Blog Big Molecule Watch March 18, 2020

Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected by the 35 U.S.C. 271(e)(1) safe harbor because it was not “reasonably related to developing and submitting information to the FDA,” as recited by the jury instruction.

Following the Federal Circuit’s affirmance, Hospira filed a petition for rehearing en banc, and Amgen filed a response, focused on the issue of the safe harbor provision.

The Federal Circuit’s order on Monday denied Hospira’s petition for rehearing.  The mandate will issue on March 23, 2020.

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