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Is it possible to obtain an SPC on the basis of an MA granted for a new formulation of an active ingredient that has already been authorized ?

In the Neurim case (C-130/11 ; 19 July 2012), the Advocate General of the Court of Justice of the European Union (CJEU), recognized the possibility of obtaining an SPC for a new “application” of a product, for which an MA had been granted, provided such application was protected by the basic patent.

The question arose as to what scope should be given to the term “application”.

Was it solely a new therapeutic use of a known active ingredient, or could it more generally be other applications, such as a new formulation or a new dosage?

This is was the question asked of the Court of Justice in the case Abraxis Bioscience LLC (C-443/17).

In this case, the Attorney General handed down his findings on 13 December 2018.

According to the Attorney General, it is not possible to obtain an SPC for a new formulation of an active ingredient that has already been authorized.

However, from his grounds, it would appear that the Attorney General wished to go further, since he wanted the Neurim decision itself to be called into question.

He is favorable to a strict interpretation of the Regulation on SPC’s which would allow the grant of an SPC only on the basis of the first MA, and not on the basis of a subsequent MA. even if granted for a new therapeutic indication.

Will the CJEU follow the Attorney General?

It is to be recalled that in the Neurim case, the Attorney General was not opposed to obtaining an SPC for a new application of an active ingredient. However, he made the grant of such an SPC dependent upon conditions that are different from those which were finally adopted by the CJEU.

It cannot be ruled out that, in the Abraxis case, the CJEU will again take a decision diverging from the position of the Attorney General.

                               Thierry Caen                                                                     Léa-Marie Rogemont