United States: Amgen v. Sandoz: Final Judgment Of Non-Infringement: Clearance For Biologics Still Being Finalized At The Time Of Judgment?

Last Updated: May 22 2019
Article by Jenny Shmuel, Tasha M. Francis and Tucker N. Terhufen

Decisions in the Amgen v. Sandoz case involving Sandoz's biosimilar versions of Amgen's Neupogen® and Neulasta® drugs have provided significant guidance to biosimilar litigants over the years. In the context of this case, the Supreme Court held that the "patent dance" is optional and that a Notice of Commercial marketing may be provided before FDA approval. In a recent opinion involving the same case, the Federal Circuit addressed possible outcomes where, during litigation, a biosimilar manufacturer makes clear its intention to amend its abbreviated biologics license application and its manufacturing process. Among other things, the Federal Circuit provided guidance about whether a non-infringement finding would insulate any subsequent manufacturing and abbreviated biologics license application changes.


Through the Biologics Price Competition and Innovation Act ("BPCIA"), Congress provided manufacturers an abbreviated means for achieving FDA clearance to manufacture, market, and sell "biosimilars" of biologic drugs. The BPCIA permits biosimilar manufacturers to submit an abbreviated biologics license application ("aBLA") to the FDA to demonstrate that the biosimilar drug is highly similar to the reference product in terms of safety, purity, and potency. This abbreviated process is intended to save the biosimilar manufacturer time and money, so that the biosimilar drug can be sold at lower cost. The BPCIA does not, however, excuse biosimilar manufacturers from liability for infringing patents covering a reference product.

The BPCIA and provisions governing infringement in the Patent Act allow a biosimilar manufacturer to determine whether its biosimilar would infringe any relevant patents of the reference product manufacturer by receiving infringement rulings from a federal court. This process provides some business certainty to biosimilar manufacturers by allowing them to mitigate risk by resolving some patent disputes before launch through the "patent dance." If the parties choose to engage in the patent dance, a biosimilar applicant generally shares its confidential aBLA with the reference product sponsor, and may share detailed information about its proposed manufacturing process. The parties then exchange a list of patents that may be asserted, along with contentions regarding those patents, which culminates in litigation in federal court. A potential benefit to biosimilar manufacturers is that they may receive clearance from a court by way of final judgment of non-infringement or invalidity of patents identified during the patent dance before making any sales. One open question is what may happen if an aBLA applicant later amends its aBLA, or changes its manufacturing process during the litigation and this issue was addressed in Amgen v. Sandoz.

Amgen v. Sandoz Federal Circuit Opinion (May 2019)

In the Sandoz case, Amgen asserted, inter alia, that U.S. Patent Nos. 8,940,878 (the "'878 Patent) and 6,162,427 (the "'427 Patent") were infringed by Sandoz's launched Zarxio® product, a biosimilar of Neupogen® (filgrastim), and Sandoz's proposed biosimilar of Neulasta® (pegfilgrastim). After claim construction, Amgen and Sandoz stipulated to non-infringement of the '427 Patent. In December 2017, the Northern District of California granted summary judgment of non-infringement of the '878 Patent because the asserted protein purification method required separate washing and eluting steps, but Sandoz's process for both its biosimilars involved a single, simultaneous washing and eluting step.

The district court also denied Amgen's Rule 56(d) motion to deny or continue the motion for summary judgment until Sandoz submitted its intended new purification method to the FDA. During discovery, Sandoz disclosed that it planned to change certain aspects of its manufacturing process by changing a refold solution used in its separation matrix and consequently amend its aBLAs. The district court denied Amgen's motion because the revised method would substitute one separation matrix for another, which was immaterial to the infringement analysis because the new process would still involve a simultaneous washing and eluting step. While the appeal turned significantly on specific issues of claim construction, this article focuses on the Rule 56(d) arguments.

Rule 56(d) allows a district court to deny or postpone summary judgment if the nonmovant shows that "it cannot present facts essential to justify its opposition." Fed. R. Civ. P. 56(d). During the district court litigation, it was undisputed that Sandoz intended, at some point in the future, to modify its purification process to use a different resin in its separation matrix. Amgen Inc. v. Sandoz Inc., __F.3d__, 2019 WL 2017501, at *5 (Fed. Cir. May 8, 2019). Amgen contended that Sandoz had neither submitted its amended aBLA, nor provided Amgen with the details of the modification such that it could properly respond to the motion for summary judgment of non-infringement. Id. Amgen further contended that the court could not render a final judgment on a technical act of infringement where a biosimilar applicant plans to submit a modification of a relevant process to the FDA but has not done so. Id. Finally, Amgen contended that if infringement were determined before aBLA amendment, then it would be effectively "deprived of the ability to allege infringement in the future," and that Sandoz would be free "to make any changes it wishes to the modified process because it has been declared non-infringing in advance." Id.

Sandoz argued in response that it provided sufficient detail about the modified process and that Amgen's alleged inability to stave off summary judgment was due to its failure to diligently pursue discovery. Id. Sandoz also highlighted that the details sought by Amgen were immaterial to infringement because the claim did not require a specific resin and Sandoz would continue its non-infringing single-step washing and eluting process. Id.

The Federal Circuit sided with Sandoz. With respect to Sandoz's proposed pegfilgrastim biosimilar, the Federal Circuit first stated that "a proper analysis of a technical act of infringement under § 271(e)(2) requires a determination of whether 'what is likely to be sold' will infringe 'in the conventional sense' of patent infringement." Id. at *6 (internal quotations omitted). The Court acknowledged that the inquiry may be complex because abbreviated new drug application ("ANDA") and aBLA applicants are permitted to amend their process while the application is pending. Id. Thus, while a district court cannot "ignore amendments to an ANDA or aBLA," "it also has a broad mandate to render a just, speedy, and inexpensive decision based on the evidence of record." Id. (internal quotations and citations omitted) (citing Ferring B.V. v. Watson Labs., Inc.-Fla., 764 F.3d 1382, 1391 (Fed. Cir. 2014) (holding that a district court has discretion to consider an amended ANDA after issuing a decision but before final judgment)). The district court was therefore "not obligated to postpone summary judgment until Sandoz submitted its amended pegfilgrastim aBLA." Id.

The Court noted that the proposed pegfilgrastim biosimilar would likely follow the same one-step washing and eluting process, and would therefore not infringe under the affirmed claim construction. Id. The proposed process would only substitute resins, and the asserted claim did not distinguish between types of resins. Id. Accordingly, the Federal Circuit held that the district court did not abuse its discretion in denying Amgen's Rule 56(d) motion.

With respect to Sandoz's Zarxio® biosimilar, the Court stated, "[b]ecause Zarxio® is currently marketed, it is unnecessary to determine 'what is likely to be sold,' as is required for a technical act of infringement." Id. Instead, infringement turned on whether Sandoz's current process for manufacturing infringed the claim according to "conventional principles of patent infringement." Id. "Applying those principles . . . the district court did not err either in construing claim 7 or in granting summary judgment." Id.

The Federal Circuit further clarified that Amgen would not be without a remedy for possible future infringement should Sandoz change its process. "It [Amgen] may in a future action plead infringement of claim 7 by Zarxio® or, if approved, Sandoz's pegfilgrastim biosimilar to the extent permitted by the Patent Act and the principles of res judicata and collateral estoppel." Id. (citing Bayer AG v. Biovail Corp., 279 F.3d 1340, 1349-50 (Fed. Cir. 2002) (declining to apply collateral estoppel from previous Hatch-Waxman case when defendant's marketed product differed from that of the hypothetical inquiry)). Thus it appears that if Sandoz were to change its manufacturing process for Zarxio® or its proposed pegfilgrastim biosimilar in a way that would infringe the claim, Amgen would not be precluded from seeking relief.

Notably, the collateral estoppel issue in Bayer turned on a distinction between litigation based on hypothetical infringement as compared to infringement by manufacture of commercial tablets. See Bayer, 279 F.3d at 1350. The court there noted that "evidence of actual infringement (contrasted with evidence of a 'hypothetical' infringement) may differ in substance and may become available only after manufacture of the composition." Id. Thus, in the earlier Hatch-Waxman case Bayer "did not have a full and fair opportunity to litigate the issue of infringement by the commercial tablets because those tablets were not available until after ANDA approval." Id. Based on the Federal Circuit's opinions in Sandoz and Bayer, it appears that being absolved at one stage (pre-approval) doesn't necessarily absolve at all stages (post-approval, particularly where there are amendments or changes to the biosimilar actually manufactured). In Sandoz, the proposed manufacturing process would not change in any way material to the infringement analysis, so this pre-approval/post-approval distinction did not matter.

Looking Forward

In situations where a biosimilar manufacturer signals that its process and aBLA may change, reference product manufacturers should make early and repeated efforts to pursue discovery into those changes. District courts have discretion to move forward with summary judgment findings of non-infringement with or without that information. But a court may be more likely to wait to rule on summary judgment where a reference product manufacturer has diligently sought such discovery and been denied by the other party. Alternatively, as happened here, district courts may consider the limited new information along with the original process disclosed to find non-infringement on summary judgment. This does not mean a biosimilar manufacturer would then have free-rein to change its process after a final judgment of non-infringement. As explained by the Court in Sandoz, collateral estoppel may not apply where the marketed product materially differs from the product found to not infringe.

It is also worth noting, in Sandoz, the Federal Circuit again analogized several BPCIA issues with Hatch-Waxman litigation. First, the Court analogized the "technical act of infringement" included in § 271(e)(2) of the Patent Act, as requiring a look at "what is likely to be sold" in both instances. For example, in the Hatch-Waxman context, this requires a look at the process disclosed in an ANDA, whereas the same inquiry requires a look at the aBLA in a biosimilar litigation. Sandoz, 2019 WL 2017501, at *6 (noting that this inquiry may be complex because ANDA and biosimilar applicants can amend their applications). Second, the Court acknowledged that both ANDA and biosimilar applicants may amend their applications while they are pending. Id. Third, the Court analogized principles of res judicata between Hatch-Waxman and biosimilar cases as described above. In short, the Federal Circuit seems inclined to draw analogies from the more advanced body of law in the Hatch-Waxman context.

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
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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