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Genentech Sues Apotex Claiming Valcyte Patent Infringement

Roche Holding AG’s Genentech unit sued Apotex Inc. for planning to sell a generic version of Valcyte, which treats a virus that afflicts transplant patients and people with AIDS, before Genentech’s patent for the drug expires.

Apotex, based in Toronto, told Genentech on April 6 that it had applied for approval from the U.S. Food and Drug Administration to make a generic of Valcyte, according to the complaint filed today in federal court in San Francisco.

Genentech, based in South San Francisco, California, said the plan to market the generic will cause “massive infringement” of its patent covering the drug. Genentech seeks a court order declaring that the Apotex generic is a patent-infringing drug, blocking the FDA from approving it until Genentech’s patent expires in 2015 and barring Apotex from engaging in commercial activity that would infringe the Genentech patent.

Genentech last month filed a suit based on similar claims against Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG.

Roche has sued other drug manufacturers over generic copies of Valcyte. The company settled a lawsuit with Ranbaxy Laboratories Ltd. last year with Ranbaxy agreeing to sell its generic copy of Valcyte in 2013, two years before a patent expires, Basel-based Roche said in an August statement.

Elie Betito, an Apotex spokesman, said the company hadn’t reviewed the complaint and had no immediate comment.

The case is Genentech Inc. v. Apotex Inc., 11-2410, U.S. District Court, Northern District of California (San Francisco).

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