U.S. Supreme Court turns away Biogen bid to reinstate MS drug patent

[October 04, 2022]  By Blake Brittain

WASHINGTON (Reuters) -The U.S. Supreme Court on Monday declined to hear Biogen Inc's bid to win reinstatement of a patent on the company's blockbuster multiple sclerosis drug Tecfidera in a dispute with Viatris Inc subsidiary Mylan Pharmaceuticals Inc.

The justices turned away Biogen's appeal of a lower court's decision to invalidate the patent in a ruling that helped clear the way for Mylan's generic version of Tecfidera.

Biogen sued Mylan, now part of Canonsburg, Pennsylvania-based Viatris, in West Virginia in 2017, saying Mylan's proposed generic version of Tecfidera would infringe Biogen patents. U.S. District Judge Irene Keeley ruled in 2020 that a key Tecfidera patent was invalid. Mylan launched its generic that August.
 

Tecfidera is still one of Cambridge, Massachusetts-based Biogen's best-selling drugs. But the company's revenues from it have dropped because of generic competition.

The patent-focused U.S. Court of Appeals for the Federal Circuit upheld the judge's ruling in favor of Mylan in a 2-1 decision, finding the patent's written description did not outline its method for treating MS clearly enough.

Biogen logo and stock graph are seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration/File Photo

The Federal Circuit decided 7-3 not to have all of its judges hear the appeal after the three-judge panel's ruling.

Biogen told the Supreme Court that the Federal Circuit had added "additional, atextual requirements that distort" the standard for securing a patent involving a clear written description of the invention and how it is made and used. Biogen also said the decision would "chill investment in innovative technologies, including life-altering medical treatment."

Mylan responded that the relevant part of Biogen's patent failed to describe its method for treating MS with specificity "even once."

(Reporting by Blake Brittain; Editing by Will Dunham)

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