Neurim judgment liberalises SPC system

Today marked the publication of the eagerly-awaited decision of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Phamaceuticals, which the Court of Appeal for England and Wales sent for a preliminary ruling on the basis that it was up to the CJEU to determine whether the SPC Regulation was "fit for purpose" or not.

The full text of the judgment of the CJEU can be read here. Meanwhile, the following note has been kindly provided for The SPC Blog by Edward Oates (Carpmaels & Ransford). Edward writes:

Earlier this morning the CJEU, Europe’s highest court, issued its ruling in case C-130/11 Neurim Pharmaceuticals. The CJEU’s judgment has a liberalising effect on supplementary protection certificate (“SPC”) law and presents new opportunities for extending patents through SPC filings.

Prior to today, and based on a line of CJEU jurisprudence (C-31/03 Pharmacia, C-431/04 MIT, C-202/05 Yissum, C-195/09 Synthon and C-427/09 Generics), it was generally thought that an SPC was precluded (or its duration was truncated) if the active ingredient in question had been authorised in any earlier marketing authorisation within the EU, even if the earlier authorisation related to a different use in a different species. Today’s ruling clarifies that that is not the case and thereby provides an incentive for companies to engage in the research of new uses of previously authorised actives. The precise terms of the Court’s ruling are as follows.

1. Articles 3 and 4 of Regulation ... 469/2009 ... concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation 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 supplementary protection certificate.

2. Article 13(1) of Regulation ... 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

In referring to “a case such as that in the main proceedings” and “an earlier marketing authorisation obtained for a veterinary medicinal product”, the above ruling at first sight avoids explicitly addressing the question of whether the CJEU would have reached the same conclusion had the earlier marketing authorisation related to human use. However, the CJEU’s reasoning makes it clear that the CJEU would indeed have reached the same conclusion had the earlier marketing authorisation related to human use (emphasis added):

“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.

26 In such a situation, only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be 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…

30 … 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.”

As such, today’s judgment widens the possibility of obtaining SPC protection and will be enthusiastically received by holders of pharmaceutical and agrochemical patents.