United States: Supreme Court Issues First Interpretation Of The BPCIA

The Supreme Court yesterday issued its first opinion interpreting the Biologics Price Competition and Innovation Act ("the BPCIA"), the statute which created a pathway for the approval of abbreviated applications to market biological products. The Court's unanimous opinion contained two holdings. First, the Court determined that an injunction under federal law is not available to enforce the requirement set forth in 42 U.S.C. § 262(l)(2)(A) that a biosimilar applicant provide a reference product sponsor with a copy of its biosimilar application and manufacturing information. Second, the Court determined that a biosimilar applicant need not wait until its product is licensed by FDA to provide the reference product sponsor with notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A).

On July 7, 2014, FDA notified Sandoz Inc. ("Sandoz") that Sandoz's biosimilar application referencing Neupogen® (filgrastim)—a blockbuster biologic marketed by Amgen Inc. ("Amgen")—had been accepted for review. On July 8, 2014, Sandoz notified Amgen that its biosimilar application had been accepted for review and that it intended to market its biosimilar product immediately upon FDA approval. Sandoz did not provide Amgen with a copy of its biosimilar application and manufacturing information on July 8, 2014, and it later represented to Amgen that it did not intend to provide the same to Amgen.

In October 2014, Amgen sued Sandoz for patent infringement. Amgen also asserted two claims under California's unfair competition law. Amgen sought an injunction to require Sandoz to provide it with a copy of Sandoz's biosimilar application and manufacturing information as stated in 42 U.S.C. § 262(l)(2).1 Amgen also sought an injunction to require Sandoz to provide notice of commercial marketing only after Sandoz's product became licensed by FDA.2 Sandoz counterclaimed for declaratory judgments that the asserted patents were invalid and not infringed and that it had not violated the provisions of the BPCIA.

The United States District Court for the Northern District of California granted partial judgment on the pleadings to Sandoz on its BPCIA-related counterclaims and dismissed Amgen's state law claims with prejudice. Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2015 U.S. Dist. LEXIS 34537, at *33–35 (N.D. Cal. Mar. 19, 2015). A divided United States Court of Appeals for the Federal Circuit affirmed in part, vacated in part, and remanded. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015). The Federal Circuit: (1) affirmed the district court's dismissal of Amgen's state law claims; (2) affirmed the district court's determination that a biosimilar applicant does not have to comply with the disclosure requirement of 42 U.S.C. § 262(l)(2)(A); and (3) reversed the district court's conclusion that notice of commercial marketing may be given prior to licensure of a biosimilar product. Id. at 1354–61.

The Supreme Court vacated in part and reversed in part the judgment of the Federal Circuit. Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, slip op. at 18 (U.S. June 12, 2017) ("Slip Op."). The cases were remanded to determine whether California law would treat noncompliance with the BPCIA as "unlawful." Id.

On the first issue, the Supreme Court held that federal law does not provide an injunction to enforce the BPCIA's requirement for the biosimilar applicant to provide the reference product sponsor with its application and manufacturing information. Here, the Court generally agreed with the Federal Circuit, "though for slightly different reasons." Slip Op. at 10. The Supreme Court explained that the submission of a biosimilar application is an artificial act of infringement under 35 U.S.C. § 271(e)(2)(C), and the only remedies available for such infringement are provided at 35 U.S.C. § 271(e)(4). Id. at 12. A biosimilar applicant's failure to provide the disclosure under 42 U.S.C. §262(l)(2)(A) is not an act of infringement, and 35 U.S.C. § 271(e)(4) does not provide a remedy for that failure. Id. Rather, 42 U.S.C. § 262(l)(9)(C) provides the remedy for a biosimilar applicant's failure to disclose its application and manufacturing information to the sponsor—that is, the ability of the reference product sponsor alone to immediately bring an action on any patent that claims the biological product or its use. Id. And the declaratory judgment remedy provided in 42 U.S.C. § 262(l)(9)(C) "excludes all other factual remedies, including injunctive relief." Id. The Supreme Court concluded that "[t]he presence of [42 U.S.C.] § 262(l)(9)(C), coupled with the absence of any other textually specified remedies, indicates that Congress did not intend [reference product] sponsors to have access to injunctive relief, at least as a matter of federal law, to enforce the disclosure requirement." Id. at 13.

The Court also explained that statutory context confirmed its interpretation. Slip Op. at 13. The BPCIA provides for injunctive relief where there is a violation or threatened violation of the rules governing the confidentiality of information disclosed under 42 U.S.C. § 262(l). Id. (citing 42 U.S.C. § 262(l)(1)(H)). Thus, in the Court's view, Congress acted intentionally when it provided an injunctive remedy for breach of confidentiality requirements but did not provide the same for a breach of the disclosure requirement of 42 U.S.C. § 262(l)(2)(A). Id.

On the second issue, the Supreme Court concluded that a biosimilar applicant may provide notice of commercial marketing either before or after receiving FDA approval based on the plain language of the statute. Slip Op. at 15–16. 42 U.S.C. § 262(l)(8)(A) states that the biosimilar 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)." The Court reasoned that the phrase "of the biological product licensed under subsection (k)" modifies "commercial marketing" and not "notice." Id. at 16. The Court explained that the use of the word "licensed" in the statute "reflects that fact that, on the date of first commercial marketing,' the product must be 'licensed.'" Id.

The Court also explained that statutory context confirmed its interpretation. Slip Op. at 16. 42 U.S.C. § 262(l)(8)(A) contains only one timing requirement, i.e., the biosimilar applicant must provide notice at least 180 days prior to marketing its biosimilar. Id. This stands in contrast to 42 U.S.C. § 262(l)(8)(B), which imposes two timings requirements: "After receiving notice under subparagraph (a) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction." Id. Thus, the court reasoned, "'[h]ad Congress intended to' impose two timing requirements in § 262(l)(8)(A), 'it presumably would have done so expressly as it did in the immediately following' subparagraph." Id. (quoting Russello v. United States, 464 U.S. 16, 23 (1983)).

Justice Breyer joined the Court's opinion, but he wrote separately to note the fact that the FDA "may well have authority to depart from, or to modify, [the Court's] interpretation" if it "determines that a different interpretation would better serve the statute's objectives." Slip Op. at 1 (Breyer, J., concurring).

Footnotes

1 42 U.S.C. § 262(1)(2) provides:
(2) Subsection (k) application information Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant—
(A) 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; and
(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.

2 42 U.S.C. § 262(1)(8)(A) provides:
(A) Notice of commercial marketing The 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).

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
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
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