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BY SONIA SARROCA, NÚRIA COLL AND ORIOL RAMON
The Judgment of the Barcelona Court of Appeal (Section 15) No. 477/2020 of 15 January (ECLI:ES:APB:2020:477) confirmed the validity, already declared in the first instance, of a patent on a pharmaceutical formulation for administration by injection, by intramuscular or subcutaneous route, of an active ingredient already known in the prior art, where said active ingredient is suspended in water, which is the pharmaceutically acceptable vehicle.
Although we did not participate as lawyers in the aforementioned case and, therefore, cannot critically assess the final outcome of the decision, we thought it would be interesting to comment on some of the issues addressed in the ruling. Though, from a general perspective and, necessarily, distant from the case.
Entering into the analysis of the Judgment, in the aforementioned case, the plaintiff filed a claim for the nullity of said patent for non-compliance with the requirement of inventive step in Article 56 of the European Patent Convention (“EPC“). The Judgment, considering that it did not correctly determine either the content of the closest prior art (first step of the problem-solution approach of the European Patent Office, “EPO“) or the objective technical problem (second step of the problem-solution approach of the EPO), concluded that it could not carry out the analysis of the inventive step of the patent.
The closest prior art
According to the contents of the Judgment, the parties agreed that the closest prior art was contained in a patent document, owned by the defendant itself. That document anticipated the active ingredient that was the subject of the pharmaceutical formulation of the contested patent, as well as procedures for its preparation. The plaintiff argued that one of its examples, which disclosed a formulation of the active ingredient in an injectable oil solution, should be taken into account along with other teachings from the document where it was admitted that suspensions with liquid vehicles could also be prepared from the compounds claimed by the patent. The patent holder, however, disagreed with this approach, arguing that the teaching of the closest prior art should comprise only such an example, which was the only “complete technical rule”.
The Court of Appeal accepted the patent holder’s argument, since it understood that the closest prior art document, despite mentioning the possibility of preparing water-based injectable suspensions of the active ingredients, did not describe how to do so and did not include any examples of such suspensions. Therefore, the expert in the field would not combine both teachings.
The objective technical problem
As to the definition of the objective technical problem, the claimant proposed that it be formulated as an alternative, based on its determination of the closest prior art and because it understood that it was not plausible that the invention would achieve certain technical effects identified in the patent. Instead, the patent holder argued that the problem identified by the patent should be maintained. The Court held that the technical effects that the plaintiff wanted to disregard should be considered plausible.
To the extent that the plaintiff had determined the closest prior art with a content that was not correct and had disregarded certain technical effects of the invention, the judgment held that the objective technical problem was not well formulated. That is why it did not continue with the analysis of the inventive step and, therefore, did not analyse the obviousness.
In considering that the technical effects should be considered plausible, the Court stated that: “if it were true that the composition of the owner Janssen is not effective, i.e. not applicable to humans, it is not easy to explain why the plaintiff should seek a declaration of invalidity of a patent protecting a useless composition” (para. 80). However, we deem appropriate to point out that the interest of the plaintiff may lie in the circumstance of wanting to exploit a development, which does have a certain technical effect, but which falls within the scope of protection of a more general claim that does not have such an effect, or in the circumstance that such an effect was not plausible, according to the content of the patent, on its application date, even if it is proven subsequently.
The non-analysis of the obviousness
In our opinion, the Judgment, by not analyzing the obviousness because it considered that the first two steps of the problem-solution approach had not been correctly determined by the plaintiff, attributes a character of quasi-legislative authority to the problem-solution approach developed by the EPO.
This will undoubtedly have to be taken into account for future cases, in which it may be preferable to make auxiliary arguments, whenever possible, when determining the closest prior art and the objective technical problem, at the risk that, if this is not done, the analysis of the obviousness will not be carried out.
However, we consider that it is worth noting that the problem-solution approach is just that, only a method that is at the service of the law, in this case of Art. 56 EPC. The intention with the first two steps of the method (the determination of the closest prior art and the objective technical problem) is, exactly, to create a fictitious scenario, with the aim that the assessment of the obviousness (third step) is carried out an objective and non-retrospective (ex post facto) perspective. However, an error in the first or the second step according to a methodology does not necessarily mean that art. 56 EPC is not complied with.
In our opinion, any errors should always be viewed in relation to the requirements of Art. 56 EPC. This may lead in some cases, if the problem-solution approach is to be followed, to having to justify the relevance of the possible error with respect to Art. 56 EPC (e.g. because the determination of the state of the art is being subjective) or even to having to carry out the analysis in spite of the error. For example, returning to the specific case, perhaps, whether or not the closest prior art includes a “water suspension”, the result of the analysis of the obviousness could be the same. However, we will never know this if we do not perform the analysis.
The fact is that not carrying out the analysis of the obviousness due to a lack of strict compliance with a methodology entails the risk of putting the law at the service of the methodology, when it is the methodology that should be at the service of the law.
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