By Judgment of 30 September 2024, the Commercial Court No. 1 of Barcelona dismissed the infringement action brought by three companies of the BAYER Group against four companies that had launched generic drugs based on the active ingredient sorafenib in the form of its tosylate salt on the Spanish market. The Court, upholding the defendants’ counterclaim, concluded that both Claim 12 of patent EP 2,305,255 (“EP’255“), invoked by BAYER in its granted version, and the two limitation proposals invoked auxiliary, were invalid for lack of inventive step. This also confirmed the conclusion previously reached by the same Court (ECLI:ES:JMB:2021:2692A) and the Barcelona Provincial Court (ECLI:ES:APB:2022:7529A) in the preliminary injunction proceedings.
This is a case, like so many others in patent matters, in which the course of events has so far led to a divergent outcome at European level in the countries where the validity of the BAYER patent is in dispute. Different court proceedings, different strategies of the parties, different proposals for limitation of the patent, or the submission and examination of different evidence are factors which have led to a situation of disparity, although this is expressly provided for in the European Patent Convention (Articles 2 and 64).
Claim 12 of the granted EP’255 protected the active substance sorafenib in the form of its tosylate salt. The limitation proposals defended by BAYER auxiliary added the features of the use of the active substance in therapy and its administration in tablet form (“Limitation proposal 1“) and the use of the substance for the treatment of cancer and its oral administration (“Limitation proposal 2“). The patent expired on 3 December 2022, so BAYER’s claims were in practice reduced to potential damages.
The defendants’ defence was based on the invalidity of the granted patent on the grounds of lack of novelty, as the priority claimed by the patent was invalid and two prior art documents that anticipated the tosylate salt of sorafenib came into play; and lack of inventive step, applying the problem-solution approach developed by the European Patent Office. Regarding Limitation proposals 1 and 2, it was also argued that they did not comply with the requirement of prohibition of addition of subject-matter with respect to the original patent application.
The Court ruled only on the lack of inventive step, which was sufficient to grant the defendants’ claims.
In doing so, the Court started from the most favourable scenario for BAYER as regards the formulation of the objective technical problem allegedly solved by the patent with respect to the prior art document closest to the invention (an article identified as “LYONS“). Thus, it concluded that it would have been obvious to a person skilled in the art to prepare a tosylate salt of the compound sorafenib in order to improve its bioavailability.
Among the aspects under discussion between the parties, we highlight the motivations and knowledge that the person skilled in the art had to determine whether he/she would have prepared a tosylate salt of sorafenib to improve its bioavailability despite the low solubility of sorafenib in free base form and even in the form of its tosylate salt. This has led to different court decisions in relation to the same patent, albeit on different amendments to Claim 12, and is not so much the result of different legal analyses, but of different assessments arising from the specific evidence submitted in each of the court proceedings.
As we have said, this situation of divergent judicial decisions at the European level is not unique to the sorafenib case but has occurred in many other patent cases. This situation is beginning to change with the advent of the European patent with unitary effect, over which the Unified Patent Court has exclusive jurisdiction. It should be remembered that Spain is not currently part of this unitary system for various reasons, and that the percentage of European patent applications originating from Spain is currently particularly low. Therefore, to what extent uniformity or the current greater possibility of obtaining divergent decisions could work in favour of or against the particularities of the national industry is, perhaps, a point to be considered in the debate on Spain’s eventual accession to the unitary system.
Finally, it should be mentioned that BAYER has filed an appeal against the Judgment of the Commercial Court No. 1 of Barcelona and the defendants have filed their corresponding opposition, so the decision is not yet final.