Updates on Legal Developments in the EU Life Sciences Industry
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:
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:
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:
