After a bit of lull in 2015 and most of 2016, there has been a flurry of questions being referred to the CJEU seeking clarity on the interpretation of certain provisions within Council Regulation 469/2009/EC of 6 May 2009 (the SPC Regulation). The most recent referrals were made pursuant to two judgments handed down in the UK by Mr Justice Arnold on 13 January 2017.
In the below table, we list these pending SPC referrals and what they relate to. We'll be watching out for any developments and will update this blog accordingly.
Case name |
Date of referral |
Originating country |
Subject matter of questions referred |
Status |
Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala (Case C-492/16) |
14 Sept 2016 |
Hungary |
Date of expiry of SPC |
Awaiting CJEU hearing date |
Merck Sharp v Comptroller-General of Patents, Designs and Trade Marks (Case C-567/16) |
10 Nov 2016 |
UK |
Whether a so-called “end of procedure notice” can be considered equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation) |
Awaiting CJEU hearing date |
Pfizer Ireland Pharmaceuticals, Operations Support Group v Orifarm GmbH (Case C-681/16) |
27 Dec 2016 |
Germany |
SPCs and the specific mechanism to prevent the importation of products in the Federal Republic of Germany
|
The time for submitting written observations expires on 12 April 2017 Any comments to UKIPO by 16 February 2017 |
Teva UK Limited & Others v Gilead Sciences Inc [2017] EWHC 13 (Pat) |
13 Jan 2017 |
UK |
Interpretation of the meaning of "protected by basic patent" in Article 3(a) of the SPC Regulation |
UKIPO yet to provide notification of this reference |
Abraxis Bioscience LLC v The Comptroller-General of Patents [2017] EWHC 14 (Pat) |
13 Jan 2017 |
UK |
Interpretation of the meaning of "product" in Article 3(d) of the SPC Regulation |
UKIPO yet to provide notification of this reference |