Big Molecule Watch
November 27, 2019

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) initiated by Pfizer. In October 2018, Pfizer succeeded in persuading the PTAB that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies, were unpatentable on obviousness grounds. After appealing to the Federal Circuit, Biogen settled with Pfizer, which  consequently declined to participate in the appeal and was replaced by the United States as an intervening party to defend the PTAB’s IPR decision. The parties completed briefing in June of this year.

The Federal Circuit also recently scheduled oral argument for January 6, 2020 in AbbVie’s consolidated appeals from several final written decisions.  In the appealed IPRs, the PTAB found claims of certain adalimumab-related dosing regimen patents to be unpatentable on obviousness grounds. In 2017, Coherus succeeded in challenging the claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 before the PTAB, and Boehringer Ingelheim was similarly successful in challenging the ’135 patent. Earlier this year, however, Coherus and Boehringer Ingelheim withdrew from the appeals after they each reached settlements with AbbVie concerning their respective adalimumab biosimilars. The United States government intervened in their stead to defend the PTAB’s unpatentability decisions. Appellate briefing concluded this past August.

Appeals Awaiting Oral Argument Dates

There are also a number of biosimilar-related appeals that have completed briefing but are still awaiting scheduling of oral argument.

First, this past June, Janssen and Celltrion completed briefing their consolidated appeal and cross-appeal in their BPCIA litigation concerning Celltrion’s INFLECTRA (infliximab-dyyb). In July 2018, the district court granted summary judgment of non-infringement in Celltrion’s favor—Janssen appealed to the Federal Circuit on that issue, whereas Celltrion appealed the district court’s ruling that Janssen had standing to assert the patent-in-suit, U.S. Patent No. 7,598,083.

Second, in September 2019, the parties in Genentech v. Amgen, a BPCIA litigation concerning Amgen’s KANJINTI (trastuzumab-anns) biosimilar, completed appellate briefing.  In this interlocutory appeal, Genentech is appealing the district court’s denial of its preliminary injunction motion that sought to block Amgen’s U.S. launch of KANJINTI.

Third, in October, Genentech submitted reply briefs, concluding appellate briefing, in four related appeals from IPR proceedings in which the PTAB found claims of U.S. Patent Nos. 7,846,441 and 7,892,549, related to trastuzumab, to be unpatentable on obviousness grounds. Celltrion, Pfizer/Hospira, and Samsung Bioepis had filed the IPRs, but withdrew from Genentech’s subsequent appeals after reaching settlements concerning their respective trastuzumab biosimilars. The Director of the U.S. Patent and Trademark Office has intervened in the appeals to defend the PTAB’s unpatentability decisions.

Appeals Awaiting Decision on the Merits

Two biosimilar-related appeals have already been heard for oral argument in recent months and are now awaiting decisions on the merits from the Federal Circuit.

On August 5, 2019, a Federal Circuit panel heard oral argument in Genentech’s appeal from an IPR final written decision in which the PTAB found claims of U.S. Patent No. 7,807,799, directed to a protein purification method using protein A affinity chromatography, to be unpatentable on grounds of anticipation and/or obviousness. Genentech has asserted the ’799 patent against Pfizer, as well as others, in BPCIA litigations concerning Pfizer’s TRAZIMERA (trastuzumab-qyyp) and ZIRABEV (bevacizumab-bvzr) biosimilar products. Genentech and Pfizer settled those BPCIA litigations in December 2018 and September 2019, respectively.

Then, on September 30, 2019, a Federal Circuit panel heard oral argument in Amgen v. Hospira, a consolidated appeal and cross-appeal in the parties’ BPCIA litigation concerning Hospira’s RETACRIT (epoetin alfa-epbx) biosimilar. In the appeal, the parties dispute the issues of validity and infringement of U.S. Patent Nos. 5,856,298 and 5,756,349, as well as the district court’s damages award to Amgen of $70 million (plus at least $10 million in interest).

Beyond the appeals discussed above, other biosimilar-related appeals are pending at various stages of appellate proceedings. Stay tuned to Big Molecule Watch for further developments.

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