Tag Archives: EU Courts

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

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 … Continue Reading

Parents’ Liability for Antitrust Infringements of 50:50 JVs: European Court confirms the new stringent approach in EU law

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 … Continue Reading

Judgment of the Court of Justice in AstraZeneca v Commission

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 … Continue Reading

Judgment of the Court of Justice in AstraZeneca v. Commission

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 … Continue Reading

Cost Considerations Should Not Drive Off-Label Drug Use in the EU

Article originally published in Scrip Regulatory Affairs, June 2012 With off-label drug use in the EU moving into the regulatory spotlight, it is becoming clear just how limited member states are in their power to stimulate – or indeed allow – the practice. Off-label use of medicines always used to be somewhat in the shadows in … Continue Reading

Advertising of Medical Products and Summary of Product Characteristics (Smpc) before the European Court Of Justice

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 … Continue Reading

The AKZO Judgment of the Court of Justice Confirms the Scope of Legal Professional Privilege in EU Competition Investigations

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 … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: the European Court of Justice’s Ruling In Gsk v Commission

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) … Continue Reading

Limiting Parallel Trade

Article originally published in Competition Law Insight on November 25, 2008 May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU member state in order to limit parallel trade in its products in the European Union? This was the question addressed by the European Court … Continue Reading

Parallel Trade in Pharmaceuticals and EC Competition Law

Article originally published in PLC Cross-border Life Sciences Handbook, 2007/08 Apart from patent disputes linked to generic entry, perhaps no issue has spawned more litigation in the European pharmaceutical sector than parallel trade. At the root of the problem are price differences among member states for pharmaceutical products which are caused by national price controls. … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: The European Court of Justice’s Ruling in Syfait v. GSK

Originally published as Covington Life Sciences Alert on June 1st, 2005 May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU country in order to limit parallel trade in its products in the European Union? This was the question put to the European Court of … Continue Reading
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