UK: Are Second Medical Use Patents Still Worthwhile In Light Of Warner-Lambert Supreme Court Decision

Last Updated: 14 December 2018
Article by Barbara Rigby

On 14 September 2018 the UK Supreme Court unanimously opined that the marketing of generic pregabalin by Actavis would not have been an infringement of Warner-Lambert's claims directed to a further medical use of pregabalin, namely for the treatment of pain. The judgment, summarised in an earlier post, dealt for the first time with the issue of how infringement of 'second medical use' patents should be assessed in the UK. This article explores the implications of this aspect of the judgment and its potential impact on the value of second medical use patents.

Key points on second medical use claims in Europe

Second medical use patents are available in Europe to reward the development of a new medical application for a known drug. Methods of treatment are excluded from patentability in Europe, but inventions in this field could traditionally be protected via the so-called 'Swiss-type' claim format1: "Use of compound X in the manufacture of a medicament for medical condition Y". In December 2007, the so-called 'EPC2000' format was introduced: "Compound X for use in the treatment of condition Y". The Swiss-type format was abolished in Europe for any applications filed after 29 January 2011, but this format remains relevant for earlier patents.

It was the intention of the legislator that the EPC2000 claim format would afford protection equivalent to that of the Swiss-type format. However, the EPO's Board of Appeal held in T1780/12 that a Swiss-type claim is a purpose-limited process claim, whereas an EPC 2000 second medical use claim is a purpose-limited product claim. The Board concluded that there is variance in the protection afforded by these two different claim formats. According to the Board, a purpose-limited process claim (i.e. a Swiss-type claim) confers less protection than a purpose-limited product claim (i.e. an EPC 2000 second medical use claim).

This distinction has been adopted by several national courts, notably the UK courts, whereas e.g. German and Dutch courts treat both claim types as affording equivalent protection2,3.

Basic facts of the UK Warner-Lambert case 

Warner-Lambert established that pregabalin, a drug already on the market for the treatment of epilepsy and generalized anxiety, was also effective in the treatment of pain.  The Company obtained a second medical use patent in this regard.

Once any European patents protecting pregabalin itself and the use thereof in the treatment of epilepsy and generalized anxiety had expired, generics manufacturer Actavis launched the drug in Europe. To avoid infringement of the pain patent, the generic drug was launched under a 'skinny label' for the off-patent indications epilepsy and generalised anxiety disorder.

However, concerned that the generic drug would nevertheless be used for the treatment of pain, Warner-Lambert brought an infringement action against Actavis. This was the first time that the UK courts were asked to consider how infringement of second medical use patents should be assessed.

Potential infringement tests

The UK courts had to grapple with the issue of how to devise an infringement test that provides the patentee with a fair monopoly for his patented invention, without depriving generics companies of the opportunity to enter the market in the off-patent field.

At first instance, a 'subjective intent' test was proposed, under which there is infringement if the manufacturer makes the product with the intent to target the patent-protected market.

By contrast, an 'objective intent' test was favoured at the appeal stage. Under this test, a manufacturer must be taken to intend the foreseeable consequences of his actions. However, the intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring.

Both of these tests were rejected by the majority of the UK Supreme Court judges. As Lords Sumption and Reed put it: "a test for infringement which depended on intention, whether objective or subjective, would be contrary to principle and productive of arbitrary and absurd results" [paragraph 71].

Instead, Lords Sumption and Reed concluded that infringement depends on the physical characteristics of the product as it emerges from the relevant process, including its formulation and dosage, packaging and labelling and the patient information leaflet, which in the EU will identify the conditions for whose treatment the product is intended. This is referred to as the 'outward presentation' test [paragraph 84].

However, the outward presentation test was rejected by Lords Briggs and Hodge, who favoured a subjective intention test [paragraphs172-174; 188].

A somewhat intermediate position was taken by Lord Mance.  He acknowledged that in some cases, it may not be appropriate to consider the outward presentation in isolation, without regard to issues such as advertisements by the manufacturer, or the manufacture of the drug in quantities that greatly exceed the market for the off-patent indication [paragraph 217].

Value of second medical use patents in the UK

The judgment acknowledged that - in view of the UK's regime for prescribing and dispensing drugs - package labels limited to an off-patent indication will not necessarily prevent the generic drug from being dispensed for the patented indication in the UK [paragraph 128]. The proposal of the 'outward presentation' test by Lords Sumption and Reed has therefore prompted innovators to question the value of second medical use patents.

However, it must be remembered that Supreme Court held that the claims at issue before it were invalid, so the comments on infringement were obiter and hence do not represent a binding authority.

Uncertainty therefore remains over what the correct infringement test should be, so it would be premature to conclude that an 'outward presentation' test will indeed be applied in all future cases. Moreover, it is entirely conceivable that the 'outward presentation' test will evolve, as it has done in Germany (see below).

It is also important to note that in the Warner-Lambert case the same formulation and dosage regime was suitable for the patented and the off-patent indication, whereas in many cases differences in the formulation and/or dosage may well make it less appropriate to dispense a generic drug for a patented indication.

It should also be remembered that generic drug marketing under a skinny label is only possible where the active ingredient is authorised for the treatment of an off-patent indication. There are many instances where a first medical treatment with a particular active agent has been investigated to some extent, and some results have published, but no relevant marketing authorisation exists. In such instances, an invention relating to a different medical treatment with the active agent may only be patent protected via a second medical use claim, but the patent would cover the only authorised indication. The absence of a marketing authorisation for the first medical treatment would prevent a generic company from launching a skinny label generic of the active agent.

It must also be appreciated that the Warner-Lambert case concerned the Swiss-type medical use claim format, which is only relevant to historic patents, whereas more recent and future patents contain second medical use claims in the EPC2000 format. As mentioned above, in the UK EPC2000 claims are considered to be purpose-limited product claims. The infringement of such claims has not yet been tested before the UK courts, but it is surely only a matter of time before the UK courts will be asked to consider this issue.

Another important factor to bear in mind is that the approach proposed by the UK Supreme Court differs from the practice that has developed in other European countries, such as Germany and the Netherlands (discussed below).

Second medical use patents in other European jurisdictions

There is a significant lack of harmonisation among the various European countries regarding the interpretation of second medical use claims and the assessment of infringement of such claims.

In particular, whilst the UK courts have adopted the position that Swiss-type claims do not confer the same protection as EPC 2000 claims (see above), the Supreme Courts of Germany and the Netherlands do not distinguish between these different claim formats when assessing infringement.

Traditionally, German courts assessed infringement of such claims by considering the 'sinnfällige Herrichtung' (which roughly translates as 'manifest arrangement')4, which has been equated to the 'outward presentation' test. However, the jurisprudence is constantly evolving and more recent decisions5 highlight that when assessing infringement, the German courts are increasingly prepared to take into account factors going beyond the drug label and package insert.

In the Netherlands, the Supreme Court has adopted an objective foreseeability test(3) and established that if use of the generic drug for the patented indication is foreseeable, the generic manufacturer/supplier should implement effective measures to try to prevent the generic product from being dispensed for the patented indication.


It is debatable whether the approach for assessing infringement of Swiss-type second medical use claims in the UK proposed by the UK Supreme Court strikes the right balance between allowing the manufacture and supply of generic drugs for off-patent indications and providing adequate protection for the holders of patents with Swiss-type second medical use claims.  However, the law is far from settled in this area, and it is conceivable that UK practice may in future become more aligned with German or Dutch practice in this field, which is widely considered to be more favourable to patentees. The importance of second medical use patents in Europe should therefore not be underestimated.


1 G5/83 confirmed that the Swiss-style claim format may be used to protect a second/further medical use

2 For example, in "Kollagenase I" the German Federal Supreme Court did not distinguish between the different kinds of claim language.

3 Merck Sharp & Dohme Corp. v. Teva Pharma B.V. and Pharmachemie B.V., Supreme Court of The Netherlands, The Hague, 3 November 2017, Case no ECLI:NL:HR:2017:2807

4 For example "Ribavirin" Düsseldorf District Court, docket number 4a 0 12/03

5 "Dexmedetomidin" Düsseldorf Higher Regional Court decision of March 2018 Az. I-2 U 30/17

Are Second Medical Use Patents Still Worthwhile In Light Of Warner-Lambert Supreme Court Decision

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

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 (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