United States: Supreme Court Decision Largely Favors Biosimilar Applicants

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues raised in Sandoz Inc. v. Amgen Inc. (No. 15-1039). The Court's unanimous decision was authored by Justice Thomas. Justice Breyer wrote a concurring opinion that invites the U.S. Food and Drug Administration (FDA) to "depart from" or "modify" the decision if it "determines that a different interpretation would better serve the statute's objectives."

With regard to the first step of the patent dance, the Court held that the requirement that a biosimilar applicant share its biosimilar application with the reference product sponsor (in this case, Amgen) is not enforceable by an injunction under federal law. The Court left open the possibility that an injunction might be available under state law (here, California law), but also advised the Federal Circuit to consider on remand whether any state law remedies are preempted by federal law. With regard to the premarketing notice requirement, the Court held that the biosimilar applicant does not have to wait for FDA approval before giving 180-day premarketing notice, meaning that once a biosimilar is approved, it could be marketed as long as there are no preliminary injunctions stemming from any still-pending patent litigation.

The ruling, therefore, vacated-in-part and reversed-in-part the Federal Circuit decision, and remanded to the Federal Circuit for consideration of the state law issues.

The Biosimilar Framework

Since 1991, Amgen has marketed filigrastim, a recombinantly produced human granulocyte colony-stimulating factor protein (C-CSF) under the brand name Neupogen®. Neupogen® is used in certain patients at risk of infection, such as those receiving chemotherapy. In May of 2014, Sandoz sought FDA approval of a biosimilar of Neupogen® (filgrasim-sndz or Zarxio®) under the BPCIA, by filing an abbreviated pathway application created by the BPCIA, such as an abbreviated Biologics Licensing Applications (aBLA) or subsection (k) application.

Similar to the Hatch-Waxman Act that governs traditional generic drugs, the BPCIA allows a biosimilar applicant to rely on the FDA's previous approval of the reference product (e.g., the original biologic product); such that the biosimilar applicant does not need to provide clinical data demonstrating the safety and efficacy of its product. As summarized by the Supreme Court, the biosimilar applicant need only "show that its product is 'highly similar' to the reference product and that there are no 'clinically meaningful differences' between the two in terms of 'safety, purity, and potency.'" Slip op. at 3 (quoting 42 U.S.C. §§ 262(I)(2)(A)(B)). As also recognized by the Court, a biosimilar application cannot be filed until the reference product has been approved for at least four years, and a biosimilar application cannot be approved until the reference product has been approved for at least 12 years. In this case, since Amgen's Neupogen® product had been approved for more than 12 years before the BPCIA was enacted, those time periods were not relevant.

Sandoz notified Amgen of its biosimilar application, but did not provide a copy to Amgen and did not follow any of the other patent dispute resolution procedures of the statute. As to premarketing notice, Sandoz first notified Amgen of its intent to commercially market Zarxio® in July of 2014, before it was approved, and gave notice again when it became the first approved biosimilar product on March 6, 2015.

Amgen sued Sandoz in the United States District Court for the Northern District of California alleging, among other things, violation of California's unfair competition laws and conversion based on Sandoz's alleged failure to comply with the BPCIA. The district court ruled in favor of Sandoz, and found no violation of the BPCIA to support Amgen's state law claims. The Federal Circuit affirmed the district court on the patent dance issue, but ruled that premarketing notice cannot be given until the FDA approves the biosimilar product.

The Biosimilar Patent Dance

Like the Hatch-Waxman Act, the BPCIA includes patent dispute resolution procedures, but the similarity ends there. The BPCIA lays out a multi-step, two-stage process that has been come to be known as the "biosimilar patent dance." The patent dance:

  • commences when the biosimilar applicant shares its biosimilar application with the reference product sponsor in accordance with 42 U.S.C. § 262(l)(2)(A),
  • continues with exchanges of lists of patents and validity/infringement contentions and negotiations of the patents to be litigated,
  • requires the reference product sponsor to assert the negotiated patents to avoid limitations on remedies, and
  • culminates with a last-chance opportunity to assert additional patents after the biosimilar applicant provides 180-day premarketing notice in accordance with 42 U.S.C. § 262(l)(8)(A).

Although Judge Lourie's majority opinion for the Federal Circuit described the statute as "a riddle wrapped in a mystery inside an enigma," Justice Thomas described it as providing "a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement."

The Supreme Court "agree[d] with the Federal Circuit that an injunction under federal law is not available to enforce § 262(l)(2)(A), though for slightly different reasons than those provided by the court below." In particular, the Court disagreed with the Federal Circuit's reading of 35 U.S.C. § 271(e)(2)(C)(ii) and the relevance of 35 U.S.C. § 271(e)(4) to the issue at hand, and determined instead that 42 U.S.C. § 262(l)(9)(C) is dispositive and sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application. The Court reasoned that "[t]he BPCIA's carefully crafted and detailed enforcement scheme provides strong evidence that Congress did not intend to authorize other remedies that it simply forgot to incorporate expressly." Slip op. at 12 (internal quotations omitted).

As noted above, however, the Court did not rule out the possibility that an injunction might be available under state law. On this point, the Court expressly declined to decide whether the application-sharing provision in 42 U.S.C. § 262(l)(2)(A) is "mandatory or conditional," explaining that "the nature of the BPCIA's requirements matters only for purposes of California's unfair competition law, which penalizes 'unlawful' conduct." Slip op. at 15. The Court found that the Federal Circuit "erred in attempting to answer that question by referring to the BPCIA alone." Id. Thus, the Court directed the Federal Circuit to determine on remand "whether California law would treat noncompliance with § 262(l)(2)(A) as 'unlawful,'" and "whether the BPCIA preempts any additional remedy available under state law for an applicant's failure to comply with § 262(l)(2)(A)." In forcing the Federal Circuit to look further at California's unfair competition laws, the Supreme Court left open whether Sandoz's decision to take a path at least technically permitted by a federal statute can be a violation of state law, and, thus, give rise to remedies not available under the BPCIA.

Premarketing Notice

On the premarketing notice issue, the Federal Circuit had read the reference in 42 U.S.C. § 262(l)(8)(A) to "the biological product licensed under subsection (k)" to mean that notice could not be given until the biosimilar product had been "licensed" (approved). The Supreme Court disagreed, finding that the phrase at issue "modifies 'commercial marketing' rather than 'notice.'" The Court emphasized that the statute only includes one timing requirement—that the applicant give notice "at least 180 days prior to marketing its biosimilar"—while the Federal Circuit imposed "two timing requirements"—that the applicant give notice "after the FDA licenses the biosimilar and at least 180 days before the applicant markets the biosimilar." In view of its interpretation, the Court held that a biosimilar applicant "may provide notice either before or after receiving FDA approval."

What's Next for Biosimilars?

Without going too far out on a limb, we believe it is unlikely that the Federal Circuit will find room for a state law-based injunction to enforce 42 U.S.C. § 262(l)(2)(A). Thus, we believe biosimilar applicants will continue to be able to choose how and when to address patent disputes. A biosimilar applicant who wants to resolve them early could share its application at the outset, to force the reference product sponsor to bring suit pursuant to the patent dance or face the limitations on remedies set forth in 35 U.S.C. § 271(e)(6)(B). A biosimilar applicant who wants to defer the patent issues could decide not to share its application, and perhaps challenge the patents in an inter partes review or post-grant review proceeding at the Patent Office, where it could take advantage of the lower burden of proof for invalidity. While a reference product sponsor could bring suit under 42 U.S.C. § 262(l)(9)(C) without having been given a copy of the biosimilar application, originators may prefer to postpone litigation until the biosimilar product is closer to approval, when the possible infringement issues will be more certain and when pending litigation could keep the biosimilar product off the market after approval.

As noted above, the Court's decision on the premarketing notice issue will mean that biosimilar products could be marketed as soon as they are approved, as long as there are no preliminary injunctions stemming from any still-pending patent litigation. This possibility might encourage biosimilar applicants to participate in the patent dance, to increase the likelihood that all patent disputes will be resolved by the time the product is approved.

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.