In its implementation of the TRIPS Agreement, India incorporated a clever provision into its Patents Act. This clever provision, Section 3(d), is essentially aimed at preventing the grant of secondary patents on trivial modifications of existing drugs. This provision was relied upon by the Indian Supreme Court in 2013 to deny Novartis a patent on its drug, Glivec. It should however be stressed that while Section 3(d) might be effective against secondary pharmaceutical patents, it may not really prevent the grant of pharmaceutical patents on new molecular entities. This raises a crucial question: what impact will Section 3(d) have on the Indian pharmaceutical patenting landscape with regard to new molecular entities in the future?
This crucial question is addressed in an interesting article on drug patenting in India written by Bhaven Sampat and Kenneth Shadlen and published in August 2015 in Nature Reviews: Drug Discovery. Sampat and Shadlen make a number of important observations in their article. I will try to highlight some of their observations in this post. As Sampat and Shadlen point out, ‘while Section 3(d) has attracted considerable attention, another aspect of India’s TRIPS implementation was to disallow any patents with a priority year (that is, the year of first global filing) before 1995.’ Thus, by necessary implication, with or without Section 3(d), Sampat and Shadlen note that ‘pre‑1995 compound patents are not eligible for protection in India.’ This explains why, as Sampat and Shadlen note, ‘drugs with pre‑1995 primary patents must rely on ‘weaker’ secondary patents as their only form of protection in India, as illustrated by the Glivec case.’
What about drugs with post-1995 primary patents? According to Sampat and Shadlen, ‘For drugs with pre‑1995 compound patents that are not eligible in India, Section 3(d) and other restrictions on secondary patenting may determine whether a drug gets any patent protection at all. For drugs with post‑1995 compound patents that are likely to be patented in India, the main effects of Section 3(d) and other restrictions on secondary patents will be on the duration of protection.’ In other words, the term of patent protection for drugs with post-1995 primary patents will not be extendable through the grant of secondary patents.
It is therefore true that Section 3(d) makes it difficult to obtain pharmaceutical patents in India, but this is only true with respect to secondary patents and not primary patents. Section 3(d) does not and (as Sampat and Shadlen note) ‘will not necessarily make India a patent-free zone.’ Besides, the TRIPS Agreement does not make it mandatory for countries to grant secondary patents on pharmaceutical products. More importantly, as Sampat and Shadlen rightly point out, ‘if Section 3(d) is implemented as intended — to limit secondary patents — then as 1995 fades further into the past, most new molecular entities will get one patent in India, but only one.’