A Swiss MA is the ‘first authorisation’ for the purpose of an SPC

Further to a request for a preliminary ruling from the High Court of Justice (England and Wales), in the proceeding AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, the Court of Justice of the European Union (CJEU) has ruled that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of article 13(1) of Regulation (EC) No 469/2009 for the purposes of obtaining a supplementary protection certificate (SPC).

This applies in circumstances where the authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency or by the competent authorities of European Union member states in accordance with the requirements laid down in Directive 2001/83/EC on the Community code relating to medicinal products for human use, and the authorities of the Republic of Iceland and the Kingdom of Norway…

Click on the link below to read the rest of the Taylor Wessing briefing.

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

Turnover (£m): 228.00
No. of lawyers: 860
Jurisdiction: UK
No. of offices: 4
No. of qualified lawyers: 67 (International 50)

Jobs