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July 01, 2022

Federal Appeals Court Reverses Novartis Gilenya Patent Win

On June 21, the U.S. Court of Appeals for the Federal Circuit found that Novartis' patent for the multiple sclerosis drug Gilenya was invalid due to insufficiency of description on the drug's label. Specifically, the description of the drug fails to specify loading doses, which are required at the start of treatment. This decision is a reversal of the Court's January 2022 decision that found the patent valid and rejected arguments from defendant generic drugmaker HEC Pharm Co which hoped to market its generic version of Gilenya before 2027, when Novartis’s patent is set to expire. Novartis has since released a statement confirming its plans to file an appeal. The company has indicated that it intends to consider "all available options," including seeking review by the full panel of the Court. 

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