The United States, the largest pharmaceuticals market in the globe, still lures Indian generic firms to grab a pie of the patent protected drugs through the litigation route. In the latest incident, Dr Reddy’s Labs (DRL) has been sued by US major, AstraZeneca, following DRL’s paragraph IV abbreviated new drug application (ANDA) submission for marketing Accolate, the US firms’ leading drug used to treat asthma.
In a suit filed on June 27 in the district court of New Jersey, AstraZeneca has accused DRL of infringing their patents for zafirlukast (Accolate) with DRL’s proposed generic version. Last month, Ranbaxy’s acquirer, Daiichi Sankyo, had also filed an infringement suit in the US against Matrix Labs for alleged infringement of the patents for its anti-hypertension drug Azor following Matrix’ ANDA submission.
The attraction of getting 180-day marketing exclusivity if it wins the litigation compels the Indian firms for filing more paragraph IV ANDAs with the US Food and Drug Administration (FDA) despite the litigation cost increasing drastically. In February, FE had reported that drugs worth about $20 billion are losing its patent protection in the US this year. According to IMS Health, by 2011, drugs worth some $60 billion will become off patent.
According to a DRL statement, as on March 31, 2008, 122 ANDAs have been filed in the US, out of which 35 are para IV and 23 are with first-to-file status. Fifty-eight ANDAs, targeting innovator sales of $78 billion in 2007-08, are pending for approval. GV Prasad, vice-chairman and CEO, DRL, had earlier told FE that company is planning to increase its expenditure for litigation to $15 million from the current figure of $10 million per year. Varun Chhonkar, CEO, IP Feathers, the Mumbai-based intellectual property consultancy firm, said, “In the last few years, Indian generic companies have not been able to consolidate position in para IV litigation and also continue facing tough business competition in the US. Increasing legal cost and stiff competition are slowly outweighing the para IV charm.?