The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) do not trigger a new notice requirement under Section 262(l)(8)(A).
Genentech, Inc. and City of Hope (collectively, “Genentech”) manufacture and sell bevacizumab (Avastin), an antibody used to treat cancer. Immunex Rhode Island Corporation and Amgen, Inc. (collectively, “Amgen”) filed an abbreviated biologics license application under the BPCIA to market a biosimilar version of Avastin called Mvasi. After receiving FDA approval, on October 6, 2017, Amgen notified Genentech of its intent to commercially market Mvasi in at least 180 days, pursuant to 42 U.S.C. § 262(l)(8)(A).
Amgen later supplemented its Abbreviated Biologics License Application (aBLA) to add a manufacturing facility and modify the label for Mvasi. Despite these supplements, the drug product, Mvasi, did not change. By July 8, 2019, Amgen decided to commercially market Mvasi. Genentech filed an emergency motion and a motion for a temporary restraining order to preclude Amgen from entering the market. Genentech argued that Amgen’s supplemental applications created a distinct biological product licensed under Section 262(k), thus necessitating a new notice of commercial marketing and a renewed 180-day waiting period under Section 262(l)(8)(A). The district court denied both motions and this appeal followed.
On appeal, the Federal Circuit rejected Genentech’s argument that new disclosures relating to licensure (i.e., manufacturing facilities and labeling provisions) triggered a new notice requirement. The court observed that Section 262(l)(8)(A) relates to timing of notice for the biological product, whereas Section 262(k) pertains to licensure requirements. By its ordinary meaning, Section 262(l)(8)(A) requires that a biosimilar applicant provide notice to the reference product sponsor before commercially marketing a “biological product.” Section 262(k), on the other hand, sets for the contents that must be included to license the biosimilar product. Amgen’s supplemental applications submitted under Section 262(k) did not modify Mvasi—the biological product was the same. The Federal Circuit, therefore, declined to impose a requirement for a new notice of commercial marketing.
In reaching its decision, the court made clear that its interpretation was consistent with the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017). In Sandoz, the Court construed “licensed under subsection (k)” merely to require that the biological product was licensed by the date of commercial marketing. Further, Sandoz emphasized that Section 262(l)(8)(A) only includes one timing requirement, whereas Genentech’s interpretation could require notice each time a supplemental application was filed. Nothing in Section 262(l)(8)(A) turns on the characteristics of the biosimilar application or the merits of licensure. Thus, supplementing an aBLA with additional information does not trigger a requirement for a new notice of commercial marketing when the supplements are directed to the same biological product.
Practice Tip: The Federal Circuit noted that none of the supplemental applications at issue here changed the biological product. In most cases, changes to the biological product are likely to trigger a requirement for a separate original application. Thus, this case likely closes the door on the question of whether a supplemental application can ever trigger a new notice requirement. However, parties should still look to the specific nature of the supplemental application to determine whether the reasoning of this case can be distinguished.
Genentech, Inc. v. Immunex Rhode Island Corp., 2019-2115, 2020 WL 3635031 (Fed. Cir. Jul. 6, 2020)