Federal Circuit Called on Once Again to Judge the 'Patent Dance'
Genentech is looking to block sales of Amgen's cancer biosimilar Mvasi because Amgen failed to provide 180 days' notice when it shifted manufacturing plans from California to Rhode Island. Judge Kimberly Moore said Genentech is proposing "an extraordinarily broad view" of the Biologics Price Competition and Innovation Act.
June 03, 2020 at 09:12 PM
4 minute read
A Federal Circuit panel seemed to resist Genentech Inc.'s efforts Wednesday to pull a generic Amgen Inc. cancer treatment off the shelves for six months.
Genentech told a Federal Circuit panel that Amgen failed to serve the 180-day notice of commercial marketing required by the Biologics Price Competition and Innovation Act when, in August 2018, it supplemented its Food and Drug Administration application for Mvasi, Amgen's biosimilar version of Genentech's $3 billion-a-year drug Avastin.
Roche-owned Genentech asked the Federal Circuit to enjoin Amgen from marketing Mvasi until it complies with the BPCIA, the 2009 law that established "the patent dance" for biosimilars.
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