Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents.
Date: 2012-07-19
20. As is apparent from the respective headings of Articles 2 and 3 of the SPC Regulation, namely, ‘Scope’ and ‘Conditions for obtaining [an SPC]’, first, Article 2 of that regulation seeks to determine in a general manner which products may be the subject of an SPC and, then, Article 3 sets out the conditions under which those products may be granted an SPC (see Case C-195/09 Synthon [2011] ECR I-7011, paragraph 41).
22. That being so, it must also be noted that the fundamental objective of the SPC Regulation is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health (see Case C-322/10 Medeva [2011] ECR I-12051, paragraph 30 and the case-law cited, and Case C-422/10 Georgetown University and Others [2011] ECR I-12157, paragraph 24).
23. The reason given for the adoption of the SPC Regulation is the fact that the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research and the regulation thus sought to make up for that insufficiency by creating an SPC for medicinal products (see Medeva , paragraph 31, and Georgetown University and Others , paragraph 25).
24. It is apparent from paragraph 29 of the explanatory memorandum to the proposal for a Council Regulation (EEC) of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), that, like a patent protecting a ‘product’ or a patent protecting a process by which a ‘product’ is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product, within the limits laid down by Article 4 of that regulation (see, by analogy, Medeva , paragraph 32, and order of 25 November 2011 in Case C-630/10 University of Queensland and CSL , ECR I-12231, paragraph 38).
25. Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.
29. It must be pointed out that the MA in the European Union referred to in Article 13(1) of the SPC Regulation is not intended to take the place of the MA provided for in Article 3(b) of that regulation, that is to say, the authorisation granted by the Member State in which the application is submitted; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the European Union (see, to that effect, Case C-127/00 Hässle  [2003] ECR I-14781, paragraph 73).
30. However, although those two provisions of the SPC Regulation thus refer to the two different territorial areas of the authorisations in question in defining the duration of the protection conferred by the SPC in a particular situation, there is no reason why, as regards the assessment of the very nature of those authorisations, it is necessary to use different criteria according to which the article is applicable. Therefore, the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.