U.S. District Court for the Southern District of New York in summary motion judgment has ruled in the favor of Eisai Co. over blockbuster ulcer drug, Aciphex, generically known as Rabeprazole sodium, ruling basic compound patent issued as the U.S. Patent # 5,045,552 (the ‘552 patent) to be valid, and thereby reducing the risk of generic penetration in the U.S. Aciphex market which worth around US $ 1.2 billion. The ‘552 patent will be running out patent protection in May 2013. However, the court reserved its ruling on the enforceability arguments until after trial. In addition, the court will continue to hear arguments from the generic makers, who say there were flaws in Eisai’s patent procedure.
Earlier in November 2003, Eisai filed patent infringement lawsuits in the U.S. District Court against Teva Pharmaceutical and Dr. Reddy’s Laboratories, in response of their abbreviated new drug applications filed with USFDA, seeking marketing approval for their generic Aciphex.
Later in January 2004, Eisai filed another patent infringement lawsuit against Mylan in response of abbreviated new drug application filed by Mylan with USFDA.
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