July 6, 2020

42 U.S.C. § 262(l)(8) Simply Requires 180 Day Notice before Sale of a Biosimilar Product

In Genentech, Inc. v. Immunex Rhode Island Corp., [2019-2155] (July 6, 2020), the Federal Circuit affirmed the denial of Genentech’s motion for a temporary restraining order (TRO) based upon Immunex Rhode Island Corporation’s and Amgen Inc.’s (collectively, Amgen) alleged failure to comply with the notice requirement of 42 U.S.C. § 262(l)(8)(A).

On October 6, 2017, Amgen sent a letter pursuant to 42 U.S.C. § 262(l)(8)(A) notifying Genentech of its intent to commercially market Mvasi — a biosimilar version of Avastin — starting no earlier than 180 days from the date of the letter. In August 2018, after two prior supplements, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 8, 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately.

Genentech filed two motions seeking to preclude Amgen from commercially marketing Mvasi until Amgen provided notice of its intent to commercially market such product pursuant to 42 U.S.C. § 262(l)(8) and 180 days had elapsed. Genentech argued that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices under Section 262(l)(8)(A). The district court denied both motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements, and Genentech appealed.

The Federal Circuit said that the statute makes clear that a biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product. Section 262(l)(8)(A) expressly requires prior notice regarding commercial marketing of the “biological product,” the definition of which makes no reference to licensing under Section 262(k). Section 262(l)(8)(A) relates to timing. The Federal Circuit said this interpretation is consistent with the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017).

The Federal Circuit concluded that Amgen’s October 6, 2017 letter, which notified Genentech of Amgen’s intent to commercially market Mvasi at least 180 days before its July 2019 launch, satisfied Section 262(l)(8)(A), and affirmed the district court.