Supplementary protection certificates: clarifications from the EU Court of Justice
In its judgment on Case C-443/17 of March 21, 2019, the European Court of Justice ruled on a significant patent issue following a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (TFEU) from the High Court of Justice (England & Wales).
The Court of Milan on the urgent protection of patents infringed by products sold under the framework of a public tender
In an urgent proceeding before the Court of Milan, the claimant, licensee of the European patent 1089726B1 (correspondent to the Italian patent IT 99930567.5) relating to a food supplement essentially composed of HMB, arginine and glutamine, requested the court grant an injunction against the alleged infringer.
Procedural issues in medical lawsuits
On April 1, 2017, the Gelli – Bianco law, or Italian Law no. 24 of March 8, 2017, hereinafter the “Law”, is now in force, bringing significant changes in medical liability.
A joint HMA and EMA taskforce analyzes the use of big data for the evaluation and monitoring of medicines
The Joint Big Data taskforce (“Taskforce”) between the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) was formed to describe the big data landscape from a regulatory perspective in order to ensure that the EU regulatory system has the capability and capacity to guide, analyze and interpret this data. Its work aims to facilitate the use of such data for the process of evaluation and monitoring of medicines by the regulatory authorities, analyzing the risk-benefit of medicinal products during their lifetime.