United States: Supreme Court Issues Highly Anticipated Decision Interpreting The Biologics Price Competition And Innovation Act

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for approval of "biosimilar" drugs and sets forth a complex scheme for resolving patent disputes between the biosimilar applicant and the sponsor of the reference biological product. The Court considered whether two key provisions of the BPCIA — the pre-litigation exchange of information (commonly known as the "Patent Dance") and the biosimilar applicant's 180-day notice of commercial marketing — are mandatory and enforceable by injunction, and whether the 180-day notice must await biosimilar approval. The Court issued a unanimous decision, holding that: (1) the failure of a biosimilar applicant to provide its application to the reference product sponsor is not enforceable by injunction under federal law; and (2) the biosimilar applicant's 180-day notice of commercial marketing may be given prior to FDA approval of the biosimilar application. Justice Breyer issued a separate concurring opinion.

Proceedings Below

In a split decision in the case below, a majority of the Federal Circuit held that a biosimilar applicant can opt out of the Patent Dance exchanges, but must wait to provide 180-day notice of commercial marketing until after receiving FDA approval. Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015).

The Federal Circuit held that 42 U.S.C. § 262(l)(2)(A), which sets forth that a biosimilar applicant "shall" provide a copy of its application and manufacturing information to the reference product sponsor, the first step of the Patent Dance, is a voluntary provision and a reference product sponsor's only remedy is to bring a declaratory judgment action pursuant to 42 U.S.C. § 262(l)(9)(C) and/or a patent infringement action pursuant to 35 U.S.C. § 271(e)(2)(C)(ii). Id. at 1356-57. The Federal Circuit further held that the 180-day notice of commercial marketing provision of 42 U.S.C. § 262(l)(8)(A) is a "stand-alone" provision and that such notice is mandatory and may be given only after the FDA approves the biosimilar application, in effect providing an additional 180-day exclusivity to the reference product sponsor. Id. at 1358-59.

Sandoz and Amgen filed cross-petitions for a writ of certiorari requesting that the Supreme Court consider the following issues: (1) whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its abbreviated biologics license application and related manufacturing information;1 (2) whether a biosimilar applicant's failure to provide such information is enforceable by injunction or whether the sole remedy is to bring a declaratory judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent infringement action under 35 U.S.C. § 271(e)(2)(C)(ii);2 (3) whether the notice of commercial marketing set forth in 42 U.S.C. § 262(l)(8)(A) can be effective if given before FDA approval of the biosimilar;3 and (4) whether the notice of commercial marketing is a stand-alone requirement enforceable by injunction.4 The Court granted cert and, on April 26, 2017, heard oral argument.

Supreme Court Decision

Justice Thomas, writing for a unanimous Court, held that the § 262(l)(2)(A) step of the Patent Dance is not enforceable by an injunction under federal law. As the Court reasoned, "[w]hen an applicant fails to comply with § 262(l)(2)(A), § 262(l)(9)(C) authorizes the sponsor, but not the applicant, to bring an immediate declaratory judgment action for artificial infringement as defined in § 271(e)(2)(C)(ii)" and "Section 262(l)(9)(C) thus vests in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation."5 Although the Court characterized the § 262(l)(2)(A) step of the Patent Dance as a "requirement," the Court said it was not reaching the decision of whether it was "mandatory."6 The Court remanded to the Federal Circuit to decide Amgen's state unfair competition claims, specifically to decide whether "California law would treat noncompliance with § 262(l)(2)(A) as 'unlawful,'" and if so, whether the state law claims are pre-empted by the BPCIA.7

As to the notice of commercial marketing provision of § 262(l)(8)(A), the Court held that notice may be given prior to FDA approval of the biosimilar. The Court reasoned that "[t]he statute's use of the word 'licensed' merely reflects the fact that, on the 'date of the first commercial marketing,' the product must be 'licensed.'"8 Thus, the Court held that "because Sandoz fully complied with § 262(l)(8)(A) when it first gave notice of commercial marketing (before receiving FDA approval), the Federal Circuit erred in issuing a federal injunction prohibiting Sandoz from marketing its biosimilar, Zarxio, until 180 days after licensure."9 In reaching this decision, the Court therefore rejected the Federal Circuit's effective grant of a 180-day extension to the reference product's regulatory exclusivity.

In a brief concurrence, Justice Breyer noted that "Congress implicitly delegated to the [FDA] authority to interpret [the statutory terms]" and "so, if that agency, after greater experience administering this statute, determines that a different interpretation would better serve the statute's objectives, it may well have authority to depart from, or to modify, today's interpretation."10

Although this decision finally resolves the questions of whether a reference product sponsor may enforce § 262(l)(2)(A) by an injunction under federal law and whether the notice of commercial marketing extends regulatory exclusivity by 180 days, it remains to be seen whether state law claims remain a viable avenue for reference product sponsors to enforce compliance with the BPCIA's requirement that a biosimilar applicant provide its application and manufacturing information.

Footnotes

1 See Brief in Opposition at ii, Sandoz, Inc. v. Amgen, Inc., No. 15-1039 (S. Ct., filed Mar. 21, 2016).
2 Id.
3 See Petition for a Writ of Certiorari at ii, Sandoz, Inc. v. Amgen, Inc., No. 15-1039 (S. Ct., filed Feb. 16, 2016).
4 Id.
5 Sandoz Inc. v. Amgen Inc., slip op. at p. 12.
6 Id. at pp. 14-15.
7 Id. at p. 15.
8 Id. at p. 16.
9 Id. at p. 18.
10 Sandoz Inc. v. Amgen Inc., J. Breyer concurring, at p. 1.

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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions