Drugmakers gear up to challenge MNC patents

Leading domestic drugmakers have decided to collectively challenge frivolous patent applications filed by multinationals in India under the aegis of the Indian Pharmaceutical Alliance (IPA). IPA members include Sun Pharmaceuticals and Dr Reddy’s Laboratories.

Leading domestic drugmakers have decided to collectively challenge frivolous patent applications filed by multinationals in India under the aegis of the Indian Pharmaceutical Alliance (IPA). IPA members include Sun Pharmaceuticals and Dr Reddy’s Laboratories.

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“Multinationals are filing patents in large numbers and Indian patent offices have granted patents to products that do not merit patent protection under domestic laws,” said D.G. Shah, secretary-general, IPA.

The IPA was planning to challenge such “frivolous patent applications in the pre-grant stage itself,” Shah said. “Once granted, it is a very time-consuming and expensive process to challenge patents.”

The IPA has identified hundreds of cases where drug patent applications have been filed on “false grounds”.

An IPA study revealed that 86 patents granted by the Indian government for pharmaceutical products after 2005 were not breakthrough drug inventions, but only minor variations 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 enhanced efficacy.

According to the IPA, many of the patent claims made by multinationals do not necessarily enhance the efficacy of previously-known drugs. MNCs were doing so only to extend the period of patent, commonly known as evergreening, by tweaking the molecules a bit.

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 the IPA has constituted a team of experts, including four scientists, and has begun scrutinising pharmaceutical patent applications.

The IPA’s strategy to oppose patents at the pre-grant stage will focus on applications made from October, 2009, onwards, Shah said.