Supplementary protection certificates for medicinal products: interplay between regulatory law and patent law | Practical Law

Supplementary protection certificates for medicinal products: interplay between regulatory law and patent law | Practical Law

Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs.

Supplementary protection certificates for medicinal products: interplay between regulatory law and patent law

by Carla Schoonderbeek and Paul van Dongen, NautaDutilh
Law stated as at 01 Nov 2010 • European Union
Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs.
This article looks at the:
• Legal framework. • Interaction between pharmaceutical regulatory law, patent law and the SPC and the Paediatric Regulation in case law in Europe.
This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.