Bolar exemption and third-party supply referred to CJEU

By Christoph de Coster and Julia Bödeker

Last month the Düsseldorf Court of Appeal referred questions to the Court of Justice of the European Union (CJEU) on whether and under what conditions the supply of patent-protected substances by a third party to a generic company, which intends to use the substance for obtaining a marketing authorisation, is covered by the Bolar exemption. The decision of the German court and the referred questions are now available in English.

While it is undisputed that generics themselves are allowed to manufacture the patent-protected substance for marketing authorisation purposes under the Bolar exemption, it was unclear whether API suppliers may sell a protected substance to generics for Bolar purposes. The question is crucial for the API suppliers and the generic industry in Europe. If a supply in the development phase is not possible under the Bolar exemption, European API suppliers will be forced out of Europe and the supply sources for generic companies and their ability to enter the market immediately after patent expiry will be seriously limited. The objectives of the Bolar exemption to strengthen the generic industry in Europe and allow immediate market entry of generic products after patent expiry would be at risk…

If you are registered and logged in to the site, click on the link below to read the rest of the Taylor Wessing briefing. If not, please register or sign in with your details below.

Briefings from Taylor Wessing

View more briefings from Taylor Wessing

Analysis from The Lawyer

  • merger deal

    Corporate crunch time: who will triumph at The Lawyer Awards 2014?

    As the equity capital markets rocketed back into favour and global M&A saw at least a partial return to form, there have been some rich pickings for The Lawyer’s Corporate Team of the Year award shortlisted firms in 2014. 

  • singapore orchid

    Singapore: Cash course

    The city-state is working hard to become a global wealth management hub, and law firms are gearing up for a prosperous new world

View more analysis from The Lawyer

Overview

5 New Street Square
London
EC4A 3TW
UK
http://www.taylorwessing.com

Jurisdiction: UK
No. of offices: 4
No. of qualified lawyers: 67 (International 50)

Jobs