The UPC, a single patent court for European Union Member States, has published the first statistics on its case load since its establishment in 2023. Between June 1, 2023, and January 31, 2024, a total of 196 cases were filed...more
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
1/31/2019
/ Criminal Liability ,
Disclosure Requirements ,
Distributors ,
Emotional Distress Damages ,
EU ,
France ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Standards ,
Supreme Court of France
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
The Situation: The French Intellectual Property Office ("IPO") previously refused to adjust the expiration date of a granted supplementary protection certificate ("SPCs") when it had been calculated on the date of grant of...more
French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more