National Competition Authorities

On 27 May 2015, the Italian Competition Authority (ICA) issued a decision launching a sector inquiry into the supply of vaccines for human use.

The ICA has stated that it has launched the sector inquiry because of:

  • the importance of vaccines in terms of health care costs borne by the Italian National Health Service (over

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 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 French Competition Authority (“FCA”) is currently investigating the intensity of competition in the supply of pharmaceuticals.  The investigation was launched in February 2013 and concerns all levels of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).

In July 2013, the FCA submitted to public consultation its initial assessment of the pharmaceutical sector.  The FCA raised multiple concerns at every level of the distribution channel.  The main areas of concern identified by the FCA are as follows:
Continue Reading French Competition Authority Issues Preliminary Assessment of Pharmaceutical Sector

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

In February 2013, the French Competition Authority (“FCA”) launched an inquiry into the pharmaceutical sector, examining each level of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).  The FCA is likely to focus on a broad range of issues, including:

  • Generic entry: The inquiry will likely examine pay-for-delay arrangements and other issues relating to generic entry.  Both the FCA and the European Commission are currently investigating several cases relating to practices allegedly aimed at disrupting generic entry.   The FCA has also indicated that, following the sector inquiry, it may publish specific guidance on practices affecting generic entry.
  • Parallel trade: In 2007, the FCA cleared  (subject to certain commitments) the quota systems implemented by several major pharmaceutical companies.  Quota systems are aimed at rationalising wholesale distribution and limiting parallel trade.  The FCA may use the sector inquiry to revisit the issue of parallel trade and re-examine the quota systems.
    Continue Reading French Competition Authority Launches Pharmaceutical Sector Inquiry