The SPC Regulation requires that a product is protected by a basic patent (Article 3(a)) and that the product has not already been the subject of an SPC (Article 3(c)). There has been uncertainty on how these provisions should be interpreted. A particular source of uncertainty has been the application of these provisions to combination products where one of the active ingredients has already been the subject of an SPC, leading to several referrals to the CJEU (e.g., C-443/12 Actavis and C‑577/13 Actavis II). The CJEU’s judgment in joined cases C-119/22 and C-149/22 Merck Sharp & Dohme (Merck) is the latest in a long line of judgments aiming to provide clarity on the meaning of Articles 3(a) and 3(c).
By way of background, Merck derives from referrals from the Finnish and Irish courts on similar facts concerning combination products, which were joined by the CJEU. In both referrals, a patent was granted for a first substance A, which was authorised as a monotherapy. SPCs were granted for A. The patents also contained claims reciting the combination of A with a further substance B, which was known from the prior art. A+B was authorised subsequently as a combination product and further SPCs were obtained for A+B. The SPCs for A+B had a later expiry date than those directed to A alone. The Finnish and Irish courts referred several questions to the CJEU on whether Articles 3(a) and/or 3(c) precluded the availability of the combination SPCs. After joining the referrals, the CJEU considered there to be two essential questions: (1) whether Article 3(c) precludes the grant of an SPC for A+B when an SPC has already been granted for A and where B is known from the prior art; and (2) whether it suffices for a product to be expressly mentioned in the claims for it to be regarded as protected under Article 3(a).
Article 3(c)
On the first of these questions and Article 3(c), 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.” (the first ruling of the judgment)
Although the ruling concerns the specific scenario of the validity of an SPC for A+B in light of a prior SPC for A, the approach taken by the CJEU appears to be more widely applicable. The CJEU stated that whether two products are identical or different “depends only on the comparison of the active ingredient or ingredients which they contain, irrespective of their therapeutic applications” (paragraph 45). The CJEU also held that “the content of the basic patent is irrelevant in the context of Article 3(c)” (paragraph 54). Therefore, the CJEU appears to consider the assessment of Article 3(c) to be a simple question of whether the product for which an SPC is sought has already been the subject of a granted SPC. This is consistent with the CJEU’s statement that SPC Regulation was “intended to establish a simple system based on conditions which are, in principle, easy to verify.” (paragraph 55, emphasis added).
Article 3(a)
Turning to Article 3(a), the CJEU gave two rulings:
“Article 3(a)… must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.” (the second ruling of the judgment)
“Article 3(a)… must be interpreted as meaning that 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.” (the third ruling of the judgment)
The first of these rulings clarifies that the express mention of a product in the claims of a patent is not sufficient to meet the requirements of Article 3(a). Instead, it is necessary for the product to fall under the invention covered by the patent. The second ruling is subsidiary to the first, referring to the specific case of a combination of A+B and repeating the requirement that the product must fall under the invention covered by the patent.
The CJEU gave some guidance on how to determine whether a product falls under the invention covered by the patent. The CJEU repeatedly referred to whether the patent discloses “how the product is required for the solution of the technical problem disclosed by the basic patent” (paragraphs 62, 64, and 69). Therefore, to demonstrate that the requirements of Article 3(a) are met, it may be necessary to establish a technical problem disclosed by the patent and to explain how the product for which the SPC is sought is required to solve that problem.
For the specific case of a combination product A+B, the CJEU stated that “If the basic patent discloses that the combination of the two active ingredients 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, it may be concluded that the combination of those two active ingredients necessarily falls under the invention covered by that patent” (paragraph 70, emphasis added). Thus, the CJEU considers disclosure of a synergy between A+B to be an example of when the requirements of Article 3(a) may be met.
It remains to be seen whether the CJEU’s ruling on Article 3(a) achieves the goal of providing a simple system which is easy to verify.
Summary
Although the CJEU’s ruling in Merck will hopefully simplify the assessment of Article 3(c), the rulings on Article 3(a) are potentially more complex. We are waiting to see how these rulings will be applied in practice.
Originally published in the CIPA Journal