In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and …›
The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law, also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more than …›
The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process of executing clinical trials as a prerequisite for obtaining market authorization. In this context, the fact that trademark laws in most jurisdictions …›
In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled in …›
In response to the opinion of European Data Protection Board (EDPB) (see our alert), the European Commission has issued its Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A). The non-binding Q&A offers …›
On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009, effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC …›
There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds …›
In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years. Once a patent has been filed, a …›
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that …›
The United Kingdom is set to leave the European Union on 29 March 2019 (“Exit Date”). With Brexit fast approaching, on 25 November 2018 the EU and the UK announced their consensus on a withdrawal agreement that sets out the terms of the …›