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.

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

Italian reform of clinical trial rules out of the starting blocks

Marco de Morpurgo

Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force.  The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country.  The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the Read More

Life Sciences IPOs – 5 things to consider

Michael Bloch

After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early.  IPO planning and Read More

UK Court of Appeal asks the CJEU when Markush claims will be sufficiently specific for Article 3(a) of the SPC Regulation

Steven Baldwin

The Appellants in this action, Sandoz and Hexal, are appealing Arnold J’s decision to uphold SPC/GB07/038 on the basis that the Markush formulae in the basic patent are sufficient to satisfy the requirements of Article 3(a) of the SPC Regulation (Regulation (EC) No 469/2009). We have previously commented on the facts here and the first Read More

EU General Court rules on transparency of clinical trial data

Marco de Morpurgo

Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU.  The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier.  The three rulings uphold the European Medicines Agency (EMA)’s decisions to Read More