In December 2024, we reported on the CJEU's judgment in combined cases C-119/22 (Teva) and C-149/22 (Merck) which introduced a new "invention test" for assessing the availability of SPCs for "fixed" combination products (combi-SPCs). For the first time, two national courts have applied the Teva/Merck judgment, with contrasting outcomes for patent proprietors despite broadly similar fact patterns.
The CJEU "invention test" for Article 3(a) of the SPC Regulation
Article 3(a) of the SPC Regulation requires that:
"A[n SPC] shall be granted if ... the product is protected by a basic patent in force"
Decisions C-121/17 (Teva) and C-650/17 (Royalty Pharma) of the CJEU established the following two-step test for determining whether the requirements of Article 3(a) are met.
- The product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by the basic patent.
- The person skilled in the art must be able to identify the product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned.
In Teva/Merck, the CJEU considered the application of step (1) of this test to combi-SPCs, and held that whilst it is possible to obtain separate SPCs to both (i) a monotherapy A and (ii) combination therapy A+B based on the same patent, to obtain the combi-SPC, it is necessary to demonstrate that the combination of ingredients constitutes a feature required to solve the technical problem underlying the basic patent. It is not sufficient for there to be a mere express mention of the combination A+B in the basic patent. Rather, there must be an invention associated with the combination which goes beyond the invention of the monotherapy alone. An example of such an invention explicitly mentioned by the CJEU is evidence of an unexpected synergistic activity between A and B.
As highlighted in our analysis of the Teva/Merck decision, though, the CJEU did not comment on the stage at which evidence of a separate invention in the combination of active ingredients should be provided. In particular, the question remained: must this evidence be present in the patent application as filed?
The first two applications of Teva/Merck, by the Paris Court of Appeal and the Swedish Court of Appeal, highlight that this is indeed a pertinent question, and one to which there is not yet a clear answer. Both of these decisions related to SPC applications based on patents which asserted synergy for a combination A+B, but in which no evidence of said synergy was provided in the patent. The French and Swedish courts have come to different views on whether this scenario satisfies the Teva/Merck invention test.
French court: a reference to synergy in the patent may be sufficient
The Paris Court of Appeal ruled in decision 22/19239 (full text available here) that the requirements of the SPC Regulation, and notably Article 3(a), were satisfied for a combi-SPC application made by Janssen directed to rilpivirine + tenofovir alafenamide based on EP1632232 and the authorisation of the anti-HIV medicine Odefsey®.
In these cases, the basic patent was primarily directed to the drug rilpivirine, though it noted that rilpivirine could be used in combination with other antiretroviral compounds, which explicitly included emtricitabine and nucleotide-like reverse transcriptase inhibitors. Tenofovir alafenamide was known at the priority date of the basic patent to be a nucleotide-like reverse transcriptase inhibitor, such that the court accepted that combinations (a) and (b) were "specifically identifiable" from the basic patent.
The basic patent alleged that by administering rilpivirine with other anti-viral agents, the combination therapy could "exert a synergistic effect in inhibiting HIV replication because each component of the combination acts on a different site of HIV replication". There were, however, no experimental data provided in the patent to substantiate this assertion.
In applying the Teva/Merck invention test, the Paris Court of Appeal held that because the description of the basic patent had referred to synergy, the combination(s) could indeed be considered an invention of the patent. The court considered that the existence of examples relating to the combination in the patent is not a condition for it to fall within the scope of the invention. Thus, the court held the requirements of Article 3(a) to be met.
Swedish court: no substantiation of synergy means no combi-SPC
In contrast to the above decision, the Swedish Court of Appeal ruled in decision PMÄ 15113-22 (full text available here) that the requirements of Article 3(a) of the SPC Regulation were not satisfied for a combi-SPC application made by AstraZeneca directed to dapagliflozin + metformin based on EP1506211 and the authorisation of the diabetes treatment Xigduo®.
The facts at issue in this case are broadly similar to those in the French case. The basic patent was primarily directed to the monotherapy dapagliflozin, but mentioned possible combinations of dapagliflozin with other antidiabetic agents (which explicitly included metformin). The patent also postulated a synergistic effect between the components, reciting that "it is believed that the use of [dapagliflozin] in combination with 1, 2 or 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". Again, there were no experimental data provided in the patent to substantiate this assertion.
The Swedish court took the view that a mere prediction of synergy between two components, with no substantiating evidence, was not enough to satisfy the Teva/Merck invention test. In reaching this conclusion the court considered that without evidence, (i) the asserted synergistic effects cannot be considered to contribute to the solution of the technical problem formulated in the basic patent, and moreover (ii) the effects of the combination are not the results of the research that led to the invention protected by the patent. With the latter reasoning, the Swedish court appears to give weight to the 'spirit' underlying the Teva/Merck decision, in which the CJEU emphasised that it would be contrary to the overriding purpose of the SPC Regulation to grant an SPC that does not relate to the results of the research claimed under the basic patent.
Where does this leave us?
The contrasting outcomes of these proceedings in France and Sweden illustrate that the interpretation of Article 3(a) for combi-SPCs remains uncertain despite the introduction of the Teva/Merck "invention test". In particular, it remains to be seen how other national courts will react in the scenario where a basic patent explicitly envisages a synergistic interaction between A and B (or other beneficial effect of the combination A+B over the respective monotherapies), but does not provide evidence of that synergy/benefit.
Ultimately, the specific facts of any given case will likely prove influential in borderline cases. For instance, a distinction one could draw between the French and Swedish proceedings is that in the patent at issue in France, at least some rationale was provided for why synergy was expected (that the different components of the combination act on a different site of HIV replication), whereas no such theoretical justification was present in the basic patent at issue in Sweden.
It is also worth noting that French proceedings in MSD v Teva – which are parallel proceedings to those in Finland that led to the C-119/22 referral – remain pending before the French Supreme Court. It will be interesting to see whether that higher court in France interprets the CJEU ruling differently to the Paris Court of Appeal.
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