Arnold J describes SPC system as ‘dysfunctional’

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Arnold J has 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…

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