On 19 December 2024 the CJEU handed down their judgment in co-joined cases C-119/22 and C-149/22 (Teva/MSD) concerning Article 3(a) and 3(c) of the SPC Regulation No 469/2009. Article 3(a) of the Regulation requires that “the product is protected by a basic patent in force”. Article 3(c) of the Regulation requires that “the product has not already been the subject of [a SPC]”. Both these provisions have previously been the subject of a number of CJEU referrals, as the CJEU has attempted to provide clarification on how these articles should be interpretated particularly with respect to combination products (i.e. when the product comprises two or more active ingredients, A+B).
The referrals came from the Finnish (C-119/22) and Irish (C-149/22) courts. Both cases concerned SPCs for combination products (A+B) where an SPC for a monotherapy A had already been granted based on an earlier marketing authorisation for A on the same basic patent. The underlying patents (EP1412357 for C-119/22 and EP0720599 for C-149/22) both had claim 1 directed to the compound A, with dependent claims directed to combinations comprising A in combination with other active ingredients, where B was explicitly mentioned in the dependent claims as one of those other active ingredients. For the Irish case the combination product was ezetimibe and simvastatin, and the monotherapy product comprised ezetimibe. For the Finnish case the combination product was sitagliptin and metformin, and the monotherapy product comprised sitagliptin.
There two main issues that the CJEU had to consider can be summarised as follows:
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whether Article 3(c) precludes the grant of an SPC for A+B if an SPC has already been granted for A only, and B is already known from the prior art; and
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whether explicit mention of the combination product (A+B) in the claims is sufficient for the product to be protected by the basic patent under Article 3(a).
The judgment provides clarification on the application of Article 3(c). The CJEU confirmed that Article 3(c) does not preclude the grant of an SPC for A+B if an SPC has already been granted for A only, and B is already known from the prior art.
The CJEU concluded that the Regulation:
“must be interpreted as not precluding 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.”.
The CJEU also confirmed that the condition of Article 3(a) (the product is protected by the basic patent) is not relevant when considering Article 3(c).
With regards to Article 3(a), the CJEU did confirm that the express mention of a product in the claims (as was the situation in the referred cases) was not sufficient for the product to be considered to be “protected by a basic patent”. The CJEU states that it was also necessary “that the product fall under the invention protected by that patent”. The CJEU confirmed the two step test set out in their earlier decision, C-121/17 (Teva), “applies indistinctly, whether or not the product at issue is expressly mentioned in the claims of the basic patent”.
In this two step test from C-121/17 (hereafter referred to as the “Teva test”) a combination is protected by the basic patent if:
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the combination necessarily, in light of the specification and drawings, falls under the invention covered by the patent, and
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each active ingredient is specifically identifiable in light of the information disclosed by the patent and the prior art at the priority or filing date of the basic patent.
In Teva/MSD the CJEU provides an example of one way that a combination may be considered to “fall under the invention” by stating:
“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.”.
However, this decision still left some uncertainty around what level of disclosure in the patent can be relied on for a combination product to be considered to “fall under the invention” of the patent and whether additional evidence could be provided.
We have now had national Courts in France, Austria and Sweden apply the Teva/MSD judgment, with differing conclusions of whether Article 3(a) is met. The French and Austrian Courts concluded the requirements of Article 3(a) were met, whilst the Swedish Court concluded the requirements of Article 3(a) were not met.
The French and Austrian cases concern the same two products and basic patent and were Appeals from decisions to refuse the application for the SPCs from the French and Austrian Patent Offices. The applications for the SPCs are directed to a combination of rilpivirine hydrochloride and tenofovir alafenamide, and a combination directed to rilpivirine hydrochloride, emtricitabine and tenofovir alafenamide. Both are based on EP1632232 and the marketing authorisation for Odefsey®. Claim 1 of the patent is directed to a solid pharmaceutical composition comprising rilpivirine hydrochloride with dependant claims directed to the composition comprising one or more other anti-retroviral agents. The basic patent states in the description that “Combination therapies as described above exert a synergistic effect in inhibiting HTV replication because each component of the combination acts on a different site of HIV replication”.
Both the Paris Court of Appeal (in decisions 22/19239 and 22/19235) and the Vienna Higher Regional Court (in co-joined decision for 33 R 30/25m and 33 R 31/25h) concluded that the products fall under the invention of the basic patent taking into account the guidance provide by the CJEU in the Teva/MSD judgment (step (i) of the Teva test). Both the Paris and Vienna Courts also stated that all the active ingredients of the products are specifically identifiable in light of the information disclosed by the patent and the prior art at the priority or filing date of the basic patent (step (ii) of the Teva test). Thus, both Courts considered that the requirements of Article 3(a) were met and the SPCs should be granted. In particular the Paris Court concluded that the basic patent discloses that the combination of the active ingredients has a combined effect that goes beyond the simple addition of the effects of the active ingredients taken separately, and considered that the existence of examples of the combination in the patent is not a condition for it to fall within the scope of the invention.
The Swedish case was an appeal from a decision to refuse an application for a SPC from the Swedish Patent Office. The application for the SPC is directed to a combination of dapagliflozin and metformin based on EP1506211 and the marketing authorisation for Xigduo®. Claim 1 is directed to the compound dapagliflozin with further claims directed a pharmaceutical combination comprising dapagliflozin and an antidiabetic agent, with metformin expressly mentioned in the claims as an antidiabetic agent.
The basic patent stated “It is believed that the use of the compound of structure I in combination with 1, 2, 3 or more other antidiabetic agents produces antihyperglycemic results greater than that possible from each of these medicaments alone and greater than the combined additive antihyperglycemic effects produced by these medicaments”. The Swedish Patent and Market Court of Appeal (in decision PMA-15113-22) concluded that whilst they considered that step (ii) of the Teva test in C-121/17 was met (i.e. that all the active ingredients of the product were specifically identifiable), they did not consider step (i) of the Teva test to be met. The Swedish Court acknowledged that the description of the basic patent did contain a presumption of a “combined effect” . However the Court did not consider this combined effect was supported by the patent. The Court did not consider the combination contributed to the solution of the technical problem formulated in the basic patent nor that any combined effect is the result of the research that led to the invention protected by the patent. Therefore the Court concluded that the requirements of Article 3(a) were not met.
Whilst the French, Austrian and Swedish cases all related to combination SPCs where the basic patents disclosed a synergistic effect, without any data in the patent demonstrating an effect of the combination, it is noted that other facts of the cases differ. The Swedish case was more in line with the referred cases in the Teva/MSD judgment, in that the basic patents were compound per se patents, in contrast to the basic patent in the French and Austrian cases, in which claim 1 is directed to a formulation. Additionally the basic patent in the French and Austrian cases provided an explanation of the mechanism by which the synergistic effect of the combination can be achieved (“each component of the combination acts on a different site of HIV replication”).
The different outcomes by the Courts demonstrate that there is still uncertainty in the application of the first step of the Teva test provided in C-121/17. However, it is clear that the facts of any given case will be important when determining whether the requirements of Article 3(a) are met.
We wait to see how further national courts and Patent Offices apply the Teva/MSD judgment to combination SPCs and in particular whether they follow the French and Austrian approach or the Swedish approach.
Kilburn & Strode are the instructing attorneys for the French and Austrian cases. Our team has considerable experience advising clients on SPC, please get in touch with Dayle Callaghan, or your usual Kilburn & Strode advisor if you have any related queries.