CAFC interprets Hatch-Waxman in Genentech v. Immunex

Genentech filed two motions in the District of Delaware seeking to preclude Amgen from commercially marketing Mvasi “until such time as Amgen . . . provides notice
of its intent to commercially market such product[] pursuant to [42] U.S.C. § 262(l)(8) and 180 days have elapsed.”
J.A. 3. It 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. Genentech appeals. We have jurisdiction under 28 U.S.C. §§ 1292(a)(1)
and (c)(1).


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Our interpretation is consistent with the Supreme
Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct.
1664 (2017) (Sandoz II). In Sandoz II, the Supreme Court
explained that the term “licensed” in Section 262(l)(8)(A)
simply means that the product must be licensed on the date
of the first commercial marketing, id. at 1677, not that each
supplemental application results in a new license requiring
the biosimilar applicant provide further notice. In fact,
Sandoz II recognized that “nothing in § 262(l)(8)(A) turns
on the precise status or characteristics of the biosimilar application.” Id. at 1678. Section 262(l)(8)(A)’s notice requirement is separate from Section 262(k)’s licensure
requirements. Sandoz II also explained that “Section
262(l)(8)(A) contains a single timing requirement: The applicant must provide notice at least 180 days prior to marketing its biosimilar.” Id. at 1677. Thus, Genentech’s
interpretation, which would impose several timing requirements where each supplement necessarily triggers another
notice requirement, is inconsistent with the statute and
with Sandoz II. A biosimilar applicant that has already
provided Section 262(l)(8)(A) notice regarding its biological
product need not provide another notice for each supplemental application concerning the same biological product.
Accordingly, we conclude 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).