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Mylan Defeats Biogen MS Drug Patent in Split Fed. Cir. Ruling

Nov. 30, 2021, 6:58 PM

Biogen Inc. failed to convince a Federal Circuit majority to revive its method of treatment patent for the multiple sclerosis drug Tecfidera in hopes of blocking Mylan Pharmaceuticals Inc. from selling a copycat version.

Biogen’s patent doesn’t show the company possessed the claimed therapeutically effective dose to treat MS at the time it filed the patent application, the U.S. Court of Appeals for the Federal Circuit said in a precedential opinion upholding a trial court’s ruling.

The decision drew a lengthy dissent from Judge Kathleen M. O’Malley, who pointed to the trial court’s “threshold error” of conflating therapeutic and clinical ...