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.
The Consiglio di Stato rules Italian regions cannot introduce restrictions to the prescription of innovative drugs
The Italian administrative court of last instance (“Consiglio di Stato”), in its recent ruling no. 4546 of 29 September, 2017, stated that Italian regions cannot issue recommendations to limit the prescription of innovative drugs compared to those established by the Italian Agency for Medicines (the “AIFA”).