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 represented 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: 1 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, Proskauer Rose, Los Angeles, CA; STEVEN M. BAUER, JOHN E.

ROBERTS, Boston, MA; MELANIE K. SHARP, Young, Conaway, 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, Genentech) filed an emergency motion and a motion for a temporary restraining order based on 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). 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 biological product used to treat certain types of cancer, under 

the name Avastin. Amgen filed a biologics license application with the Food and Drug Administration (FDA) pursuant 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 Genentech 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 supplement to its Mvasi application to add a manufacturing 

facility and a fourth supplement to change its drug label. 

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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 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).

DISCUSSION

The parties’ dispute centers on the district court’s interpretation of Section 262(l)(8)(A)’s notice requirements. 

“Statutory interpretation is a question of law that we review 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 examination of the ordinary meaning and structure of the law 

itself. Where, as here, that examination yields a clear answer, 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 marketing of the biological product licensed under subsection (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 

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4 GENENTECH, INC. v. IMMUNEX RHODE ISLAND CORP.

Biologics Price Competition and Innovation Act defines “biological product” as used in Section 262 as:

a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or 

arsphenamine or derivative of arsphenamine (or 

any other trivalent organic arsenic compound), applicable 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. Genentech, therefore, had notice of Amgen’s intent to commercially market Mvasi as required under Section 262(l)(8)(A) 

as early as October 6, 2017.

Genentech argues that the phrase “licensed under subsection (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 product(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, including 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.

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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 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).

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 notice under Section 262(l)(8)(A) and therefore properly denied Genentech’s motions for failure to establish likely 

success on the merits, we affirm. 

AFFIRMED

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