Pharma Patents after 10 Years

Ten years have passed since the Indian Patents Act, 1970 was amended in 2005 to bring the country’s laws in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The most important of the 2005 amendments was the introduction of product patents for 20 years, including for pharmaceutical products, but with the following safeguards: the amended Section 3(d) of the Patents Act that put paid to attempts to evergreen patents (extending patent protection by making minor changes to the original drug), the expanded compulsory licence (CL) provisions and the retention of pre-grant (and the introduction of post-grant) opposition to patents. Section 3(d) incorporates a strict bar for what constitutes an invention and clarifies what is not patentable in India: “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use of a known substance…”

This single provision, cited in a slew of cases, has prevented the runaway pricing of medicines seeking patents—notably Novartis’s Glivec (imatinib mesylate, an anti-cancer agent). The case of the CL on Bayer’s patent on Nexavar (sorafenib tosylate, also an anti-cancer agent) issued to Natco clarified the circumstances under which a CL could be issued. These cases have subsequently shown the true cost of manufacture once generic competition sets in. Several of these patent case rulings since 2005 have taken cognisance of the overpricing and consequent lack of access to patented medicines. In the Natco case, they constituted sufficient grounds for the issue of a CL.