France

French IPO allows extension of the duration of SPCs on the basis of the MA notification date

Laëtitia Bénard

The French Intellectual Property Office (IPO) recently issued a notice (French language) advising that the expiration date of French supplementary protection certificates (SPC) can be extended upon request of the registered SPC holder. The notice applies the 2015 Seattle Genetics ruling of the European Court of Justice (ECJ) which held that the relevant date for the Read More

ANSM recommendations prohibit use of umbrella brands with respect to health products in France

Eveline Van Keymeulen

Last week, the French National Agency for Medicines and Health Products Safety (ANSM) published its final recommendations for applicants and holders of marketing authorisations (MA) on the choice of medicinal product names (the Recommendations). The Recommendations were issued following a public consultation by the ANSM in October-November 2016 (see our previous blog post: ANSM opens Read More

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

France issues guidance on reporting non-compliant prescribing or use of medicinal products

Eveline Van Keymeulen

On 22 December 2017, the National Agency for Medicines and Health Products Safety (ANSM) published guidelines to assist pharmaceutical companies when reporting intentional non-compliant prescribing or use of medicinal products. Non-compliance can in particular relate to the indication, patient characteristics, administration route or posology of the products. French law requires pharmaceutical companies to report to Read More

French court confirms that pharmacists can sell non-prescription medicinal products on Doctipharma e-platform

Patricia Carmona Botana

In December 2017, the Court of Appeal of Versailles ruled  that retail pharmacy websites can sell non-prescription medicinal products on the online platform doctipharma.fr, thus overruling the May 2016 first instance decision of the Court of Nanterre. The Court of Appeal confirmed that Doctipharma does not act as an illicit “intermediary” in the sale of Read More