Pharma cos hit by new Patent Act concoction, filings drop 41%

Patent applications filed by Indian pharma firms have witnessed a sharp fall of 41% during FY08. Data provided by the Controller General of Patents shows that only 449 patent applications were filed in 2007-08 compared to 765 filed in 2006-07. This is the first dip in number of patent applications by Indian companies in the past four years. It was on a steady rise since 2004. In FY05, 278 patents were filed while in FY06, 542 applications were filed. Among the domestic pharma firms, Ranbaxy has filed 208 patent applications in the last two years while Cipla has filed 53 patents since 2006. Nicholas Piramal filed one application in 2006-07 and four in 2007-08. Unimark Remedies filed three applications in 2007-08. “From about 2002, many Indian pharma companies, big and small, have been filing several defensive patent applications on what might not be considered patentable invention under the amended Indian Patent Act, which came into effect in January 2005. While such filing and prosecution cost money, most of these applications did not translate into granted patents,” said Ranbaxy Laboratories executive director Ramesh Adige. He said once the initial euphoria of being named an inventor in a patent application or merely filing an application wore off, companies might have looked at their filing strategies more critically, especially from a return on investment point of view. “This could have resulted in a reduction in the number of filings. But by itself, it cannot account for over 41% drop in filings in one year,” Mr Adige said. An Indian Drug Manufacturing Association (IDMA) official said: “The time required for the patent controller to approve patents is longer as it requires clinical trials. Many companies are also not applying for patents in India but abroad. Even smaller companies have started patenting in the US thus bringing down the number.” Post 2005, Indian pharma companies have been forced to spend more on R&D since India has amended its Patent Act to make it Trade-Related Aspects of Intellectual Property Rights (Trips) compliant. They now have to file product patents to protect their research instead of process patents. An apt example of this is the controversy over Gleevec, a cancer drug manufactured by Novartis. The company is trying to patent Gleevec as well as a generic version of the drug, a move which is being opposed by health activists. They are objecting on grounds that it violates a clause in the Act which states that a product can only be granted a patent if it is proved that it has better effects than the earlier version. “It is just not enough to submit a dossier. The sponsor must prove that the product results in better patient outcomes vis-a-vis existing products,” said Ernst & Young analyst Utkarsh Palnitkar. Globally, patent approvals are anticipated to remain at modest levels until and unless USFDA gets a clear mandate from Congress on improving regulatory pathway for faster approvals, Mr Palnitkar said. By Ms.Bobby Aanand, Metropolitan Jury.

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