The Court of Justice of the European Union (CJEU) has issued its long-awaited judgement on the interpretation of Articles 3(a) and (c) of the SPC Regulation in the joined cases C-119/22 and C-149/22.
These cases relate to SPCs for combination products where one active ingredient is the subject of its own claims in the patent and the other active ingredient was already known yet is also expressly referenced in the claims. The CJEU confirms that:
- Grant of SPC for Combination Products: Article 3(c) does not prevent the grant of an SPC for a product consisting of two active ingredients, even if one of those ingredients has already been the subject of an earlier SPC and is the only one disclosed by the basic patent, while the other active ingredient was known at the filing or priority date of the patent.
- Express Mention in Patent Claims is Insufficient: Simply being expressly mentioned in the claims of the basic patent is not enough for a product to be considered protected by that patent under Article 3(a). The product must also necessarily “fall under the invention” covered by the patent, as understood by a person skilled in the art, based on the description and drawings of the patent at the filing or priority date.
- Combination Must Fall Under the Invention: For a combination of two active ingredients (A+B) to be protected by a basic patent under Article 3(a), the combination must “fall under the invention” covered by the patent. This means that the combination must be a feature required for solving the technical problem disclosed by the patent.
The aim of the referrals from the Finnish Market Court (C-119/22; our article here) and the Irish Supreme Court (C-149/22; our article here) was to harmonise the interpretation of Articles 3(a) and (c) for combination products, an area that has seen divergence across different courts, to provide clearer guidelines for SPC eligibility.
As a reminder, Article 3 requires that:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted […];
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
“Product” is, in turn, defined in Article 1(b): “‘product’ means the active ingredient or combination of active ingredients of a medicinal product”.
The referred questions were considered and answered by the CJEU in three parts:
- Would Article 3(c) preclude the grant of an SPC for a product consisting of two active ingredients where one of those two active ingredients has already, alone, been 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 already known at the filing date or priority date of that patent?
The CJEU held that the concept of 'product' should be understood strictly as the definition in Article 1(b), and depends solely on the comparison of the active ingredients they contain, not on their therapeutic applications. Accordingly, a combination of active ingredients (A+B) is considered a different product from a product consisting of only one of those ingredients (A or B).
In light of these considerations, the CJEU concluded that Article 3(c) does not preclude “the grant of an 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”.
- Must Article 3(a) be interpreted as meaning that it suffices 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?
The referring court raised the issue of the scope of the two-stage test identified by the CJEU in the judgment in Teva v Gilead (C-121/17). The question was whether this test applies only to situations where the product is not expressly mentioned in the claims of the basic patent.
As a reminder, the Court’s two-stage test in Teva v Gilead states that Article 3(a) is satisfied where:
“even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the inventioncovered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.”
The Court clarified that the two-stage test established in Teva v Gilead applies generally, regardless of whether the product is expressly mentioned in the claims of the basic patent. The Court emphasised that an SPC must relate to the results of the research claimed under the basic patent and for that reason, the claims of the basic patent must be construed in light of the limits of the protected invention, as described in the description and drawings.
Thus, 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” (emphasis added).
- Must Article 3(a) 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?
Regarding the two-stage test in Teva v Gilead, the Court stated that a product consisting of two active ingredients (A+B), for which both active ingredients are expressly mentioned in the claims of the basic patent, must necessarily “fall under the invention” covered by that patent.
The express mention of the two active ingredients comprising the product, in the claims of the basic patent, is sufficient only in the light of the second stage of the test. Accordingly, for a product consisting of two active ingredients (A+B), the Court clarified that it must still be shown that the combination necessarily falls under the invention covered by the patent.
Merely mentioning the possibility of combining an active ingredient disclosed by the patent with another known active ingredient in the public domain is not enough. The patent specification must disclose how the combination of the two active ingredients is a feature required for solving the technical problem disclosed by the patent.
In conjunction, the Court emphasised that the mere fact that one of the active ingredients (B) was known and in the public domain at the filing or priority date does not necessarily disqualify the combination product from being protected. If the combination of the two active ingredients (A+B) has a combined effect that goes beyond the mere addition of their individual effects and contributes to solving the technical problem, it may be concluded that the combination falls under the invention.
Thus, 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” (emphasis added).
COMMENTS
The CJEU's decision has significant implications for SPC cases involving combination products. The court has confirmed that the two-stage test from the Teva v Gilead case now applies universally to all SPC cases. This includes both single active ingredients and combination products, regardless of whether or not the ingredients are expressly mentioned in the patent claims.
The ruling means that patentees may face greater challenges in obtaining SPCs for combination products if their patents disclose both single active ingredients and combinations. The combinations must themselves “fall under the invention” and must be necessary for solving the technical problem disclosed by the patent. Simply listing combinations in a patent, such as from a laundry list, will not be sufficient.
Nevertheless, the application of the test remains somewhat ambiguous, with limited guidance on how to assess whether a combination (A+B) is required for solving the technical problem, and therefore “falls under the invention” of the patent. A synergistic effect between A and B would likely justify an SPC as this is by definition an effect which goes beyond the mere additive effects of A and B. However, the ruling does not define what it means by the terms “invention” and “problem”, nor does it discuss the prospect of there being multiple “inventions” or “problems” in a basic patent. Thus, the extent to which combination products without a synergistic effect are eligible for an SPC remains unknown. At the very least, it seems that patentees will need to demonstrate that the combination per se (e.g. A+B, not just A) genuinely corresponds to the (or at least “an”) invention of the patent. In practice, therefore, it may be best to defer discussion of combinations in patent applications until there has been more experimental work to support arguments for inventive step for particular combinations.
These points highlight the complexities and potential challenges in obtaining SPCs for combination products under the new CJEU ruling and we look forward to seeing how the referring courts assess the CJEU’s references to the invention in the context of assessing Article 3(a). If you have any specific questions or need further clarification on any of these points, feel free to contact our SPC and Regulatory team.
