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# Industry Council Wants SCOTUS to Hear Biosimilar Case
- URL: https://www.fdaweb.com/industry-council-wants-scotus-to-hear-biosimilar-case/
- Published: 2016-03-31T12:00:00.000Z
- Updated: 2026-09-14T20:52:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135239

> The Biosimilars Council, a division of the Generic Pharmaceutical Association, is asking the Supreme Court to hear Sandoz’ appeal of its biosimilars patent dance case against Amgen. The council’s *amicus* [brief](http://www.bigmoleculewatch.com/wp-content/uploads/2016/03/15-1039BiosimilarsCouncilAmgenvSandozSCOTUS.pdf?ref=fdaweb.com) says that the decision by the Court of Appeals for the Federal Circuit requiring “patent dance” notification only after FDA licensing of a biosimilar “conflicts with the text, structure, and purpose of the Biologics Price Control and Innovation Act (BPCIA)” in three ways. It says that the ruling blocks patients’ access to affordable medicines for six months longer than Congress intended, delays resolution of patent disputes between a reference-product sponsor and a biosimilar applicant until after FDA licensure of the biosimilar, and permits a reference-product sponsor to compel notice through an automatic private injunction, which conflicts with the congressional remedy for lack of notice.  
>  
> According to the council, the appeals court’s holding that the 180-day notice of commercial marketing of a biosimilar is mandatory and can only be effective after FDA licenses the biosimilar effectively grants a reference product sponsor six additional months of statutory exclusivity on top of the 12-year period included in the law.  
>  
> It also argues that the overturning the appeals court ruling is “critical to the continued growth of the biosimilars industry, and to the realization of the BPCIA’s objectives.”