Leading domestic drugmakers have decided to collectively challenge frivolous patent applications filed by multinationals in India under the aegis of the Indian Pharmaceutical Alliance.
"Multinationals are filing patents in large numbers and Indian patent offices have granted patents to many products that do not merit patent protection under domestic laws," Indian Pharmaceutical Alliance (IPA) Secretary-General D G Shah told PTI.
He said IPA is planning to challenge such "frivolous patent applications in the pre-grant stage itself".
"Once a patent is granted, it is a very time-consuming and expensive process to challenge the patents," Shah said.
He said IPA has identified hundreds of cases where drug patent applications have been filed on "false grounds".
A study by IPA revealed that 86 patents granted by India for pharmaceutical products after 2005 were not breakthrough drug inventions, but only a minor variation of existing products.
Under Section 3(d) of the Indian Patent Act, intellectual property claims related to modified versions of known substances are only permissible if it can be proved that the variation has significantly enhanced efficacy.
According to IPA, many of the patent claims made by multinationals do not necessarily enhance the efficacy of previously known drugs. Rather, the MNCs were doing so only to extend the period of patent, commonly known as evergreening, by tweaking the molecules a bit.
"Strategically, big pharma (companies) feel that the number of new chemical entities is dwindling and since most of the block busters are going out of the patent regime soon, they need to hang on to their existing patented drugs in all possible ways in order to maintain their dominant positions," Shah said.
Many Indian drugmakers have already locked horns with multinationals over patents. For instance, Cipla had recently won a challenge against Bayer's kidney cancer drug, Nexavar. Similarly, Novartis' patent claim on cancer drug Glivec is pending in the Supreme Court after being challenged by domestic firms, including Natco Pharma and Cipla.
Shah said IPA has constituted a team of experts which includes four scientists and it has begun the scrutinising all pharmaceutical patent applications.
He said the IPA's strategy to oppose patents at the pre-grant stage will focus on applications made from October, 2009, onwards.
IPA members, including Indian companies such as Sun Pharmaceuticals and Dr Reddy's Laboratories, account for a third of the country's annual drug exports, worth Rs 55,000 crore, Shah said.
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