EU and US Approaches to Delayed Access to Generic Drugs by Enforcement of a Patent or SPC Procured by Fraud

Abstract

This article examines the impact of pharmaceutical patent protection on the introduction of generic drugs on the market. Basing itself on the Court of Justice of the European Union (CJEU) AstraZeneca case and US case law it examines, in particular, the way in which pharmaceutical companies may have created artificial barriers to entry for the market launch of generic drugs, so as to maintain market dominance by way of “life cycle management strategies”. Moreover, it compares the different ways, in which the EU and US have chosen to address the problem of the abuse of regulatory procedures by fraud with its purpose of delaying generic drug approvals. It also seeks to answer the question of whether the existence of a legal entitlement to a patent under the rules of patent law excludes competition-law liability.

This article examines the impact of pharmaceutical patent protection on the introduction of generic drugs on the market. Basing itself on the Court of Justice of the European Union (CJEU) AstraZeneca case and US case law it examines, in particular, the way in which pharmaceutical companies may have created artificial barriers to entry for the market launch of generic drugs, so as to maintain market dominance by way of “life cycle management strategies”. Moreover, it compares the different ways, in which the EU and US have chosen to address the problem of the abuse of regulatory procedures by fraud with its purpose of delaying generic drug approvals. It also seeks to answer the question of whether the existence of a legal entitlement to a patent under the rules of patent law excludes competition-law liability.