United States: Federal Circuit Suggests Solution To Patent Owner's Dilemma When Applicant For Biosimilar Product Refuses Discovery

Last Updated: August 21 2017
Article by Allen M. Sokal

In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) must do when the applicant refuses discovery that the patent owner needs to determine whether it has a good faith basis for suit. Neither the collateral order doctrine nor mandamus provides the solution.

Under the BPCIA, an applicant for a biosimilar product can piggyback on a reference biological product that FDA has approved by showing that "there are no clinically meaningful differences between the biological product and the reference product in terms of … safety, purity, and potency." Slip op. at 3 n.1 (citing 42 U.S.C. § 262(l)(2)(A)-(B)). Under the head-spinning statutory patent dance addressed by the Supreme Court in Sandoz, Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017), the applicant must, inter alia, provide the patent owner (the sponsor of the reference product) a copy of the application "and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application." Slip op. at 3 (citing 42 U.S.C. § 262(l)(2)(A)). Based on that information, the parties identify patents to be immediately litigated in a first phase of the litigation under paragraph (l)(3). Id.

Hospira filed an application seeking approval of a biosimilar of Amgen's approved biological product EPOGEN® and, as required, provided Amgen with a copy of its application. It refused to provide any additional information about the manufacturing process, contending that its application disclosed sufficient information. But its application did not disclose the composition of the cell-culture medium Hospira used to manufacture its biosimilar product, which precluded Amgen from determining whether its patents that claim processes for culturing cells used in manufacturing biological products would be infringed. Consequently, although Amgen identified two patents and ultimately sued Hospira for infringing them, it did not identify any cell-culture patents on its "list of patents for which [it] believe[d] a claim of patent infringement could reasonably be asserted." Slip op. at 5 (citing 42 U.S.C. § 262(l)(3)(A)).

Amgen therefore sought discovery on the composition of Hospira's cell-culture medium in the suit it had filed for infringement of two patents. But the cell-culture information that Amgen needed to determine whether it had a good faith basis for asserting its cell-culture patents was irrelevant to the patents in suit. The district court accordingly denied Amgen's motion to compel discovery. Amgen appealed from that interlocutory order, and Hospira moved to dismiss the appeal for a lack of jurisdiction. The Federal Circuit in turn asked the parties to brief "whether this court has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act." Id. at 6.

Since the appeal was from an interlocutory order rather than a final judgment, the court considered whether it had jurisdiction under either of the two theories it asked the parties to brief. It concluded that it did not have jurisdiction under either the collateral order doctrine or the All Writs Act, and therefore dismissed the appeal. In doing so, however, it suggested a solution to Amgen's dilemma.

The court observed first that the collateral order doctrine is a narrow exception to the requirement for a final judgment that ends the litigation on the merits. Id. Under the collateral order doctrine, the interlocutory order "must conclusively determine the disputed question, resolve an important issue completely separate from the merits of the action, and be effectively unreviewable on appeal from a final judgment." Id. (citing Coopers & Lybrand v. Livesay, 437 U.S. 463, 468 (1978), and Cohen v. Beneficial Indus. Loan Corp., 337 U.S. 541, 546 (1949)). Although the order at issue satisfied the first two conditions, the court ruled that discovery rulings generally are reviewable on appeal from a final judgment and do not qualify for the collateral order doctrine. Slip op. at 7. Amgen argued that requiring it to wait until final judgment would defeat the statutory purpose of enabling immediate infringement litigation before FDA approval of the applicant's biological product, but the court reasoned that "there is no clear-cut statutory purpose that would be undermined by denying immediate appeal." Id. at 7-8.

As to mandamus under the All Writs Act, the court noted that such relief requires that the moving party "'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.'" Id. at 8-9 (quoting Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367, 380-81 (2004)). Although the Federal Circuit purported to focus on whether Amgen had established a clear and indisputable right to relief, id. at 9, it instead considered whether there was any other avenue available to Amgen to obtain the desired process information under paragraph (l)(2)(A). It held that such an avenue did exist.

Specifically, the court ruled that Amgen could obtain the process information by suing on patents described in paragraph (l)(3) of the BPCIA, i.e., the "list of patents for which the sponsor believes a claim of patent infringement could reasonably be asserted … [against] a person … engaged in the making, using, selling, offering to sell, selling, or importing into the United States of the biological product that is the subject of" Hospira's application." Id. at 9-10 (quoting 42 U.S.C. § 262(l)(3)(A)(i)). The court added that Amgen "could also sue on a patent that 'could be identified' under paragraph (l)(3)." Id. at 10 (citing 35 U.S.C. § 271(e)(2)(C)(i) and (ii)). But the court noted that Amgen did not list any of its cell-culture patents, much less bring suit on any of them. Id.

Amgen maintained that it could not list its cell-culture patents under paragraph (l)(3)(A) unless it first had a good faith belief that Hospira would infringe those patents, which it could form only if it had the information it sought through discovery. Otherwise, according to Amgen, it could be subject to sanctions under Fed. R. Civ. P. 11 or antitrust liability. But the Federal Circuit responded that Amgen had misconstrued the statute. Listing the cell-culture patents could create no adverse consequences if done in good faith, even if mistaken. Once a sponsor lists a patent, the applicant is obligated to "provide … a detailed statement that describes on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed." Slip op. at 12 (quoting 42 U.S.C. § 262(l)(3)(B)(ii)). And if the applicant still refuses to provide the required information, "the sponsor would have a reasonable basis for asserting a claim of patent infringement." Id.

Thus, although the Federal Circuit dismissed Amgen's appeal, it made clear that patent owners in Amgen's situation have a safe means to obtain the information they require from applicants for biosimilar products to determine whether a basis for suit exists.

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.