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Daiichi Sankyo Wins Dismissal of Apotex Patent Suit

Daiichi Sankyo Co. won dismissal of an Apotex Inc. lawsuit that sought a court finding that its plan to market a generic form of the blood-pressure drug Benicar didn’t infringe a Daiichi-held patent.

U.S. District Judge Sharon Johnson Coleman in Chicago said that because Daiichi disclaimed the disputed patent, there was no legal controversy on which she could rule. Her decision, dated yesterday, was released today.

Apotex sued Tokyo-based Daiichi in 2012. A finding of non-infringement would have enabled it to compete sooner with generic-drug maker Mylan Inc., which also plans to bring a form of Benicar to market.

While Daiichi disclaimed the patent and in 2006 asked the U.S. Food and Drug Administration to de-list it, the agency never acted on that request, the judge said.

Still, all parties agree Daiichi can never again assert claims under it, Coleman said. The FDA’s failure to de-list isn’t a basis for Toronto-based Apotex to “seek a declaratory judgment regarding a nonexistent patent,” the judge said.

Mylan, based in Canonsburg, Pennsylvania, lost a challenge to another Benicar patent in 2010. Because Mylan was the first to seek FDA permission to sell its version of the drug, it will have exclusive rights to do so for at least 180 days after that Daiichi patent expires in 2016.

The case is Apotex Inc. v. Daiichi Sankyo, 12-cv-09295, U.S. District Court, Northern District of Illinois (Chicago).

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