Renewed campaign by global pharma companies against a key provision in India?s Patent Act, which seeks to prevent patenting of trivial inventions, has been strongly resisted by the domestic industry. A recent conference by industry chamber Ficci has endorsed the utility and tenability of Section 3 (d) of the Act, in what looks like a near consensus on the continuance of this provision introduced through the third amendment to the Act in 2005.
Section 3(d) essentially says that an incremental invention can be patented only if it enhances the efficacy of the original patented invention to the satisfaction of the patent authorities. The section, therefore, includes what can be called an exclusion criteria ? a list of possible trivial changes that might not qualify for patenting.
A recent report by Delhi-based think tank National Intellectual Property Organisation (NIPO) has noted that contrary to what has been projected by the Big Pharma, Section 3(d) wouldn?t prevent patenting of ?genuine incremental innovations?. ?Scrapping Section 3(d) would merely serve their business interests. In the absence of the section, launch of generic drugs that are generally much cheaper than the patented ones, could get delayed too, argues NIPO director TC James.
The NIPO report, backed by the Indian Pharmaceutical Alliance, rebuts claims of an earlier report by the US India Business Council (USIBC), which said that scrapping section 3(d) would allow most incremental innovations to be patented and in turn would benefit even Indian pharma companies that invest in R&D. Going by patent applications filed by India?s companies across the world, and other claims, majority of their inventions are incremental in nature.
James, however, contests this contention. Both in the number of patent applications filed and patents granted since 2005, the MNCs far outnumber the domestic firms, he points out. While in 2005, 80% of 17,466 patent applications filed in India were from non-residents, the corresponding figure has increased to 83% of 35,218 application in 2008. Of the patents granted, foreign constituency has grabbed 79% share of 15,261 awards in 2008, up from 60% of 1,911 in 2005.
Although there is no break up of how many of these patents are for pharma innovations, and how many have been granted for incremental innovation to multinationals vis-a-vis domestic companies, a separate compilation by IPA shows that at least 86 patents have been awarded to pharma products since 2005, not for breakthrough drugs but for improvements over existing products.
It has also been pointed out that the USIBC report is backed by the OPPI, body of pharma MNCs in India. ?With a large number of drug patents slated to expire in the next few years and a drying up of the pipeline of new blockbusters, many large pharma firms are exploring strategies to extend their hold on the Indian market through minor improvements of existing drugs. The efforts to get 3(d) scrapped should be understood as part of this strategy. The USIBC report is a tool in these efforts,? James said.
Pratibha Singh, patent lawyer representing Cipla in the Bayer?s case, said that courts have already upheld the constitutional validity of the section and it shouldn?t be tinkered with. Public health groups are also apprehensive that scrapping the section would delay the launch dates of generics in the Indian market. ?It is not conclusively proven that patent protection drives innovation. It is competition that drives innovation in pharma industry. There have been instances when the use of essential vaccines have been delayed only on account of patent protection,? said Leena Menghaney of Medecins Sans Frontieres.
?While the letter of the law ? Section 3(d) ? is understood and appreciated by the stakeholders, its spirit would become clear to one and all once judicial pronouncements on the same are made by high courts and the apex court,? Ashok Kumar, secretary, department of pharma said in a Ficci forum on Monday.
