No new SPC possible for active ingredient combined with another active ingredient which is not protected by the patent

PATENT LAW

Situation differs from Biogen and AHP Manufacturing: namely whether such a patent may permit its holder to obtain more than one SPC

"28. However, the main proceedings concern a different situation. They entail a situation in which the same patent may be regarded as protecting a number of products within the meaning of Article 3(a) of Regulation No 469/2009, thus raising a different question from those referred in, inter alia, the cases which gave rise to the decisions in Biogen and AHP Manufacturing, namely whether such a patent may permit its holder to obtain more than one SPC."

No new SPC possible in case the holder of a patent each time he places a medicinal product on the market containing a (1) principle active ingredient, protected by the basic patent and (2) another active ingredient which is not protected by the patent

"30. However, in circumstances such as those in the main proceedings, even if the condition laid down in Article 3(a) of Regulation No 469/2009 were satisfied, for the purpose of the application of Article 3(c) of that regulation, it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent.

31. The SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted (Case C‑229/09 Hogan Lovells International [2010] ECR I‑11335, paragraph 50, and Georgetown University, paragraph 36).

32. In the main proceedings, Sanofi’s patent, which protects the active ingredient irbesartan as such within the meaning of Article 3(a) of Regulation No 469/2009, has already enabled its holder to obtain an SPC relating to that active ingredient. Moreover, it is common ground that hydrochlorothiazide, an active ingredient that is a member of a class of diuretics, is not protected as such by that patent or indeed by any other patent."

Basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent

"41. It should be recalled that the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent, namely, in the main proceedings, irbesartan. In the light of the need, referred to in recital 10 in the preamble to that regulation, to take into account all the interests at stake, including those of public health, if it were accepted that all subsequent marketing of that active ingredient in conjunction with an unlimited number of other active ingredients, not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, such as, in the case of the patent in the main proceedings, ‘beta-blocking compound’, ‘calcium antagonist’, ‘diuretic’, ‘non-steroidal anti-inflammatory’ or ‘tranquilizer’, conferred entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs."

IPPT20131212, CJEU, Actavis v Sanofi

C-443/12 - ECLI:EU:C:2013:833