Article 101

On 11 December 2013, the European Commission (“Commission”) sanctioned pharmaceutical firms Johnson & Johnson and Novartis with fines totaling EUR 16.3 million over a co-promotion agreement which allegedly delayed the sale of generic versions of pain killer Fentanyl in the Netherlands.

Johnson & Johnson initially developed and commercialised Fentanyl in the 1960s.  In the Netherlands, patent protection for the Fentanyl depot patch expired in 2005 and Sandoz (a subsidiary of Novartis) was on the verge of launching its generic fentanyl patch.  According to the Commission, it had already purchased packaging material and obtained market authorizations.
Continue Reading Johnson & Johnson / Novartis: Another Pay-For-Delay Down for the European Commission

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

On 19 June 2013, the European Commission imposed fines totaling EUR 146 million to Lundbeck and several producers of generic medicines, including Alpharma, Merck KGaA/Generics UK, Arrow, and Ranbaxy, for infringement of Article 101 TFEU.  This is the first Commission decision dealing with so-called “reverse payment” patent settlements or “pay for delay” agreements.
Continue Reading Lundbeck: First European Commission Decision on “Pay for Delay”

The times when private antitrust damages claims were not a serious risk in the European Union are gone.  The European Commission and national competition authorities are actively promoting follow-on damages claims by private plaintiffs, and national health authorities are themselves bringing huge claims for damages arising from anticompetitive practices.

The following are examples of recent claims:

  • Servier.  In parallel with the EU Commission’s investigation into Servier’s reverse payment patent settlements concerning perindopril, a number of UK health authorities have filed damage claims seeking more than ₤230 million in damages from Servier.
  • Reckitt Benckiser. In connection with the OFT’s 2010 decision imposing a ₤10.2 million fine on Reckitt Benckiser for practices related to Gaviscon Original Liquid, the UK health authorities and a generic competitor have brought follow-on damage claims seeking approximately £89 million from Reckitt Benckiser.
    Continue Reading Private Antitrust Damages Claims in the Pharmaceuticals Sector: Gaining Momentum

Originally published as Covington E-Alert on February 26, 2013

On  20  February  2013,  the  European  Commission  published  for  consultation  its  proposal  for revisions to the EU technology transfer competition regime.  The consultation period runs until 17 May 2013.  The new regime will be adopted before April 2014.  The EU’s approach…
Continue Reading European Commission Consults On Revised Competition Regime For Technology Transfer Agreements

Article originally published in Journal of European Competition Law & Practice Advance Access on July 31, 2012

This survey article discusses the major EU competition law developments in the pharmaceutical sector from 1 July 2011 through 30 June 2012. The developments during this period were largely incremental, but presage what…
Continue Reading The Application of EU Competition Law in the Pharmaceutical Sector

Originally published as Covington E-Alert on April 27, 2010

 On 20 April 2010, the European Commission published new rules governing so-called “vertical” agreements, such as distribution and supply agreements. The new rules are set out in the Vertical Restraints Block Exemption Regulation and the related Guidelines (see DG Competition’s website).

Continue Reading European Commission Revises Distribution Rules

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

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…
Continue Reading Parallel Trade in Pharmaceuticals and EC Competition Law