Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute

We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. Last week, Amgen filed its response.

As background, in December 2019, the Federal Circuit affirmed a jury’s finding that 14 of 21 accused batched of drug substance manufactured by Hospira were not protected by the safe harbor provision of 35 U.S.C. Section 271(e)(1) because they were not reasonably related to seeking FDA approval. In its response to the petition for rehearing en banc, Amgen argues that the Federal Circuit panel and the district court did not improperly focus on the underlying purpose for making the accused batches, as evidenced by: (1) the jury instruction that “underlying purposes for the manufacture and use of [a] batch would not remove that batch from the Safe Harbor defense”; and (2) the jury’s finding that 7 of the 21 accused batches were protected by the Safe Harbor. Amgen’s response further asserts that the panel “did not announce a special Safe Harbor rule for process patents” and, instead, the panel merely stated that the Safe Harbor would apply if an “ ‘act of manufacture’ (that is, an infringing act) ‘was for uses reasonably related to submitting information to the FDA.’” Finally, Amgen argues that the panel’s decision that substantial evidence supports the jury’s verdict does not warrant rehearing en banc.

Stay tuned to Big Molecule Watch for further developments.

Download PDF