One of the requirements to obtain a Supplementary Protection Certificate (“SPC”) for a medicinal product is that the marketing authorisation (“MA”) for the product for which the SPC is sought must be the first authorisation to place the product on the market as a medicinal product (Article 3(d) of Regulation EC No. 469/2009). The interpretation of this requirement has for some time generated considerable debate in legal doctrine and case-law, particularly following the CJEU’s judgment of 19 July 2012 in case C-130/11 Neurim. In said judgment, the CJEU found that the existence of an earlier MA for a veterinary medicinal product did not preclude the grant of a SPC for a different application of the same product
However, after that judgment the following doubts arose:
- Did this interpretation only apply to cases where the first MA referred to a veterinary medicinal product and the second to a human medicinal product? or would it also extend to cases of new indications or new uses of active ingredients whose first MA referred to medicinal products of the same kind (human or veterinary)?
- Would it also extend to cases of new formulations of active ingredients whose first MA referred to medicinal products of the same kind (human or veterinary)?
The CJEU provided an answer (in the negative) to this second question in its judgment of 21 March 2019 in case C-443/17 Abraxis: SPCs cannot be granted for new formulations of old active ingredients.
The issue of the first question has now been resolved by the CJEU in its judgment of 9 July 2020 in the above-mentioned Santen case. Again, the court answers in the negative: it is not possible to grant a SPC for a new therapeutic application of an old active ingredient. Below is a summary of the national proceedings that led to this judgment and of the reasoning followed by the CJEU in its decision:
The main proceedings involved the pharmaceutical company Santen and France’s National Industrial Property Institute (“INPI”). Santen, a pharmaceutical laboratory specializing in ophthalmology, was the holder of, on the one hand, a patent protecting an ophthalmic emulsion in which the active ingredient was ciclosporin and, on the other, a MA for a medicinal product marketed under the name “Ikervis”, the active ingredient of which was ciclosporin, used to treat severe keratitis in adult patients with dry eye disease. On the basis of that patent and MA, Santen filed an application with the INPI for a SPC for the aforementioned medicinal product. However, the INPI rejected the application, finding that the MA in question was not, for the purpose of Article 3(d) of Regulation EC No. 469/2009, the first MA for ciclosporin: a MA had been issued in 1983 for a medicinal product marketed under the name “Sandimmun”, which also had ciclosporin as its active ingredient. “Sandimmun” was indicated for preventing the rejection of solid organ and bone marrow grafts and for other therapeutic uses such as the treatment of endogenous uveitis, an inflammation of all or part of the uvea, the middle part of the eyeball.
Santen appealed the rejection and it was brought before the Court of Appeal in Paris, the court that referred the matter on which the CJEU has now issued a preliminary ruling.
The CJEU’s judgment is based on the following reasoning:
- The key to determining whether a SPC can be granted for a new therapeutic application of an active ingredient for which authorisation was issued in the past in respect of another therapeutic application, is whether the products that are the subject of the past MA and the new MA can be understood to be different due to the fact that they are intended for different therapeutic uses.
- The text of Regulation EC No. 469/2009 defines the concept of “product” in relation to an active ingredient, not in relation to a specific therapeutic application of an active ingredient. It follows that the fact that an active ingredient is used for a new therapeutic application does not make it a “different” product when it has been used for an already known therapeutic application.
- Therefore, Article 3(d) of Regulation EC No. 469/2009 must be interpreted as meaning that it is not possible to consider a MA to be the first MA of a product when it refers to a new therapeutic application of an active ingredient that has already been the subject of another MA for another therapeutic application.
With this judgment the CJEU overturns the Neurim doctrine, opting for a strict interpretation of the requirement of Article 3(d) of Regulation EC No. 469/2009. This ruling will not have been well received by the pharmaceutical industry, which has seen a restriction on the opportunities for securing extended protection of patent rights for new medicinal products consisting of a new therapeutic application of an old active ingredient. However, as the CJEU points out, the intention of the EU legislature was “to protect not all pharmaceutical research giving rise to the grant of 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”.
Author: María Cadarso
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