United States: Biosimilars, The BPCIA, And Amgen v. Sandoz: The Federal Circuit's First Attempt To Make Sense Of "A Riddle Wrapped In A Mystery Inside An Enigma"

Last Updated: July 23 2015
Article by Thomas H. Wintner

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No. 2015-1499. A divided panel of the Court decided two issues on appeal, giving the nod to Sandoz on the first issue and to Amgen on the second. As previously reported in a June 4 post on our Global IP Matters blog, the appeal had been fast-tracked because of the potentially imminent marketing of Sandoz's Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen's Neupogen® (filgrastim). Perhaps for similar reasons, the Court issued its 46-page opinion very quickly – less than two months after the parties' oral argument was held on June 3, 2015.

The Issues

The Federal Circuit's decision focused on two issues, both of which had been decided largely in Sandoz's favor during the district court proceedings:

  1. Whether the BPCIA's patent exchange provisions – specifically, 42 U.S.C. § 262(l)(2)-(6) – are mandatory (Amgen's view) or optional (Sandoz's view), and what the consequences of non-compliance or "opting out" of these exchange provisions should be; and
  2. Whether the 180-day pre-launch notice required under 42 U.S.C. § 262(l)(8) may be given immediately upon FDA's acceptance of the biosimilar application (Sandoz's view) or only upon FDA's approval of the biosimilar product for licensure (Amgen's view).

The Court's Decision

The Court was split 2-1 on both issues, with a different two-judge majority agreeing on each issue. On the first issue, Judges Lourie and Chen sided with Sandoz, affirmed the district court, and held as follows:

[E]ven though under paragraph (l)(2)(A), when read in isolation, a subsection (k) applicant would be required to disclose its aBLA and the manufacturing information to the RPS by the statutory deadline, we ultimately conclude that when a subsection (k) applicant fails the disclosure requirement,42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e) expressly provide the only remedies as those being based on a claim of patent infringement. Because Sandoz took a path expressly contemplated by the BPCIA, it did not violate the BPCIA by not disclosing its aBLA and the manufacturing information by the statutory deadline.

Maj. Op. at 15 (emphasis added). Critical to the majority's reasoning was the presence of an express remedy within the BPCIA itself, a remedy that the majority believed was designed to address precisely the path that Sandoz had chosen. Judge Newman dissented from this portion of the opinion, arguing that the BPCIA's disclosure requirements under (l)(2)(A) are mandatory, and that "[t]hese deliberate violations of the requirements of the BPCIA forfeit Sandoz' access to the benefits of the BPCIA." Newman Op. at 2; see also id. at 8 ("Subsection (k) and subsection (l) are components of an integrated framework; to enjoy the benefits of subsection (k), the biosimilar applicant is obligated to comply with subsection (l).").

On the second issue, Judges Lourie and Newman sided with Amgen, reversed the district court, and held as follows:

We ... conclude that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketingafter the FDA has licensed its product. The district court thus erred in holding that a notice of commercial marketing under paragraph (l)(8)(A) may effectively be given before the biological product is licensed....

Maj. Op. at 18 (emphasis added). Judges Lourie and Newman based their decision on the rationale that "[r]equiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief," and that the 180-day post-licensure period therefore "provide[s] 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." Id. at 17. Judges Lourie and Newman also made clear that the (l)(8)(A) notice requirements are mandatory where, as here, a biosimilar applicant "completely fails to provide its aBLA and the required manufacturing information to the RPS by the statutory deadline." Id. at 21.

The majority conceded that, at least in this case, its ruling would effectively provide Amgen with an additional 180 days of market exclusivity for Neupogen. Id. at 18. But the majority argued that this would not necessarily be the case for other reference biologic drugs where the 12-year exclusivity period had not already expired. Id. ("A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case."). Judge Chen dissented vigorously, arguing that the majority decision results in an "extra-statutory windfall" for Amgen and other reference product sponsors under the BPCIA. Chen Op. at 2. Judge Chen also disagreed that the (l)(8)(A) notice requirements are always mandatory. If a party does not engage in the (l)(2) exchange procedures, Judge Chen reasoned, then (l)(8) "lacks meaning" and "does not apply" (in the same way that (l)(3)-(l)(7) also would not apply). Id. at 6, 10.

What Does the Court's Decision Mean for the Parties?

The practical effects of the Federal Circuit's decision are as follows:

  1. Sandoz may not market its biosimilar filgrastim product until September 2, 2015, which is 180 days from March 6, 2015, the date that Sandoz received FDA licensure/approval for Zarxio. Maj. Op. at 21. Consistent with this finding, the Federal Circuit also extended its injunction pending appeal to September 2, 2015. Id. at 25.
  2. Amgen's state law claims for unfair competition and conversion are dismissed, some on substantive grounds (because Sandoz did not violate the BPCIA with respect to certain of Amgen's claims) and some on mootness grounds (because the 180-day extension through September 2, 2015 provides all the relief Amgen could otherwise obtain on its other claims). Maj. Op. at 22-23.
  3. The case is remanded to the district court for consideration of Amgen's infringement claims and Sandoz's counterclaims regarding U.S. Patent No. 6,162,427 (covering a method of using filgrastim), as well as "any other patents properly brought into the district court action." Maj. Op. at 25. If Amgen wishes to prevent Sandoz from marketing Zarxio after September 2, 2015, it will likely have to obtain an injunction from the district court based on the '427 or other patents (all of which will need to take place in a very short time frame).

What Does the Court's Decision Mean for the BPCIA?

The Federal Circuit's decision in Amgen v. Sandoz is far from the end of the story for the BPCIA. First, there are several important issues — such as that of "preemption" under the BPCIA, or interpretation of other aspects of the Act's patent exchange and dispute resolution provisions — that were not squarely raised by this appeal, and thus were not addressed by the court. See, e.g., Maj. Op. at 21 n.5 (declining to address the preemption issue). Second, given the panel split on both key issues, the case is ripe for en banc rehearing by the full Federal Circuit and potentially for certiorari to the U.S. Supreme Court. Third, without expressly asking Congress to rewrite the BPCIA, the Court did not hesitate to express its frustration with the statute's text. On this point the entire panel of judges even appeared to be in agreement. As Judge Chen wrote, "[t]o fulfill our judicial obligation to say what the law is, we must choose from a series of imperfect choices." Chen Op. at 11 (internal quotations omitted). And as Judges Lourie and Chen wrote in the opening of the Court's opinion:

Winston Churchill once described Russia as "a riddle wrapped in a mystery inside an enigma." Winston Churchill, The Russian Enigma (BBC radio broadcast Oct. 1, 1939), available at http://www.churchill-societylondon.org.uk/RusnEnig.html. That is this statute. In these opinions, we do our best to unravel the riddle, solve the mystery, and comprehend the enigma.

Maj. Op. at 3 n.1.

In other words, and as is usually the case with biosimilars and the BPCIA, 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.

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


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.


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