News from Abroad: UK High Court Considers quia timet Injunctions

by McDonnell Boehnen Hulbert & Berghoff LLP

MerckThe UK High Court recently gave its judgment in the case of Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva) (decision).  The judgement is interesting as it is one of the few so called "quia timet" injunctions that has been issued by the UK High Court on the basis of a contention by a patent proprietor that a generic pharmaceutical company intends to launch its generic drug whilst the patent and SPC under which the drug is protected are still in force.  A quia timet injunction is an injunction to restrain harm which has not yet occurred but what is being threatened is imminent.

The patent

Efavirenz is a drug used to control HIV infections and is protected by the patent EP (UK) 0 582 455 (and its associated SPC) which is owned by Merck.  The patent will expire on 3 August 2013 and the SPC on 20 November 2013.

Interim injunction

Teva #2Teva obtained a marketing authorisation for Europe for generic efavirenz in early 2012.  From its actions in previous cases, such as the Warner Lambert case concerning generic atorvastatin, Teva had a reputation to launch generic versions of a drug while the patent and SPC protecting the drug were still in force.  BMS therefore asked Teva what its intentions were regarding the launch of generic efavirenz.  Teva replied that its policy was to not divulge commercial information to its competitors.  It also pointed out that the grant of the marketing authorisation for generic efavirenz permits but does not require Teva to market the generic product and that it was Teva's policy to not infringe valid patents.

Dissatisfied with Teva's reply, BMS applied to the UK court for injunctive relief alleging that Teva's actions to obtain a marketing authorisation for Europe at an unusually early time during the patent term and its reluctance to provide details of its intentions concerning the launch of generic efavirenz in the UK indicated an intention to infringe the patent and SPC.

Teva countered that the claim should be struck out because it was not based on the validity of the patent but instead on whether Teva's actions amounted to a threat to infringe.

Bristol-Myers Squibb #2The judge believed that BMS had reasonable grounds for seeking injunctive relief.  In the judge's view, the fact that Teva went to the trouble of obtaining a marketing authorisation for efavirenz gave a concrete inference that Teva intended to sell efavirenz at some time.  Furthermore, the judge found that the fact that Teva obtained the marketing authorisation almost 22 months before patent expiry, which is unusually early, supported an inference that generic efavirenz was intended to be launched before patent expiry.

An interim injunction was therefore granted on 15 March 2012 against Teva to prevent the launch of generic efavirenz in the UK.

Final trial

At final trial (decision issued on 9 July 2013) the only question that was considered was whether Teva, by its actions, threatened to infringe EP (UK) 0 582 455 and its associated SPC before their expiry and, thus, whether a final injunction for the remaining term of the patent and SPC ought to be granted.

Teva argued that at the time the action was brought (February 2012) it did not intend to launch generic efavirenz before expiry of EP (UK) 0 582 455 and its associated SPC.  Teva presented documentation from its in-house legal and commercial departments which, Teva asserted, supported its position.

The judge summarised the test under UK law for granting quia timet injunctions as whether, in all the circumstances, there is a sufficiently strong probability that an injunction will be required to prevent harm to the claimant occurring that the bringing of proceedings by the claimant is justified.  The defendant's intentions before the action is brought are central to the assessment.  Important considerations are the defendant's subjective intentions and acts and what third parties would perceive the defendant's intentions to be.

In the present case, in considering the "third parties perceptions" arm of the test, the judge held that when the action was brought, third parties would perceive that there was a threat to infringe EP (UK) 0 582 455 and its associated SPC because in the past Teva had launched products before expiry and without notice to the patentee.  In considering the "subjective intentions" arm of the test, during the case Teva had informed BMS that it did not "have any plans to supply pharmaceutical products containing efavirenz" in the UK before SPC expiry.  However, from internal documents disclosed by Teva during the trial, the judge found that Teva was actively considering whether or not to launch its generic drug in the UK before the expiry of the SPC.

The court therefore held that it was appropriate to continue the preliminary injunction to restrain Teva from infringing the patent and the SPC up to their expiry.

The judgement provides useful guidance for pre-action correspondence which seeks to ascertain when a company plans to launch its generic drug.  If generics companies withhold such information from patent proprietors they may face actions for quia timet injunctions.  Therefore, if a generics company is asked by an originator company about its intentions concerning the launch of a generic drug, the generic company should consider supplying assurances that generic drugs will not be launched while patent rights remain in force.  Such assurance may be given under confidence to prevent commercially sensitive information being divulged to competitor generics companies.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.