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.


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.

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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.


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.