Pfizer has become the latest Western drugmaker to fall foul of India’s increasingly contentious intellectual property (IP) environment, losing patent protection for its kidney cancer drug Sutent.
The country’s Patent Office revoked the basic patent for Sutent (sunitinib malate) on the grounds that it did not include an inventive step, backing the position taken up by Indian drugmakers Cipla and Natco Pharma in a legal challenge to Pfizer’s IP.
Cipla had argued that the inventiveness of Pfizer’s patent was compromised by “structural obviousness”, in other words the compound’s structure could have been deduced from similar drugs already covered by earlier patents.
Pfizer said immediately it would lodge an appeal against the Patent Office’s decision, which is the third defeat for a major pharma company in India in as many weeks, all involving widely-used cancer drugs.
The company sells its Sutent product for 1.96 lakh (about $3,800) for a 45-day course, and Cipla says it will make its Sunitib version available at a 10 per cent discount, according to a LiveMint report.
Last month, Bayer failed in a bid to overturn a compulsory license which removed patent protection for its Nexavar (sorafenib) cancer drug, allowing a cut-price competitor from Natco to enter the market.
Just a few days before the Nexavar verdict Roche lost a four-year legal dispute with Cipla over patent rights to Tarceva (erlotinib), while Novartis is still in the throes of a long-running legal dispute as it tries to defend blockbuster cancer drug Glivec (imatinib) and is expecting a verdict before the end of this year.
Pfizer had already protected Sutent from a compulsory license challenge in 2008, a year after the company was awarded its patent and launched the product, and in an interview with the Business Standard said the Patent Office’s latest action “raised concerns over India’s commitment to protect intellectual property”.