The Impact of Regulatory Systems in Life Sciences: Emerging Exclusive Rights Growing outside the Scope of the Traditional Intellectual Property System?

摘要

Regulatory rights, introduced in order to address public health concerns, have recently evolved into valuable components of the pharmaceutical industry's exclusive rights portfolio. This article looks into two regulatory systems, namely the Orphan Drugs Regulation Regulation 141/2000 and the Paediatric Extension, introduced by means of Regulation 1901/2006. Taking into consideration the fact that both these systems share terminology and a number of central provisions with the Data and Marketing Exclusivity Directive, Directive 2001/83 on the Community code relating to medicinal products for human use (Consolidated version: 16 November 2012), the article will also briefly refer to the rights granted as a result of the submission of clinical data for the grant of a marketing authorisation. The article attempts to shed light on the intertwining relationship of regulatory rights that constitutes both the source of their value as well as the source of complications as to their interpretation and application.