Federal Circuit Round Up: Epoetin Alfa, Adalimumab, Rituximab

April has seen a flurry of biosimilar-related appellate activity before the Federal Circuit. Below are some highlights.

The parties in the Amgen v. Hospira BPCIA litigation concerning Hospira’s RETACRIT (epoetin alfa-epbx) biosimilar concluded appellate briefing this month.  As we previously reported, Hospira is appealing the district court’s adverse judgment that U.S. Patent No. 5,856,298 was infringed and not invalid, and a damages award to Amgen of $70 million (plus interest), while Amgen is cross-appealing the district court’s judgment that Hospira did not infringe U.S. Patent No. 5,756,349.  On April 1, Hospira filed a brief in response to Amgen’s cross-appeal and in reply regarding Hospira’s own appeal, once again challenging the district court’s infringement judgment and damages award with respect to the ’298 patent, and in support of the district court’s judgment of non-infringement of the ’349 patent.  On April 22, Amgen filed its cross-appellant’s reply brief, asserting that it is entitled to judgment as a matter of law of infringement of the ’349 patent or, alternatively, to a new trial.  Now that briefing is completed, the Federal Circuit will schedule the case for oral argument.  We included the Federal Circuit’s upcoming decision in this appeal on our list of decisions to keep an eye out for in 2019, since the case concerns a variety of interesting legal issues, including the safe harbor of 35 U.S.C. § 271(e)(1), which allows use of patented processes if reasonably related to the development and submission of information to the FDA.

On April 17, the United States and USPTO jointly filed an appellate brief in the consolidated appeal from final written decisions in 2017 that the challenged claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987, directed to methods of using adalimumab, are unpatentable on obviousness grounds.  This consolidated appeal stems from IPRs petitioned by Coherus against all three patents, and IPRs petitioned by Boehringer Ingelheim against the ’135 patent.  Coherus and Boehringer Ingelheim filed their responsive appellate briefs in March 2018, but, after Coherus settled with AbbVie and withdrew from the appeal earlier this year, the USPTO intervened to defend the Board’s decisions.  The United States, on the other hand, intervened in this appeal in late 2018 to respond to AbbVie’s challenge to the constitutionality of subjecting pre-AIA patents to IPR.  In the intervenor brief, the Government argued in support of the Board’s unpatentability rulings and in support of the constitutionality of conducting inter partes review of the patents-as-issue, and further asserted that AbbVie forfeited its constitutionality challenge by failing to raise it to the Board.  On April 29, AbbVie filed a reply brief in which it challenges the positions taken by the Government and Boehringer Ingelheim.

On April 15, Biogen filed its opening appellate brief in its appeal of the Board’s final written decision finding unpatentable all claims of U.S. Patent No. 8,821,873, which is directed to a method of treating lymphoma with anti-CD20 antibodies. As we previously reported, although Pfizer filed the IPR that resulted in the final written decision, Pfizer reached a settlement with Biogen regarding this and other patents related to rituximab, and notified the Federal Circuit that it would not be participating in this appeal.  The United States intervened in this appeal in March in response to Biogen’s constitutionality challenge to subjecting the pre-AIA ’873 patent to inter partes review, and the USPTO intervened earlier this month to step into Pfizer’s shoes in this appeal to defend the Board’s final written decision.