

Published: Tue, 07/16/2013 - 08:30

The Supreme Court judgment in the Glivec case is a landmark instance of Third World jurisprudence tackling big pharma ‘mischief’ 

Dwijen Rangnekar Coventry (UK) 

In John le Carré’s The Constant Gardener, that remarkable novel of big pharma’s unrelenting power and corrosive collusion with government, Tessa Quayle, a mid-level British diplomat’s wife, is murdered when she threatens to expose the cover-up of countless deaths of participants in a pharmaceutical company’s clinical trials in Kenya. As the novel goes on, we find the British government involved with the company and abetting the murder of its own diplomat — Tessa’s husband. But such practices are not purely fictitious. The Supreme Court of India’s recent judgment, rejecting Novartis’s patent plea for an updated version of its cancer drug, Glivec, illuminates other aspects of big pharma operations: incremental drug development, artful drafting of patent applications, and, of course, cross-contamination with regulatory and governance agencies. The judgment is a signifier of a changing landscape with regard to access to medicine that involves Third World jurisprudence. 

Glivec (called Gleevec in the US) is a drug for chronic myelogenous leukaemia (CML). It is the result of considerable publicly funded/conducted basic and clinical research, which isolated the cause of CML, the BCR-ABL oncogene, and identified a promising candidate (STI 571, imatinib mesylate). Novartis grudgingly arrives late on the scene and synthesises STI571 (US Patent 5,521,184; May 1996).

Finding a beta crystalline form of imatinibmesylate more stable, Novartis seeks to patent this too (US Patent 6,894,051; May 2005). It also submits an application in India (Application 1602/MAS/98) in 1998. This application is examined only in 2005 when the country comes into full compliance with TRIPS. With a number of domestic pharmaceutical firms and patient groups lodging their opposition, claiming that it was either ‘anticipated’, ‘obvious’, foul of Section 3(d), among others, the Patent Controller (in January 2006) found cause to reject the patent application. The decision was upheld, with some qualifications, by the Intellectual Property Appellate Body in July 2009.

Novartis’s argument was premised on Glivec’s improved bioavailability, storability and flow properties. However, the IPAB considered these as enhancing the functionality and presentability of the drug but not its efficacy, that is, the “healing of disease”. And, as I note later, the Supreme Court, explicating Section 3(d), expands on this principle.

Most narratives of the Uruguay Round negotiations, which culminated in TRIPS and WTO, note how the US dominated the agenda. And how corporate lobby groups were informally and formally authoring the TRIPS agreement. They emphasise the economic coercion of trade sanctions deployed by the US. For that matter, while the US opposed apartheid-era trade sanctions against South Africa, the Bill Clinton government was alert about slapping a newly democratic South Africa with trade sanctions when they used TRIPS provisions to allow import of generic AIDS drugs.

These narratives make silent the resistance and struggle that accompanied these negotiations. It is not just a matter of illuminating the activism of collectives like the National Working Group on Patent Law (in India) or UN agencies like UNCTAD, or movements like the ‘Beej Bachao Andolan’ in the hills of Garhwal in India and elsewhere. But also of recognising how opposition to TRIPS was persistent and has never succumbed to the domination. This may even occur through the cunning use of procedure. Consider the very first TRIPS dispute: a US complaint about India’s failed attempts to legislate on ‘exclusive marketing rights’ and ‘mail-box’. I recall an Indian bureaucrat communicating that the government knew it had “no argument”. So, in challenging the US claim, India actually invites the dispute and then proceeds to question the panel’s decision. In essence, an obligation due in January 1995 was only enacted in March 1999.

 Brian Drucker, one of the ‘inventors’ of Glivec, stated that Novartis’s behaviour is an ‘abuse’ in ‘seeking patents over minor changes to extend monopoly prices’. Not only did Novartis proceed, it aggressively pursued generic producers

Tellingly, an agreement once thought settled is being chipped away at — both on the periphery through ingenious jurisprudence and at the centre through proposed amendments. Consider Brazil’s compulsory licensing provisions which require ‘local working’ of a patent through ‘local production’ and not importation. This is remarkable as the general consensus even amongst critical readers of TRIPS has been that ‘local working’, a pre-TRIPS flexibility, is eliminated by Article 27.1, which states that “… 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”. When the US sought a dispute, it was forced to retreat by Brazil threatening a counter-suit! 

The legacy of Section 3(d): Section 3(d) sits alongside other such struggles to resist, revise, and reject TRIPS. This much is evident when the Supreme Court says it is “necessary to find out the concerns of Parliament… What was the mischief Parliament wanted to check and what were the objects it intended to achieve through these amendments?” A broadly expressed concern, even noted by the US Federal Trade Commission (e.g. ‘To Promote Innovation’, 2003), relates to corporate practices of patent stacking, overlapping and multiple patents. Compounded by low quality patent examination, this chokes technological progress. Particularly perverse in pharmaceuticals are patent thickets around a single molecule when minor modifications such as changes in size, colour, dosage, delivery mechanism and composition are either simultaneously or sequentially patented. Note an oft-quoted fact: of the 1,035 new drug applications approved by the US Food and Drug Authority between 1989 and 2000, only 15 per cent were considered ‘highly innovative’ ( that is, medicines with new active ingredients and/or contributing significant clinical improvement).

Much of this is evident in Glivec’s case. For instance, it becomes apparent that the drug in the US, Gleevec, was launched in May 2001, on the basis of the 1996 ‘Zimmerman’ patent, thus suggesting that the beta crystalline form was a ‘mere modification’. In fact, that patent — which is the one disputed — was initially rejected by the US patent authorities and only granted on appeal in May 2005. Another point of evidence was the legal notice that Novartis served on NATCO in the UK in February 2004. NATCO’s drug has an active ingredient, Imatinib Mesylate, and the matter was settled out of court. In noting this, the Supreme Court makes clear that Glivec was part of the Zimmerman patent.

One of Novartis’s responses was to concede that while Gleevec could be claimed by the Zimmerman patent, it was not fully disclosed in an enabling manner. This wonderful legalese was eloquently rejected by the Supreme Court: “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”

It is worth recalling the local and global campaign pressuring Novartis to drop the case. Alongside public health groups like MSF were a variety of social actors. Novartis shareholders made repeated requests to the company to drop the case. A number of medical practitioners, including those intimately involved with Glivec, criticized Novartis’s challenge.

Those who have read the novel and seen the film will squirm in recalling that glossy hint of Hollywood justice the film inserts. The film ends at the funeral of Tessa’s husband, where Tessa’s cousin speaks to reporters on the reasons for the dual murder, leaving viewers with a hint of remedial action. It’s in stark contrast to the grim ‘reality’ of the novel. John le Carré informs us, ‘As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard’

Brian Drucker, one of the ‘inventors’ of Glivec, publicly stated that Novartis’s behaviour is an “abuse” in “seeking patents over minor changes to extend monopoly prices”. In contrast, not only did Novartis proceed with the case, but it also aggressively pursued generic producers. Those who have seen Dying for Drugs, a 2005 documentary on access to medicine produced by Brian Woods, may recall the ‘nudge’ that Novartis gives to get the US embassy in South Korea to pressure the country against issuing a compulsory licence.

In seeking to stop ‘mischief’, alongside Section 3(d) are ingenious provisions in India’s patent laws — the possibility of pre- and post-grant opposition, which allows a variety of third parties to intervene in the arcane of patent examination and grant. This is significant in opening interpretative custody and patent examination to wider scrutiny. And this is where groups like the Cancer Patients Aid Association, among others, become significant.

 

Patent reform discussions in the US have repeatedly noted the problem of low quality of patent examination and the significance of pre- and post-grant opposition. Yet, such reforms have failed to be adopted. Perhaps, Third World jurisprudence will flow north. There is much talk of Section 3(d) being emulated in Argentina, China and Thailand. Soon after the judgment, there were reports that Australia and Canada were also considering similar provisions.

What then of le Carré’s novel — is there hope for reform? Or space for justice?

Those who have read the novel and seen the film will squirm in recalling that glossy hint of Hollywood justice the film inserts. The film ends at the funeral of Tessa’s husband, where Tessa’s cousin speaks to assembled reporters on the reasons for the dual murder, leaving viewers with a hint of remedial action. It’s in stark contrast to the grim ‘reality’ and ‘end’ of the novel. For that matter, le Carré informs us, “As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard.”

We should celebrate the Supreme Court judgment and note how it testifies to the flawed project of global harmonization of Intellectual Property laws. But this shouldn’t mask the reality around us. In this respect, a TRIPS Council meeting of March 2013 is a sobering reminder of some of the hurdles ahead. ‘Least developed countries’ had submitted a proposal for an extension to their implementation deadline, suggesting that an appropriate moment would be when an LDC achieves ‘developing country’ status (according to World Bank categorization). While considered a reasonable request by nearly all developing countries at the WTO, both the EU and the US expressed concern and advised caution. They forestalled a decision.   

The writer is Associate Professor of Law at the School of Law, University of Warwick (UK). He has previously held positions at University College London (UK) and Kingston University (UK). He is currently completing a monograph titled ‘Re-Making Place: The Social Construction of Geographical Indications’ (Palgrave Macmillan, 2014). 

 

The Supreme Court judgment in the Glivec case is a landmark instance of Third World jurisprudence tackling big pharma ‘mischief’
Dwijen Rangnekar Coventry (UK) 

Read more stories by Novartis firmly put in place

This story is from print issue of HardNews