Back in March, Mr Justice Arnold
referred two short, succinct questions to the Court of Justice of the European Union for a preliminary ruling. Just eight months later we now have, in place of the Advocate General's Opinion and CJEU ruling, what the CJEU calls a "reasoned order". The case in question is Case C-210/13
Glaxosmithline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller-General of Patents, Designs and Trade Marks and the questions referred were these:
Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC ?
2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?
The answer given in the reasoned order is as follows:
"Article 1(b) ... must be interpreted as meaning that, just
as an adjuvant does not fall within the definition of 'active ingredient' within
the meaning of that provision, so a combination of two substances, namely an
active ingredient having therapeutic effects on its own, and an adjuvant
which, while enhancing those therapeutic effects, has no therapeutic effect on
its own, does not fall within the definition of 'combination of active
ingredients' within the meaning of that provision".
You can read the reasoned order (which is not currently on the Curia website)
here or download it
here.
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