EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.
Published the new ministerial decree on compassionate use of medicinal products
On 7 September 2017, the Italian Ministry of Health issued a new decree on compassionate use of medicinal products (“Decree”) that, starting from 2 December 2017, will replace the previous ministerial decree of 8 May 2003.
Digital health revolution, how medicine is changing
When you hear about digital health, it’s sometimes hard to understand what it is really about.
Positive outcome for ema’s policy 0070, one year after the publication of the clinical trial results
On October 18, 2017, the European Medicines Agency (EMA) published a report on the implementation of the Policy 0070 on the proactive publication of clinical trials results (Policy).
Diligent requirements for life sciences deals and earn-outs
Contingent payments (a.k.a. earn-outs in transactions among private companies, and contingent payment rights (CPRs) in transactions among listed companies) are a very common and valuable component of purchase price constructs in today’s life sciences and healthcare M&A deals.
Relevance of prosecution history in the assessment of the patent infringement by equivalents: a new trend in Italy
In a recent urgent decision, the Court of Milan held that the prosecution history must be taken into account, and is therefore relevant when assessing patent infringement by equivalence.