Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in Epoetin Biosimilar Dispute

Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. This past week, Hospira filed a petition for rehearing en banc asking the full Federal Circuit to reconsider certain issues in the panel’s opinion and reverse the judgment of infringement.

Hospira’s petition is primarily devoted to arguments related to the safe harbor provision of 35 U.S.C. § 271(e)(1), which shields otherwise infringing uses that are reasonably related to the development and submission of information to FDA in connection with the regulatory approval process. At trial, the jury found Hospira’s manufacture of 14 out of the 21 accused batches of drug substance to have been performed outside of the safe harbor and therefore constituted patent infringement. Last month’s Federal Circuit panel opinion found that the jury’s safe harbor findings were supported by substantial evidence. In its recently filed petition, Hospira argues that the panel’s safe harbor assessment, contrary to controlling precedent, focused on Hospira’s subjective underlying purpose for manufacturing the accused batches, rather than on whether the use was objectively related to seeking FDA approval.

Hospira’s petition also argues that the panel’s safe harbor analysis was legally incorrect because it applied a different safe harbor rule for manufacturing process patents than the rule used for other types of patents. In encouraging the full Federal Circuit to take up this issue, Hospira emphasizes the outsized importance of manufacturing process patents in the context of biosimilars and the BPCIA, and argues that the panel’s decision “threatens to eviscerate the protections Congress intended to provide under the Safe Harbor, particularly in the BPCIA context.”

Finally, Hospira’s petition argues that the panel erred in its claim construction analysis. More specifically, Hospira asks the full Federal Circuit to reverse the judgment of infringement on the ground that the panel violated principles of claim construction by reading a claim limitation out of the claim.

Stay tuned to Big Molecule Watch for further developments.