Tagged: legal certainty

Lundbeck: Remedying IP Overprotection through Competition Law Enforcement in the Pharma Sector

By Konstantinos Sidiropoulos

Introduction

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

Had they only worked one month longer! An Analysis of the Alimanovic Case [2015] C-67/14

By Dion Kramer

In November 2014 the Dano judgment attracted unusual public attention, not least because of its importance for UK Prime-Minister David Cameron’s campaign against the phenomenon of ‘welfare tourism’. Although political and administrative attention has been redirected towards the mounting refugee crisis, scholars, administrators and some politicians have been eagerly awaiting the CJEU’s Alimanovic judgment in the sensitive field of EU citizens’ right to equal treatment as regards access to national welfare benefits. Dano made clear that Member States may reject claims to social assistance by EU citizens who have no intention to work and cannot support themselves. Alimanovic gave the Court the opportunity to clarify the application of this principle in the more complicated factual situation of an EU citizen who applies for social benefits after having worked for 11 months. In its bid to contribute to ‘legal certainty’ and ‘transparency’, Member States will for sure welcome the Court’s judgment, but the legacy of Brey still complicates the desired carte blanche for national authorities to refuse any claim to social assistance by indigent EU citizens. Continue reading