UK: Lifesciences Snapshot: Winter 2009


Actavis UK Ltd v Novartis AG, Patents Court, 16 January 2009

A patent for a drug called fluvastatin, used to reduce cholesterol, has been found to be invalid by the High Court on the grounds of obviousness. The case turned on the facts but there was some interesting discussion on the concept of 'secondary common general knowledge'. The judge acknowledged that there are two types of common general knowledge: actual and secondary. Ideally, secondary common general knowledge should be pleaded as prior art, but this is a desirable practice rather than an inflexible rule. The case also involved a discussion of the case of Conor Medsystems and its effect on Pozzoli SPA.

For the full text of the decision, click here.

CoreValve Limited v Edwards Lifesciences AG, Patents Court, 9 January 2009

The Patents Court considered the issue of sufficiency in relation to an artificial heart valve mounted on a stent which can be implanted by cathertisation. The test does not require the patentee to go beyond the claims and instruct the reader how to use the product (in this case, how to insert the valve by catheter). It was found to be enough to instruct the reader how to make a device that can be inserted by a catheter and that the instructions made the invention plausible.

Observations were also made in relation to the experimental use defence.

For the full text of the decision, click here.

The Wellcome Foundation Limited v Paranova Pharmzeutika Handels GmbH, ECJ, 22 December 2008

The ECJ made a finding in a pharmaceutical parallel trade case referred by an Austrian court that:

i. In reviewing repackaging of branded products there is no principle of "minimum intervention", ie. interfering with the original packaging in the minimum way. The sole criterion on which the lawfulness of the new packaging is to be measured is whether it is such as to damage the reputation of the trade mark and its proprietor (assuming that the other criteria relating to repackaging of branded products have been met, as per ECJ case law, set out in Boehringer -v- Swingward 1 and 2).

ii. It is for the parallel importer to provide to the trade mark owner in its notice the information which is necessary and sufficient to enable the trade mark owner to determine whether the repackaging of the product under that trade mark is necessary in order to market it in the Member State of importation.

For the full text of the decision, click here.

The patentability of products relating to stem cells

Inventions concerning products which can only be obtained by the use and destruction of human embryos cannot be patented, the European Patent Office (EPO) has ruled.

Thirteen years since an original patent application was made by the Wisconsin Alumni Research Foundation and after a long history of decisions and challenges, the EPO's highest decision-making body issued its final judgment last week. In a restrictive interpretation of the European Patent Convention's rules on public order and morality, the Enlarged Board of Appeal ("EBoA") ruled that applications relating to products which could be prepared only by destroying human embryos would be refused, even if the application did not specifically describe the method involving this destruction and if a new method had been found since the application was filed which avoided such destruction.

For our full Law-Now on this, click here.

Company Names Adjudicator issues first decision, 3 December 2008

In its first decision since the new right of complaint came into force on 1 October 2008, the Company Names Adjudicator has made an order against Coke Cola Limited to change its name within one month to one which does not offend section 69 of the Companies Act 2006. The Coca-Cola Company Limited filed an application on the basis that Coke Cola Limited's name was 'sufficiently similar' that it would be likely to mislead when used in the UK by 'suggesting a connection between the company and the applicant'. Since the company was incorporated before the legislation came into effect, the decision also confirms that complaints can be made in relation to companies incorporated prior to 1 October 2008.

For the full text of our Law-Now update, click here.


Pharma firm challenges ASA powers to remove posters pre-adjudication

An Australian pharmaceutical firm recently challenged the Advertising Standards Authority's ("ASA) right to take down its controversial poster campaign prior to an investigation being concluded.

Posters for the Advanced Medical Institute's ("AMI") nasal spray drug for male sexual dysfunction read: "WANT LONGER LASTING SEX?" in large, red letters on a yellow background. The posters have appeared in almost 200 places across London since December 2008 and have drawn more than 450 complaints, mostly that the ad is offensive, gratuitous and inappropriate for public display.

The ASA has launched an investigation into the ad and, in the meantime, has asked AMI to take the posters down "in the interest of public safety", on the basis that AMI was unlawfully advertising a prescription-only medicine.

For our full Law-Now on this, click here.


EU Pharmaceutical Sector Inquiry – Preliminary Report

The European Commission has published its preliminary report in the Pharmaceutical Sector Inquiry on 28 November 2008. Although the report is work in progress, the Commission claims to be 'shocked' that originator companies use patent rights and other legal measures to delay entry by generic companies.

The report explores innovators' actions against other innovators and shortcomings in the patent and regulatory systems. However, it reserves most criticism for innovators' actions against generics. The Commission claims that innovators use a 'toolbox' of measures against generics i.e. the use of ancillary patents, patent litigation, patent settlements, regulatory intervention and follow on product switching.

For our full Law-Now on this, click here.

For the text of the full report, click here.

European Commission publishes much anticipated paper on abuse of dominance

On 3 December 2008, the European Commission published a guidance paper on the prohibition of the abuse of a dominant position under Article 82 EC Treaty. The paper addresses the Commission's enforcement priorities regarding the application of Article 82. Almost three years ago the Commission published a discussion paper on Article 82 and since then debate has continued on the contents of the Commission's finalised guidance on Article 82, particularly in the light of a number of Commission and European Court rulings including the Court of First Instance's ruling in Microsoft.

The main message of the new guidance paper is that the Commission intends to prioritise enforcement of cases where a dominant undertaking's conduct is exclusionary and liable to have harmful effects on consumers. The Commission is advocating an effects-based approach i.e. it will focus on the economic effects of the conduct at issue. The Commission's stated intention to follow an effects-based approach may lead to greater flexibility in assessing the circumstances of individual cases; on the other hand, businesses may feel that such an approach reduces legal certainty in the application of Article 82.

For our full Law-Now on this, click here.


Rights issue guidelines relaxed - implications for life sciences companies

Following the issue of new Association of British Insurers (ABI) guidelines, raising equity capital by way of a rights issue should become more streamlined for companies in all sectors. Although the guidelines were relaxed following the problems experienced by UK banks in strengthening their balance sheets, the outcome will be of particular interest for innovative, cash-hungry companies, such as those in the life sciences sector.

The ABI relaxed its guidelines on the limits on directors' authority to allot share capital on 31 December 2008. The ABI's previous guidelines limited the general authority to allot new shares to be given to directors of quoted companies at each AGM to one third of the company's existing issued share capital. The new guidelines allow shareholders to give an annual allotment authority of up to two thirds: half of this is to be reserved for rights issues, while the other half can be used for any purpose. This should result in companies being able to raise significant new funds by way of a rights issue without the need for an EGM to be convened for the purpose. This should make rights issues quicker and cheaper to arrange.

For our full Law-Now on this, click here.

For a more detailed review of the new guidelines, see our recent Rights Issue Guidelines Relaxed Law-Now article by clicking here.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 12/03/2009.

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.

In association with
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