Benjamin F. Jackson, Associate

Recently, in Amgen Inc. v. Hospira, Inc., the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods.

In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia. Following a trial, a jury issued a $70 million verdict for Amgen, which was based in part on the jury’s conclusion that fourteen batches of drug substance for Hospira’s EPO biosimilar product were not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(1). After the district court denied Hospira’s motion for judgment as a matter of law or alternatively for a new trial, Hospira appealed on a number of issues, including the jury instructions and jury findings on its Safe Harbor defense.

Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation.  In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period for purposes of patent term extension.  As discussed below, the Mayo decision could have implications for the terms of biologics patents issued following a request for continued examination.

Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019).  While many had hoped the decision would provide clarity on whether a biosimilar maker who has not yet filed an aBLA has standing to appeal a PTAB decision upholding an innovator patent, the Federal Circuit instead dismissed the appeal for lack of standing and mootness based on post-appeal developments making it clear that Momenta had abandoned its efforts to develop the biosimilar in question.  Nevertheless, Momenta is important in that it illustrates the continued risk to biosimilar makers of unappealable IPR decisions when they bring IPRs years before filing an aBLA.

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application.  The Federal Circuit is expected to decide whether a petitioner must have filed a marketing application in order to have Article III standing to appeal from an unfavorable PTAB decision.  As months have passed without a decision, Momenta and BMS have both used the time to further press their case. 

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing application.  Such early IPRs are attractive to biosimilar makers, because they provide a chance to challenge innovator patents years before the biosimilar maker files a marketing application with FDA.  Since a petitioner need not have Article III case-or-controversy standing to bring an IPR, the remoteness and uncertainty of future infringement in such circumstances does not preclude these early IPRs.  Under settled precedent, however, a biosimilar maker must have Article III standing to seek a Federal Circuit appeal if the PTAB issues a final decision upholding the challenged patent.  A decision expected from the Federal Circuit this quarter in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017) will address how and when a biosimilar maker can establish that standing.