Advocate General's Opinion Concerning the EU Harmonised Test For Granting An Extension Of The Term Of A Patent For Medicinal Products

Author:Ms Sangeeta Puran and Sarah Byrt
Profession:Mayer Brown
 
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Originally published 22 July 2011

Keywords: advocate general, EU harmonised test, extension of term, patent, medicinal products, supplementary protection certificates, SPCs

The Advocate General has delivered her advisory opinion on questions referred to the European Court of Justice seeking clarification on the conditions for obtaining supplementary protection certificates ("SPCs") for medicinal products marketed in EU Member States. The references are from the following UK proceedings: Medeva BV v Comptroller-General of Patents, Designs and Trade Marks (case C-322-10) and Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks (Case C-422/10).

The questions referred to the ECJ consider the conditions for the grant of an SPC set out under Articles 3(a) and 3(b) of Council Regulation (EC) No. 469/2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation"). The key question on which EU harmonisation is sought, is whether Articles 3(a) and 3(b) allow the grant of an SPC for medicinal products comprising active ingredients that are only partially disclosed or claimed in the patent whose term is effectively sought to be extended through the SPC framework.

The reference also asked the ECJ to consider the conditions governing the grant of an SPC for a multi-disease vaccine comprising multiple antigens, including where only one antigen is protected by the patent of interest. The questions relating to vaccines stem from a background where vaccine manufacturers are effectively required by government policy to aim towards large combinations of vaccines wherever possible. The concern by relevant vaccine manufacturers is that, on the application of the narrow test that has been applied to date in the UK to determine whether relevant conditions for the grant of an SPC have been satisfied, no SPC can ever be granted for multi-disease vaccines even though such vaccines require costly investment before marketing authorisation for these vaccines is obtained.

The Advocate General's opinion in effect dismisses the broader "infringement test" argued by the vaccine manufacturer claimant in the underlying Medeva proceedings. Her approach regarding whether relevant conditions for the grant of an SPC have been met supports the narrow test that has been applied to date in the UK. In addition to the specific concerns raised by vaccine manufacturers, it has been argued more generally, that the application of such a test is less favourable to an SPC applicant whose medicinal products comprise active ingredients that are only partially disclosed or claimed in the patent whose term is sought to be extended...

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