United States: A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

Last Updated: July 27 2015
Article by Donald R. Ware and Barbara A. Fiacco

On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA ("k applicant") is required to comply with the BPCIA's detailed patent challenge process. In a fractured decision, Judges Lourie and Chen joined in holding that a (k) applicant does not violate the BPCIA when it fails to disclose its application and manufacturing information by the statutory deadline. Judge Newman dissented. Then, Judges Lourie and Newman, with Judge Chen dissenting, joined in holding that the (k) applicant is nevertheless required to give a 180-day notice of commercial marketing after FDA approval of its biosimilar product, giving the reference product sponsor six months to seek a preliminary injunction to block launch of the product until resolution of any patent disputes.

The BPCIA established procedures to define and narrow disputes between biosimilar applicants and reference product sponsors after the (k) application is filed. That procedure contemplated that the (k) applicant would share the contents of its application with the reference product sponsor so that the parties could determine which patents may cover the biosimilar product or its manufacture or use. Although the statute provides that the (k) applicant "shall provide" the contents of its (k) application, Judges Lourie and Chen reasoned that "shall" does not mean "must" when the statute is read as a whole, because when the application is not provided, the statute provides the reference product sponsor with specified remedies. In particular, they noted that when the (k) application is not provided, the reference product sponsor can immediately sue for infringement or file a declaratory judgment action asserting any patents that cover the biosimilar product, including process patents covering its manufacturing. In their view, the statute made these remedies exclusive. Judge Newman's dissent warns that the majority's interpretation of the BPCIA information exchange process as "optional" eviscerates the purpose of the BPCIA, which "requires the statutorily identified disclosures at the threshold, in order to both avert and to expedite litigation."

Judge Newman joined Judge Lourie, however, in a second part of the decision holding that the BPCIA's requirement of a 180-day notice of commercial marketing prior to biosimilar launch is mandatory when the applicant has failed to disclose its application by the statutory deadline. Importantly, they ruled that the requisite notice cannot be given until after the FDA has approved the biosimilar product, thereby allowing the reference product sponsor a six-month period in which to seek a preliminary injunction prohibiting launch of the product as approved. In his dissent, Judge Chen interpreted the notice of commercial marketing as part of the larger BPCIA litigation procedures, not a standalone provision, and argued that a (k) applicant who opts out of the early information exchange is opting out of the entire BPCIA process, including the notice requirement.

The outcome of this case is surprising to many who participated in the development of the BPCIA patent procedures. As Judge Chen acknowledged, Congress created the BPCIA as a "comprehensive, integrated litigation management system." Congress had prior experience with the Hatch-Waxman Act, which provided a means for generics manufacturers to challenge innovator companies' patents on small molecule drugs, and led to the FDA's creation of the familiar "Orange Book" as the means to identify relevant patents. During the debate on the proposed biosimilars legislation, however, stakeholders urged Congress not to create an Orange Book for patents covering biologics and biologics manufacturing processes. The information exchange procedures in the BPCIA, including the requirement that the (k) applicant disclose its application and manufacturing information, and the requirement that the reference product sponsor thereafter identify relevant patents that could be asserted, were intended as a way to replace the Orange Book and allow for the orderly resolution of patent challenges prior to approval and launch of biosimilar products. If these procedures are not mandatory, a reference product sponsor has no way to know in advance of litigation the range of patents that may apply to a biosimilar product, and a (k) applicant has no way to identify all the patents the reference product sponsor believes will cover the product or its manufacture. This will lead to more at-risk launches and make it harder to achieve Congress's goal of creating an efficient process for clearing patent disputes in advance.

It remains to be seen whether (k) applicants will take advantage of the panel's decision and choose to opt out of the BPCIA procedures. Participating in the BPCIA "patent dance" offers many advantages to a biosimilar applicant, including the ability to manage the scope and timing of patent infringement litigation and to force the reference product sponsor to identify relevant patents and provide pre-litigation infringement and validity contentions. To be sure, following the BPCIA procedures may lengthen the time to patent resolution, but in future cases, where the (k) application can be filed prior to expiration of the reference product's 12-year data exclusivity period, the advantages to a (k) applicant would seem to outweigh the disadvantages. If so, the Amgen decision may turn out to be simply an anomaly, a transitional set of patent rules applied mainly to reference products that no longer enjoy data exclusivity, as was the case here.

In the meantime, we can expect to see reference product sponsors closely monitoring the activities of biosimilar applicants and preparing for infringement and declaratory judgment actions as soon as they become aware of the filing of a (k) application. Where the (k) applicant opts out of the BPCIA and litigation results, early discovery will be important to identify all of the manufacturing process patents that may be asserted against the biosimilar product.

With respect to the 180-day notice of commercial marketing, biosimilar applicants will be disappointed that the reference product's 12 years of exclusivity has effectively been extended by six months, at least when the applicant fails to participate in the initial information exchange. The decision leaves the door open, however, to the possibility that, where the FDA gives tentative approval to a biosimilar product prior to the expiration of the 12-year period, that itself may be a sufficient trigger to allow the (k) applicant to give notice of commercial marketing and start the clock running. Judge Lourie seemed to think so, noting that "the extra 180 days will not likely be the usual case, as aBLA's will often be filed during the 12-year exclusivity period."

This decision may not be the last word. The importance of this first interpretation of BPCIA, the need for certainty in this area as more and more biosimilar products are submitted for FDA approval, and the conflicting interpretations offered by the three judges who made up the panel suggest the prospect of an en banc rehearing by the full Court before these issues are finally resolved. Stay tuned.

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