In the recent UK Intellectual Property Office decision of Neurim Pharmaceuticals (1991) Ltd's application, BL O/384/09, hearing officer Dr C Davies rejected an application to an SPC because it did not comply with Article 3(d) of Regulation (EC) 469/2009.
The facts of the case are as follows: Neurim Pharmaceuticals filed an application for the product melatonin (Ciracadin) based on EP 0518468 (concerning the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject) and authorisation EU/1/07/392/001 as the first authorisation to place the product on the market.
The examiner observed that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product because there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season.
The applicants disagreed arguing that the Regulation should be interpreted teleologically and on such an interpretation the SPC should be granted and that the application does meet the requirements of Article 3(d).
The hearing officer held that, although the applicant was correct in arguing that the SPC Regulation had to be given a teleological interpretation, the case could not be distinguished from the ECJ decision in Pharmacia and the case law was clear that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.
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Strangely for the relevant Pharmacia/Ceftiofur case, the corresponding SPC's are marked as valid in the UK patent register. There's SPC SPC/GB98/004 granted on Ceftiofur hydrochloride (vet) and SPC/GB05/051 (vet) granted on Ceftiofur free acid additionally to the original SPC SPC/GB93/129 Ceftiofur sodium from Sanofi for human use. How comes these can be valid (same indication)and the Melatonin application not. If anyone has an idea ...
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