March 26, 2019

March 26, 2019

Subscribe to Latest Legal News and Analysis

March 25, 2019

Subscribe to Latest Legal News and Analysis

Will Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. Perhaps more importantly, the clock still may be running against Genentech to make the next move in the patent dance.

Genentech’s Patent Dance Complaint

As explained in this article, this case arose from Amgen’s November 2016 aBLA for a biosimilar version of Genentech’s Avastin® (bevacizumab) product, which Genentech describes as it “best-selling cancer drug.” However, Genentech’s complaint was not for patent infringement, but rather alleged that Amgen failed to comply with the information exchange requirements of the “patent dance” provisions of the BPCIA. Although Amgen provided a copy of its aBLA to Genentech in accordance with 42 USC § 262(l)(2)(A), Genentech alleged that Amgen failed to provide additional required information, such as informaton regarding its manufacturing process.

Amgen’s Right To Sit This One Out

In a letter to the court dated February 27, 2017, Amgen argued that Genentech’s complaint should be dismissed as “procedurally improper” under the Federal Circuit decision in Amgen v. Sandoz. According to Amgen:

[That case] squarely holds that the sole and exclusive remedy for any alleged non-compliance with 42 U.S.C. 262(/)(2)(A) is a patent infringement action.

As explain in this article, the Federal Circuit ruled in Amgen v. Sandoz that if a biosimilar applicant fails to follow the “patent dance” procedures of 42 U.S.C. § 262(l)(2)(A), the only “remedy” available to the reference product sponsor is to pursue a patent infringement claim under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).

(Amgen acknowledged that it has asked the Supreme Court to reverse that decision, but noted that the decision “remains controlling authority here.”)

Since Genentech’s complaint did not assert any claims of patent infringement, Amgen argued that it was precluded under Amgen v. Sandoz.

Must Genentech Keep Dancing By Itself?

Genentech filed a responsive letter to the court dated February 28, 2017, arguing that Amgen v. Sandoz only applies when a biosimilar applicant opts out of the patent dance altogether. According to Genentech, because Amgen opted into the patent dance by providing a copy of its aBLA to Genentech, the court should have the authority to resolve this dispute so the patent dance can go on.

Genentech also argued that biosimilar applicants who opt into the patent dance benefit considerably because it imposes certain limitations on “how and when the innovator [reference product sponsor] can exercise its patent rights.” That also means that the reference product sponsor is at a disadvantage when the biosimilar applicant withholds information needed to assess patent infringement. For example, Genentech argues that it will be forced “either to produce a list of potentially infringed patents under § 262(l)(3)(A), without the full production of materials or expert assistance that should have informed that list, or sue Amgen for infringement and wait and see whether that lawsuit was proper at some later time.”

Is This Dance Over? 

Judge Sleet dismissed Genentech’s complaint for lack of subject matter jurisdiction without prejudice, and gave Genentech the opportunity to filed an amended complaint within 45 days (i.e., April 15). However, according to its February 28 letter, Genentech faces a March 24, 2017 deadline for serving Amgen with its list of potentially infringed patents under § 262(l)(3)(A). It will be interesting to see whether Genentech continues on with the patent dance or opts out itself by filing a declaratory judgment action under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).

© 2019 Foley & Lardner LLP

TRENDING LEGAL ANALYSIS


About this Author

Jennifer L. Bachorik, Foley Lardner, patentability analyses lawyer, pharmaceutical industry attorney
Associate

Jennifer L. Bachorik, Ph.D., is an associate and intellectual property lawyer with Foley & Lardner LLP. She is a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice.

Prior to joining Foley, Dr. Bachorik was an associate and patent agent with BakerHostetler, where she was responsible for prosecuting and drafting biotechnology and pharmaceutical patent applications, and performing freedom to operate and patentability analyses for pharmaceutical, biotechnology, and chemical cases. Before this, she attended law school in...

608.258.4275
Courtenay C. Brinckerhoff, intellectual property  law attorney, Foley & Lardner  Law Firm
Partner

Courtenay Brinckerhoff is a partner and intellectual property lawyer with Foley & Lardner LLP. Ms. Brinckerhoff’s practice focuses on client counseling in all aspects of obtaining, licensing and enforcing patents and conducting freedom-to-operate and due diligence investigations. She is chair of the firm’s IP Law and Practice committee, immediate past vice chair of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and a member of the firm's Patent Trials group, Appellate Practice and Life Sciences Industry Team. She also is involved with Foley’s Medical Device Initiative and Nutraceuticals Team. Ms. Brinckerhoff is the editor and primary author for Foley’s PharmaPatentsBlog.com.

Over the past 20 years, Ms. Brinckerhoff has represented clients before the U.S. Patent Office, the Patent Trial and Appeal Board, and the U.S. Court of Appeals for the Federal Circuit, and has been involved in complex patent matters, including a four-party interference, Inter Partes Reexaminations, Inter Partes Reviews, and ANDA litigation.

Ms. Brinckerhoff works with clients in diverse industries, including pharmaceuticals (chemical and biotechnological), human and animal food products, nutraceuticals, and medical devices. She has particular experience with transdermal pharmaceutical products (patches, gels, and liquids), oral dosage forms (including controlled/extended release formulations), enzyme-based technologies, diagnostic and therapeutic antibodies, active and passive immunization therapies, and personalized medicine.

She has served as vice chair of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and is an active member of the firm's Appellate Practice and Life Sciences Industry Team.

202.295.4094