1
Jun 19
Adverse reaction to medicines and pharmaceutical companies’ liability: valuable tips from the Court of Cassation
With Judgment no. 6587 of March 7 2019, the Italian Court of Cassation clarified the conditions for the liability of a medicine manufacturer in the event of rare adverse reactions.
9
Apr 19
EU General Court provides guidance to assess whether patent settlements between originator and generics infringe antitrust law (Servier)
On 12 December 2018 the General Court of the EU (“GC”) has passed a set of parallel judgments (we will referrer to Case T-691/14,Servier and Others v. Commission and Case T-684/144,Krka v. Commission) on the incompatibility with Article 101 TFEU of a number of settlement agreements in patent disputes between Servier, which is the originator of Perindopril (a drug primarily intended for the treatment of hypertension and heart failure), and five manufacturers of that drug’s generic versions.
8
Apr 19
Paper on new governance procedures for medical devices in Italy
On March 22, 2019, the Italian Ministry of Health published a document outlining the new governance procedures for medical devices that the Government intends to implement in Italy.
7
Apr 19
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).
6
Apr 19
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.
5
Apr 19
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.