Dealing a blow to the efforts of Dr Reddy’s Laboratories (DRL) to capture a share of the largest selling anti-ulcer drug in the US, the United States Court of Appeals for the Federal Circuit has ruled that DRL?s application to launch the copycat version of Aciphex, a leading anti-ulcer drug of the Japanese major, Eisai, is invalid. By affirming the US District Court for the Southern District of New York’s summary judgment, on Monday, the court ruled that the patent for Aciphex remains valid and the proposed generic versions of DRL and Israel-based Teva will infringe the patent of Aciphex.
Last fiscal, sales of Aciphex rose 12.8%, to ?174.3 billion (around $1.63 billion). Eisai filed the infringement actions in November 2003 challenging the largest generic firm, Teva’s and DRL’s submission of abbreviated new drug applications (ANDAs) to the USFDA seeking marketing approval for generic Aciphex. In October 2006, the court granted partial summary judgment to Eisai, upholding the validity of the Aciphex composition of matter patent. In a subsequent ruling in May 2007, the court also determined that Eisai’s patent is enforceable. A DRL spokesperson did not response to the queries sent by FE.
Varun Chhonkar, CEO, IP Feathers, a Mumbai-based intellectual property consultancy firm, said, “Continuous loss of paragraph IV litigations by Indian pharma companies reflects lack of groundwork required to nail down Orange Book listed patents. In the last two-three years, apart from Ranbaxy?s Lipitor case and Lupin?s Altace case, Indian companies failed to consolidate a strong foothold in para IV winning streak. It seems to be that most Indian companies were in race to claim first-to-file status.”The combined sales of Aricept, Eisai’s leading Alzheimer?s drug and Aciphex, 67.7% of which were generated in the US, accounted for 63.4% of company’s net sales.
Our Hyderabad Bureau reports: DRL chairman K Anji Reddy clarified on Tuesday that the promoters are not open for selling their stake in the firm. “We are not open to selling out our firm,” he said, addressing shareholders at DRL?s 25th AGM. “We are open to any kind of collaboration that would help realise our vision and in the process, create greater shareholder value.”