This is an informal case summary prepared for the purposes of facilitating exchange during the 2025 WIPO IP Judges Forum.
Session 2: Pharmaceutical Patents
Supreme Court of Spain [2025]: Teva Pharma S.L.U. v Bristol Myers Squibb Holdings, Case No. 7920/2024
Date of judgment: April 24, 2025
Issuing authority: Supreme Court of Spain
Level of the issuing authority: Final Instance
Type of procedure: Judicial (Civil)
Subject matter: Patents
Plaintiff: Teva Pharma S.L.U.
Defendant: Bristol-Myers Squibb Holdings Ireland Unlimited Company
Keywords: Pharmaceutical patents, Priority, Invalidity, Plausibility, Inventive step, Sufficiency of description
Basic facts: Bristol-Myers Squibb Holdings Ireland Unlimited Company (BMS) is the current holder of Spanish patent ES01, which is the national validation of European patent EP01. BMS acquired the patent from Bristol-Myers Squibb Company (BMS Company). The patent protects the active ingredient APIXABAN, which helps prevent blood clots by blocking coagulation factor Xa.
EP01 stems from international application PCT01, filed by BMS Company on September 17, 2002. This application claimed priority from US patent application USP01, which was filed with the United States Patent and Trademark Office on September 21, 2001.
USP01 was filed by its inventors, who were employees of DuPont Pharmaceuticals Company. This company was acquired by BMS Company on October 1, 2001 and renamed BMS Pharma. On November 3, 2001, the inventors signed an agreement to assign all rights to USP01, including the right to claim priority, to BMS Pharma.
BMS is also the holder of the supplementary protection certificate SCP01, which extends exclusivity for the product until May 20, 2026, following expiry of the underlying patent.
ES01 contains 29 claims:
- Claim 1 relates to a compound represented by a chemical formula identifying the active ingredient APIXABAN or a pharmaceutically acceptable salt thereof.
- Claims 2 to 4 relate respectively to a compound represented by the chemical formula identifying the active ingredient APIXABAN, a pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1 and a pharmaceutical composition comprising a therapeutically effective amount of a compound represented by the chemical formula identifying the active ingredient APIXABAN.
- Claims 5 to 22 relate to the use of APIXABAN or pharmaceutical compositions comprising an effective amount of APIXABAN: as a therapeutic agent (claims 5 and 6); as a product in the treatment of thromboembolic disorders (claims 7 to 10); and as a product in the treatment of specific thromboembolic disorders (claims 11 to 22).
- Claims 23 to 29 relate to the use of APIXABAN, or a pharmaceutical composition comprising a therapeutically effective amount of APIXABAN, in the treatment of thromboembolic disorders, in combination with another compound selected from several possibilities.
Claims 1 to 6 are anticipated by the international application PCT02, which was filed on December 3, 2002 and claims priority from December 10, 2001.
As originally filed, the application comprised several compounds, among them APIXABAN. During the granting procedure, in view of the objections raised by the examining body, the applicant limited the claims to APIXABAN and submitted experimental evidence on its technical effect, after which the patent was granted.
Teva Pharma, S.L.U. (TEVA) filed a lawsuit against BMS seeking a declaration that ES01 and SCP01 are invalid, on the following grounds:
(i) Claims 1 to 6 lack novelty as the owner cannot benefit from the claimed priority date (September 21, 2001). TEVA argues that BMS PHARMA did not assign the rights to USP01 to BMS COMPANY in writing during the priority year. Therefore, TEVA asserts that the relevant date for assessing novelty and inventive step is the filing date of PCT01 (September 17, 2002). This means that the novelty of claims 1 to 6 is undermined by PCT02, which claims priority from December 10, 2001.
(ii) Nullity of all claims due to a lack of inventive step, as it was not plausible that the compounds in the patent application, nor APIXABAN, were suitable compounds for the treatment of thromboembolic diseases and represented an improvement over the prior art. Teva argued that the application did not provide the skilled person with sufficient information to consider the technical effect attributed to the compounds disclosed in the application as plausible in light of common general knowledge. This effect involves the precise inhibition of factor Xa to the extent necessary for achieving the desired therapeutic outcome.
(iii) Claims 5 to 29 are invalid due to insufficient description, as the claimed therapeutic uses are not plausible.
BMS opposed the lawsuit, arguing that the claimed priority was valid and that plausibility is not a requirement for patentability. Furthermore, they claimed that the therapeutic technical effect of the compound in question was plausible.
The Court of First Instance upheld the plaintiff’s action. Claims 1 to 6 were declared invalid due to lack of inventive step and claims 7 to 29 were declared invalid due to insufficient description.
BMS appealed, challenging all the rulings in the judgment. TEVA also appealed on the grounds that the judgment did not address certain issues.
The Court of Appeal overturned the ruling of the Court of First Instance and dismissed TEVA’s claim in its entirety. The Court of Appeal’s reasoning was essentially as follows:
(i) The Court rejected the requests for invalidity of claims 1 to 6 due to a lack of novelty, noting that TEVA lacked the right of action to bring an invalidity action based on the challenge to the priority right invoked by the patent holder. The Court ruled that, in such a case, the right of action would only correspond to those who could have exercised the right of priority. The Court added that invoking the different legal personalities of BMS Company and BMS Pharma as the basis for the action constituted an extremely formal and abusive exercise given the circumstances of the case. Finally, the Court stated that the evidence presented did not detract from the fact that BMS COMPANY could be considered the successor in title for the purposes of claiming priority derived from USP01, in accordance with Article 87 of the EPC.
(ii) With regard to the arguments relating to the lack of inventive step, the Court clarified the EPO Boards of Appeal’s jurisprudence on the plausibility of the technical effect sought by the patent and its impact on the assessment of inventive step, to which TEVA referred. Having noted that the requirement of plausibility of the intended technical effect was established in the EPO Boards of Appeal doctrine to prevent the granting of purely speculative patents that did not contribute to the state of the art, and that this requirement had given rise to different interpretations, the Court referred to the EPO’s Enlarged Board of Appeal decision G 2/21 of March 23, 2023. This decision aims to resolve the issues arising from the variety of interpretations on this matter and the related question of the admissibility of evidence published after the application date to demonstrate the intended technical effect for the purpose of recognizing inventive step. The Court emphasized that, as set out in the conclusions of G 2/21, the term ‘plausibility’ is neither a distinctive legal concept nor a specific requirement of patent law under the EPC. The Court also emphasized that the Enlarged Board of Appeal had set out the relevant criterion for applicants to rely on the technical effect attributed to their invention to demonstrate inventive step as follows: ‘A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.’
The Court then considered whether national courts of EPC contracting states are obliged to apply the criterion established in G 2/21 when assessing the inventive step requirement in invalidity proceedings. The Court observed that this would lead in the case to examine the inventive step of the patent on the basis of the application as originally filed, even though the application was amended during the grant procedure (in order to limit the claims to the compound APIXABAN and its therapeutic uses). However, the Court rejected this approach, recalling the different roles of the EPO Boards of Appeal and the national courts within the EPC system. The Court concluded that, in the context of invalidity proceedings, national courts must analyze inventive step based on the granted patent. Otherwise, they would be in breach of Articles 123(1) and 183(1)(a) EPC.
For the sake of completeness, TEVA's argument was rejected when it stated that, in applying the test established by G 2/21, it is necessary for the application to have made it plausible that the technical effect is an embodiment of the original invention when verifying the second condition indicated therein (that the technical effect is embodied by the invention as originally disclosed). The Court maintained that, according to G 2/21, in order to determine that this condition is not met, it is necessary to establish that there were reasons to doubt that the intended technical effect, in conjunction with the claimed subject matter (i.e. APIXABAN and its capacity to inhibit factor Xa), does not constitute a concrete realization of the invention as originally disclosed. The Court emphasized that this has not been TEVA’s approach.
(iii) The Court also rejected the arguments for invalidating claims 5 to 29 due to an insufficient description. TEVA based these arguments on Article 83 EPC and the EPO Boards of Appeal jurisprudence regarding compliance with the requirements set out in that provision in the case of a medical use claim. However, the Court held that national courts must refer to the patent document, as provided for in Article 138(1)(c) EPC, and not to the application, in order to declare a patent invalid on the grounds of insufficient description. The Court added that the considerations concerning medical use claims set out in paragraph 77 of G 2/21 (stipulating that in order to meet the requirements of Article 83 EPC, proof of the claimed therapeutic effect must be provided in the application as filed, particularly if experimental data are lacking and it would not be credible to a person skilled in the art that the therapeutic effect has been achieved) refer only to second medical use claims. The Court noted that claims 5 to 29 do not relate to a second medical use.
TEVA lodged an appeal with the Supreme Court, asserting all of the grounds for invalidity that had been put forward in the lower courts.
Held: The Supreme Court dismissed the appeal on the grounds set below.
Relevant holdings in relation to pharmaceutical patents:
1. The first ground of appeal was that the decision to deny Teva standing to challenge the lack of novelty of claims 1 to 6 violated various articles of the EPC, as well as Article 4.A.1 of the Paris Convention for the Protection of Industrial Property.
The Supreme Court dismissed this ground because only one of the legal reasons for the contested ruling was challenged. Therefore, even if the arguments in the ground were upheld, the other two legal reasons would remain unchallenged (doctrine of the equivalence of results and the lack of useful effect of the appeal).
2. The second and third grounds of appeal referred to the requirement of plausibility of the intended technical effect in order to assess inventive step, arguing that the contested judgment infringed various articles of the EPC. The Supreme Court analyzed both grounds together and dismissed them on the following grounds.
The Supreme Court began by observing that the necessity for the intended technical effect to be plausible in accordance with the technical teaching of the patent is not a requirement for patentability. However, it pointed out that the analysis of the inventive step requirement inherently implies that the intended technical effect of the invention must derive from its technical teaching. It is in this sense that the Supreme Court referred to the ‘requirement’ or ‘condition’ of plausibility in the rest of its reasoning.
In order to determine the scope of this requirement within the context of the analysis of inventive step, the Supreme Court based its decision on G 2/21. The Supreme Court clarified that, while not bound by the EPO Enlarged Board of Appeal decisions, it follows G 2/21 in view of the force of conviction of its reasoning.
The Supreme Court emphasized that the assessment of inventive steps must be made on the effective date of the patent, based on the information contained in the application and the general knowledge available to an expert at that time. It also emphasizes that, in this examination and when determining the technical problem, it must be possible to evaluate the technical effect sought by the claimed invention in comparison with the closest prior art.
The Supreme Court then referred to the conclusions reached in G 2/21 and the interpretation given to them by the Board of Appeal that had referred the question to the Enlarged Board of Appeal in its subsequent decision, T 116/18, dated July 28, 2023. From its reading, the Supreme Court concluded that G 2/21 leans towards the ‘ab initio implausibility’ line of reasoning, according to which it is sufficient that, based on the information contained in the patent application or on the common general knowledge at the filing date, the expert would not have seen any reason to consider the technical effect attributed to the invention as implausible. This is in contrast to the ‘plausibility ab initio’ approach, according to which it is necessary for the expert, based on the information contained in the patent application or on the common general knowledge at the time of filing, to have considered the technical effect of the invention as plausible.
The Supreme Court expressly adopted the ‘ab initio implausibility’ criterion, noting that TEVA based its arguments on the ‘ab initio plausibility’ criterion, which the Court rejected.
The Supreme Court went on to point out that this does not determine the outcome of the appeal, and that it is necessary to examine whether in the case the intended technical effect was covered by the technical teaching and embodied by the invention as originally disclosed, following the lead of G 2/21, which in section II of its Concluding considerations states: ‘A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.’
The Supreme Court addressed this examination, and began by noting that although the original application referred to a large number of compounds in claim 1, during the grant procedure, following objections by the examining body that it was not credible that all those compounds possessed sufficient factor Xa inhibitory activity to serve as anticoagulants for the treatment or prevention of thromboembolic disorders with improved pharmacological properties, the applicant limited the application to a single compound, APIXABAN. As there was no evidence that this limitation involved the addition of matter, the Supreme Court considered that the plausibility examination should be limited to APIXABAN, without prejudice to it being carried out on the basis of the disclosure contained in the application as originally filed.
The Supreme Court noted that the application disclosed the compounds listed in a series of examples which taught the expert how to synthesize the disclosed compounds. A number of these compounds (74) were distinguished as being preferred since they were mentioned by their common chemical name in claim 8, the first dependent claim to mention compounds by name. APIXABAN was included in this group of compounds.
Similarly, the Supreme Court observed that the importance of inhibiting factor Xa for anticoagulant candidates was part of common general knowledge and that the expert would know, based on their common general knowledge and the information provided by the patent application, that the ability of the preferred compounds to inhibit factor Xa, as well as their selectivity, could be verified by tests described in the application and forming part of common general knowledge.
On this basis, the Supreme Court considered that the G 2/21 test was satisfied in this case.
The Supreme Court concluded by noting that its decision aligns with those of courts in other jurisdictions, citing the Oslo District Court judgment of May 22, 2023; the Paris Court, Third Chamber, First Section judgment of June 8, 2023; and the Court of Appeal of The Hague judgment of August 15, 2023. The Supreme Court emphasized that the view of the judgment of the High Court of England and Wales of April 7, 2022, confirmed by the Court of Appeal in its judgment of May 4, 2023—which found invalidity due to lack of plausibility—was not taken into account, since it did not apply the criterion established by G 2/21.
3. The fourth ground of appeal concerned the application of the plausibility test in relation to the description of the invention. TEVA alleged that the contested judgment infringes Article 83 EPC, by failing to recognize the inadequacy of the description of claims 5 to 29. The appeal is based on the argument that the plausibility test required for the sufficiency of the description, as set out in point 77 of G 2/21, was not applied. TEVA argued that the fact that the intended technical effect is plausible does not mean that the therapeutic effect necessary for sufficiency of description is also plausible.
The Supreme Court agreed with the assessment made in the contested judgment that the test referred to in point 77 of G 2/21 applies to second medical use claims, whereas claims 5 to 29 are for first medical use (since the active ingredient, APIXABAN, was claimed for the first time in the same patent in which its medical use was claimed).
Finally, the Court added that it has been established in the proceedings that factor Xa inhibitors were commonly known to be useful in treating thromboembolic disorders due to their good anticoagulant activity at the time of the application. Therefore, it would have been credible to the expert that a factor Xa inhibitor such as APIXABAN could be used in therapy to treat these disorders.
Relevant legislation: Articles 54, 56, 68, 83, 87,123 and 138 of the European Patent Convention