Analysis of Amgen v. Sandoz Federal Circuit Opinion

by Goodwin
Contact

The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court.  In that decision, the Federal Circuit held that Amgen’s state law claims, based on the failure to follow procedures of the BPCIA patent dance, “are preempted on both field and conflict grounds.”  The decision does not address specifics of California law and seems to foreclose any attempts to enforce BPCIA provisions on state law grounds.

By way of background, Amgen had argued that (1) Sandoz waived any argument with regard to preemption by failing to pursue it before the District Court; and (2) the BPCIA does not preempt any existing state law remedies for the failure to comply with the patent dance provisions in § 262(l)(2)(A); and (3) Sandoz’s failure to comply with § 262(l)(2)(A) is both “unlawful” and an act of conversion under California state law.

On the issue of waiver, the Federal Circuit first decided that the preemption issue deserved immediate resolution because it presented a significant question of general impact or great public concern and, therefore, it exercised its discretion to address the issue without a lower court decision.  The court noted that Sandoz had preserved preemption as a defense in its answer, and Sandoz could thus raise the issue on remand.  While Amgen emphasized that Sandoz had not relied on preemption in its successful motion for judgment on the pleadings in the district court, the Federal Circuit thought the issue sufficiently important to address without a district-court decision on the subject:  “The issue of preemption is a significant question regarding the interpretation of the BPCIA.”  The court concluded that there was no prejudice to Amgen from deciding the preemption issue now rather than later.

Turning to the substantive issue of whether Congress had preempted any state law remedy for the failure to engage in § 262(l)(2)(A), the Federal Circuit concluded that there was a field preemption.  The court first noted that there is no presumption against preemption in this context.  States have not traditionally occupied the field of biosimilar patent litigation.  Patents exist under federal law, and federal courts have exclusive jurisdiction over patent cases.

The Federal Circuit then analyzed the BPCIA, finding the law to be a complex statutory scheme that carefully balances innovation and consumer interests.  Like the federal alien registration system in Arizona v. United States, 567 U.S. 387 (2012), the patent dance has complete governing standards for information exchanges and penalties for noncompliance.  The Federal Circuit held that the BPCIA leaves “no room for States to supplement it.”  The injunctive relief and damages that Amgen sought were not permitted under federal law and would conflict with the careful framework that Congress adopted.  Differing remedies between federal and state law as here are the very reason for field preemption according to the Federal Circuit.  The federal government thus fully occupied the field of biosimilar patent litigation.

The Federal Circuit also concluded that conflict preemption barred Amgen’s state law claims.  The court reasoned that Amgen’s state law claims clashed with the BPCIA, and the differences between the federal statutory scheme and the state law claims supported the conclusion that any state law claims otherwise available were preempted.  The court further reasoned that Congress must have acted intentionally in not providing for injunctive relief for a breach of the § 262(l)(2)(A) disclosure requirements.  The court held that state laws imposing such penalties would interfere with the “careful balance struck by Congress” and are preempted.  The Federal Circuit also noted that “compliance with the BPCIA’s detailed regulatory regime in the shadow of the 50 States’ tort regimes and unfair competition standards could dramatically increase the burdens on biosimilar applications beyond those contemplated by Congress.”

The Federal Circuit’s decision makes clear that there is no legal or equitable remedy, under either federal or state law, when a biosimilar applicant opts not to comply with § 262(l)(2)(A).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.