Bio-Science Law Review - Volume 14 - Issue 3

Evaluating NICE: Good Value for Money?
Pinsent Masons LLP

Since its inception, the role of the National Institute for Health and Care Excellence (NICE), as well as the uptake of its recommendations by NHS organisations has frequently excited comment and criticism. Both the industry and patients have complained about a phenomenon known as 'NICE blight', whereby the NHS will not provide a treatment until it has been approved by NICE, particularly with cancer drugs, where NICE's huge backlog has held back the launch of new treatments. Whilst there is general respect for the role NICE has played over the past 15 years, its status, procedures and remit are under continual review.  When NICE stepped back from making changes to the current value-based assessment model in September last year, NICE chief executive, Sir Andrew Dillon, said that following an extensive consultation, it was clear that just changing NICE's methods would not overcome concerns about how the NHS accesses new innovative treatments and he recommended a broader review. On 21 November 2014 the UK Government announced an 'Innovative Medicines and Med Tech Review' to consider the opportunity for new pathways for the development, assessment and adoption of emerging 21st-century drugs, diagnostics and devices.

Publication of Clinical Trial Data by the European Medicines Agency
Taylor Wessing LLP

The European Medicines Agency ('the EMA') has committed itself to extending its approach to transparency. A key goal for the EMA in this process is the proactive publication of clinical trial data for medicines once the decision-making process on an application for a European Union-wide marketing authorisation is complete. Recently, the EMA has decided to publish the clinical reports that underpin the decision-making on medicinal products for human use. This development follows a process that the EMA started in 2010. Before 2010, the EMA refused access to clinical study reports on the grounds that this would undermine the commercial interests of the manufacturers of those medicinal products. After a complaint filed with the European Ombudsman the EMA decided to grant access to those reports and committed itself to taking appropriate measures to implement the Ombudsman's recommendations.

Intellectual Property Protection of New Varieties of Plants in Sub-Saharan Africa: Overview of Existing Regimes (Part 1)

The 1994 WTO TRIPs Agreement requires WTO members, except least developed countries (for the time being if they do not want to) to provide some form of intellectual property protection to plant varieties, but does not oblige them to utilise a specific IP tool (between patents or sui generis Plant Breeders' Rights) for such protection. In this article, the African Agricultural Technology Foundation (AATF) has sought to provide an overview of the approaches adopted by 33 jurisdictions across Africa for the protection of new varieties of plants using either a sui generis system (UPOV-based or not) or the patent system. These jurisdictions include the two main African regional intellectual property organizations, the Organisation Africaine de la Propriété Intellectuelle (OAPI) and its English-language counterpart, the African Regional Intellectual Property Organization (ARIPO), and 31 national regimes for plant variety protection in Africa. Part 2 of the article will appear in the next issue of the journal.

Case Comments
The European Court of Justice Refines the Meaning of 'Human Embryo'
Redd Solicitors LLP

In International Stem Cell Corporation v Comptroller General ('International Stem Cell Corporation'), the Court of Justice of the European Union ('CJEU') held that a parthenote does not constitute a 'human embryo' if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.  As a result, stem cells derived from parthenotes are not necessarily excluded from patentability in Europe, as was thought to be the case following the CJEU's earlier decision in Brüstle.

What are the Limits of Swiss Form Claims?
Warner-Lambert v Actavis
Kempner & Partners

In two judgments which raise a number of novel and interesting legal points, Arnold J has dismissed Warner-Lambert's application against Actavis for interim relief in respect of its second medical use patent covering the use of pregabalin for treatment of pain.  The judgments address the issue of the mental element of Swiss form claims in the context of infringement.  In Arnold J's view, nothing less than actual subjective intent on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition will suffice to establish infringement of a second medical use patent in Swiss form.  However, Warner-Lambert's claim will now proceed to trial in summer 2015, in which all issues, including construction of Swiss form claims, are likely to be in contention.

Skinny Labelling and indirect Infringement - Consider being Proactive
Novartis v Son
Gertjan Kuipers De Brauw Blackstone Westbroek N.V. Amsterdam