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Pfizer To Appeal Canadian Lipitor Ruling

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By: Tim Wright

Editor-in-Chief, Contract Pharma

According to a company statement, Pfizer will appeal a decision by the Canadian Federal Court in Toronto denying its application to block approval of Ranbaxy’s generic version of Lipitor. The ruling involves a patent (Canadian Patent No. 2,021,546) covering the calcium salt of atorvastatin, Lipitor’s active ingredient, which expires in July 2010. The ruling on this patent will not have immediate commercial impact as Ranbaxy is subject to other pending patent litigation with Pfizer. The decision, based on Canadian law, does not pertain to Lipitor patent cases in other jurisdictions, including the U.S.

“This decision presents clear and substantive issues for appeal and we will begin that process immediately in an effort to sustain Lipitor’s exclusivity through July 2010,” said Pfizer’s general counsel Allen Waxman.

The court also ruled that Pfizer’s basic atorvastatin patent (Canadian patent No. 1,268,768), which expires in May 2007, would be infringed by Ranbaxy.

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