Brussels Seminar:
European Regulatory Law
In early 2012 we will be sending invitations for a seminar being held in Brussels on the subject of European regulatory law. If you are interested in attending please send a note of your interest to Karla Fryer: karla.fryer@twobirds.com
Patents and SPC Decisions
A busy year for the CJEU in interpreting the SPC Regulations; more excitement to come
Trevor Cook, London
This year has seen a welter of decisions from the Court of Justice of the EU (CJEU) about Supplementary Protection Certificates (SPCs). In our last Life Sciences Update we reported on its decisions that medicinal products containing active substances that had previously been on the market without having been the subject of authorisation under the EU medicinal products regulatory regime were not eligible for SPCs when they were later the subject of such authorisations.
Oliver Brüstle v Greenpeace e.V. (C-34/10)
Tim Harris, London
The CJEU has handed down its decision in Brüstle on the interpretation of Article 6(2)(c) of the Biotechnology Directive (98/44EC), relating to the concept of a 'human embryo' and its patentability.
UK Supreme Court reverses lower courts as to the validity of HGS' "gene patent" after a thorough analysis of EPO case law on "industrial application"
Trevor Cook, London
On 2 November 2011 the UK Supreme Court delivered judgment in Eli Lilly v Human Genome Sciences, the first patent case it has heard since replacing the House of Lords as the final appellate court in the UK. It reversed the decisions of the lower English courts which had found the patent to be invalid and so in effect upheld the validity of the UK designation of Human Genome Sciences' (HGS) patent EP 0,939,804, as the other issues that remained open in the Court of Appeal and to which the case was remitted are unlikely to result in the patent being held invalid.
Ex parte preliminary injunction in the Valsartan case
Pauline Debre, Paris
On 27 October 2011, the President of the Court of First Instance in Paris ordered ex parte preliminary injunctions against Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S. (hereinafter "Sanofi"), prohibiting the Valsartan generic Zentiva from being sold on the French market.
Regulatory News
New transparency rules on the publication of financial relations between healthcare professionals and the pharmaceutical industry
Colette Mulder, The Hague
In the Netherlands, the advertising of medicinal products is governed by the Medicines Act, which implemented Directive 2001/83/EC on the community code relating to medicinal products for human use, as amended. In addition, the Foundation for the Code for Pharmaceutical Advertising (the "Foundation CGR") has set out, within the legal framework of the Medicines Act, detailed advertising rules in its self-regulatory Code of Conduct for Advertising of Medicinal Products.
Decision n. 5790 of 27th October 2011 of the Conseil d'État on the prescription of medicinal products
Mauro Turrini, Rome
On 27 October 2011 the Conseil d'État upheld the appeal filed by Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. against the decision n. 28/2010 of TAR Puglia.
Industry News
Value Added Tax (VAT) for "Services" to Promote the Life Sciences Sector Does Not Constitute VAT Deduction
Ulrika Hansson and Oscar de Hoog, Stockholm
In two recent cases The Administrative Court of Uppsala (Sw. förvaltningsrätten) delivered interesting judgements relating to VAT deduction for services which promote life sciences in the Stockholm–Uppsala region.
Relocation Programme of the Finnish Medicines Agency Fimea Revisited
Ella Mikkola, Helsinki
As reported in the previous Life Sciences Updates, in 2009 a decision was taken to relocate the Finnish Medicines Agency (Fimea) from the capital city of Helsinki to the city of Kuopio in Eastern Finland. The distance from Helsinki to Kuopio is 400 kilometres.
UK IPO publishes its response to the Research and Bolar Exceptions Consultation
Henry Elliott, London
The UK Intellectual Property Office (IPO) has published its response paper to the consultation launched on 6 June 2011 to investigate the impact of UK patent legislation on the conduct of clinical trials involving pharmaceuticals in the UK.
Contact Us