Arnold J Describes SPC System As 'Dysfunctional'

Yesterday Arnold J handed down a judgment referring yet another SPC question to the CJEU in GlaxoSmithKline Biologicals SA v Comptroller [2013] EWHC 619 (Pat).

The referral relates to GSK's applications for SPCs on an adjuvant (AS03) that it has developed alone, and in combination with an influenza virus antigen.

Previous case law of the CJEU (Pharmacia, MIT and Yissum) suggests that adjuvants are not "active ingredients" and so do not come within the definition of "product" in Article 1(b) of Council Regulation 469/2009/EC (the "SPC Regulation") and cannot be the subject of a certificate. On the other hand, in order to give effect to the overriding objective of the SPC Regulation - that is to encourage research - Neurim interpreted "product" more broadly by including a purpose within the definition.

Depending on which precedent is applied, a different result is achieved, making the issue not acte clair and suitable for a reference to the CJEU. In addition, there had been inconsistent decisions across the EU on the same facts and a similar case had already been referred (Bayer CropScience C-11/13). Arnold J therefore referred questions on whether an adjuvant could be an active ingredient or a constituent part of a combination of active ingredients and so fall within Article 1(b).

As is now customary, Arnold J offered his own view in case it was of assistance. His view is that the SPC system is dysfunctional as it does not provide any certainty and cannot be applied consistenly by local patent offices. The blame for this, he says, lies with a number of EU institutions, in the original drafting of the SPC Regulation, in not amending the drafting to address clear problems and in the lack of clarity in the...