Dec 23, 2022 UK Supreme Court to assess plausibility of anaemia patents By Heidi Hurdle The UK Supreme Court has just confirmed that it will hear the appeal in FibroGen Inc v Akebia Therapeutics concerning patents for...
Dec 12, 2022 The Legal 500: Pharmaceutical Advertising Comparative Guide 2022 By Sally Shorthose Alexandre Vuchot Johanna Harelimana Christian Lindenthal, LL.M. +1 more... Show less The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
Dec 09, 2022 Rebranding generics as branded medicines – CJEU issues new guidance By Heidi Hurdle The CJEU has provided welcome new guidance on when parallel importers can rebrand generic medicines with the original trade mark of the...
Dec 01, 2022 Dialogue at EU level on the legalisation of recreational cannabis – the German Federal Government’s White Paper will not suffice By Dr. Niels Lutzhöft, LL.M. Dr. Christoph Hendel The Federal Government submits its White Paper on the legalisation of recreational cannabis to the EU Commission for an informal review....
Nov 22, 2022 To repackage or not? Latest CJEU rulings provide guidance for parallel traders of medicines By Guillaume de Villegas Repackaging of medicine is a hotly debated issue between pharmaceutical companies and parallel traders. Last week the CJEU published its...
Nov 03, 2022 The Second Draft Patent Examination Guidelines on Patent Linkage Invalidation, PTE and PTA By Alison Wong Martoe Xu TTThe second draft amendment to the Patent Examination Guidelines (the “Second Draft”) was issued by the China National Intellectual...
Oct 31, 2022 Update on the UK’s future medical device regulations: Extended timelines By Pieter Erasmus The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...
Oct 25, 2022 Blood, cells and tissues: regulatory change is coming By Phillipus Putter Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the...
Oct 10, 2022 Publication of the English version of the new French Clinical Trial Agreement templates By Johanna Harelimana Alexandre Vuchot Nour Saab The French legislator recently updated the French clinical trial agreement template also called “clinical trial sole agreement”...
Oct 07, 2022 The Activation of Payback on Medical Devices By Simone Cadeddu Mauro Turrini The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...
Sep 16, 2022 The Pharmaceutical Intellectual Property and Competition Law Review By Sally Shorthose Christopher de Mauny Pieter Erasmus Peter Willis +1 more... Show less The Pharmaceutical Intellectual Property and Competition Law Review provides a practical overview of pharmaceutical intellectual property...
Sep 07, 2022 China’s First Supreme Court Patent Linkage Decision By Alison Wong Martoe Xu On 5 August 2022, the Chinese Supreme Court (the “SPC”) handed down the second instance judgment on Chugai Pharmaceutical Co.,Ltd (the...
Jul 18, 2022 Final(ly) Rules of Procedure of the UPC By Christopher de Mauny Domien Op de Beeck Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations, directives and laws governing the...
Jul 18, 2022 Spanish Competition Authority analyses distribution of medicines in Spain By Candela Sotes On June 22, 2022, the Spanish Competition Authority (“CNMC”) published a study about the wholesale distribution market for medicines in...
Jun 15, 2022 European Commission proposes to change the rules on regulatory data protection for medicines By Marc Martens Sarah Faircliffe Benedicte Mourisse This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
Jun 01, 2022 To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall By Henri Kaikkonen Mikko Nurmisto Early this year it became clear that the long-pending reform of the European patent system is finally coming to fruition. With the...