Is the strong stand taken by pharma major Novartis AG, questioning India’s patent law for rejecting its leukaemia drug Glivec, in the face of tremendous opposition across the world, surprising? No, given the stakes—Novartis has applied for several patents in India, and Glivec was the first to be rejected. Its motive is clearly to get the threshold for patenting lowered in India.
At the core of the litigation is Section 3(d) of Indian Patent Law, which says that modifications of known medicines can’t be patented, unless they make the drug significantly more effective. In the instant case, as patent coverage in India is applicable only for filings on or after 1 January 1995, Glivec’s basic molecule “Imatinib” was not eligible. Novartis was seeking protection for a patent filed post-1995, on the drug’s beta crystalline polymorph form, Imatinib Mesylate. In January 2006, that patent was denied. It then took the stand that Section 3(d) is not compliant with the Trade Related Aspects of Intellectual Property Rights (Trips) pact that India implemented in 2005.
But, as the government argued back, the Trips pact provides for flexibility in the degree of strictness a country could apply to its patentability criteria. Articles 7 and 8 of the Trips agreement indicate that member countries, while formulating or amending their laws, can adopt measures necessary to protect public health, and to promote public interest. India’s Section 3(d) specifically excludes salt forms, polymorphs, et al, unless efficacy is established. Indeed, other countries may also have similar conditions. For instance, legislation in the EU considers different salts, esters, ethers or derivatives of an active substance to be the same active substance, unless they differ significantly with regard to safety or efficacy.
Novartis has been quoted saying that efficacy could be known only after the trial phase and the product needed to be patented before that. India may do well to have some testing rules in place to assist its patent offices in evaluating this. But if patents were to be granted before testing, would they be revoked after the said testing proved no enhanced efficacy? Usually, pharmaceutically active organic bases are converted to salt forms as higher solubility leads to improved efficacy. This much is known. But then how would we define the degree of enhanced efficacy for patenting? This aspect still seems ambiguous and if the litigation does any good—it would be to induce more clarity.
Novartis says that generics would still be available despite the court ruling. But it was just after India approved five-year exclusive marketing rights (in line with the law) in 2003 for the crystalline form of Imatinib in India, that Novartis got injunctions against key domestic firms that had already launched generic Imatinib—at under one tenth of the price of Glivec. Agreed, Novartis does give its drug away to those who can’t afford it. But surely this is no sustainable approach for affordable access—donations can be and have been seen as revocable, and tough to access.
The right signals are crucial to this story. While Novartis says it wants to ensure patent rights that induce investments in research for patients’ benefit, it is not likely to plan its research based on a relatively small market. India has to ensure it defines protection of intellectual property rights adequately, while preventing the same from creating monopolies that raise prices astronomically on the back of marginal innovations.
How can patent rights and the issue of affordable access to medicines be balanced? Write to us at email@example.com