Lifesciences Snapshot: Autumn 2007

United Kingdom

Bringing you quarterly news of key developments of relevance to the Lifesciences sector

INTELLECTUAL PROPERTY

End to trade mark examination on relative grounds

From the 1 October 2007, the UK Intellectual Property Office will no longer examine trade mark applications on relative grounds. The onus will be on proprietors of potentially conflicting marks to object to the mark.

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

ECJ rules that National Courts are free to decide whether or not to apply TRIPs

The Portuguese Supremo Tribunal de Justica, in Merck Genéricos - Produtos Farmacêuticos Ldª v Merck & Co. Inc. and Merck Sharp & Dohme Ld, referred two questions to the European Court of Justice. The first question being ‘Does the [ECJ] have jurisdiction to interpret Article 33 of the TRIPs Agreement?’ and the second being if the ECJ did have jurisdiction, ‘must national courts apply that article, on their own initiative or at the request of one of the parties, in proceedings pending before them?’

The ECJ declared that it did have jurisdiction to interpret the provisions of the TRIPs agreement and went on to rule that as Community legislation now stands with regards to patents, it is not contrary to Community law for Article 33 of TRIPs to be directly applied by a national court subject to any conditions provided for by national law.

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

Comparative advertising and trade mark infringement

Two recent cases, both of which were cases in which trade mark infringement was alleged, involved applications for interim injunctions to prevent publication of comparative advertising. The outcome of both cases highlighted that advertising, as a form of expression, is protected by the Human Rights Act 1994 and as result both of these cases will make it considerably more difficult to obtain interim injunctions in future comparative advertising cases.

For our full Law-Now on the impact of these cases, click here.

Les Laboratoires Servier and others v Apotex Inc

The High Court held that a patent for manufacturing a single crystalline form of a known pharmaceutical, which could take three possible crystalline forms, is invalid. The original patent for manufacture of the pharmaceutical showed that this process would inevitably produce the claimed crystalline form. In arriving at his decision, Pumfrey J held that although claims had to be construed at their priority date, it was irrelevant that at the date of the original patent it was not known that the pharmaceutical could have more than one form. The original patent anticipated the patent in suit, which also was obvious in the light of the original patent.

For the full judgment in this case, click here.

REGULATORY

Eisai Ltd v National Institute for Health and Clinical Excellence

In the first ever judicial review of NICE, Eisai Limited challenging the decision of the NICE Appeal Panel and the consequent guidance issued by NICE in relation to a particular class of Alzheimer’s medicines, which the guidance stated should not be made available to mild Alzheimer’s sufferers. The High Court decided that the consultation procedure employed by NICE (including the disclosure of only a "read only" version of the economic model used by NICE) did not deny Eisai access to significant information or the opportunity to make an intelligent response. The court decided that NICE were under no obligation to allow consultees to quality assure the model and that there was no substantive legal right for consultees to see every document. The Court rejected all four grounds on which Eisai claimed there had been errors of reasoning which robbed both the guidance and the decision of the NICE Appeal Panel of logic. The Court declined to open up the underlying experts’ debate about the clinical and cost-effectiveness of this class of Alzheimer’s disease medicines by deciding which experts were to be preferred. However, the Court did decide that the NICE guidance was unlawful in that its treatment of certain non-typical patient groups and discriminated against them in breach of anti-discrimination legislation. In consequence, NICE has had to revise its guidance to ensure that this no longer discriminates against those non-typical groups of patients.

Eisai has now applied to the Court of Appeal for permission to appeal the High Court decision on the point of NICE’s refusal to disclose a fully executable version of the economic model.

For the full judgment in this case, click here.

Following the outcome of this case, Shuna Mason and Tony Marks held a briefing seminar at CMS Cameron McKenna’s London office, in which the decision was reviewed and the overall judicial review process examined.

For a copy of the seminar pack that accompanied this briefing please contact Shuna Mason or click here.

HFEA approve hybrid embryo creation in principle

The HFEA’s long awaited decision into the creation of human-animal embryos was released in September, with the Authority deciding that such research did fall within their licensing remit. It had been argued that the creation of hybrid embryos was necessary in order to provide the number of embryos required for the creation of human stem cell lines. Previously researchers have had to rely on surplus human embryos left over from fertility treatment, with such supply being limited in quantity and quality.

The Authority were keen to stress that they were not "green-lighting" hybrid embryos and that each application would be decided on a merit basis with applications likely to be approved if researchers can show, to the satisfaction of the Authority’s Licensing Committee, that the project is necessary and desirable and that it meets the Authority’s standards for embryo research.

The decision has paved the way for previous licence applications made by Kings College London and the University of Newcastle to be considered. Both of these applications were made earlier in the year but were put on hold whilst the Authority completed a public consultation into the issue. The Authority has indicted that it hopes to reach a decision on both of these applications in November and it is expected that both centres will be granted licences.

It still remains to be seen what impact, if any, the Authority’s decision will have on the ongoing review by the Government on the laws on embryo research and assisted reproduction. A move way from the Government’s original plans to ban hybrid embryos has already been seen in the draft Human Tissue and Embryos Bill.

COMMERCIAL

GlaxoSmithKline UK Ltd v Department of Health [2007] EWHC 1470 (Comm) Queen’s Bench Division (Commercial Court)

GlaxoSmithKline ("GSK") has succeeded in an appeal against a decision of a panel appointed under the Pharmaceutical Price Regulation Scheme ("PPRS") on whether branded medicines reimbursed as generics should be included when calculating the overall price reductions given by a particular pharmaceutical company. The Court determined that, under the terms of the PPRS, this practice was not prohibited and that sales of branded products sold to fulfill generic prescriptions could be included in the price reduction calculations. The Court also found that the PPRS was a binding contract.

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

COUNTERFEITING

MHRA successful in medicines counterfeit case

A MHRA investigation in to counterfeit Cialis, Propecia and Viagra has successfully resulted in four men being convicted of offences under the Trade Marks Act 1994 and the Medicines Act 1968. The investigation began back in 2002 when HM Revenue & Customs seized counterfeit drugs at Heathrow and Stanstead airports.

The counterfeits were marketed through licensed wholesalers and Internet sales sites and in some cases the drugs made their way to pharmacies. Counterfeit Cialis was found in the supply chain as far up as patient level, a result of which was a recall of the drug from the UK market in 2004.

The MHRA investigation found that those convicted were part of a larger counterfeiting ring that operated from China, India and Pakistan and that extended as far as the USA. It is believed that during the three year period between 2002 and 2005, over £1,500,000 worth of counterfeit drugs were seized.

R v Wendyfair Markets (St Albans County Court)

In a criminal trail before St Albans County Court, Wendy Fair Markets Ltd ("the Company"), which runs Bovingdon Market, and two of its directors were found guilty of money laundering as a result of counterfeit goods being sold by stallholders. Evidence produced at the trial estimated that 20% of the stalls were selling counterfeit goods, which included CDs, DVDs and computer software. The Company and its directors, who received money in the form of pitch rentals, were found to have ‘turned a blind eye’ to the infringement of intellectual property rights.

COMPETITION

Akzo Nobel Chemicals Ltd and another v Commission of the European Communities (Court of First Instance of the EC)

The Court of First Instance of the EC has maintained the European Court of Justice’s restrictive approach to legal professional privilege by confirming that legal professional privilege does not apply to in-house lawyers in relation to European Commission investigations under EC competition rules.

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

Patent Ambush may be anti-competitive

The European Commission in a Statement of Objections has outlined its preliminary view that Rambus has infringed Article 82 of the EC Treaty (abuse of a dominant position). The alleged infringement stems from the unreasonable level of royalties being charged by Rambus for use of the relevant technology, which in this case was high bandwidth chip connection technologies, which resulted from the patent ambush (a ‘patent ambush’ occurs when, during a standard-setting process, an intellectual property owner fails to disclose its ownership of intellectual property which then subsequently forms part of the new agreed standard.)

This is the first time the Commission has characterised a patent ambush as an abuse of a dominant position.

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

LITIGATION PROCEDURE

Nichia Corporation v Argos Ltd (Court of Appeal)

The majority of the Court of Appeal allowed an appeal against the High Court’s decision to refuse an application for disclosure of an inventor’s records. The majority judges refused to endorse a prima facie rule preventing such disclosure being ordered as they thought it would be unjust. They considered that rather than adopting a blanket rule of non-disclosure of inventor’s records, in the interests of proportionality, disclosure should be tailored depending on the likely value and significance of the evidence to be disclosed. The case highlights the increasing costs of patent litigation.

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

CORPORATE

Employee share incentives in recent Biotech IPOs

CMS Cameron McKenna has recently surveyed employee share plan arrangements as disclosed in company admission documents and prospectuses for biotech companies.

For our full Law-Now on the outcomes of this survey, click here.