New decision of the Court of Justice of the European Union ("ECJ") regarding the possibility of issuing a second valid supplementary protection certificate (“SPC”) concerning a further combination of two active ingredients, one of which is the subject of the basic patent and covered by a first SPC, and the other in the public domain but claimed in the patent in combination with the principle subject of the invention.

This case features the companies  Actavis and Boehringer Ingelheim, two renowned pharmaceutical companies. Boehringer, in particular, was the holder of a patent concerning the active principle “telmisartan” (a hypertensive ingredient) and obtained a first SPC for that active ingredient in the medicinal product “Micardis”. Subsequently, Boehringen had requested and obtained a second SPC for the combination of telmisartan with the diuretic “hydrochlorothiazide”, which had already been in the public domain for several decades, combination which was claimed in one of the claims of the basic patent granted through a subsequent modification of the patent.

Actavis has instead challenged the validity of the second SPC on the basis of Article 3 of the EU Regulation n. 469/09, under which a valid SPC can be granted only if “the active ingredient or combination of active ingredients of a medicinal product is protected by a basic patent in force”(Art. 3 (a)) and “was not already granted a certificate” (art. 3 (c)).

The Judge has accordingly referred the matter to the ECJ, asking, essentially, whether the product given by the combination of telmisartan and hydrochlorothiazide could be considered a product protected “as such” by the basic patent on telmisartan, as required by the combination of Articles 1(c) and 3 (a) of the EU Regulation 469/09 in order to be issued a valid SPC on this product. According to Boehringer, the fact that such a combination was claimed by the patent it was sufficient to meet this requirement; on the contrary, Actavise challenged the fact that the hydrochlorothiazide did not constitute the object of the patented invention, but instead was in the public domain and therefore did not meet the requirement of the European provision: the combination of the two principles could not constitute, for the purposes of release of the SPC, a different "product" from the only telmisartan, already the subject of the first SPC.

To answer the question put forward by referring Court, the ECJ firstly stated that “a patent protecting various 'products' can certainly allow in principle to obtain more SPCs in relation to each of these different products, to the extent that in particular, each of the latter are “protected” as such by that 'basic patent'".

Secondly, the Court recalls that “the SPC aims to re-establish a sufficient period of effective protection of the basic patent, allowing the right holders to benefit from an additional period of exclusivity from the expiry of their patent, designed to compensate, at least partially, the delay in the commercial exploitation of his invention because of the lapse of time between the filing date of the patent application and the issuing of the first marketing authorization in the European Union”. However, the Court also stated that the objective of the SPC “is not to cover all of the delays in the commercialization of an invention or to compensate for these delays with respect to all forms of possible commercialization of that invention, including the forms of the compositions generated from the same active ingredient”. Consequently, “it is unacceptable that the holder of a basic patent in force has obtained a new SPC, possibly with a more extended period of validity, each time it enters the market in a Member State with a medicinal product containing on one side, an active principle, protected as such by its basic patent and that constitutes the object of the invention of this patent, and, on the other hand, another substance that does not form the object of the invention protected by the basic patent”. 

In light of the above considerations, the Court of Justice has answered the question by stating that in order fo a product to be considered “protected as such” by a basic patent and therefore worthy of a SPC, the product (in this case, the active principle) “must be the subject of the invention protected by the patent”. Consequently, “where a basic patent includes a claim of a product containing an active ingredient which is the sole object of the invention, for which an SPC has already been issued to the holder of this patent, as well as a claim of a further product containing a composition of this active ingredient with another substance”, a second CPC relating to such composition cannot be obtained.