New therapeutic applications of already authorized active ingredients and SPCS: the CJEU reviews its position on Neurim (CJEU judgment 07.09.2020, Santen Case, C-673/18)

Supplementary Protection Certificates (SPCs) for medicines and, in particular, the requirements they must meet to be granted have generated a significant flow of cases for the Court of Justice of the European Union (“CJEU”) in recent years. The vague wording of Article 3 of Regulation (EC) 469/2009, of May 6, and the hesitant decisions of the court interpreting it have not exactly added clarity to a subject that is so important for the pharmaceutical industry.

The Santen case, on which the CJEU ruled on July 9 (judgment in Case C-673/18), specifically deals with the condition that must be met to grant a SPC, namely that the product in question must have obtained a marketing authorization, which must be the first marketing authorization of the product as a medicine (Article 3.d of Regulation 469/2009).

The court has already ruled on this matter on several occasions. Initially, based on the literal wording of Article 3.d, the CJEU had favored considering that the concept of product contained in this article must be interpreted restrictively as an “active ingredient” or “combination of active ingredients,” and that the use assigned to the medicine was irrelevant so that the first marketing authorization of the active ingredient excluded the possibility of obtaining SPCs for other subsequent uses (Pharmacy, MIT, Yissum cases).

The Neurim case changed everything. Here, the CJEU applied a purposive interpretation of the regulation and determined that an SPC could be granted to an already authorized active ingredient for a different application if this new application is within the protection limits of the basic patent invoked in the SPC application. Thus, in this case, the fact that the active ingredient was already authorized as a veterinary medicine did not prevent it obtaining an SPC to be used as a human medicine if the latter was within the scope of the patent invoked to apply for that new SPC.

Subsequently, in Abraxis, the CJEU seemed to take a backward step and advocated for a restrictive interpretation of Neurim, ruling against granting an SPC to a new formulation of an active ingredient that already had a marketing authorization, even when the new formulation was included in the basic patent invoked.

The Santen case now entails a total U-turn in the CJEU’s position, returning to its starting position and expressly abandoning its Neurim stance. In this case, the court decrees that an SPC cannot be granted to a new therapeutic application of an active ingredient or combination of active ingredients that had already been subject to a marketing authorization for another therapeutic application.

This judgment has major implications for the industry. An article published following the judgment in the blog of the European Patent Lawyers Association (EPLAW), signed by Dr. Tobias Wuttke and Dr. Tobias Popp (Meissner Bolte), quoted a statistic published by the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller e.V.) stating that 63 new medicinal products were launched in Germany in 2019, of which only 25 (40%) consisted of new active ingredients. Of the remainder, 6 (10%) of the launches were new combinations of pre-existing active ingredients. There were 18 (29%) that corresponded to new therapeutic indications of active ingredients that had earlier marketing authorizations, and 14 (22%) to new formulations of active ingredients with previous authorizations. Applying these statistics, the Santen judgment would affect 29% of these medicinal products, which cannot access an SPC and, if we add the Abraxis judgment, the figure is 51%. These are very significant figures that should be subject to reflection on the alignment of the legal regime of SPCs with the purpose of their creation.

By Jorge Llevat