Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses

Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit.

Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein purification method IPR appeal

Today, the Federal Circuit issued a 2-1 opinion affirming a 2018 final written decision of the Patent Trial and Appeal Board (PTAB) that found the challenged claims of Genentech’s U.S. Patent No. 7,807,799 unpatentable on anticipation and obviousness grounds. This patent, which Genentech has asserted in seven different BPCIA litigations relating to either the monoclonal antibodies bevacizumab, rituximab, or trastuzumab, is directed to a protein purification method using protein A chromatography. The parties completed briefing in late 2018, shortly after the United States intervened to defend the constitutionality of subjecting the pre-AIA ’799 patent to IPR. In affirming the PTAB, the majority of the Federal Circuit panel found that substantial evidence supported the PTAB’s findings as to both anticipation and obviousness, and that the PTAB did not err in reaching its conclusions. The panel also rejected Genentech’s constitutionality challenge based on recently established precedent in other IPR appeals. Judge Newman dissented with regard to anticipation and obviousness, but did not address constitutionality.

AbbVie v. U.S. & Iancu, Fed. Cir. Case No. 17-2304 (cons.) – adalimumab IPR appeals

Earlier this week, on January 7, 2020, the Federal Circuit affirmed, without opinion, five final written decisions where the PTAB had found the claims of AbbVie’s U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987, directed to adalimumab dosing regimens, unpatentable as obvious. Those IPRs were initiated in 2015 by Coherus and Boehringer Ingelheim. The affirmance without opinion comes after an appeal that was pending for nearly two and a half years, with extensive briefing, and just one day after hearing oral argument. During the appeal, Coherus and Boehringer Ingelheim settled with AbbVie, and U.S. Patent and Trademark Office intervened to step into their shoes to defend the PTAB’s decisions after Coherus and Boehringer Ingelheim withdrew from the proceeding. The U.S. Government also intervened in the appeal to respond to AbbVie’s challenge to the constitutionality of subjecting pre-AIA patents to IPR, a challenge which the Federal Circuit has repeatedly rejected.

Genentech v. Amgen, Fed. Cir. Case No. 19-2155 – bevacizumab preliminary injunction appeal

On December 30, 2019, Amgen filed a responsive brief urging the Federal Circuit to reject Genentech’s appeal from the district court’s denial this past July of Genentech’s motion to enjoin Amgen’s U.S. launch of MVASI (bevacizumab-awwb), a biosimilar of AVASTIN. Genentech had argued to the district court—and subsequently argued in a motion and opening brief to the Federal Circuit—that, although Amgen served a notice of commercial marketing pursuant to subsection (l)(8)(A) of the BPCIA in 2017, Amgen was required to provide a new notice because it subsequently filed supplements to its approved biosimilar application. Because Amgen failed to provide a second notice, Genentech argued, Amgen was legally barred from commercially marketing its biosimilar until 180 days after it served such notice. In rejecting Genentech’s bid to halt MVASI sales, however, the district court rejected Genentech’s argument and found Amgen’s first notice to be legally effective and the proposed second notice to be unnecessary. In its recent responsive brief to the Federal Circuit, Amgen reiterated many of the same arguments that already succeeded in the lower court.

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