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Court of Appeal Ruling Opens Door for Sandoz's Neupogen Copy


July 22, 2015.

With the U.S. Court of Appeals for the Federal Circuit in Washington, DC, rejecting arguments that Sandoz failed to follow regulatory rules, the Novartis unit may begin selling the first copy of Amgen Inc.’s cancer treatment Neupogen as soon as Sept. 2.

Sandoz did not violate the rules when applying to sell its drug, Zarxio, the Court said. According to a report on Bloomberg Business, this is the first time the appeals court specializing in patent law has applied rules for copying drugs derived from living organisms.

Amgen can still ask the judge to halt the sales until the patent-infringement claim is decided. Neupogen was first approved by U.S. regulators in 1991. Bloomsberg reported that the company declined to comment on its next steps.


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