July 8, 2020
Authored and Edited by Michelle (Yongyuan) Rice; Caitlin E. O'Connell; Elizabeth D. Ferrill
In Genentech, Inc. v. Immunex R.I. Corp., No. 2019-2155 (Fed. Cir. July 6, 2020), the Federal Circuit held that supplements to an FDA approved biologics license application do not trigger obligations to provide new marketing notices under 42 U.S.C. § 262(l)(8)(A). Under 42 U.S.C. § 262(l)(8)(A), biosimilar applicants must notify a reference product sponsor at least 180 days before commercially marketing a “biological product.”
In September 2017, Amgen obtained FDA approval to market Mvasi, a biosimilar version of Genentech’s cancer treatment drug Avastin. In October 2017, Amgen notified Genentech that it intended to commercially market Mvasi. Amgen subsequently filed supplements to its application. In July 2019, Amgen decided to commercially launch Mvasi. Genentech filed two emergency motions in the district court seeking to preclude Amgen from marketing Mvasi, until Amgen provided the requisite notice under 42 U.S.C. § 262(l)(8)(A). The district court denied both motions.
On appeal, Genentech argued that Amgen’s third supplement, which added a manufacturing facility for Mvasi, and Amgen’s fourth supplement, which amended the Mvasi label, created distinct “biological product[s],” thus triggering new notice obligations. The Federal Circuit disagreed, explaining that despite Amgen’s later supplements to its application, the “biological product,” Mvasi, did not change. The Court rejected Genentech’s interpretation of 42 U.S.C. § 262(l)(8)(A), noting that the statute “contains a single timing requirement” and a biosimilar applicant “need not provide another notice for each supplemental application” concerning the same product. Accordingly, the Court held that Amgen’s 2017 letter satisfied the notice obligations under Section 262(l)(8)(A) and affirmed the district court’s denial of Genentech’s motions.
Copyright © 2020 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
INCONTESTABLE® Blog
Winning the Battle but Not the War: Disclaimer Requirement Overturned, Section 2(d) Objection Upheld
March 28, 2024
Conference
2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities
March 20, 2024
Boston
Ad Law Buzz Blog
“Banning” a Banned Ingredients Claim: NAD’s Application (and Expansion) of the FTC’s Green Guides
March 18, 2024
INCONTESTABLE® Blog
Trademark Application for Fruity Pebbles’ Colors—“Yabba-Dabba-Delicious” but Not Protectable
March 8, 2024
Virtual Seminar
Prosecuting and Challenging Patent Applications/Careers in IP Law: A World of Possibilities
February 28, 2024
Virtual
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.