Bayer HealthCare LLC v. Baxalta Inc., No. 19-2418 (Fed. Cir. 2021)Annotate this Case
Bayer’s patent is directed to recombinant forms of human factor VIII (FVIII), a protein that is produced, and released into the bloodstream, by the liver. In Bayer’s suit, alleging that Baxalta’s biologic product Adynovate® infringes certain claims of the patent, a jury found that the asserted claims were enabled and infringed, and that Bayer was entitled to reasonable-royalty damages. The district court did not send the question of willful infringement to the jury, holding as a matter of law that Baxalta’s conduct did not meet the requirements for willfulness.
The Federal Circuit affirmed, rejecting Baxalta’s challenges to the district court’s construction of the claim term “at the B-domain” and its interpretation of the word “random” in its construction of the claim term “an isolated polypeptide conjugate.” The court upheld the district court’s judgments of infringement and enablement as supported by substantial evidence, along with the court’s awards of damages and pre-verdict supplemental damages. Even accepting Bayer’s evidence as true and weighing all inferences in Bayer’s favor, the record is insufficient to establish that Baxalta’s “conduct rose to the level of wanton, malicious, and bad-faith behavior required for willful infringement.”