In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that

On 26 September 2013, the highest EU Court issued two important judgments, Dow and EI DuPont.  These judgments confirm that a parent company can be held liable and fined by the European Commission (“Commission”) for the antitrust infringement of its 50:50 JV in the EU.  In so stating, the EU Court endorsed the current hardened approach of the Commission and the General Court, which seeks to attribute antitrust liability to parent companies wherever possible.

In years past, JVs were in principle classified as separate undertakings (with the once-off exception of Avebe).  According to the Commission’s decisional practice, they should not be grouped together with their controlling parents, particularly for the purpose of attributing liability and collecting fines (e.g., Ijsselcentrale, Gosme/ Martell, Rubber Chemicals).  The situation changed with the Commission’s decision in Chloroprene Rubber, where it was held that both parent companies of a 50:50 JV should be held jointly and severally liable for the JV’s conduct. 
Continue Reading Parents’ Liability for Antitrust Infringements of 50:50 JVs: European Court confirms the new stringent approach in EU law

This post originally appeared on our sister blog, InsideMedicalDevices.

The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD).

Case C-219/11 Brain Products GmbH V BioSemi VOF and Others, concerned the product ActiveTwo, a “biopotential measurement system” that records electrical signals from the brain, heart and muscles, manufactured and is marketed by Dutch company BioSemi. ActiveTwo is not designed for use in any medical diagnosis or treatment, but is used by researchers for clinical investigation of cognitive sciences. BioSemi’s website and promotional material state that the product is “not designed or intended to be used for diagnosis or treatment of disease.” As such, BioSemi argued that the ActiveTwo was not a medical device and so did not require CE-marking.
Continue Reading CJEU Clarifies Medical Device Borderline

Originally published as Covington E-Alert on December 10, 2012

On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General

Article originally published in Covington E-Alert, 10 December 2012

On 6 December 2012, the EU Court of Justice dismissed AstraZeneca’s appeal of the General Court’s judgment in AstraZeneca v Commission. The Court of Justice affirmed the reasoning and holdings of the General Court and rejected all of AstraZeneca’s arguments, including its challenge to the General

Originally published as Covington E-Alert on May 17, 2012

On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission.1 The Advocate General largely agreed with the reasoning and holdings of the General Court, and recommended that the

Originally published as Covington E-Alert on May 9, 2011

The EU Court of Justice just issued two long awaited rulings on the interpretation of the rules governing advertising of medicines in Europe. They address (i) the requirement that all advertising must comply with the prescribing information (SmPC) for the product and (ii) the distinction between

Originally published as Covington E-Alert on September 15, 2010

On 14 September 2010, the Court of Justice, the highest court in the European Union (“EU”), ruled that, in the context of EU competition law investigations, legal professional privilege (“LPP”) does not cover communications between in-house lawyers and other employees at a company, even where the

Originally published as Covington E-Alert on October 9, 2009

May a pharmaceutical company charge its wholesalers one price for products to be resold under the national healthcare reimbursement rules, and another, higher price for products to be resold in another EU member state? This was the question addressed by the European Court of Justice (ECJ)