• May 9 2019
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  • Category: CAFC Updates

Amgen appealed from two District Court decisions in two patent infringement actions brought by Amgen under the Biologics Price Competition and Innovation Act (“BPCIA”). The District Court construed claims of the asserted patents (relating to methods of protein purification by adsorbent chromatography and methods of treating diseases requiring peripheral stem cell transplantation), and granted summary judgment of non-infringement by Sandoz’s filgrastim biosimilar and its proposed pegfilgrastim biosimilar. The CAFC finds that because the claim language logically requires that the process steps, lettered (a) through (g), be performed in sequence and washing and eluting are consistently described in the specification as separate steps performed by different solutions, the district court correctly construed the “washing” and “eluting” claim limitations as requiring distinct solutions added to the matrix at different times. The CAFC further finds that the district court was correct to grant summary judgment that Sandoz does not infringe under the doctrine of equivalents because Sandoz’s one-step, one-solution purification process works in a substantially different way from the claimed three-step, three-solution process. Finally, Amgen argued that the district court abused its discretion by denying Amgen’s motion for a continuance, arguing that judgment cannot be rendered on a technical act of infringement of a process patent under 35 U.S.C. § 271(e)(2) if a biosimilar applicant plans to submit a modification of a relevant process to the FDA but has not yet done so. The CAFC notes that a proper analysis of a technical act of infringement under § 271(e)(2) requires a determination of whether what is likely to be sold will infringe in the conventional sense of patent infringement, and recognizes that, while a district court cannot ignore amendments to an ANDA or aBLA, it also has a broad mandate to render a just, speedy, and inexpensive decision based upon the evidence of record. The CAFC therefore concludes that the district court was not obligated to postpone summary judgment until Sandoz submitted its amended pegfilgrastim aBLA. The judgment of the district court is therefore affirmed.

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