Supplements to Biologics License Application Do Not Trigger New Notice Obligation under Section 262(l)(8)(A)

In Genentech, Inc. v. Immunex R.I. Corp., No. 2019-2155 (Fed. Cir. July 6, 2020), the Federal Circuit held that supplements to an FDA approved biologics license application do not trigger obligations to provide new marketing notices under 42 U.S.C. § 262(l)(8)(A). Under 42 U.S.C. § 262(l)(8)(A), biosimilar applicants must notify a reference product sponsor at least 180 days before commercially marketing a “biological product.”

In September 2017, Amgen obtained FDA approval to market Mvasi, a biosimilar version of Genentech’s cancer treatment drug Avastin. In October 2017, Amgen notified Genentech that it intended to commercially market Mvasi. Amgen subsequently filed supplements to its application. In July 2019, Amgen decided to commercially launch Mvasi. Genentech filed two emergency motions in the district court seeking to preclude Amgen from marketing Mvasi, until Amgen provided the requisite notice under 42 U.S.C. § 262(l)(8)(A). The district court denied both motions.

 On appeal, Genentech argued that Amgen’s third supplement, which added a manufacturing facility for Mvasi, and Amgen’s fourth supplement, which amended the Mvasi label, created distinct “biological product[s],” thus triggering new notice obligations. The Federal Circuit disagreed, explaining that despite Amgen’s later supplements to its application, the “biological product,” Mvasi, did not change. The Court rejected Genentech’s interpretation of 42 U.S.C. § 262(l)(8)(A), noting that the statute “contains a single timing requirement” and a biosimilar applicant “need not provide another notice for each supplemental application” concerning the same product. Accordingly, the Court held that Amgen’s 2017 letter satisfied the notice obligations under Section 262(l)(8)(A) and affirmed the district court’s denial of Genentech’s motions.