SPCs: the end of the long and winding road?

This article is part of our Biotech Review of the Year - Issue 12 publication.

On 19 December 2024, the CJEU handed down its decision in joined cases C-119/22 and C-149/22, bringing some clarity to the law surrounding SPCs for combination products in Europe. 

This decision came 6 months after Advocate General (AG) Emiliou handed down his opinion on 6 June 2024. Cases C-119/22 and C-149/22 were referrals from the Finnish Market Court and Irish Supreme Court respectively, regarding the conditions for grant of combination product SPCs held by Merck Sharp & Dohme Corp (Merck). 

Background to the referrals 

The Finnish referral (Teva v Merck) concerned Merck’s SPC for Janumet, which contains the active ingredients sitagliptin and metformin and is used for the treatment of diabetes. Merck was granted this SPC based on its marketing authorisation (MA) for sitagliptin in combination with metformin and EP 1 412 357, having previously obtained an SPC for sitagliptin alone based on the same patent but its earlier MA for sitagliptin. The Irish referral (Merck v Clonmel) concerned Merck’s SPC for Inegy, which contains the active ingredients ezetimibe and simvastatin and is used for the treatment of atherosclerosis. Merck obtained this SPC based on its MA for ezetimibe in combination with simvastatin and EP 0 720 599, having previously obtained an SPC for ezetimibe alone based on the same patent but its earlier MA for ezetimibe. In both cases, the underlying patents included claims to the mono-products (sitagliptin and ezetimibe, respectively) and later claims to the combination products. Importantly though, the second active ingredient in each of these combination products (metformin and simvastatin, respectively) were known compounds at the relevant dates. Accordingly, there was no invention in the use of metformin for the treatment of diabetes or the use of simvastatin in the treatment of atherosclerosis.

The SPCs were challenged on the basis that the products (i) were not ‘protected’ by a basic patent within the meaning of Article 3(a) of the SPC Regulation (Regulation), and (ii) were already the subject of earlier SPCs contrary to Article 3(c) of the Regulation. In both cases, the central question was whether an SPC may be granted for a combination of active ingredients (A+B), where an SPC had already been granted for one of those active ingredients (A). Furthermore, is it sufficient for a product to be expressly mentioned in the claims of a basic patent to be “protected” or must it fall under the invention covered by the patent? Given the similarities between the two cases, the referrals to the CJEU were combined.

As acknowledged by AG Emiliou, the issues raised by these referrals are by no means new and have in fact already been the subject of previous CJEU decisions, including those in Actavis I (C-443/12), Actavis II (C-577/13), and Teva I (C-121/17). Nonetheless, uncertainty remained regarding the correct tests to apply, prompting the national courts to make the present referrals. 

Article 3(c) – “the product has not already been the subject of a certificate”

AG Emiliou and the CJEU first addressed Article 3(c) of the Regulation, which several interveners considered to be the key provision for resolving the present cases. The AG disagreed and instead endorsed a straightforward approach to Article 3(c), which was followed by the CJEU. The first step was to determine the “product”, which is defined in Article 1(b) of the Regulation as “the active ingredient or combination of active ingredients of a medicinal product” and was the combination (A+B) in each of these cases. The CJEU reiterated that “active ingredient” does not include substances forming part of a medicinal product which do not have an effect on their own, and an active ingredient or combination of active ingredients do not constitute a distinct product by virtue of a new therapeutic application. The second step was to determine whether the patent holder had already obtained an earlier SPC for that product (ie for A+B). As no prior SPC had been granted for A+B in either case, Article 3(c) was fulfilled. It was irrelevant that earlier SPCs existed for the single active ingredients (A), as these were distinct products. 

In his Opinion, AG Emiliou distinguished this approach to Article 3(c) from the earlier decisions in Actavis I and II (Actavis Cases), which contained similar fact patterns, but in which the CJEU considered that Article 3(c) precluded the grant of a later SPC for a combination product A+B. In the Actavis Cases, the combination SPCs in question were considered invalid on the basis that only ingredient A was “protected” by the basic patent under Article 3(a), being the “core inventive advance” or “sole subject matter of the invention”, and an SPC already existed for ingredient A. Therefore, the grant of an SPC for A+B would be tantamount to the grant of a second SPC for A, contrary to the requirements of Article 3(c). 

Whilst having sympathy for the “pragmatic and teleological reasoning” of the CJEU in the Actavis Cases, the AG considered these decisions erroneously conflated the tests for Articles 3(a) and (c), which must instead be assessed independently, and overlooked the definition of “product” in Article 1(b). The CJEU in the present case, whilst not directly addressing the Actavis Cases, generally followed the AG’s approach, finding that each condition under Article 3 is cumulative and “pursues its own logic and objective, which would be compromised if those conditions were to be confused or merged”. Whilst the condition under Article 3(a) seeks to delimit the material scope of the SPC by reference to the basic patent, the condition under Article 3(c) seeks to limit the temporal scope of the SPC conferred on a given product. 

Departing from the earlier Actavis Cases, the CJEU ruled that Article 3(c) “must be interpreted as not precluding the grant of a supplementary protection certificate (SPC) for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent”.

Article 3(a) – “the product is protected by a basic patent in force”

The remaining questions referred concerned Article 3(a), on which AG Emiliou included a discussion of the previous CJEU case law which was likened to “The Long and Winding Road”, as sung by The Beatles.

According to the AG, the earlier CJEU cases endorsed either an “identification test”, which requires the product to be specified or identified in the wording of the claims (Medeva (C-322/10); Eli Lilly (C-493/12)), or an “invention test”, which requires the product to be the core inventive advance or sole subject matter of the invention (Actavis Cases). This case law led to the two-limbed test in Teva I, which AG Emiliou refers to as the definitive test on Article 3(a) and which the CJEU confirmed applies regardless of whether or not the product at issue is expressly mentioned in the claims. Under the Teva I test, a combination product is protected where: (i) the combination necessarily, in light of the specification and drawings, falls under the invention covered by the patent, and (ii) each active ingredient is specifically identifiable in light of the information disclosed by the patent (this could be an express reference but does not have to be). Importantly, the product must satisfy both limbs (the invention and identification limbs) to be protected. Moreover, the test confirms the autonomous (stricter) meaning given to the term “protected” in the context of SPCs, such that a product could be protected under patent law but not under SPC law.

With regard to satisfying the first limb (the invention limb) of the Teva I test, and by way of example only, AG Emiliou referred to a scenario whereby the active ingredients, when combined, displayed an innovative “synergistic” effect that is useful for treating a particular disease. Such a combination should be the subject matter of a dedicated patent and, assuming the other conditions were satisfied, be open to SPC protection. In this regard, the CJEU decision states that where the patent discloses that the combination has “a combined effect going beyond the mere addition of the effects of those two active ingredients and which contributes to the solution of the technical problem”, then the combination may necessarily fall under the invention covered by the basic patent. In contrast the mere mention, even an express one, in the claims of the possibility of combining the active ingredient (A) with another known active ingredient in the public domain (B, C and so on) is not sufficient to satisfy the invention limb of the Teva I test, without also disclosing how the combination is a required feature of the invention. This may include disclosing a synergistic effect.

In light of this, the CJEU ruled that for Article 3(a) of the Regulation to be satisfied, “it does not suffice that a product is expressly mentioned in the claims of the basic patent for that product to be regarded as being protected by that patent. It is also necessary that the product, from the perspective of the skilled person and in light of the description and drawings of that patent, necessarily falls under the invention covered by the patent at the filing date or priority date.”

Moreover, “a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provision, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combination of those two active ingredients necessarily falls under the invention covered by the same patent.”

What lies ahead for combination SPCs? 

The CJEU decision, which largely follows the AG’s Opinion, appears to be rooted in a policy decision aimed at prohibiting the grant of SPCs for combination products wherein the combination itself is not central to the invention. It endorses an interpretation of the Teva I test which requires an invention test as well as an identification test to be satisfied under Article 3(a). 

Crucially, the CJEU decision does not preclude the grant of all combination SPCs. However,  such SPCs should only be granted where the combination of active ingredients (A+B) forms the genuine subject matter of the invention, for example where the combination provides a synergistic effect to solve a technical (medical) problem.