Judgment of the CJEU of July 9, 2020, Case C-673/18, Santen
One of the requirements for obtaining a Supplementary Protection Certificate (“SPC”) for a medicinal product is that the marketing authorization (“MA”) for the product for which the SPC is sought must be the first MA granted for that product as a medicinal product (Article 3(d) of Regulation (EC) No. 469/2009). The interpretation of this requirement has long been the subject of significant debate in legal scholarship and case law, particularly following the July 19, 2012, judgment of the CJEU in Case C-130/11 Neurim. In that judgment, the CJEU held that the existence of a prior MA for a veterinary medicinal product did not preclude the granting of a SPC for a different use of the same product.
However, following this ruling, the following questions arose:
- Did this interpretation apply only to cases in which the first marketing authorization concerned a veterinary drug and the second concerned a human drug? Or would it also apply to cases involving new indications or new uses of active ingredients whose first marketing authorizations concerned drugs for the same species (human or animal)?
- And would this also apply to cases involving new formulations of active ingredients whose first marketing authorizations pertained to drugs for the same species (human or animal)?
This second question was decided by the CJEU in the negative in its March 21, 2019, judgment in Case C-443/17 Abraxis: CCPs may not be granted for new formulations of existing active ingredients.
The CJEU has just resolved the first issue in its July 9, 2020, judgment in the Santen case referenced above. It also ruled against the claim: it is not possible to grant a CCP for a new therapeutic use of an existing active ingredient. Below, we summarize the national litigation that gave rise to this judgment and the reasoning followed by the CJEU in its decision:
The main dispute pitted the pharmaceutical company Santen against the French National Institute of Industrial Property (“INPI”). Santen, which specializes in ophthalmology, held, on the one hand, a patent protecting an ophthalmic emulsion whose active ingredient was cyclosporine and, on the other hand, a marketing authorization (MA) for a drug called “Ikervis,” whose active ingredient was cyclosporine, intended to treat severe keratitis in adult patients with dry eye. Relying on that patent and marketing authorization, Santen filed an application with the INPI for a SPC for the aforementioned drug. However, the INPI denied its application, finding that the marketing authorization in question did not constitute, for the purposes of Article 3(d) of EC Regulation No. 469/2009, the first marketing authorization for cyclosporine: in 1983, a marketing authorization had been issued for a drug called “Sandimmun,” whose active ingredient was also cyclosporine. “Sandimmun” was indicated to prevent the rejection of solid organ or bone marrow transplants and for other therapeutic uses, such as the treatment of endogenous uveitis, a complete or partial inflammation of the uvea, the central part of the eyeball.
Santen appealed the previous denial, and the case reached the Paris Court of Appeal, which referred the preliminary ruling question that the CJEU has just resolved.
The CJEU’s ruling is based on the following reasoning:
- The key to determining whether a CCP should be granted for a new therapeutic use of an active ingredient that was previously authorized for another therapeutic use is whether the products covered by the previous marketing authorization and the new marketing authorization can be considered different products simply because they are intended for different therapeutic uses.
- The text of EC Regulation No. 469/2009 defines the concept of “product” in relation to an active ingredient, not in relation to a specific therapeutic use of an active ingredient. It follows that the fact that an active ingredient is used for a new therapeutic use does not make it a “distinct” product when it has already been used for a known therapeutic use.
- Therefore, Article 3(d) of EC Regulation No. 469/2009 must be interpreted to mean that an authorization cannot be considered the first authorization for a product when it concerns a new therapeutic use of an active ingredient that was already the subject of another authorization for a different therapeutic use.
With this ruling, the CJEU overturns the Neurim doctrine, opting for a restrictive interpretation of the requirement set forth in Article 3(d) of EC Regulation No. 469/2009. This ruling will not have been well received by the pharmaceutical industry, which now finds its options limited when it comes to obtaining extended protection of its patent rights for new drugs consisting of a new therapeutic use of an existing active ingredient. However, as the CJEU points out, the EU legislature’s purpose “has been to promote not the protection of any pharmaceutical research leading to the grant of a patent and the marketing of a new drug, but rather that which leads to the first marketing of an active ingredient or a combination of active ingredients as a drug.”
Author: María Cadarso