Spanish Supreme Court, 24 April 2025, Teva v. BMS – Apixaban Case no. ECLI:ES:TS:2025:1714
Bristol-Myers Squibb’s (hereinafter “BMS”) patent EP1427145, validated in Spain as ES2329881, protecting the anticoagulant drug apixaban (Eliquis®) has given rise to influential international patent litigation in recent years. Although the patent expired in September 2022, its SPC (Spanish number 201100043) will be valid until 2026.
In 2022, Teva Pharma S.L.U. (“Teva”) filed an invalidity action against this patent and the SPC before the Courts of Barcelona. Firstly, Commercial Court No. 4 of Barcelona agreed with Teva and found the patent to be invalid by decision dated 15 January 2024. However, on 18 July 2024 this first-instance decision was reversed on appeal by the Court of Appeals of Barcelona.
Teva then filed an appeal to the Supreme Court which was however dismissed. By decision dated 24 April 2025, the Barcelona Court of Appeals decision was confirmed in full and therefore the validity of BMS’ patent.
Novelty / right of priority
Teva challenged the priority date of the patent for novelty assessment purposes, arguing that there had been an incorrect assignment of patent rights between the BMS group companies (from the company who had applied for the U.S. priority patent to the company who had applied for the patent application that would give rise to EP1427415. The law of the State of Delaware was applicable to said assignment, of which there was no written agreement.
However, the Barcelona Court of Appeals considered that Teva did not have legal standing to challenge the right of priority and therefore found such lack of priority attack as inadmissible.
According to such Court, the legal standing to bring an invalidity action that is based on a right of priority challenge must be limited to whoever could have made use of said right of priority. It would be different, as the Court pointed out, if other legal requirements were under dispute, such as, for example, when a later applicant claims priority form an earlier application when it relates to the “same invention”. However, in the present case, the Court found that Teva was not entitled to challenge the legal relationship between the first and second applicants given that there was no conflict between them.
The Supreme Court fully agreed with the Court of Appeals on this point and, consequently, dismiss Teva’s invalidity attack for lack of novelty.
Inventive step
Teva argued that all the claims of the granted patent were invalid for lack of inventive step since apixaban would be an arbitrary selection from a large number of prior art compounds.
More specifically, Teva claimed on the basis of the so-called “ab initio” plausibility test (EPO decision T 488/16 dasatinib) that it was not plausible from the original patent application for apixaban to be suitable for the treatment of thromboembolic disorders and that the patent could not rely on said technical effect to demonstrate inventive step.
Firstly, the Court of Appeals of Barcelona addressed the question of whether national courts had to apply the plausibility test for the patent holder to be able to rely on a technical effect to demonstrate inventive step, given the different role that national courts hold with respect to the EPO in the European patent system. To this regard, BMS had insisted during the proceedings that the plausibility requirement for assessing inventive step does not derive from the EPC.
In the Court of Appeals’ opinion, it is not for the national courts to review EPO’s actions, but only to assess the patent as granted, in the context of an invalidity action, on the grounds provided for in the EPC. Therefore, once the patent has been granted, the EPC does not allow national courts not to recognize the inventive step of a granted claim relating to a single product on the grounds that the original application sought protection of other products or compounds that might not have the desired technical effect, when in the end these other products have not been subject to patent protection.
Having said that, for the Barcelona Court of Appeals, the G 2/21 test (EPO Enlarged Board of Appeal decision of 23 March 2023) for the patentee to be able to rely on the technical effects of apixaban described in the application as filed (consisting of inhibiting factor Xa in a sufficiently effective and specific manner for its therapeutic purpose), “does not need to contain information that would make its efficiency plausible to a skilled person“.
In addition, the Court considered that even in the hypothesis that national courts should apply the G 2/21 plausibility test, for a patent to be found invalid, it must be proved that the claimed effect of the claimed subject matter, i.e. apixaban and its ability as a factor Xa inhibitor, are not a concrete embodiment of the original invention. According to the Court, the requirement that the technical effect be plausible “ab initio”, defended by Teva, would have been abandoned by the EPO in G 2/21. BMS could therefore argue the technical effect of apixaban as a new factor Xa inhibitor with improved pharmacological properties, meaning that the patent did have inventive step.
The Supreme Court upheld the appeal judgment in full and, with respect to whether national courts should apply the G 2/21 plausibility test, noted that “although we are not bound by the decisions of the EPO Enlarged Board of Appeal, like so many other national courts, we follow its opinion in view of its authority on the matter and the conviction of its reasoning”.
Furthermore, the Supreme Court added that G 2/21 was more in line with the “ab initio” implausibility test than with the “ab initio” plausibility alleged by Teva: “as opposed to the ab initio plausibility doctrine (based on the information contained in the patent application or common general knowledge, the person skilled in the art at the filing date of the patent application would have considered a plausible effect), Decision G 2/21 is understood to be better aligned with ab initio implausibility (based on the information contained in the patent application or common general knowledge, the person skilled in the art at the filing date of the patent application would have seen no reason to consider the effect implausible).”
Taking into account the common general knowledge of the skilled person which included the importance of the anticoagulant candidates’ inhibiting factor Xa, which is the main technical effect highlighted in the patent application, the expert would have known based on its common general knowledge and the information provided in the patent application that the ability to inhibit factor Xa of these pre-specified compounds, in particular apixaban (ultimately the only compound protected by the patent), as well as the selectivity could be verified by tests that were described in the application and were part of the common general knowledge. Thus, the Court concluded that the expert, based on his knowledge and information in the application, would have considered the technical effect of apixaban (factor Xa inhibitor) included in the technical teaching of the application and also incorporated by the same invention originally disclosed, since the only compound protected in the patent after limitation (apixaban) was explicitly disclosed in the application.
Considering the above, the Supreme Court confirmed the assessment made by the Court of Appeals and considered that BMS’ patent did pass the G 2/21 plausibility test of and was therefore inventive.
Finally, the Supreme Court also referred to other national court rulings on the same issue and in particular to Court of Appeals of The Hague decision of 15 August 2023 which had reached the same conclusion. However, it clarified that it the judgment of the High Court of England and Wales of 7 April 2022, confirmed by a judgment of 4 May 2023 of the Court of Appeals, which found invalidity for lack of plausibility, had not been taken into account because, in addition to no applying G 2/21, it had referred the descriptive insufficiency test set by the Supreme Court of the United Kingdom in Warner Lambert.
Insufficiency of the description
Teva also argued in addition to the above invalidity attack for lack of inventive step that since the therapeutic effect of apixaban was not plausible, claims 5 to 29 protecting therapeutic uses of apixaban would be invalid due to the insufficiency of the description. Teva argued that according to the teachings of G 2/21, proof of therapeutic effect should have been provided in the application originally filed.
In this regard, the Court of Appeals first of all pointed out that such patent claims were not second or further medical use claims referred to in G 2/21 (of known products) but claims for therapeutic uses of a novel product. Therefore, the Court considered that even if G 2/21 was applicable, for the requirement of descriptive sufficiency to be fulfilled, it is not necessary to provide experimental data with the application, unless the expert did not consider the therapeutic effect to be plausible. In any case, for the same reasons explained regarding inventive step, the Court pointed out that BMS could rely on the technical effect of apixaban as a new factor Xa inhibitor with improved pharmacological properties, and that therefore the expert, with the information contained in the application, together with the common general knowledge, made it plausible or had no reason to rule out that apixaban had the claimed therapeutic effects.
Before the Supreme Court, although Teva had not disputed that the attacked claims were not second medical use claims but first medical use claims since apixaban was claimed for the first time in the same patent in which the use was also claimed, it argued that the Court of Appeals of Barcelona had not properly applied the test contained in paragraph 77 of decision G 2/21 (ruled “obiter dictum” by the EPO Enlarged Board of Appeal). However, the Supreme Court considered that this test was not applicable to use claims as in the present case, in line with some subsequent decisions of the Board of Appeals interpreting G 2/21 (e.g. T 2037/22).
In any case, the Supreme Court upheld the assessments made by the Court of Appeals of Barcelona, considering that at the time of the patent application, there was evidence that it was common general knowledge that factor Xa inhibitors were useful for treating thromboembolic disorders due to their good anticoagulant activity, so understandably it contributed to an expert’s finding that a factor Xa inhibitor such as apixaban could be used for the treatment of thromboembolic disorders.
A copy of the decision (in English) can be read here.
A copy of the decision (in Spanish) can be read here.
