By Dr. Dr. Adem Koyuncu, Covington & Burling LLP In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may … Continue Reading
Yesterday’s Opinion from Advocate General Saugmandsgaard Øe (AG) in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato takes the position that licensed and unlicensed pharmaceutical products used for the same indication may fall within the same relevant product market. The Italian Council of State (ICS) referred a number of questions to the EU … Continue Reading
The UK’s Competition and Markets Authority (the “CMA”) imposed a £84.2 million (€99.7 million) fine on Pfizer yesterday. In addition, the CMA also fined distributor Flynn Pharma £5.2 million (€6.1 million). The CMA found that Pfizer and Flynn Pharma abused their dominant positions by charging excessive and unfair prices for phenytoin sodium capsules, drugs used … Continue Reading
In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on … Continue Reading
The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine) … Continue Reading
In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union … Continue Reading
The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK.… Continue Reading
Since its in-depth inquiry into the pharmaceutical industry in 2008-2009, the European Commission (the “Commission”) has monitored patent settlement agreements. In its 2014 report published on 2 December 2015, the Commission revealed the results of its analysis of 76 patent settlement agreements between originators and generics (a number “far below” the figures of previous years), … Continue Reading
On Thursday the General Court (the “GC”) held the first two hearings in the Lundbeck case. Generics UK, now part of the Mylan group, and its former parent Merck KGaA (“Merck”) challenged the European Commission’s (the “Commission”) analysis, arguing that the Commission had wrongfully concluded that Generics UK’s settlement agreement with Danish originator Lundbeck restricted competition … Continue Reading
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 … Continue Reading
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 … Continue Reading
On 9 July 2014, the European Commission’s Directorate General for Competition imposed fines totalling € 427.7 million on innovative pharmaceutical company Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin. The Commission’s decision was the result of proceedings opened in 2009 and follows a Statement of Objections sent to the parties involved … Continue Reading
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, … Continue Reading
Earlier this year, the French Competition Authority (“FCA”) held that Sanofi-Aventis infringed the competition laws by implementing a “denigration strategy” aimed at convincing healthcare professionals to limit prescriptions and sales of generic versions of its branded product, Plavix. As punishment for the infringement, the FCA fined Sanofi-Aventis €40.6 million. This decision is another example of … Continue Reading
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
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
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 … Continue Reading
Market definition is integral to a competition authority’s ability to sanction anti-competitive practices under Article 102 TFEU. If the market is defined narrowly, a company is more likely to have a dominant position and thus is more likely to face increased scrutiny of its commercial strategies. In the pharmaceutical sector, recent developments indicate that originators … Continue Reading
Under Belgian law, legal advice provided by in-house counsel to their employers is covered by the protection for legal privilege. That is the conclusion reached by the Brussels Court of Appeal in its judgment of 5 March 2013 in the Belgacom case (Case 2011/MR/3). In addition to the legal advice itself, the legal privilege covers all related … Continue Reading
EU competition law imposes significant constraints on the ability of dominant firms in the life sciences sector to freely determine the price of their products. Price cuts and loyalty-inducing rebates can be abusive. So can excessively high or discriminatory prices. Vertically-integrated firms that control an important input must also ensure that the prices they charge … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 to the application of competition … Continue Reading
