PhRMA Says Fed. Circ. Botched Patent Term Extension Ruling

Law360 (June 2, 2020, 8:55 PM EDT) -- The Pharmaceutical Research and Manufacturers of America is urging the full Federal Circuit to reverse a panel decision tied to Biogen's blockbuster multiple sclerosis drug Tecfidera, warning that the panel's ruling misapplies circuit precedent on patent term extensions and "destabilizes" the Hatch-Waxman Act.

PhRMA said Biogen International GmbH's patent term extension, which compensates for delays in the U.S. Food and Drug Administration's regulatory process, should apply to two ingredients, not just one. The panel's April decision otherwise directly conflicts with precedent and gives generic-drug makers an unfair advantage, the amicus brief docketed Monday stated. 

Namely, the industry group argued that the Federal Circuit in...

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