Supreme Court Judgment of 24 April 2025, Teva (ECLI:ES:TS:2025:1714)
1. Facts
The litigation pits the pharmaceutical company Teva against the holder of a European patent for a compound intended to treat inflammatory diseases. Teva sought partial invalidation of the patent, alleging a lack of inventive step, arguing that the claimed technical effect was not plausible in light of the information contained in the initial application. The defendant maintained that the plausibility of the effect stemmed from general expert knowledge and subsequent studies that confirmed the compound's efficacy.
After a procedural journey through the lower and appeal courts, the case reached the Supreme Court, which had to determine whether the plausibility of the intended technical effect constitutes a requirement for assessing inventive activity within the framework of the Patent Law (LP) and of the European Patent Convention (CPE).
2. Pronouncements
The Supreme Court starts from the principle that inventive step must be assessed in accordance with Article 56 of the EPC and the established case law of the European Patent Office (EPO). It emphasizes that the invention must offer a technical solution to an objective technical problem, and that the claimed contribution must be credible at the time of the application.
The Court assumes the notion of “plausibility of the technical effectThis principle, developed by EPO jurisprudence, establishes that a mere assertion of the technical effect is insufficient: it is necessary that, based on the application and the general knowledge of the expert in the field, the effect appears plausible or reasonably supported. If the effect is not plausible at that point, the invention lacks inventive step.
The Supreme Court clarifies that plausibility does not constitute a new, independent patentability requirement, but rather a methodological criterion for assessing inventive step. It rejects the use of subsequent evidence or data to remedy an initial lack of plausibility, as this would disrupt the balance of the patent system and unduly broaden the scope of the original application.
Applying this doctrine to the case, the Supreme Court concludes that the contested patent did not provide sufficient data to make the alleged anti-inflammatory effect credible. The description did not contain experimental examples or specific references that would allow an expert to consider the compound's mechanism of action plausible. Consequently, it upholds the partial invalidity of the patent due to a lack of inventive step.
3. Comment
The Supreme Court ruling consolidates in Spain the European doctrine on the plausibility of the technical effect as an essential element for assessing inventive step. The Court adopts the jurisprudence of the EPO and the CJEU, establishing that the applicant must provide, from the time of filing, a sufficient technical basis that makes the effectiveness of the invention credible. This prevents the granting of speculative patents or those based on mere hypotheses.
In practice, this forces companies to justify their inventions more rigorously, incorporating data or references that support the plausibility of the alleged effect.
Ana Sanz, Associate Partner in the Legal Department.
