AARP, AHIP, and Others File Amicus Briefs in Sandoz v. Amgen

by Goodwin

As we have previously reported, the Supreme Court will next month hear arguments in Sandoz v. Amgen regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions.  Several amicus briefs in support of Sandoz were filed last week.

One brief was filed by AARP, AARP Foundation, Citizens Against Government Waste, the UAW Retiree Medical Benefits Trust, the National Health Law Program, and the Coalition to Protect Patient Choice.  In their brief, the amici discussed spending on prescription drugs and the disproportionate effect that high drug costs has on older Americans.  In particular, biologic drugs are more expensive than traditional prescription medications, and even as the cost of traditional drugs has decreased in recent years, biologic costs have been increasing.  The amici explained that the availability of more biosimilar products will result in lower cost and greater access to lifesaving medications, as has already been the experience in European markets.  On the merits, the amici argued that the notice of commercial marketing and the patent litigation provisions of the BPCIA are separate and were intended to run parallel to each other.  In other words, “Congress did not intend to penalize biosimilars manufacturers for their readiness to bring their products to market immediately upon their approval by FDA.”  In short, the amici argued that the statute provides for only twelve years of marketing exclusivity, which in itself was the result of a contentious legislative negotiation, and does not provide an additional 180 days of exclusivity under the notice provision.

America’s Health Insurance Plans (“AHIP”) also submitted an amicus brief last week.  Similar to AARP’s brief, AHIP provided a detailed discussion of drug cost and spending and made similar arguments in support of Sandoz’s position based on the text, structure, and history of the relevant provisions of the BPCIA.  AHIP in particular noted the pediatric exclusivity provision, arguing that where Congress wanted to provide an exclusivity period beyond twelve years, it did so explicitly.  Unlike AARP’s brief, however, AHIP also took a position on Amgen’s cross petition.  AHIP argued that the Federal Circuit’s decision below was correct and that the biosimilar applicant’s sharing of its application with the RPS is optional.  AHIP noted that the biosimilar applicant’s choice not to disclose its application under 42 U.S.C. § 262(l)(2)(A) is specifically contemplated by 35 U.S.C. § 271(e)(2)(C)(ii), which provides that such a choice not to disclose creates an act of infringement allowing for immediate litigation.  AHIP further argued that requiring the biosimilar applicant to disclose its application would frustrate the purpose of the statute, which provides a range of patent dispute resolution options.  AHIP also argued that a reversal of the Federal Circuit’s interpretation would lead to the absurd result of requiring the biosimilar applicant to dance even when there is no dispute to be resolved, such as when, for example, “there are no relevant, unexpired patents … when the application is submitted.”

Stay tuned to Big Molecule Watch for more coverage of the amicus briefs filed in Sandoz v. Amgen last week.

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 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):

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.


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 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:

- 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.