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...
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!