ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Drug Firms vs Public Health

ECONOMIC AND POLITICAL WEEKLY Drug Firms vs Public Health Five years have passed since the World Trade Organisation

December 30, 2006 ECONOMIC AND POLITICAL WEEKLY
Drug Firms vs Public Health Five years have passed since the World Trade Organisation’s (WTO) Doha declaration on the trade-related aspects of intellectual property rights (TRIPS) agreement and public health. Article 4 of that declaration stated that the TRIPS agreement “does not and should not” prevent member countries from taking measures to protect public health. It was then agreed that the TRIPS agreement “can and should be interpreted and implemented in a manner supportive of …[the] right to protect public health and, in particular, to promote access to medicines for all”. The Doha declaration thus allowed WTO members to make use of the presumed “flexibilities” inherent in the TRIPS agreement to safeguard public health. On the strength of such interpretations, section 3(d) of the (third) amended Indian Patents Act (IPA) 1970, which excludes certain new forms or new uses of already patented chemical entities from the realm of further patenting, has so far not been deemed to be TRIPS incompatible. But this very section of the IPA has now been challenged in the courts by the Swiss transnational corporation, Novartis, in a case that will have important implications for market dominance and therefore the issue of access at reasonable and affordable prices to new and not-so-new medicines. In a move reminiscent of the 2001 campaign to pressurise the pharmaceutical transnational corporations to drop their case against the South African government challenging the latter’s imports of much cheaper generic AIDS medicines, the humanitarian agency and 1999 Nobel peace prize recipient, Medecins Sans Frontieres (MSF or Doctors Without Borders), has urged Novartis to immediately drop the case it filed in May this year in the Chennai High Court against the union of India and others. In 1998 Novartis had submitted a product patent application for the beta crystalline form of imatinib mesylate, the active pharmaceutical ingredient of its branded drug Glivec, used in the treatment of blood cancer and gastro-intestinal stromal tumours, under the mailbox provisions of TRIPS. A pre-grant opposition by the Cancer Patients Aid Association and generic manufacturers like Natco Pharma, Cipla and Ranbaxy in 2005 challenged the patent application, mainly on the basis of section 3(d) of the IPA. And, Novartis’ patent application was rejected under section 3(d) of the IPA in January this year, allowing the generic companies to continue making available the drug at one-tenth of the price of Glivec. In May, Novartis not only appealed against the rejection of its patent application, but also more importantly, challenged the constitutional validity of section 3(d) as added to the IPA. The company claims that section 3(d) is inconsistent with the TRIPS agreement, in particular, with Article 27 of that agreement, which has to do with patentable subject matter. Glivec is Novartis’ second-best selling drug, with sales revenue of $ 2.8 billion in 2005. New uses of this drug have made it important in the company’s drug portfolio, for these allow the company to extend the patent life further, thereby delaying the introduction of affordable generic versions in a number of countries. Novartis’ challenge of Indian patent law is important for other transnational corporations in the pharmaceutical industry and seems to be part of a larger strategy to “align Indian IP laws with TRIPS”. Another case that is being closely monitored is an opposition to the grant of a patent to Glaxo for Combivir, a fixed dose combination of two HIV/AIDS drugs, AZT and 3TC, by the Indian Network of People Living with HIV/AIDS and the Manipur Network of Positive People. Those opposing the grant of the patent argue that the fixed dose combination is not an invention; it is, quite simply, just a combination of two known pharmaceutical substances. The two cases are instances of so-called incrementally modified drugs (IMDs), which US patent law allows for the grant of patent. New formulations, new combinations of active ingredients, and new salts and esters of known and approved compounds are eligible for the grant of patent under US patent law, extending patent

life and delaying the introduction of generic medicines, and thus keeping the prices high. Indeed, when the Indian “mailbox” of product patent applications was opened to begin the process of examination by the controller general of patents and designs, it was found that not only a significant proportion of the 9,000 or so product patent applications related to pharmaceutical substances, but the bulk of the latter were IMDs. It is interesting to know that between 1995 and 2003, the US Food and Drug Administration had approved only 274 new chemical entities (or new molecular entities) for marketing. IMDs thus seem to be the name of the game in commercial R&D in the pharmaceutical industry.

Now, if Indian patent law were to be judicially pronounced inconsistent with the TRIPS agreement, this would have grave consequences for access to affordable medicines for millions of people, not only in India but also across the world. The local Indian pharmaceutical industry’s ability and capacity to develop, produce and market, nationally and internationally, generic drugs would be jeopardised. Clearly, the TNCs should not be allowed to engage in “evergreening”, where, at the end of the patent term, they seek to prolong their exclusive intellectual property rights by patenting a small improvement. Public health and the rights of patients have to come into the equation. EPW

Economic and Political Weekly December 30, 2006

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