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Amgen Inc. v. Hospira, Inc.

“Purpose” of Activities May Be Considered When Evaluating Safe Harbor for Biologics Applications

Amgen Inc. v. Hospira, Inc., __ F.3d __, 2019 WL 6834390 (Fed. Cir. Dec. 16, 2019) (MOORE, Bryson, Chen) (D. Del.: Andrews) (2 of 5 stars)

Fed Cir affirms judgment of infringement and $70 million damages award. Amgen’s patents relate to erythropoietin (EPO) isoforms and their production, useful in treating anemia; Amgen brands its recombinant human EPO product as Epogen.

Liability: The district court did not err in maintaining the jury’s verdict of infringement and no invalidity. The opinion rejects Hospira’s request for a limiting construction of one limitation, and discusses how the specification described at least one broader embodiment. Reviewing the evidence, the opinion finds the jury’s infringement determination supported by substantial evidence. It also finds the jury’s rejection of Hospira’s anticipation attack supported by substantial evidence.

§ 271(e)(1) Safe Harbor: The district court did not err when instructing the jury about the safe harbor for activities related to submission of biologics license applications. It was not improper for the jury instructions to include a reference to Hospira’s “purpose” for undertaking accused activities, at least because the jury was being properly tasked with determining “whether each act of manufacture was for uses reasonably related to submitting information to the FDA.” Op. at 15. Reviewing the evidence, the opinion finds the jury’s across-the-board rejection of Hospira’s safe harbor defense to have been supported by substantial evidence.

Damages: The district court did not abuse its discretion in permitting Amgen to present expert opinion on patent damages based in part on the “value of delay” to Hospira if it were able to launch its EPO product as soon as the patents expired, and utilizing a lump sum structure. The opinion discusses how Hospira was free to cross-examine and to present evidence of its own. The jury’s damages award was also supported by substantial evidence.

Cross-Appeal: Substantial evidence supported the jury’s verdict that Hospira does not infringe a separate patent, and there was no error in the district court’s denial of a new trial. The opinion rejects Amgen’s contention that Hospira attempted to argue claim construction to the jury.

KEYWORDS: BIOLOGICS; SAFE HARBOR; DAMAGES