Genentech, Inc. v. Immunex Rhode Island Corp.

Case: 19-2155 Document: 91 Page: 1 Filed: 07/06/2020

United States Court of Appeals for the Federal Circuit ______________________

GENENTECH, INC., Plaintiff-Appellant

CITY OF HOPE, Plaintiff

v.

IMMUNEX RHODE ISLAND CORPORATION, AMGEN INC., Defendants-Appellees ______________________

2019-2155 ______________________

Appeal from the United States District Court for the District of Delaware in No. 1:19-cv-00602-CFC, Judge Colm F. Connolly. ______________________

Decided: July 6, 2020 ______________________

CHARLES L. MCCLOUD, Williams & Connolly LLP, Washington, DC, argued for plaintiff-appellant. Also rep- resented by PAUL B. GAFFNEY, DAVID I. BERL, THOMAS S. FLETCHER, KATHRYN SCHLECKSER KAYALI.

JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, argued for defendants-appellees. Also represented by

Case: 19-2155 Document: 91 Page: 2 Filed: 07/06/2020 2 GENENTECH, INC. v. IMMUNEX RHODE ISLAND CORP.

MICHAEL GREGORY PATTILLO, JR., LUCAS M. WALKER; SIEGMUND Y. GUTMAN, SARAH CORK, AMIR A. NAINI, Pros- kauer Rose, Los Angeles, CA; STEVEN M. BAUER, JOHN E. ROBERTS, Boston, MA; MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor LLP, Wilmington, DE; DREW DIAMOND, NANCY GETTEL, WENDY A. WHITEFORD, Amgen Inc., Thousand Oaks, CA. ______________________

Before MOORE, O’MALLEY, and HUGHES, Circuit Judges. MOORE, Circuit Judge. Genentech, Inc. and City of Hope (collectively, Genen- tech) filed an emergency motion and a motion for a tempo- rary restraining order based on Immunex Rhode Island Corporation’s and Amgen Inc.’s (collectively, Amgen) al- leged failure to comply with the notice requirement of 42 U.S.C. § 262(l)(8)(A). Genentech appeals the United States District Court for the District of Delaware’s denial of the motions. Genentech, Inc. v. Immunex Rhode Island Corp., 395 F. Supp. 3d 357, 366 (D. Del. 2019). For the reasons stated below, we affirm. BACKGROUND Genentech manufactures and sells bevacizumab, a bio- logical product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license applica- tion with the Food and Drug Administration (FDA) pursu- ant to 42 U.S.C. § 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 14, 2017. On October 6, 2017, Amgen sent a letter pursuant to 42 U.S.C. § 262(l)(8)(A) notifying Genen- tech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, after two prior supplements, Amgen filed a third sup- plement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label.

Case: 19-2155 Document: 91 Page: 3 Filed: 07/06/2020 GENENTECH, INC. v. IMMUNEX RHODE ISLAND CORP. 3

By July 8, 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed two motions in the District of Dela- ware seeking to preclude Amgen from commercially mar- keting Mvasi “until such time as Amgen . . . provides notice of its intent to commercially market such product[] pursu- ant to [42] U.S.C. § 262(l)(8) and 180 days have elapsed.” J.A. 3. It argued that Amgen’s third and fourth supple- ments resulted in new and distinct applications that re- quire 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 Sec- tion 262(l)(8)(A)’s notice requirements. Genentech ap- peals. We have jurisdiction under 28 U.S.C. §§ 1292(a)(1) and (c)(1). DISCUSSION The parties’ dispute centers on the district court’s in- terpretation of Section 262(l)(8)(A)’s notice requirements. “Statutory interpretation is a question of law that we re- view de novo.” Forest Grp., Inc. v. Bon Tool Co., 590 F.3d 1295, 1301 (Fed. Cir. 2009). “In statutory interpretation disputes, a court’s proper starting point lies in a careful ex- amination of the ordinary meaning and structure of the law itself. Where, as here, that examination yields a clear an- swer, judges must stop.” Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2364 (2019) (citations omitted). Section 262(l)(8)(A) recites: The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial mar- keting of the biological product licensed under sub- section (k) The statute makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product. The

Case: 19-2155 Document: 91 Page: 4 Filed: 07/06/2020 4 GENENTECH, INC. v. IMMUNEX RHODE ISLAND CORP.

Biologics Price Competition and Innovation Act defines “bi- ological product” as used in Section 262 as: a virus, therapeutic serum, toxin, antitoxin, vac- cine, blood, blood component or derivative, aller- genic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), ap- plicable to the prevention, treatment, or cure of a disease or condition of human beings. 42 U.S.C. § 262(i)(1). Amgen notified Genentech of its intent to commercially market its biological product, Mvasi, on October 6, 2017. Despite its later supplements to its applications adding a manufacturing facility and changing its drug product label, Amgen’s biological product, Mvasi, did not change. Genen- tech, therefore, had notice of Amgen’s intent to commer- cially market Mvasi as required under Section 262(l)(8)(A) as early as October 6, 2017. Genentech argues that the phrase “licensed under sub- section (k)” in Section 262(l)(8)(A) is defined “by particular manufacturing facilities and labeling.” Appellant Op. Br. at 15. It argues that Amgen’s third supplement adding a manufacturing facility for Mvasi and fourth supplement amending Mvasi’s label created distinct “biological prod- uct(s) licensed under subsection (k)” triggering new notice obligations under Section 262(l)(8)(A). Id. at 17–18. We do not agree. Section 262(k), not Section 262(l)(8)(A), details the contents and requirements for biosimilar licensure, in- cluding manufacturing and labeling. Section 262(k) relates to disclosure for licensure. Section 262(l)(8)(A) expressly requires prior notice regarding commercial marketing of the “biological product,” the definition of which makes no reference to Section 262(k). Section 262(l)(8)(A) relates to timing.

Case: 19-2155 Document: 91 Page: 5 Filed: 07/06/2020 GENENTECH, INC. v. IMMUNEX RHODE ISLAND CORP. 5

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 ap- plication.” Id. at 1678. Section 262(l)(8)(A)’s notice re- quirement 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 ap- plicant must provide notice at least 180 days prior to mar- keting its biosimilar.” Id. at 1677. Thus, Genentech’s interpretation, which would impose several timing require- ments 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 supple- mental 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). CONCLUSION We have considered the parties’ remaining arguments and do not find them persuasive. Because the district court correctly determined that Amgen provided the required no- tice under Section 262(l)(8)(A) and therefore properly de- nied Genentech’s motions for failure to establish likely success on the merits, we affirm. AFFIRMED