Given that Novartis AG’s anti-cancer drug Glivec is patented in its current form in many countries from the US to China and several in Europe, it is hardly surprising that Novartis’s India chairman has reacted to the Supreme Court’s rejection of its patent application by saying big pharma is unlikely to want to invest in India. Like many others, Novartis argued India’s patent regime, particularly Section 3(d) of the Patents Act, was not compliant with the global TRIPS agreement. While agreeing with global practice that easy new forms of existing chemical substances—salts, esters, polymorphs, particle sizes and the like—cannot be patented, India had triggered a global debate on whether to introduce another layer of scrutiny which, it must be said, has no global precedent. The issue of “efficacy” in Section 3(d) was argued by many as being vague and arbitrary. Since the Supreme Court has given its view on “efficacy” while ruling Novartis’s drug failed both the tests of invention and patentability, presumably that issue has been addressed.
The Supreme Court also seems to have supported the Indian Pharmaceutical Alliance’s (IPA) argument in the Novartis case—IPA argued that Article 1(1) of TRIPS explicitly allows members “to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice”. Which is why the Supreme Court said the ruling “is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances”. Section 3(d), the Supreme Court said, was not amended “with the intent to undo the fundamental change brought in the patent regime by deletion of Section 5 from the Patent Act.”
Two points need to be stressed here. While Section 3(d) was brought in to scupper frivolous patents for evergreening of old patents, India has not been stingy about granting patents—in a reasonably short period of time, a tenth of India’s R75,000 crore local pharmaceuticals markets already comprises patented products. And for those who find the patenting regime oppressive in India, even the US turns down patents for being ‘adaptive’, ‘cumulative’ or ‘incremental’. The flip side, and this is where the government needs to apply its mind, is that Indian patients will be denied the benefits of new discoveries—both in India and overseas—if the patenting/licensing regime is seen as unfair. The Glivec case has been rejected by various levels of authorities and, now, by even the highest court in the land—so Novartis can’t complain of a systemic bias. But because of government policy, several drugs are not even produced in India, but only imported. Policies like the National List of Essential Medicines (NLEM) put caps on how much drug prices can be raised each year even though India has 5,000 to 10,000 producers of medicines, an average of 60 per drug ranging from 20 for anti-hypertensive Enalapril Maleate to 124 for painkiller Paracetamol. If the NLEM isn’t worrisome enough, granting of compulsory licences—in the case of Bayer’s liver and kidney cancer drug Nexavar—compounds the problem. This is patently problematic.