In a dispute that is being watched across the world, the Delhi High Court has granted the Indian company Cipla the right to manufacture a lung cancer drug that Swiss company Roche claimed to have a patent on.
This dispute extends outside the ken of lung cancer. India is the world’s leading producer and exporter of non-branded pharmaceuticals; these drugs are considerably cheaper than their branded counterparts, with virtually the same dosage, strength, route of administration, quality and performance characteristics. Multinational companies, in the past decade, have risen up in arms against this proliferation of drugs that they say violate patent laws. Representatives of developing countries, however, say that these alternatives offer affordable options to lifesaving drugs, and that there shouldn’t be a monopoly on such essential commodities, particularly such expensive monopolies.The Cipla-Roche battle has been ongoing for four years. In 2008, Roche filed a case against Cipla for manufacturing a generic version of its cancer drug ‘Tarceva’, which Cipla sells by the name ‘Erlocip’. While the Roche version costs about Rs.140000 per month (about $2500), the Cipla drug is available at Rs. 25000 (about $450 dollars).
Until 1995, India did not award drug patents, to ensure that drugs remained available to all income-sectors in the population. Starting in 1995, India introduced new patent laws to comply with WTO rules. However, a regulation in the Indian patent law makes the manufacture of generic drugs possible; this regulation stipulates that a variant of a drug that existed before 1995 cannot be patented, unless it offers considerable changes over the existing compound. It is this that could have let Cipla off the hook (Tarceva is a modification of a compound gefitinib/Iressa), or the other contention that Cipla offered a much cheaper alternative to a drug that could be crucial to saving lives. The details of the judgement remain unknown until now. Roche have the right to appeal to a higher court in the country; how they respond to this verdict remains to be seen.
This verdict is being seen as an indicator of how much Indian laws will offer protection to multinational companies, and also a sign of what the future of the generic-drug industry looks like. Close on the heels of this case is the next battle in court in which another Swiss firm Novartis bids for patent protection for its cancer drug Glivec.