Australia: Federal Court of Australia dismisses preliminary discovery application regarding biosimilar suspected of infringing manufacturing process patents

Last Updated: 26 March 2017
Article by Duncan Longstaff and Jacinta Flattery-O'Brien

In the recent decision of Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 (21 March 2017), Justice Stephen Burley of the Federal Court of Australia has delivered an important decision dismissing an application for preliminary discovery of documents relevant to determining whether a registered biosimilar product might infringe one or more patents claiming manufacturing processes.


Pfizer parties (collectively, Pfizer) were concerned that Samsung Bioepis Co Ltd Korea (SBK) and Samsung Bioepis AU Pty Ltd (SBA) were infringing one or more of their registered patents claiming a process for making a biological medicine, etanercept. Pfizer therefore sought orders pursuant to r 7.23 of the Federal Court Rules 2011 (Cth) for preliminary discovery of confidential documents lodged with the Therapeutic Goods Administration (TGA) in order to determine whether to commence proceedings against SBK and SBA for patent infringement.

Etanercept is the active ingredient in ENBREL, a biological medicine used in the treatment of autoimmune diseases sponsored in Australia by Pfizer Australia Pty Ltd. Until recently, it has been the only product containing etanercept registered on the Australian Register of Therapeutic Goods. In 2016, SBA sponsored the registration of two pharmaceutical products containing etanercept as their active ingredient and both have been registered on the ARTG under the name of BRENZYS. The parties agreed that BRENZYS were developed as a biosimilar to ENBREL, meaning that it is almost an identical copy of an original product that is manufactured by a different company. The TGA guidelines require that biosimilars must satisfy an extensive comparability exercise with the chosen reference medicinal product to ensure similar quality, safety and efficacy. However, Burley J noted that simply because BRENZYS and ENBREL were biosimilars does not conclusively determine that the process used to manufacture the products is the same.


Burley J accepted that through a chain of correspondence with the respondents, Pfizer had made reasonable inquiries and did not have sufficient information to decide whether to commence proceedings, as required by FCR 7.23(1)(b). On this note Burley J confirmed that it is sufficient for a prospective applicant to broadly provide the basis on which it forms the views that it holds and makes inquiries of parties from whom it might reasonably be expected that relevant information may be obtained. Burley J specifically observed that Pfizer's offer of a confidentiality regime confining access to the requested documents assisted it in establishing the reasonableness of its inquiries.

The main issue for determination was whether Pfizer had the requisite subjective and objective reasonable belief that it had the right to obtain relief for patent infringement from SBA in accordance with FCR 7.23(1)(a). There was no dispute that Pfizer had demonstrated the requisite subjective belief. However, the substantive debate was whether there was an objective basis. Pfizer reasoned that BRENZYS had a peculiar level of similarity to ENBREL and that because of the complexity of the products the similarity inferred that the process to make each product must be similar. Further, because Pfizer contended (without adducing direct evidence) that the process by which it manufactures ENBREL falls within the scope of the claims in question, the process by which SBK manufactures BRENZYS must therefore also fall within the scope of the claims. Nonetheless, Burley J held that this chain of reasoning did not rise above speculation. Accordingly, Pfizer failed to demonstrate a reasonable objective belief that they have the right to obtain relief for patent infringement from SBA in accordance with FCR 7.23(1)(a).

Further, Burley J found that even if Pfizer had established the requisite reasonable belief, he would have exercised the judicial discretion conferred by FCR 7.32(2) against granting the preliminary discovery order sought. Burley J noted in particular the scope of the documents sought and the fact that Pfizer did not adduce evidence of its own manufacturing process for ENBREL.


This decision of Burley J to dismiss Pfizer's application for preliminary discovery begs the question of how the patentee of a patent claiming a process or method of producing a product, rather than the product itself or a method of using it after it has been made and entered the market (eg, in a method of treatment), can obtain the information necessary to elevate suspicions of infringement to the requisite level of belief to commence court proceedings.

The issue is particularly stark in the context of biosimilars and generic pharmaceuticals, where associated regulatory requirements mean the allegedly infringing products are relevantly equivalent (and possibly identical) to at least the patentee's own approved products (which patentees will contend embody the inventions of one or more of their patents). The confidential nature of regulatory applications such as those made to the TGA mean the only parties with access to documents which set out the manufacturing processes for the subject products are the product sponsor and the TGA itself. The likely futility of seeking the information or documents from the TGA under the Freedom of Information Act 1982 (Cth) (see: Secretary Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Limited [2010] FCA 1442 (21 December 2010)) means that a patentee's only practical option is to seek the information required to form a view on infringement of its patents from the alleged infringer itself – either voluntarily through correspondence, or under the compulsion of a court order for preliminary discovery.

From this perspective, Burley J's decision that Pfizer had not satisfied the requirements for a preliminary discovery order appears harsh – particularly where it was clear the sought information and documents existed and access could have been confined to Pfizer's external solicitors subject to a strict confidentiality regime. However, the critical aspect underpinning Burley J's decision appears to have been that Pfizer needed to, but did not, adduce evidence regarding the processes by which its own products were produced, which would have established whether or not those processes embodied the inventions of one or more of its three patents. That is, Pfizer effectively needed to provide quid pro quo by giving the Court and SBA's external lawyers confidential access to details of its own production processes, as this could have resolved many of the uncertainties and assumptions underpinning its objective reason to believe. Although such an approach by Pfizer may not have led to a different outcome on its preliminary discovery application, it does appear that any patentee seeking such an order to establish infringement of patents claiming production processes should be prepared to adduce evidence of its own production processes, at least to the Court and the other party's external solicitors.

Pfizer has until mid-April 2017 to lodge any appeal from Burley J's decision. However, BRENZYS (to be marketed and distributed by Merck Sharp & Dohme) will be listed on the PBS, triggering price drop implications (initially 16%) for ENBREL, from 1 April 2017. Therefore, even it does successfully appeal this decision and ultimately obtain preliminary discovery of documents which provide sufficient information to sue SBK and SBA for patent infringement, Pfizer's opportunity to obtain an effective interlocutory injunction restraining BRENZYS and protecting the PBS price of ENBREL appears to have passed.

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.

Shelston IP ranked one of Australia's leading Intellectual Property firms in 2015.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Duncan Longstaff
Jacinta Flattery-O'Brien
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
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 (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

To Use 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