File(s) under permanent embargo

Activating actavis in Europe - The proposal of a ‘structured effects-based’ analysis for pay-for-delay settlements

journal contribution
posted on 2016-12-01, 00:00 authored by Sven GallaschSven Gallasch
Striking the right balance between the protection of competition law and intellectual property rights is of utmost importance,especially in the pharmaceutical sector affordable generic drugs are as important as new innovative drugs. Pay-for-delay settlements take place at exactly this intersection. They end patent infringement litigation but,at the same time,delay entry of generic drugs by means of a substantial payment from the brand company to the generic. Whereas the US Supreme Court opted for a rule of reason approach that requires an analysis of the potential anticompetitive effects,the European Commission regarded such settlements as restriction by object,finding an infringement without the need for an effects-based analysis. This approach is criticised and a novel ‘structured effects based’ approach is proposed allowing the authority to effectively scrutinise such settlements while striking the right balance in order to protect the innovative process and the exercise of intellectual property rights.

History

Journal

Legal Studies

Volume

36

Issue

4

Pagination

683 - 705

Publisher

Cambridge University Press

Location

Cambridge, Eng.

ISSN

0261-3875

eISSN

1748-121X

Language

eng

Publication classification

C1.1 Refereed article in a scholarly journal