Novartis AG Thwarted From Selling Amgen's Neupogen Until September
(Reuters) - Novartis AG must wait until Sept. 2 to sell the first biosimilar drug to be approved in the United States, a copycat version of Amgen Inc's $1.2 billion-a-year Neupogen, a U.S. appeals court said on Tuesday.
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The ruling stemmed from a lawsuit Amgen filed last October in federal court in San Francisco in which it accused Novartis' generic drugs unit Sandoz of infringing on a patent for Neupogen, which boosts white blood cell counts to fight infections in cancer patients.
In a 2-1 decision, the U.S. Court of Appeals for the Federal Circuit, the nation's top patent court, said that federal law governing close copies of biologic drugs required Sandoz to wait six months after the Food and Drug Administration approved the drug to begin to market it. FDA approval for the drug to be sold under the name Zarxio came in March.
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The ruling stemmed from a lawsuit Amgen filed last October in federal court in San Francisco in which it accused Novartis' generic drugs unit Sandoz of infringing on a patent for Neupogen, which boosts white blood cell counts to fight infections in cancer patients.
In a 2-1 decision, the U.S. Court of Appeals for the Federal Circuit, the nation's top patent court, said that federal law governing close copies of biologic drugs required Sandoz to wait six months after the Food and Drug Administration approved the drug to begin to market it. FDA approval for the drug to be sold under the name Zarxio came in March.
Help employers find you! Check out all the jobs and post your resume.