The Japanese Pharma giant Esai, won a Court of Appeals for Federal Circuit's (CAFC) ruling that blocks generic competition to its blockbuster drug Aciphex (Rabeprazole sodium) till may 2013. The CAFC (CAFC:OPINION) has affirmed the District Court of New York's summary judgment ruling on the validity of Eisai's product patent US5045552 (Expiry: May 8, 2013) and its ruling on the enforceability of the composition of matter patent.
Eisai filed the infringement actions in 2003 contesting Teva Pharmaceuticals and Dr. Reddy's Laboratories' submission of ANDA to the USFDA with Paragraph IV certification for Aciphex(R) Orange book listed patents. In October 2006, Judge Gerard E. Lynch of the United States District Court for the Southern District of New York granted partial summary judgment to Eisai, upholding the validity of the Aciphex(R) product patent '552. In a subsequent ruling in May 2007, Judge Lynch also concluded that Eisai's patent is enforceable and affirmed infringement by DRL and Teva.
CAFC decision highlights:
Teva cited EP174726, a patent by Takeda which covers Lansoprazole (Teva claims Lansoprazole is a lead compound to arrive at Rabeprazole), US4255431, which covers Omeprazole and an article on SAR of Benzimidazole by Brandstorm.
Teva claims that teachings in the said prior art make Rabeprazole invention as obvious. The CAFC observed that selection of Lansoprazole as lead at the time of Rabeprazole invention was not obvious to Skilled artisan. CAFC also rejected generic companies claim of inequitable conduct based on co-pending patent application of Esai, which covers a structural analogue of Rabeprazole
The rabeprazole generated $1.63 billion in global sales in the year ended March 31 for Eisai, according to the company's annual report. Eisai co-promotes the drug with Johnson & Johnson, the world's biggest health-products company. In June, the U.S. Food and Drug Administration approved Aciphex for short-term acid reflux in children over the age of 12.
The rabeprazole generated $1.63 billion in global sales in the year ended March 31 for Eisai, according to the company's annual report. Eisai co-promotes the drug with Johnson & Johnson, the world's biggest health-products company. In June, the U.S. Food and Drug Administration approved Aciphex for short-term acid reflux in children over the age of 12.
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