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Propiedad Industrial e Intelectual

New milestones of the Spanish Supreme Court on the inventive step requirement

This is a continuation of our previous publication dated 14 September 2009 where we analysed three Judgements of the Spanish Supreme Court in relation to the inventive step patent requirement.

With the present publication we make reference to the Judgment 20 May 2016 of the Spanish Supreme Court in relation to the validity of a patent on an extended release pharmaceutical formulation of quetiapine.

There are three issues in the Judgement that we want to highlight in relation to the inventive step requirement: that the ordinary expert in the art is not the expert witness that can be appointed in patent proceedings; the limitations to reformulate the technical problem that is disclosed in the description of the patent; the number of pieces of prior art that can be combined.

In the case at hand, the plaintiff brought just one report of an expert on pharmaceutical technology and the defendant considered that it should have brought an additional report of a psychiatrist, because the ‘expert in the art’ in the field of the patent technology would have included, at least, two specialists, one in formulation technology and a psychiatrist. However, the Supreme Court dismissed the approach of the defendant. The Judgment states that the legal figure of the ‘expert in the art’ mentioned in Article 56 of the EPC is not the expert witness that the parties and the Court could appoint to issue an opinion on those technical facts that are needed to be understood by the Court to render its final decision. In order that an expert witness can provide with the point of view of the ‘expert in the art’ that is needed to analyse the inventive step requirement it is essential that this expert, based on his education an experience, would be in a position to adopt the viewpoint of the ‘expert in the art’. This means that it is not essential that the education and experience of the expert witness would have been the same of that of the ‘expert in the art’. The knowledge of the ‘expert in the art’ can be provided by an expert witness with a different education and experience of that of the ordinary ‘expert in the art’.

In the analysis of the inventive step the plaintiff considered that the claims of the patent would have been obvious for the expert in the art in the hope of solving the ‘objective technical problem’ or in expectation of some improvement or advantage. The plaintiff based this approach on the technical problem that was determined by the applicant in the description of the patent specification. However, the patentee tried to reformulate the technical problem in order to substantiate that the claims would have not been obvious for the expert in the part in the expectation to solve this new problem. As a general rule the Supreme Court, quoting EPO case law, states in the Judgement that the reformulation is only possible if the technical problem disclosed in the patent specification has not been solved or if the state of the art used by the applicant to determine that technical problem is not appropriate. In this regard, the Court reminds that the applicant voluntarily drafted the description of the patent, thus it could not change this problem to redraft it in a wide and generic way. In that case, the patentee intended to reformulate the problem as being the provision of an alternative pharmaceutical composition. Regardless of whether this reformulation of the problem would have led to a non-obviousness of the claims, which in our opinion that should not be like this, because an alternative would be always more obvious than an improvement, what we wish to highlight is that whatever the problem is if the claims are obvious according to the problem voluntarily set by the applicant this is the end of the game.

Finally, the Court makes reference to the number of pieces of the prior art that can be combined to conclude that the patent lacks inventive step. It has to be reminded that according to the Guidelines of the EPO the fact that more than one disclosure must be combine with the closest prior art in order to arrive at a combination of features may be an indication of the presence of an inventive step, if the claimed invention is not a mere aggregation of features. About this the Supreme Court states that not all documents used in the obviousness attack were intended to be combined, but the aim was to determine the knowledge that the expert in the art would have had at the priority date of the patent.