A rare decision of the Grand Chamber of 13 judges of the Court of Justice of the European Union (CJEU) has concluded that supplementary protection certificate (SPCs) should not be available for new applications of previously authorised products. In Santen, the CJEU decided that an SPC will not be available where the applicant relies on a marketing authorisation covering a new therapeutic application of an active ingredient or combination of active ingredients, where that active ingredient/combination has already been the subject of a marketing authorisation for a different therapeutic application.
The CJEU's decision, in effect, to overturn its earlier (controversial) Neurim decision will be welcomed by generic pharmaceutical companies and opens up the possibility of challenges to other granted SPCs. This outcome was foreshadowed by the CJEU's decision last year in Abraxis (discussed here), refusing SPC protection for new formulations of old active ingredients. However, whilst the CJEU said its decision accorded with the aims of the EU legislature for the SPC Regulation, it is worth noting the views of Lord Justice Jacob (as he then was) when referring questions in Neurim in the Court of Appeal in 2011: his view was that refusal of an SPC to Neurim would mean that the SPC Regulation had not "achieved its key objects for large areas of pharmaceutical research; it will not be fit for purpose". There may be interesting questions of interpretation relating to SPCs and retained EU case law after the end of the Brexit transition period.
Article 3(d) of the SPC Regulation provides that one of the criteria for SPC protection is that the marketing authorisation (MA) relied upon is the first authorisation to put the 'product' on the market. Article 1(b) of the SPC Regulation meanwhile defines the 'product' as 'the active ingredient or combination of active ingredients of a medicinal product'.
The French National Institute for Industrial Property had rejected Santen's application for an SPC for the medicinal product marketed under the brand name Ikervis, with the active ingredient ciclosporin. Whilst Santen relied upon an MA obtained in March 2015 for Ikervis, used to treat severe keratitis in adults with dry eye disease, this was not the first MA relating to ciclosporin. In December 1983, an earlier MA had been granted for a medicinal product under the brand name Sandimmun, also with ciclosporin as its active ingredient. Sandimmun was indicated for preventing the rejection of solid organ and bone marrow grafts as well as other therapeutic indications, including the treatment of endogenous uveitis.
The question before the CJEU was whether, under Article 3(d) of the SPC Regulation, an MA may be considered to be the first MA where it covers a new therapeutic application of an active ingredient or combination of active ingredients, and that active ingredient/combination has already been the subject of an MA for a different therapeutic application.
In its earlier Neurim decision, the CJEU had ruled that, under the SPC Regulation, the mere existence of an earlier MA, obtained in that case for a veterinary medicinal product, did not preclude the grant of an SPC for a 'different application' of the same product, provided that that application was 'within the limits of the protection conferred by the basic patent' relied upon.
In order to assess the requirement under Article 3(d) relating to the first MA, the CJEU in Santen first considered the proper approach to the definition of 'product' in Article 1(b). This required an assessment of whether the definition of 'product' was dependent on the therapeutic application of the active ingredient and, in particular, whether a new therapeutic application of an active ingredient could be considered to be a product that was distinct from a different, already known, therapeutic application of the same active ingredient.
The CJEU adopted a strict interpretation of 'product' in Article 1(b) defining it by reference to an active ingredient or combination of active ingredients and not by reference to the therapeutic application of an active ingredient/combination of active ingredients protected by the basic patent. The scope of protection of an SPC, although extending only to the product covered by the MA, covered any authorised use of that product as a medicinal product. Accordingly, the term 'product' was not dependent on the manner in which that product is used, and the intended use of the medicinal product would not constitute a decisive factor for the grant of an SPC. The CJEU therefore concluded that the fact that an active ingredient/combination is used for the purposes of a new therapeutic application does not, where the same active ingredient/combination has been used for a different, known, therapeutic application, confer on it the status of a distinct product.
Accordingly, the CJEU went on to conclude that, under Article 3(d), the first MA for the product as a medicinal product means the first MA for a medicinal product incorporating the active ingredient/combination, irrespective of the therapeutic application of that active ingredient/combination for which that MA was obtained. Contrary to its earlier decision in Neurim, when defining the concept of first MA for the product as a medicinal product, there was no need to take into account the limits of the protection of the basic patent.
The CJEU was satisfied that the approach it was adopting in Santen is consistent with the origins of the SPC Regulation. It stressed that the EU legislature had not intended to protect all pharmaceutical research giving rise to a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.
The outcome allowed a fair balance between the objective of the SPC regime - of compensating for inadequate protection conferred by a patent for the level of research conducted - and all the other interests involved, including public health. It also, said the CJEU, promoted the intended objectives of 'simplicity and predictability' of the SPC regime, avoiding the risk that national offices adopt complex and divergent interpretations.