24/09/2018 - Intellectual Property

The core inventive advance of the patent as a basis for obtaining a supplementary protection certificate for a medicinal product

Autor: Sonia Sarroca Suñer

The Commercial Court No. 5 of Barcelona has recently dismissed a preliminary injunctions request for considering that a Supplementary Protection Certificate (hereinafter, SPC) of a medicinal product based on the combination of two active ingredients (active ingredient A + active ingredient B) is null and void for contravening arts. 3 a) and 3 c) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (hereinafter SPC Regulation)

The subject-matter of the patent on which the SPC is based is a family of compounds (which includes active ingredient A) which, in the words of the Court, constitutes the “core inventive advance” of the patent.

Furthermore, it mentions that it is possible to combine the claimed compounds with other active ingredients, among which is active ingredient B. Active ingredient B, besides being already part of the state of the art, is always mentioned as one more active ingredient among other alternative options which can be combined with the compounds of the invention, among which is active ingredient A.

The combination of active ingredient A with active ingredient B is not disclosed in a concrete and individualized manner, nor there is any experimental data concerning the eventual advantages it may have over the administration of active ingredient A in monotherapy. Neither there is any mention that the combination of active ingredients would solve any technical problem that is not solved with active ingredient A in monotherapy. According to the Court, “it is nonetheless remarkable… that said combination does not appear in the first claim, the independent claim“. In fact, to arrive at the combination which is the subject-matter of the SPC, active ingredient B must be selected from a list contained in a claim that is multi-dependent, both of the claims addressed to the family of active ingredient A compounds and, indistinctly, of other claims that refer to the category of compounds to which active ingredient B belongs. In short, there are millions of possible combinations.

Based on the foregoing, the Court considers that the SPC contravenes arts. 3 a) and 3 c) of the SPC Regulation. The first of the articles establishes that the product which is the subject-matter of the SPC must be protected by a basic patent in force, while the second establishes that the product must not have already been subject to a prior certificate.

Since “the product” must be the one in which the core inventive advance of the patent resides, the Court considers that only active ingredient A complies with this characteristic and is therefore the only one protected by the basic patent. On the other hand, the holder had already obtained a previous SPC for active ingredient A, which is why, mainly resorting to the Judgment of the European Court of Justice in case C-577/13 (Actavis v. Boehringer – telmisartan/HCTZ), considers that he cannot obtain new SPCs, potentially for a longer period of protection, each time he places on the market a medicinal product containing the active ingredient protected as such in the basic patent combined with other substances which do not constitute the subject-matter of the invention.