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.

Events from this Firm
1 Feb 2018, Seminar, Boston, United States

Foley Hoag LLP and Crowe Horwath invite you to a luncheon on Thursday, February 1, 2018, at Foley Hoag’s New York office prior to the start of SBIA’s Northeast Private Equity Conference.

1 Feb 2018, Webinar, Boston, United States

Protecting the value of your corporate brand is a critical mission. As companies are increasingly asked to make disclosures regarding their efforts to address social and environmental risks, these disclosures create both opportunities and challenges for those entrusted with protecting a company’s intangible assets.

8 Feb 2018, Seminar, New York, United States

Recent high-profile sexual harassment scandals have prompted renewed discussions about sexual harassment in the workplace. Join us for a breakfast seminar focused on these issues from a legal and crisis response perspective.

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
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 you may opt out by clicking here

    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.

    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.

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