By Konstantinos Sidiropoulos
On 8 September 2016, the General Court (‘GC’) handed down a seminal judgment for the pharmaceutical sector in the Lundbeck case. The judgment is of particular importance, because it is the very first ruling of the EU Courts affirming that pharma pay-for-delay agreements (or reverse payment settlement agreements) may be subject to competition law scrutiny. Pay-for-delay (‘PFD’) agreements are agreements that are intended to delay the market entry of generic manufacturers with generic drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original branded drug). The GC, upholding the European Commission’s (‘Commission’) decision of 19 June 2013, held that Lundbeck and four generic producers had infringed EU competition law by entering into such agreements.
The Commission has lately been particularly active in this area. Indeed, PFD agreements were first regarded as potential targets for scrutiny under competition law in the EU as a result of the Commission’s Pharmaceutical Sector Inquiry, leading to the publication of its Pharmaceutical Sector Inquiry Final Report in July 2009. Since then, the Commission has been continuously monitoring patent settlements between originator and generic companies, publishing six reports on this matter – the latest of those being published in December 2015. Continue reading