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12 September, 2012

On 19 July 2012 the Court of Justice of the European Union (CJEU) handed down a Decision relating to the extension of pharmaceutical patents which will be welcomed by the pharmaceutical industry. It concerns the interpretation to be given to Regulation (EC) No 469-2009 which provides for Supplementary Protection Certificates (SPCs) to extend patents where a product protected by the patent has received a marketing authorisation (MA) to sell the product within the European Union. Such extensions apply only to the product that is the subject of the MA, and are intended to compensate the innovator for delays in receiving the MA which prevent recovery of the investment needed for product development and clinical trials.

Article 3 of the Regulation sets out the conditions to be met if an SPC is to be granted. The product must be protected by a basic patent, a valid MA must have been granted and, of most relevance to the subject Decision, the MA must be the first MA to place that medicinal product on the market within the European Union (Article 3(d)).

In the case at issue, the Applicant for the SPC, Neurim Pharmaceuticals Inc., had a patent covering the new formulation of a known product, melatonin, for use in treating insomnia in humans. They duly obtained an MA for this use and applied for an SPC. The application was refused by the UKIPO on the basis that the Applicant’s MA was not the first marketing authorisation for a product containing melatonin as the active ingredient. The earlier MA was for melatonin for use in regulating the seasonal breeding activity of sheep.

This Decision was upheld by the High Court but, on subsequent appeal, the Court of Appeal referred various questions to the CJEU. In particular, the European Court was asked to consider the scope of Article 3(d) and whether it precluded the grant of an SPC based on a later MA for a different medicinal product containing the same active ingredient where the patent sought to be extended would not have covered the placing of the product the subject of the earlier MA on the market. It was also specifically asked to consider the relevance of the fact that the earlier MA had been granted for a veterinary use and the later MA for human use and for a different indication.

In addressing these questions, the Court referred to the preparatory papers leading to the adoption of the regulation and to Article 4, both of which confirm that a patent protecting a new medical application of a known product, in principle, allows an SPC to be granted which confers the same rights as the basic patent with respect to the new use.

In the Court’s view, it followed that 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, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by a 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 use of that product. Further, the Court concluded that in such a situation, only the MA of the first medicinal product, comprising the product and authorised therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application of the SPC may be considered the first MA of ‘that product’ as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation.

In the light of these considerations, the Court went on to conclude that in a case such as the present where the first MA related to a veterinary use, the mere existence of that earlier MA obtained for a veterinary product did not preclude the grant of an SPC for a different application of that same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.

This is considered a liberalising decision and opens the way for more SPCs to be granted where pharmaceutical research has led to a new pharmaceutical use for a known medicament, and thus for appropriate compensation for the research and clinical trial costs associated with such new developments. This Decision would seem to be in keeping with the fundamental objectives of the SPC Regulation and is expected to encourage this particular form of pharmaceutical innovation.

This Article is by no means exhaustive with respect to the issues raised in the Decision and further questions may be addressed to Claire Baldock – cbaldock@boult.com