Supplementary Protection Certificates: Some Further Twists

Author:Mr John Miles, Mike Snodin and Michael Pears
Profession:Potter Clarkson

On 25 November 2011, the Court of Justice of the European Union (CJEU) decided three cases relating to Supplementary Protection Certificates (SPCs) by reasoned order (i.e. without a hearing). The orders follow judgements already handed down in the Medeva (C-322/10) and Georgetown University et al (C-422/10) cases that we previously reported in our IP Update No. 165. The following are further points of note.

Queensland, Daiichi and Yeda: references by the UK courts

In Queensland (C-630/10), Daiichi (C-6/11) and Yeda (C-518/10) further clarity on aspects of SPC law was sought. The cases were referred after the Medeva and Georgetown references but before the respective decisions, and related to similar issues of interpretation. In addition to the more general questions posed in Medeva, each case involved specific questions unique to its facts.

The University of Queensland's SPC applications related to vaccines comprising multiple antigens: Is it permissible for a Product comprising multiple active ingredients to be protected by a basic patent if those actives were protected across a family of patents derived from the same application? When the basic patent claims a process for making a Product, does that Product needed to be obtained directly by means of that process in order to be considered protected?

Daiichi's SPC application related to an anti-hypertensive combination therapy. The issue was whether the 'infringement test' is the correct test for assessing whether a Product is protected by a basic patent, or whether it is necessary to have some degree of specification of the Product's active ingredients in the claims.

Yeda's SPC applications concerned the monoclonal antibody cetuximab: If the infringement test is the correct test to decide whether a Product is protected by a basic patent, does it extend to contributory infringement (i.e. where a Product only infringes by virtue of its supply to a third party to make what is actually claimed)? The question goes to whether claims that specify two active ingredients can be used to obtain an SPC for only one of those active ingredients.

CJEU's reasoned orders

Following the rulings in Medeva and Georgetown, the CJEU decided not to wait for hearings in Queensland, Daiichi and Yeda but has instead issued reasoned orders. The orders largely refer back to the Medeva and Georgetown decisions and, in line with them, conclude that the infringement test is not the correct test to decide whether a...

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