United States: Sandoz v. Amgen Supreme Court Decision

On June 12, 2017, the U.S. Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, interpreting two provisions of the Biologics Price Competition and Innovation Act (BPCIA).2 Below, a divided Federal Circuit panel held that: (1) a biosimilar applicant is not required to provide its application and manufacturing information to the Reference Product Sponsor (RPS), and the BPCIA contains the "exclusive" remedies for any such failure to comply with this disclosure provision; and (2) a biosimilar applicant may only provide its 180-day notice of commercial marketing after the FDA has licensed the biosimilar.3 On appeal, the Court vacated in part and reversed in part, remanding the cases back to the Federal Circuit for further proceedings.

Justice Thomas authored the opinion with Justice Breyer concurring. The opinion affirmed the portion of the Federal Circuit's decision that an injunction forcing disclosure of an abbreviated Biologics License Application (aBLA) under federal law is unavailable if the biosimilar applicant fails to comply with the "information exchange" provision of the BPCIA. However, the Court declined to rule on what, if any, remedies are available under a state law claim, leaving that issue for remand. The Court also reversed the Federal Circuit's determination that the 180-day notice of commercial marketing provision of the BPCIA is ineffective unless it is provided after a biosimilar applicant receives FDA licensure, holding instead that the applicant may provide notice either before or after receiving FDA approval. The Court's decision still leaves uncertain the question as to whether disclosure of a biosimilar applicant's aBLA prior to commencement of a patent infringement suit is mandatory.

Echoing statements made during oral argument and the Federal Circuit's decision, the Supreme Court's opinion provided a concise, yet detailed, overview of the "complex statutory scheme at issue in these cases."4 Justice Breyer, in his concurrence, noted that while "[t]he Court's interpretation of the statutory terms before us is a reasonable interpretation," the FDA has the Congressional authority to engage in a similar interpretation—to either "depart from, or to modify" the Court's ruling.5

1. The "information exchange" provision does not provide for a federal injunction as a remedy and the issue of what, if any, remedies are available is a question under state law.

Paragraph (l)(2)(A) (the "information exchange" provision) of the BPCIA provides that:

Not later than twenty days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.6

The first question addressed by Justice Thomas's opinion was whether the "information exchange" requirement is enforceable by injunction. In answering this question, the Court held that a failure to abide by this provision does not allow for the grant of a federal injunction, but for different reasons than those articulated by the lower court.7 Below, the Federal Circuit held that noncompliance with 42 U.S.C. § 262(l)(2)(A) constituted an act of artificial infringement with remedies available under 35 U.S.C. § 271(e)(4),8 but that § 262(l)(9)(C) provides the exclusive remedies for such a violation.9 The Supreme Court disagreed with this underlying basis of artificial infringement. Stating that the submission of the application itself is the catalyst for artificial infringement, the Court noted that the information to be exchanged merely "assists in identifying which patents will be the subject of the artificial infringement suit."10 The Court further observed that both clauses of § 271(e)(2)(C) support its determination: following the submission of the application, an act of artificial infringement occurs under clause (i) if the applicant made the disclosures; if not, infringement still occurs under clause (ii).11 The Court therefore concluded that an applicant's failure to provide its application and manufacturing information is not an act of artificial infringement, with neither § 271(e)(4) nor § 262(l)(9)(C) providing any remedy for this failure.12 The Court, however, agreed with the Federal Circuit that an immediate declaratory-judgment action under § 262(l)(9) is the appropriate form of federal relief.13 The Court noted that the BPCIA's enforcement scheme is sufficiently detailed to evidence Congress' intent for declaratory-judgment actions to be the RPS's sole remedy, "at least as a matter of federal law."14

While addressing the appropriate remedy under federal law, the Supreme Court declined to resolve the question of whether the information exchange provision is mandatory or conditional, stating that the BPCIA does not "require [them] to decide whether § 262(l)(2)(A) is mandatory or conditional," only whether the applicant supplied the required information.15 Instead, the Court stated that this issue must be addressed in the context of Amgen's state law claims. More specifically, in their first complaint, Amgen brought two claims—both arising under California's unfair competition law—against Sandoz for its failure to abide by § 262(l)(2)(A).17 The Federal Circuit dismissed both claims, holding that California's unfair competition law does not provide a cause of action when a violation of the underlying federal statute specifies the "exclusive" remedy, and that such a failure to disclose is not otherwise "unlawful," as the BPCIA provides a regulatory pathway that expressly contemplates this procedural deviation.18 The Supreme Court held otherwise and remanded. The Court reiterated that any failure by the biosimilar applicant to disclose its application and manufacturing information is not an act of artificial infringement; rather, the act of filing the aBLA itself is the infringing act.19 Therefore, the Court disagreed with the Federal Circuit that § 271(e)(4) and § 262(l)(9)(C) provides the only "exclusive," or even appropriate, remedy for Sandoz's failure to comply with the statute.20 Further, the question of whether Sandoz's failure to participate in the information exchange is "unlawful" under California law also involves the application of state law and cannot be adequately addressed by the provisions of the BPCIA alone.21 Thus, the Federal Circuit erred in its decision by only applying federal law to a state law issue.22

On remand, the Supreme Court requested that the Federal Circuit determine whether California law would view a biosimilar applicant's failure to abide by the information exchange as "unlawful."23 If that answer is yes, or if the court assumes that a state law remedy exists, the Justices believe that the Federal Circuit should next address whether the BPCIA preempts a state law remedy.24 The Court also suggested the Federal Circuit could simply assume a state remedy is available and decide only the issue of preemption.25

2. The "notice" provision does not require biosimilar applicants to give RPSs 180-days advance notice of commercial marketing following FDA licensure.

The second question addressed by the Court was whether an applicant may provide effective notice before FDA licensure, or whether it must wait, as held by the Federal Circuit, until after the biosimilar is licensed. Paragraph (l)(8)(A) (the "notice" provision) provides that "[t]he 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)."26 Below, the Federal Circuit held that a notice by the biosimilar applicant is only effective after the FDA has licensed the biosimilar.27 The Supreme Court reversed.

In reaching the unanimous decision, Justice Thomas employed a textualist analysis. Finding that the phrase "of the biological product licensed under subsection (k)" modifies "commercial marketing," not "notice," the Court held that the biosimilar applicant "may provide notice either before or after receiving FDA approval."28 To bolster its interpretation, the Court observed that the Federal Circuit improperly added a second requirement—"[t]he applicant must provide notice after the FDA licenses the biosimilar and at least 180 days before the applicant markets the biosimilar."29 Further, Justice Thomas observed that a neighboring provision allows for this dual-timing requirement and Congress expressly chose not to implement a similar scheme for § 262(l)(8)(A).30

The Court declined to address Amgen's and Sandoz's policy arguments.31 Although the oral argument featured questions concerning the pragmatic effects of the timing of the notice provision, the Court wrote that "[t]he plausibility of the contentions on both sides illustrates why such disputes are appropriately addressed to Congress, not the courts."32 Specifically noting Amgen's policy arguments may have been more persuasive, the Court concluded that the statute's plain language is the "'primary guide' to Congress' preferred policy."33


While the Supreme Court's decision in Sandoz v. Amgen provides much needed guidance that the 180-day notice of commercial marketing can be provided either before or after FDA approval, and confirms that an injunction forcing compliance with the application disclosure provision of the BPCIA is not available under federal law, it still leaves open the question as to whether disclosure is required. That question will remain open until the Federal Circuit has an opportunity to further consider Amgen's state law unfair competition claims on remand.


1 582 U.S. ____ (2017), available at https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf

2 Pub. L. No. 111-148, §§ 7001-7003, 124 Stat. 119, 804-21 (2010); see also 42 U.S.C. § 262(k), (l).

3 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58, 1360-61 (Fed. Cir. 2015).

4 Slip op. at 2.

5 Breyer Concurrence at 1.

6 42 U.S.C. § 262(l)(2)(A) (emphasis added).

7 Slip op. at 10.

8 Amgen, 794 F.3d at 1356.

9 Id. at 1356-57.

10 Slip op. at 11.

11 Id. at 12.

12 Id.

13 Id. at 12-13.

14 Id.

15 Id. at 14-15.

16 Slip op. at 14.

17 Id. at 8 ("A 'business act or practice' is 'unlawful' under the unfair competition law if it violates a rule contained in some other state or federal statute." (citation omitted)).

18 Id. at 13-14.

19 Id.

20 Id. at 14.

21 Id. at 14-15.

22 Slip op. at 15.

23 Id. at 15.

24 Id.

25 Id.

26 42 U.S.C. § 262(l)(8)(A).

27 Amgen, 794 F.3d at 1358.

28 Slip op. at 16.

29 Id. (emphasis in original).

30 Id.

31 Id. at 17-18

32 Id. at 18

33 Id. (quoting McFarland v. Scott, 512 U.S. 849, 865 (1994)(THOMAS, J. dissenting)).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Events from this Firm
27 Nov 2017, Seminar, London, UK

Finnegan partner Anthony Tridico will present “U.S. Patent Case Law Update” at the Chartered Institute of Patent Attorneys’ annual Patent Case Law Review.

28 Nov 2017, Seminar, Milan, Italy

Finnegan partner John Paul will present “Internet of Things: Patent Liability, Enforcement and Licensing” and will join the Mock WIPO Mediation at International Technology Transfer—Licensing and ADR, co-hosted by Licensing Executives Society and World Intellectual Property Organization.

29 Nov 2017, Seminar, Tel Aviv, Israel

Finnegan is a platinum sponsor IVC Research Center’s start-up forum, “The Most Promising Start Ups for 2017 – A Synergy of Big Data, Artificial Intelligence, Machine Vision and IoT.”

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.