It isn?t quite clear why the Prime Minister?s Office decided to stir a debate on the Organisation of Pharmaceutical Producers of India (OPPI)?it comprises mostly MNCs operating in India and their partners here?demand to dilute Section 3(d) of the Indian Patent Act. The Patent Act, as modified five years ago, has helped ensure India was not inundated with drugs that were just minor modifications of existing ones?something that one would expect, given the sharp slowdown in the number of new discoveries and the increased proclivity of the blockbusters-starved ?innovator firms? to look for pecuniary rewards from patenting of incremental inventions and try ?ever-greening?. When India?s lawmakers were debating 3(d) in the winter of 2004, the transnational pharma majors from the US and EU said it would violate Article 27 of the TRIPS agreement. They were subsequently proved wrong, and even the ardent votaries of undiluted and liberal patent rights like the World Intellectual Property Organization (WIPO) have endorsed 3(d) as a legitimate, TRIPS-compliant tool. The PMO?s move is also ill-timed because the Supreme Court is hearing an appeal from Swiss drug major Novartis on this matter.
The reason why Big Pharma dislikes Section 3(d) is that it makes it difficult to get patent rights for new (physical) forms or admixtures of previously known new chemical entities (NCEs) unless these seemingly trivial changes bring ?significant improvement in the efficacy? of the product in question. If vigorously implemented, 3(d) can thwart stockpiling of separate 20-year patents for multiple attributes of a single product. According to news reports, OPPI wants the term ?efficacy? to be defined and quantified. This apparently innocuous demand has the potential to undermine the utility of 3(d). It is not that the Indian patent offices haven?t granted patents for deserving incremental inventions that are of real therapeutic value to the patient-consumer. True, just about 40 of the 3,500 product patents for pharmaceuticals granted since 2005 are for new crystalline forms or polymorphs of a pre-existing NCEs. However, these patents have translated into just 30-odd products in the market so far, of which a dozen are crystalline forms. This shows how important the removal/dilution of 3(d) is to the patent seekers. Indian companies, too, may get a few patents for incremental inventions if 3(d) is diluted. But this would hardly offset the adverse effect, on the consumer or the Indian industry, of a bad patent.