Updates on Legal Developments in the EU Life Sciences Industry
On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.
The Department of Education and Cabinet Office has published guidance on key workers for COVID-19. The guidance…
On 14 July 2015, the European Commission (the “Commission”) published the preliminary non-confidential version of its decision in the Servier case, one year after the decision was issued. This is the second key Commission decision, after Lundbeck, on reverse payment patent settlement agreements.
In Servier, the Commission went further than in Lundbeck and in its Fentanyl decision concerning a co-operation agreement between Sandoz and Janssen Cilag. It not only looked at whether the settlement agreements between Servier and certain generic companies restricted competition by object, it also analysed their effects. As a result of its analysis, the Commission found that Servier’s conduct amounted to an abuse of dominance under Article 102 of the Treaty on the Functioning of the European Union (the “TFEU”).
In July 2014, the Commission fined Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin a total of €428 million for having concluded agreements that delayed market entry of generic versions of Servier’s blockbuster blood pressure medicine, perindopril, and protected it from price competition from generics in the EU. All these agreements entailed Servier making significant payments (or providing other types of inducements) to the generic companies. In addition to entering into these settlement agreements, Servier adopted various other practices that the Commission found were part of Servier’s overall strategy to delay or prevent entry of generic versions of perindopril.
Continue Reading European Commission Published Non-Confidential Version of Servier Decision
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:
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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 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 fight against bid-rigging (i.e. collusion in public tenders) has become a major enforcement priority for national competition authorities. Companies in the life sciences sector are increasingly targeted by bid-rigging investigations.[1] This development is promoted by the OECD, ICN and UNCTAD, which have done much work to sensitize competition and procurement officials about the harm caused by bid-rigging. In February 2013, a WTO working paper warned that “bid rigging can raise the price paid by governments for goods and services in the order of 20-30%”.[2] In a similar vein, the OECD emphasizes the need to contain public spending on healthcare, which has risen by over 70% per capita since the early 1990s and absorbed on average over 9% of GDP in 2010.[3] In this context, national authorities consider competition enforcement against bid-rigging as a tool to achieve value for money in healthcare public tenders.
Examples of national cases in 2008-2012
Continue Reading Combatting Bid-Rigging in Healthcare Markets: Increased Enforcement Activity
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:
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:
