Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

Medical devices industry calls for more time to implement EU Medical Devices Regulation

Jacqueline Bore

MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European Parliament and EU member states to allow more time for the implementation of the changes to the regulatory scheme for medical devices brought about by the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), Read More

European Medicines Agency suspends clinical data publication

Jacqueline Bore

The European Medicines Agency (EMA) announced on 1 August 2018 that, as part of its Brexit business continuity plan, it is temporarily suspending the publication of clinical data submitted to it as part of marketing authorisation applications. Data packages submitted before the end of July 2018 will be processed and formalised but no new procedures will Read More

French Administrative Supreme Court quashes mandatory certification of medical prescription assistance software

Eveline Van Keymeulen

On 12 July 2018, the French Administrative Supreme Court (Conseil d’Etat) partially annulled Decree No. 2014-1359 insofar as it establishes a general certification obligation for medical prescription assistance software by the High Health Authority (HAS) regardless of its functionalities (Decision n. 387156). The decision follows a December 2017 preliminary ruling of the CJEU in response Read More

SPCs: CJEU in Teva v Gilead C-121/17 adopts new two-stage test for combination products and pins Art 3(a) to the priority date of the patent

Steven Baldwin

Those looking for clearer guidance on the practical application of Art 3(a) are likely to be left disappointed by this week’s CJEU judgment in the Teva v Gilead SPC litigation. In summary, the Court (who heard this case in a Grand Chamber of 13 judges) has adopted a Lilly v HGS-based approach to Art 3(a) for combination Read More

ECJ: organisms obtained by new mutagenesis plant breeding techniques are not exempted from the GMO Directive

Sophie ten Bosch

Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9. Mutagenesis is Read More