United States: Federal Circuit Provides More Guidance On Biosimilar Patent Litigation

In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira. In particular, the court held that it lacked jurisdiction—under the collateral order doctrine—over the district court's denial of Amgen's motion to compel discovery regarding the cell-culture medium Hospira uses to make its biosimilar product. The court also held that Amgen had failed to show its "clear and indisputable'" right to the information as required for a writ of mandamus.

Any opinions expressed in this article are personal to the authors and do not reflect the views of Foley & Lardner LLP, its partners, or its clients.

The EPOGEN® Biosimilar Dispute

This case arises under the Biologics Price Competition and Innovation Act (BPCIA), and began in December 2014 when Hospira sought FDA approval of a biosimilar version of Amgen's EPOGEN® (epoetin afla) product. Although Hospira disclosed its biosimilar application to Amgen, it did not separately provide information about "'the process . . . used to manufacture the biological product,'" as set forth in 42 USC § 262 (l)(2)(A). Instead, Hospira asserted that the relevant information was disclosed in its application.

Despite this dispute, the parties proceeded with the BPCIA "patent dance." Although Amgen identified three patents on its patent list, according to the court none related to "the specific cell-culture medium used during its manufacturing process." Nevertheless, in the litigation relating to the asserted patents, Amgen sought discovery about Hospira's cell-culture medium. Hospira refused to produce the requested information, and the district court denied Amgen's motion to compel, holding that the information sought had "'essentially, no relevance to the patents that are asserted.'"

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Dyk and joined by Judges Bryson and Chen.

The Collateral Order Doctrine

The Federal Circuit first addressed Hospira's argument that the Federal Circuit lacked jurisdiction to review the district court's interlocutory order. While an appeal generally may only be brought from a "final" judgment, the collateral order doctrine provides a narrow exception where "'the order [] conclusively determine[s] the disputed question, resolve[s] an important issue completely separate from the merits of the action, and [is] effectively unreviewable on appeal from a final judgment.'" The Federal Circuit found that the first two requirements may be satisfied, but the third requirement was not met.

The court noted that discovery rulings "generally do not qualify for the collateral order doctrine's exception to the final judgment rule," and usually "are reviewable from a final judgment." Amgen argued that delaying review would "defeat ... the purpose of paragraph (l)(2)(A)'s disclosure requirements," which it said was "to enable the sponsor (here Amgen) to commence infringement litigation immediately, prior to FDA approval and commercial marketing of the biological product by the applicant." The court was not convinced, however, and so determined that it lacked jurisdiction under the collateral order doctrine.

The Writ of Mandamus

The Federal Circuit also rejected Amgen's claim that it is entitled to a writ of mandamus ordering the district court to compel the sought after discovery. The court emphasized that "[m]andamus is a drastic remedy reserved for the most "extraordinary causes." As such, [a] party seeking mandamus must 'have no other adequate means to attain the [desired] relief' and must demonstrate that its right to the writ's issuance is 'clear and indisputable.'" As explained below, the Federal Circuit found that Amgen did not establish a "'clear and indisputable' right to the relief it seeks."

The Federal Circuit noted that the Supreme Court decision in Amgen v. Sandoz limited the mechanisms by which a reference product sponsor might obtain information on the biosimilar product and manufacturing process, but identified two options that remain:

  1. sue on "patents described in [paragraph (l)(3) of the BPCIA]," 35 U.S.C § 271(e)(2)(C)(i), i.e., the 'list of patents for which the . . . sponsor believes a claim of patent infringement could reasonably be asserted ....'"
  2. sue on "a patent that 'could be identified' under paragraph (l)(3), 35 U.S.C. § 271(e)(2)(C)(ii) (emphasis added)."

However, "Amgen did not list any of its cell-culture patents, nor did it bring suit on any of these patents as ones that 'could be identified' under paragraph (l)(3)(A)." Thus, in the court's view "Amgen ... declined to pursue either [of] the ... alternatives" available to it under the BPCIA.

The Federal Rules of Civil Procedure Govern Discovery Under the BPCIA

Important to the court's decision was its conclusion that:

Access to information under paragraph (l)(2)(A) ... is governed by ordinary rules of litigation in federal district courts, i.e., the Federal Rules of Civil Procedure.

The Federal Circuit pointed to the requirement in the Federal Rules of Civil Procedure that "discoverable information must be 'relevant to any party's claim or defense.'" Since Amgen had not asserted its cell-culture patents, the Federal Circuit agreed with the district court that "the composition of Hospira's cell-culture media is not relevant to any claim of infringement of the patents asserted by Amgen or any of Hospira's defenses or counterclaims."

In reaching this conclusion, the Federal Circuit clarified that its statement in Amgen v. Sandoz that a reference produce sponsor "'can access the required information through discovery'" ... did not purport to hold that the usual rules governing discovery do not apply in the BPCIA context."

Sponsors Can Bring Suit Without Violating Rule 11

The Federal Circuit rejected Amgen's contention that not obtaining the requested discovery would thwart its ability to sue Hospira on its cell-culture patents under the BPCIA. On this issue, Amgen argued that without the discovery Amgen could not form a good faith belief of infringement and would be susceptible to sanctions under Rule 11 or antitrust laws if it listed and asserted its cell-culture patents. The Federal Circuit found that "Amgen's argument misunderstands the statute."

First, the court explained that (l)(3)(A) "merely requires the sponsor to list patents that it 'believes . . . could reasonably be asserted," but does not impose a "sanction for holding or asserting a mistaken belief in good faith." The court also explained that once the sponsor lists a patent, the biosimilar applicant "must once again come forward with additional disclosures under paragraph (l)(3)(B)," stating its reasons why a claim of patent could/not "reasonably be asserted." In the court's view:

If the applicant fails to comply with its obligation to respond under paragraph (l)(3)(B), the sponsor would have a reasonable basis for asserting a claim of patent infringement.

The court discussed how Rule 11 might operate in the BPCIA context. As noted by the court, Rule 11 permits filings to "'to the best of the person's knowledge, information and belief, formed after an inquiry reasonable under the circumstances,'" and permits allegations that "'will likely have evidentiary support after a reasonable opportunity for further investigation or discovery.'" According to the Federal Circuit:

[I]f a sponsor forms a belief based on an inquiry limited by an applicant's withholding of information, the sponsor has still satisfied Rule 11.

The Federal Circuit found further support for its reading of Rule 11 in the fact that "[t]he Supreme Court appears to have contemplated the filing of suit after an applicant fails to disclose information under paragraph (l)(2)(A)."

Overcoming The Biosimilar Information Imbalance

This Federal Circuit decision appears to weigh in favor of being over-inclusive rather than under-inclusive when deciding which patents to include on the (l)(3)(A) patent list. Indeed, the court reminds us that the biosimilar applicant can challenge the listing of a patent when it provides its (l)(3)(B) response. As such, when the full patent dance procedures are followed, the reference product sponsor may have ample basis for satisfying Rule 11. On the other hand, when the biosimilar applicant withholds information, the Federal Circuit suggests that would be a "circumstance" that would inform the Rule 11 inquiry.

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
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
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