Breaking news: Swiss/Liechtenstein questions head for CJEU

Small country with a
long name -- and not
inconsiderable
significance for SPCs

Astrazeneca AB v Comptroller-General of Patents, Designs and Trade Marks [2012] EWHC 2840 (Pat), decided by Mr Justice Arnold this morning, is the latest SPC case to be sent from the courts of England and Wales to the Court of Justice of the European Union for a preliminary ruling.

The first and second questions (at [61]) are:

""1. Is a Swiss marketing authorisation, not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC? 

2. Does it make a difference to the answer to the first question if: 

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or 

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?".

The third question (at [68]) is:

"If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?"

In his judgment, Arnold J explains both the context within which these questions are being asked and the reasoning behind them.