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 …›
Today, the Court of Justice of the European Union (“CJEU”) has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas9, Talen or zinc finger within the framework of the EU’s Directive 2001/18/EC on the deliberate release of genetically modified …›
The EU Trade Secrets Directive, officially titled “Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure” (the “TSD”), is a legal instrument by the European Union (EU) that is intended to harmonize …›
A harmonized trade secrets protection regime is coming to Europe and the U.S. Until now, the approach to trade secrets across Europe has been fragmented, with some countries having specific trade secrets legislation and others relying on unfair competition, tort, or contract law. …›
In both the U.S. and the EU, it is generally acknowledged that the enforcement and commercialization of IP rights must comply with the applicable antitrust laws. This is particularly true for IP licensing. While the majority of provisions in license arrangements will not be …›