UK: The United Kingdom Supreme Court (UKSC) Today Handed Down Its Highly-Anticipated Judgment In The Case Of Warner-Lambert V Mylan & Actavis ([2018] UKSC 56)

Last Updated: 29 November 2018
Article by Tim Powell, Bethan Hopewell, Siddharth Kusumakar and Joel Coles

The UKSC has introduced a new test for the infringement of Swiss form second medical use claims and clarified the application of the test for plausibility of purpose-limited claims

The full judgment can be accessed here and the UKSC’s press summary here.

Background

Warner-Lambert was the proprietor of a patent that claimed the use of pregabalin (marketed as Lyrica) in the manufacture of a medicament for use in treatment of pain and, in particular, to neuropathic pain and various sub-categories of peripheral neuropathic pain.  Actavis and Mylan sought to revoke the patent on the basis that the disclosure in the specification did not render the claims to the treatment of neuropathic pain conditions plausible and hence the claim to the treatment of pain as plausible across its scope.  Warner-Lambert commenced infringement proceedings in relation to Actavis’s “skinny label” pregabalin product (marketed as Lecaent), which was authorised and marketed only for the non-patented indications of epilepsy and generalised anxiety disorder.

At first instance, the High Court held that the claims to the treatment of pain and neuropathic pain were invalid on the ground of insufficiency as they were not rendered plausible across their scope.  However, despite the patent containing no data from an animal model of neuropathic pain, the High Court held that the claims to sub-categories of peripheral neuropathic pain were plausible.  The High Court further held that, even had they been valid, Actavis’s “skinny label” product would not have infringed the asserted claims.  The High Court also held that an attempt by Warner-Lambert to make a post-trial amendment to limit the neuropathic pain claim to peripheral neuropathic pain was an abuse of process.

The Court of Appeal upheld the High Court’s decision on validity but provided obiter guidance on the test for infringement, holding that it is only essential that the manufacturer is able to foresee that there will be intentional use for the patented indication but that a manufacturer would avoid infringement where all reasonable steps within his power had been taken to avoid use of the drug for the patented indication.  The Court of Appeal also rejected Warner-Lambert’s application to amend the patent post-trial as an abuse of process.

Supreme Court Judgment

Infringement

The UKSC concluded (by a majority) that the correct test for direct infringement of Swiss form second medical use claims is the “outward presentation” test, in which the objective characteristics of the manufactured product are to be considered rather than the intention of the manufacturer.  (The minority of the court adopted Actavis’s position that the correct test should be one of subjective intention on the part of the manufacturer, rather than the foreseeability test favoured by Warner-Lambert).  The “outward presentation” test had not been advanced by the parties or the interveners, but was addressed in written submissions after the hearing at the invitation of the court.  Whilst the UKSC recognises that the outward presentation test may confer imperfect protection in respect of Swiss form second medical use claims, it was held that such imperfect protection arises from a limitation inherent in a Swiss-form patent.

The UKSC also rejected Warner-Lambert’s claim for indirect infringement on the basis that the invention protected by Swiss form claims is the manufacture of the drug for the designated use, and not the subsequent use of the product for treating patients (including, for example, affixing a sticker to the product by the pharmacist).

Validity

The UKSC confirmed that the claims to the treatment of pain and neuropathic pain were invalid as these claims were not plausible across their scope on the basis of the disclosure in the patent.  However, the majority also agreed with Actavis that the dependent claims to sub-categories of peripheral neuropathic pain were also invalid for lack of plausibility on the basis that, whilst the patent contained data relating to inflammatory pain, it lacked any data showing that the drug would be efficacious for any neuropathic pain condition.  In applying the reasoning of the Technical Boards of Appeal of the European Patent Office (in particular the decision in Salk Institute for Biological Studies/AP-I complex (T 609/02)), the UKSC held that it is always necessary for the patentee to demonstrate in the specification something that makes the claim to therapeutic efficacy plausible and that a mere assertion of efficacy is not enough.  Furthermore, the patentee cannot claim a monopoly of a new use for an existing compound unless it not only makes but discloses a contribution to the art and therefore it must be possible to derive from the teaching of the patent some reason for supposing that the implied assertion of efficacy in the claim is true. 

The UKSC held that whilst post-filing data may be admissible in a dispute about sufficiency, the purpose for which they are admitted is strictly limited either to confirm the plausibility of the therapeutic use or to refute a challenger’s contention that it does not actually work.  Post-filing data cannot, however, be used as a substitute for sufficient disclosure in the specification.

Claim amendments / abuse of process

Finally, the UKSC confirmed that Warner-Lambert’s attempt to amend its patent post-trial amounted to an abuse of process.  In so doing, the UKSC drew a distinction between post-trial amendments to delete claims which had been found to be invalid at trial and post-trial amendments designed to set up a new claim which had not been adjudicated upon at trial.

Discussion

In extensive obiter remarks on infringement of Swiss-form patent claims, the UKSC has provided important guidance on what, as a matter of construction, it means to claim in a patent the use of compound ‘X’ for the preparation of a medicament “for” treating disease ‘Y’.  By rejecting the importation of a mental element into the claim and opting for a test of purpose based upon the “outward presentation” of the manufactured product, the UKSC has sought to take account of the Protocol on the interpretation of Article 69 EPC (i.e. affording reasonable protection to the patentee and the need for legal certainty for third parties) and broader policy objectives including the public interest in the free exploitation of a product for a patent-expired use.  The outward presentation test provides generic manufacturers with a clear framework for launching into second medical use markets that also aims to safeguard from liability other third parties who deal in such generic products (e.g. distributors and dispensing pharmacists).

Whilst this is a landmark judgment, it likely marks only the beginning of a new chapter.  The challenges raised by the scope of protection of second medical use patents are abundantly apparent from the lengthy considerations of several of the Justices.  In particular, the UKSC acknowledges the difficulties of ‘extreme’ cases where the outward presentation test may afford insufficient protection to the patentee (e.g. where a generic manufacturer encourages dealers and pharmacists to supply a product for the treatment of a patented indication despite its outward presentation being directed to the non-patented use only).  The UKSC leaves open the position in this type of ‘remote situation’ and recognises the potential need for the legislature to address the practical issues that may arise from purpose-limited patent protection.  This is a reminder that generic manufacturers should still act responsibly.

The UKSC has also confirmed the place of plausibility as part of the sufficiency test for second medical use claims.  In light of the judgment, patentees should ensure that patent specifications contain sufficient data not only to ensure that each claimed therapeutic use is supported but that they are supported across their scope.  Claims should therefore be suitably drafted to ensure that only those therapeutic uses which are supported are covered in order to minimise the risks that such claims are held to be invalid for lack of plausibility.

The UKSC’s decision upholding the lower court’s findings on abuse is a reminder to litigators to consider all of the options available to them during the course of proceedings, and to take timely action where necessary.  In the case of “scope of claim” arguments, in particular, patentees should avoid relying on construction arguments alone, where an allowable amendment may otherwise rescue the claim.

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.

Authors
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
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

Disclaimer

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.

General

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