United States: Sandoz Requests U.S. Supreme Court Interpretation Of The Biologics Price Competition And Innovation Act In Amgen Inc. V. Sandoz Inc.

As many expected, Sandoz Inc. filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit's decision in Amgen Inc. v. Sandoz Inc.1,2  Amgen will have an opportunity to not only oppose Sandoz's petition but also to file a conditional cross petition.3  Amgen is the first Federal Circuit decision to substantively interpret the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), so whether the Court decides to hear the case will be closely monitored by the biologics industry because it will have a significant economic impact on both reference product sponsors and biosimilar applicants, as well as the general public.4

In its fragmented July 21, 2015 opinion that generated two different dissents, the Federal Circuit held that: (1) a biosimilar applicant does not have to participate in the elaborate patent exchange procedure contemplated by § 351(l) of the PHSA;5 and (2) a biosimilar applicant must provide the reference product sponsor with 180 days' notice of commercial marketing that is not effective until after the FDA licenses the biosimilar application.6

Sandoz's petition challenges the Federal Circuit's second holding relating to notice of commercial marketing. Sandoz contends that a biosimilar applicant can provide the reference product sponsor with notice of commercial marketing prior to the FDA's licensure of the proposed biosimilar application. Sandoz phrased the question presented as:

Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) [of Title 42 of the United States Code] as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.7

Pursuant to Supreme Court Rule 15.3, Amgen may file a brief opposing Sandoz's petition "within 30 days after the case is placed on the docket."  Moreover, Amgen has the same timeframe to file a conditional cross petition pursuant to Supreme Court Rule 12.5. Absent an unduly long extension being granted to Amgen, we expect that the Court will rule on whether to hear the case before its summer recess. If Sandoz's petition is granted, oral argument will likely be heard during the Court's October Term 2016, and a decision will not be rendered until 2017.

A. Without An Amgen Cross Petition, Biosimilar Applicants Are Not Required To Participate In The Patent Exchange Procedure

Absent a conditional cross petition by Amgen that is granted by the Court, the Federal Circuit's holding in Amgen relating to the patent exchange procedure will continue to control the procedures under the BPCIA.  As such, biosimilar applicants may elect to not participate in the patent exchange procedure contemplated by § 351(l) of the PHSA.8  The majority opinion authored by Judge Lourie reasoned that the statute should be viewed as a whole and that the BPCIA "explicitly contemplates" that a biosimilar applicant has the right to forgo participation in the patent exchange procedure.9  As noted by the court, § 351(l)(9)(C) provides for a declaratory judgment action when a biosimilar applicant fails to engage in the patent exchange procedure.10 In such circumstances, a reference product sponsor is limited to the remedies provided by § 351(l)(9)(C) and 35 U.S.C. § 271(e).11

Judge Newman, who concurred in part and dissented in part, disagreed with the majority opinion on this issue. According to Judge Newman, the patent exchange procedure is "fundamental to the BPCIA purposes of efficient resolution of patent issues."12 Responding to the majority opinion, Judge Newman noted that the declaratory judgment provision of § 351(l)(9)(C) does not adequately address a reference product sponsor's needs because it is only directed to composition and method of use claims and not manufacturing and process claims.13 Thus, under Judge Newman's view, a biosimilar applicant must engage in the patent exchange procedure and must provide notice of commercial marketing after its application is licensed.

As a practical matter, the Federal Circuit's holding gives a biosimilar applicant more control over the patent disclosure and litigation process. Biosimilar applicants who believe that their product does not infringe the reference product sponsor's patents, or that such patents are invalid or unenforceable, may elect to avoid the patent exchange procedure and face a declaratory judgment action. Reference product sponsors will not have the benefit of the patent exchange procedure to learn about the proposed biosimilar product and its manufacturing process(es).  Consequently, it will be more difficult for reference product sponsors to meet the heightened pleading requirements now required for a patent-infringement suit leading to potential motion practice.14

B. In The Absence Of Supreme Court Review, Notice Of Commercial Marketing Is Required And Is Only Effective After A Biosimilar Application Is Licensed By The FDA

The majority in the Federal Circuit opinion found that the statutory language in § 351(l)(8)(A) of the PHSA supported its second holding that a biosimilar applicant is required to provide the reference product sponsor with 180 days' notice of commercial marketing, and that this notice is only effective after the biosimilar application has been licensed by the FDA.  Section 351(l)(8)(A) provides that "[t]he subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)."15 The court relied on the use of the word "licensed," which indicates that the biosimilar application must have already been approved.16

In finding that the notice of commercial marketing is mandatory, the court noted that "[p]aragraph (l)(8)(A) [of § 351 of the PHSA] is a standalone notice provision in subsection (l) . . . ."17  As a standalone provision, "nothing in subsection (l) excuses the [biosimilar] applicant from its obligation to give notice of commercial marketing to the [reference product sponsor] after it has chosen not to comply with paragraph (l)(2)(A)."18

Judge Chen disagreed with the majority that § 351(l)(8) of the PHSA is a standalone provision.19  In his view, when the statute is read as a whole, § 351(l)(8) "is simply part and parcel of the integrated litigation management process contemplated in (l)(2)–(l)(7)."20  Thus, if a biosimilar applicant fails to participate in the patent exchange procedure, the notice of commercial marketing provisions of § 351(l)(8) "cease to matter."21 Accordingly, under Judge Chen's view, a biosimilar applicant is either subject to all of § 351(l) or none of it.

In its petition, Sandoz contends that a biosimilar applicant should be permitted to provide the reference product sponsor with notice of commercial marketing prior to the FDA's licensure of the proposed biosimilar application. Sandoz argues, "[t]he text and purpose of Section 262(l)(8)(A) [of Title 42 of the United States Code] call for notice 180 days before commercial marketing; nothing requires that the applicant wait until after FDA approval to provide that notice of commercial marketing."22  Sandoz reasons that the statute's use of the word "licensed" in 42 U.S.C. § 262(l)(8)(A) "merely refers to the biosimilar product that will be marketed, which will be licensed by the time of marketing," and not that the FDA must first license the biosimilar application before an applicant can give notice of commercial marketing.23  Sandoz further argues that the Federal Circuit "compounded its error" of requiring notice after FDA approval by "disconnecting the notice provision from the BPCIA's patent resolution regime and creating an extra-textual injunctive remedy."24  Sandoz concludes that the Supreme Court "should grant review because the Federal Circuit has interpreted the BPCIA's notice of commercial marketing provision so as to grant a 180-day 'exclusivity windfall' to reference product sponsors."25

As it stands now, reference products that no longer have any statutory exclusivity remaining receive an extra-statutory exclusivity period of 180 days.26 By mandating 180 days' notice after FDA approval, the Federal Circuit's opinion provides reference product sponsors time to prepare a preliminary injunction motion and have it heard and decided by the district court before an at-risk launch of the biosimilar product. 

If the Supreme Court were to grant certiorari on Sandoz's petition and agree with Sandoz, biosimilar applicants could begin marketing their products immediately after their application is licensed by the FDA for reference products that are no longer protected by statutory exclusivity. This will require reference product sponsors to preemptively prepare a motion for a preliminary injunction.  It would also add pressure on district court judges to quickly rule on a motion for a preliminary injunction since the biosimilar applicant is launching its product at risk.



1 794 F.3d 1347 (Fed. Cir. 2015).

2 For a review of Amgen Inc. v. Sandoz Inc., as well as the Biologics Price Competition and Innovation Act, see Daniel G. Worley Jr. & Robert E. Colletti, BPCIA Primer: A Review of the Biologics Price Competition and Innovation Act in Anticipation of SCOTUS Review in Amgen v. Sandoz, 14 PHARM. L. & INDUS. REP. (BNA) 7, at 220–31 (Feb. 12, 2016) available at http://www.flhlaw.com/files/Uploads/Documents/BPCIAPrimer.pdf.

3 Amgen did not file a petition for a writ of certiorari by its January 14, 2016 deadline.

4 Enacted as part of the Patient Protection and Affordable Care Act on March 23, 2010, the BPCIA amended the Public Health Service Act ("PHSA"), among other statutes, to create an abbreviated licensure pathway for biological products that have been shown to be biosimilar to or interchangeable with an already-approved biological product known as the reference product.

Amgen, 794 F.3d at 1354–57.

Id. at 1357–59.

7 Petition for Writ of Certiorari at ii, Sandoz Inc. v. Amgen Inc., (No. 15A672).

Amgen, 794 F.3d at 1357.

Id. at 1356.

10 Id. at 1354.

11 Id. at 1357.

12 Id. at 1364 (Newman, J., concurring in part and dissenting in part).

13 Id.

14 On April 29, 2015, the Supreme Court approved and submitted to Congress proposed amendments to the Federal Rules of Civil Procedure. These amendments went into effect on December 1, 2015. Of particular relevance here is the abrogation of Rule 84.  The abrogation of Rule 84 allows courts to find complaints under Form 18 insufficient and require that direct infringement allegations comply with the heightened pleading standards set forth by the Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009).  Under the heightened pleading standards, a complaint must contain "enough facts to state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570.

15 42 U.S.C. § 262(l)(8)(A).

16 Amgen, 794 F.3d at 1357 (majority opinion).

17 Id. at 1359.

18 Id. at 1360.

19 Id. at 1367 (Chen, J., dissenting in part).

20 Id.

21 Id.

22 Petition for Writ of Certiorari at 22, Sandoz Inc. v. Amgen Inc., (No. 15A672) (emphasis in original).

23 Id. at 6.

24 Id. at 22.

25 Id.

26 It is not clear if products that still have statutory exclusivity remaining will also receive an extra-statutory exclusivity period of 180 days.  There is some tension between the majority opinion in Amgen and § 351(k)(7)(A) of the PHSA. The majority opinion in Amgen notes that the extra-statutory exclusivity "will not likely be the usual case" for biosimilar applications that are filed during a reference product's statutory exclusivity. Amgen, 794 F.3d at 1358 (majority opinion).  However, § 351(k)(7)(A) of the PHSA provides that a biosimilar application "may not be made effective by the Secretary" until after the 12-year statutory exclusivity period has expired. 42 U.S.C. § 262(k)(7)(A).  The outcome of this issue will likely depend on a court's interpretation of § 351(l)(8)(A), i.e., whether the term "licensed" requires the product to have an "effective" license or be merely "licensed."

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
McDermott Will & Emery
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
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