UK: Lifesciences Snapshot: Winter 2009

INTELLECTUAL PROPERTY

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.

REGULATORY

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.

COMPETITION/EU

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.

CORPORATE

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 www.law-now.com/law-now/mondaq

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.

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