United States: Southern District of Florida Rules that 180-Day Notice of Commercial Marketing Is Mandatory When Parties "Patent Dance"

On December 9, 2015, United States District Court Judge James Cohn, in the Amgen v. Apotex Neulasta® litigation, granted Amgen's motion for a Preliminary Injunction barring Apotex from marketing its proposed biosimilar version of Neulasta®. The issue before the court was whether the Biologics Price Competition and Innovation Act ("BPCIA") requires a company filing an abbreviated Biologics License Application ("aBLA") to give the innovator 180-day notice of its intent to market a biosimilar product that has been licensed by the Food and Drug Administration ("FDA").

The BPCIA attempts to establish "an abbreviated pathway for regulatory approval of follow-on biological products that are highly similar" to a previously approved product. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015). This process allows a biosimilar or interchangeable product to be approved using clinical data that was produced and obtained by the sponsor of the approved reference product ("reference product sponsor" or "RPS"). 42 U.S.C. § 262(k)(2)-(5). In exchange, the RPS is granted 12 years of regulatory exclusivity and "the right to file infringement suits based on a biosimilar application prior to FDA approval and prior to marketing of the biological product.'' Sandoz, 795 F.3d at 1352.

Under what has come to be known as the BPCIA's "patent dance," an aBLA filer provides the RPS with a copy of the aBLA and information about the product's manufacturing. 42 U.S.C. § 262(l)(2). The parties then exchange lists of patents they believe may be infringed by the biosimilar product. The RPS then has 30 days within which to file a patent infringement action on the listed patents. Id. § 262(l)(6). The statutory scheme provides that the biosimilar applicant "shall" provide the RPS with 180-day notice of approval before marketing the biosimilar product for sale and use in the United States. Id. § 262(l)(8)(A). This 180-day period "allows the RPS a period of time to seek a preliminary injunction based on patents that the parties initially identified during information exchange but were not selected for the immediate infringement action, as well as any newly listed or licensed patents. Id. § 262(l)(7)-(8).'' Sandoz, 794 F.3d at 1352.

The United States Court of Appeals for the Federal Circuit addressed the meaning of the 180-day notice requirement in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). In Sandoz, the aBLA filer did not provide the RPS with its aBLA or manufacturing process as contemplated by §262(l)(2). That is, the aBLA filer chose not to participate in the "patent dance." In such a circumstance, the court found that the use of "shall provide notice" in § 262(l)(8)(A) made the 180-day notice of commercial marketing mandatory. Id. at 1360.1 The court further found that, where the aBLA filer did not provide the RPS with the aBLA or manufacturing information, the 180-day notice is not effective until after the FDA has licensed the proposed biosimilar product. Id. at 1357-58. Sandoz did not specifically address whether the notice provision of § 262(l)(8)(A) applies where the aBLA filer, like Apotex, did participate in the "patent dance."

In Apotex, the court addressed questions left unanswered by Sandoz: Is the 180-day notice requirement mandatory where the aBLA filer participates in the patent dance and, if so, what is the proper timing for such notice? Judge Cohen found that § 262(l)(8)(A) requires that "Apotex give[] Amgen proper notice, at least 180 days before first commercial marketing but not before [the] biosimilar product is licensed by the FDA ...." Slip Op. at 9 (emphasis added). The court found that a different interpretation "would result in confusion and uncertainty, as well as inconsistent results, depending on which route [an aBLA filer] chooses to travel" and that "neither the statute nor the Sandoz decision condition the 180 day notice provision of § 262(l)(8)(A) upon [an aBLA filer's] compliance with § 262(l)(2)." Id. at 5-6. This interpretation of the BPCIA, the court found, "will likely result in a more crystallized patent litigation." Id. at 7. In so ruling, the court also addressed the need for a defined statutory window for giving notice:

"[G]iving notice after FDA licensure, once the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, allows the RPS to effectively determine whether, and on which patents, to seek a preliminary injunction from the court. Requiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief. It provides a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to the launch of the biosimilar product." (quoting Sandoz at 1358). That defined statutory window exists for all biosimilar products that obtain FDA licenses, regardless of whether the [aBLA filer] complies with § 262(l)(2). 

Id. at 6.

Finally, the court concluded that a mandatory post-licensure notice requirement would not unfairly grant the RPS an additional 180 days of exclusivity, because "[t]hat extra 180 days will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products." Id. at 7.

On December 10, 2015, Apotex filed a Notice of Appeal to the Federal Circuit. Meanwhile, appeal of the Sandoz decision to the United States Supreme Court is widely anticipated, with certiorari petitions to the High Court due by mid-January 2016.

Footnote

1 The court found that the use of "shall provide" in §262(l)(2)(A) did not require the aBLA applicant to provide the aBLA and related manufacturing information to the RPS because the statute contemplated alternative procedures. Id. at 1356.

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
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
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