Year in Review: notable 2020 patent cases in Spain

First marketing authorisation for SPC – Ferring International (Superior Court of Madrid)

Ferring International appealed the decision to the High Court of Justice of Madrid against the decision of the Spanish Patent and Trademark Office (SPTO) denying the grant of an SPC for the drug VIRIREC. The SPTO considered that the SPC could not be granted because the marketing authorisation designated in the certificate was not the first marketing authorisation for the product. Specifically, there was a previous drug, CAVERJET, which also had alprostadil as the active ingredient. Both drugs were intended for the treatment of erectile dysfunction, the only difference being that VIRIREC was applied as a cream and CAVERJET as an injectable solution.

The appellant argued that the differences in the route of administration of the two drugs was sufficient to grant a new SPC in light of the doctrine established by the CJEU in Neurim (Case C-130/11), which defined the concept of a “new therapeutic application” of a patented product.

The Madrid court concluded, however, that the CJEU was not referring to merely a different route of administration of an already known product (e.g. in a cream as opposed to by syringe), but to a new therapeutic application of the known and already marketed active ingredient (e.g. for treatment of a new indication). The court confirmed that article 3(c) of the SPC Regulation does not permit the same basic patent to be used to obtain several SPCs that totally or partially refer to the same product.

Expert evidence on inventive step – Valeo v Alkar (Barcelona Court of Appeal)

The Court of Appeal’s decision emphasises the need for careful preparation of expert opinions filed in patent cases.

Valeo claimed infringement of two of its illumination device patents against Alkar. In response, Alkar counterclaimed for revocation of the patents in the infringement action. At first instance, the court dismissed the infringement action, partially upholding the counterclaim.

The court analysed inventive step using the “problem-solution” approach. The court found the closest prior art selected by the defendants to be unsuitable as it was quite different from the problem solved by the patent.

The case turned on the two countervailing expert opinions. The court considered the defendant’s expert (in support of revocation) as unreliable, as she only assessed the invention underlying the patent itself. On infringement, the claimant’s expert (in support of infringement) was criticised for failing to undertake any direct inspection of any specimen. The defendant’s expert did inspect specimens, but her approach was found to be sufficient to allow for an objective assessment of the patents. The court upheld Valeo’s infringement claim.

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