On 12 March, the Court of Justice of the European Union (“ECJ”) ruled on the possibility of issuing a valid supplementary protection certificate (“SPC”) for a combination of two active ingredients, one the object of the basic patent (and already covered by an SPC) and the other one in the public domain but claimed in the patent in combination with the ingredient object of the invention. The issue, discussed in Case C-577/13, is substantially similar to that handled by the same ECJ in case C-443/12 (Actavis v. Sanofi), which we discussed here on this blog.
The case from which the decision originates is pending between the pharmaceutical companies Boehringer Ingelheim and Actavis. The former holds a patent on the antihypertensive active principle “telmisartan” and obtained a first SPC for that active ingredient in the medicine “Micardis”, which expired in 2013. Subsequently, it obtained a second SPC, expiring in 2017, for the combination of telmisartan with the diuretic “hydrochlorothiazide” (which, however, was in the public domain), a combination that was claimed in the basic patent and was contained in the medicinal product “MicardisPlus”. However, Actavis challenged the validity of the second SPC based on Art. 3 of the EU Regulation no. 469/09, under which a valid SPC can be granted only if the product (aka “the active ingredient or combination of active ingredients of a medicinal product“) “is protected by a basic patent in force” (art. 3 (a)) and “has not already been the subject of a certificate” (art. 3 (c)).
The key issue under discussion was essentially whether the product made of the combination of telmisartan plus hydrochlorothiazide could be considered a product protected “as such” by the basic patent for telmisartan, as required by the combination of Articles 1(c) and 3(a) of EU Regulation no. 469/09 for a valid SPC to be granted for that product. According to Boehringer, the fact that such a combination was claimed by the basic patent was sufficient to meet this requirement. Actavis challenged this on the grounds that hydrochlorothiazide was not the subject matter of the patented invention but was instead in the public domain: therefore, to the aim of issuing a valid SPC, the combination of the two principles could not constitute a “product” different from telmisartan alone, which had already been granted an SPC.
To answer the question submitted by the referring (English) court, the ECJ first that noted that “it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’” (as already stated in C-484/12 and in C-443/12).
Secondly, the Court reminded that “the SPC is designed to re-establish a sufficient period of effective protection of a 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 that patent was filed and the date on which the first marketing authorisation in the European Union was granted”. Nevertheless, the Court specified, the aim pursued by the SPC “is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible commercial forms, including in the form of combinations based on the same active ingredient”. Hence, as already stated in C-443/12, “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, an active ingredient, protected as such by the holder’s basic patent and constituting the subject-matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject-matter of the invention covered by the basic patent”.
It follows, the ECJ concluded, that for a product to be considered “protected as such” by a basic patent and therefore worthy of an SPC, that product (active ingredient) “must constitute the subject-matter of the invention covered by that patent”. As a consequence, “where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained an SPC, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance”, a second SPC cannot be granted for such combination.