Lifesciences Snapshot: Summer 2008

United Kingdom

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


London Agreement entered into force on 1 May

Following the deposit by France of the instrument of ratification with the German Ministry of Justice on 29 January, the London Agreement entered into force on 1 May 2008. The London Agreement is an amendment to the European Patent Convention that simplifies the language regime, largely or entirely waiving the need for translations of granted European patents. Countries such as the United Kingdom, France or Germany whose national language is also an official EPO language will dispense with translation requirements altogether. It is hoped that the reduction in costs will encourage small and medium-sized enterprises to pursue patent protection.

Actavis UK Limited -v- Merck & Co Inc [2008] EWCA Civ 444

The Court of Appeal has ruled that a Swiss form claim for the use of a pharmaceutical in the manufacture of a medicament could be allowed even where the novelty lay only in a new dosing regime. Emphasising the importance of taking an approach consistent with that of the EPO, the Court rejected arguments that it was bound not to allow such a claim on the basis of the Court of Appeal judgment in Bristol-Myers Squibb v Baker Norton.

The case is likely to be of great interest to the pharmaceutical industry, as it provides a more consistent approach to patentability of Swiss claims across the European Patent Convention countries, and will improve the prospects of pharmaceutical companies seeking to obtain patent protection in the UK for new applications of known substances.

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

T 1319/04 - 3.3.02 Dosage regimen/KOS LIFE SCIENCES, INC. (EPO Board of Appeal)

The European Patent Office Board of Appeal has referred two questions concerning the interpretation of the “second medical use” provisions of the EPC 2000 as introduced in December last year. Specifically, whether it was possible to patent a medicament which is already known for treatment of the same illness where the only novel aspect is the new method of treatment / dosing.

For the full text of the decision, click here.

Government response to the EC’s consultation on counterfeit medicines for human use

In March 2008, the European Commission released a public consultation on proposals for tackling counterfeit medicines. The Commission were of the opinion that the rise in counterfeit medicines has been caused by uncertainty as to the subjects of pharmaceutical legislation and guidance, shortcomings in product integrity and lack of compliance with pharmaceutical legislation and guidance.

The UK government response to the European Commission’s consultation on counterfeit medicines for human use was published in May 2008. In general, the UK government supported the Commission’s proposals, although it asked for further information on how the proposed schemes would operate in practice. The government commented that the requirements of a unique packaging seal from the manufacturer and a ban on repackaging could prevent importers from complying with leaflet and labelling provisions. The government also expressed concern that proposals, in particular the proposal for a centrally accessible record system, could place too heavy a burden on the healthcare profession, especially if the adopted system is incompatible with national systems. For the government’s full response, click here.


Regulation of NHS Advertisements

A Code of Practice for the Promotion of NHS-Funded Services has been issued to regulate the advertising of NHS-funded services. The new Code requires all providers of NHS-funded services to comply with applicable Advertising Standards Authority Codes and additional NHS-specific rules. The purpose is to ensure that patients have accurate information so that they can make effective choices and receive treatment that best fits their individual needs.

The Code applies to all providers of NHS-commissioned services whether independent sector, NHS providers or charities. It also applies to the entire range of promotional activity undertaken by providers of NHS-funded services, including advertising, direct marketing to patients and information directed at referring clinicians. In addition, it is intended to regulate the level of expenditure on promotional activity by requiring open disclosure of this by providers.

Enforcement of the Code will be split. Marketing communications already covered by the Advertising Codes will remain under the existing ASA regime. Complaints under the NHS-specific rules will be administered by the relevant commissioning Primary Care Trust and/or the Strategic Health Authority.

The Code sets out general principles and contains specific rules covering NHS brand/reputation protection; direct marketing to public and referring clinicians; claim substantiation and comparative claims; service providers’ representatives; promotional expenditure; gifts and inducements to clinicians and commissioners as well as the public; testimonials and endorsements; sponsorship; compliance with undertakings and complaints and enforcement.

For the full Law-Now article on this click here.


Stock management of pharmaceuticals

Advocate General Ruiz-Jarabo’s opinion in a case involving GlaxoSmithKline’s (GSK) stock management policy of certain drugs in Greece was released on 1 April 2008. GSK’s policy limited quantities of products sold to wholesalers to levels sufficient to meet the needs of the Greek market. GSK was clear that the policy was intended to limit the levels of parallel trade from Greece. Wholesalers claimed that this policy was an abuse of dominant position under Article 82 EC Treaty. Taking a tough stance towards GSK and the pharmaceutical innovator in general, AG Ruiz-Jarabo considers that a restriction of supply by a dominant pharmaceutical company in order to limit parallel trade can in principle be a breach of Article 82 EC Treaty. He does not accept that the restriction may be justified due to the negative impact of parallel trade on GSK’s incentives to innovate. It remains to be seen whether the ECJ will follow this opinion.

For the full Law-Now article on this click here.


New UK law of fair dealing

Two sets of UK Regulations came into force on 26 May 2008, implementing the EC Unfair Commercial Practices Directive (2005/29/EC). These are the Consumer Protection from Unfair Trading Regulations 2008 (SI 2008/1277 – “CPRs”) and the Business Protection from Misleading Marketing Regulations 2008 (SI 2008/1276 – “BPRs”).

Under the CPRs, unfair commercial practices are prohibited. A practice is unfair if it is a misleading action, a misleading omission, an aggressive commercial practice or is a practice listed in schedule 1 of the CPRs.

The BPRs regulate unfair business-to-business practices in the UK. The Regulations do not alter businesses’ obligations not to use advertisements that mislead other businesses. The main change from the previous legislation is that the rules apply to “indications” and not merely traditional advertising.

For the full Law-Now article on this click here.