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Novartis Fends Off Copycat of MS Drug Gilenya at Federal Circuit

Jan. 3, 2022, 7:10 PM

Novartis Pharmaceuticals Corp. convinced two out of three judges on the Federal Circuit that its patent on the dosage regimen for the blockbuster multiple sclerosis drug Gilenya adequately describes the invention.

HEC Pharm Co. appealed a ruling from the U.S. District Court for the District of Delaware that blocked it from selling a generic version of the drug until 2027 when Novartis’s patent expires.

The U.S. Court of Appeals for the Federal Circuit in a precedential opinion upheld the trial court’s findings that the patent is valid over HEC’s arguments that it lacked an adequate written description. The patent act ...