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Kaushik Sunder Rajan Property, Rights, and the Constitution of Contemporary Indian Biomedicine: Notes from the Gleevec Case IN 19 7 0 , THE IN D IA N GOVERNM ENT ENACTED A PATENT ACT THAT only allowed process patents on pharmaceuticals—not product patents. This meant that it was not possible to patent a therapeutic molecule itself but only the process by which the molecule was manufactured. This was a spur to India’s generic drug industry, and led to India’s drug prices becoming among the lowest in the world. This cost-effectiveness was not because of state socialism (as is often portrayed) but because of free market competition, whereby pharmaceuticals were sold in a competitive market like any other commodity. Indeed, India is one of the few countries where the state plays virtually no role in providing therapy to its population. Unlike Brazil or many European and East Asian countries, India does not have a program of nationalized health insurance. It also does not have a particularly functional system of government -imposed price controls on drugs. Any regulation of price that occurs has tended, since 1970, to take place through market compe­ tition. India’s competence in low-cost generic drug production was important not just for India but, through the 1990s, for the rest of the developing world, as drugs would be procured from India by groups like Doctors without Borders for distribution in the developing world. social research Vol. 78 : No. 3 : Fall 2011 975 This was particularly important in the case of anti-retrovirals for the treatment of HIV-AIDS. In the late 1980s and early 1990s, however, India came under bilateral pressure from the United States to become signatory to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agree­ ment, which became institutionalized under the aegis o f the World Trade Organization (WTO). In 1995, as India became a party to the WTO, it was allowed a 10-year grace period to change its patent laws to a TRIPS-compliant product patent regime, which allows a patent on therapeutic molecules, and thereby prevents the generic manufacture of a patented drug through any process. This meant that as o f2005, any drug developed after 1995 would be subject to a product patent regime; any drug developed before 1995 would still be subject to a process patent regime under the 1970 act. Gleevec provided the first case where the modalities of how a new patent regime would be interpreted came into question. PART 1: THE DISPUTE AROUND THE GLEEVEC PATENT Gleevec Gleevec, developed by the Swiss pharmaceutical company Novartis, is used in the treatment of chronic myelogenous leukemia (CML). It turns off the signal of a protein known to directly cause the cancer and has been shown to be considerably more effective than conventional therapy for CML.1 In the early 1990s, the core molecule that would later become developed as Gleevec, imatinib, was discovered as having potential therapeutic application. Ciba-Geigy (which subsequently became Novartis, and which had funded some of the early discoveiy research into the drug, and was also involved in developing the plateletderived growth factor [PDGF] chemical library whose screening would lead to the initial identification of imatinib as a potential therapeutic molecule) filed for a patent application for imatinib and its “pharma­ ceutically acceptable salts,” including imatinib mesylate, in the United States in 1993. Imatinib is the free base that has a potential therapeu­ 976 social research tic effect. However, the free base has low solubility and consequently poor bioavailability. The salt form of imatinib, imatinib mesylate, has greater solubility and bioavailability. The beta-crystalline isoform was developed as a drug. On July 18, 1997, Novartis filed a patent applica­ tion in Switzerland on beta-imatinib mesylate. This was developed by Novartis as Gleevec, and approved for marketing by the US Food and Drug Administration in 2001. By the time the new, TRIPS-compliant Indian Patent Act was passed in 2005, the question of the relationship between a product patent regime and access to medicines was already vexed. Gleevec was responsible for this because, before the product patent regime had been instituted, Novartis had been given exclusive marketing rights (or EMR) on...


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