It will be recalled that Spain and Italy launched challenges at the CJEU against the Council decision of March 2011 to authorise the use of the enhanced cooperation procedure used to create the unitary patent Regulations. Despite the challenges, the remaining 25 states proceeded to negotiate the Regulations which were duly adopted on 17 December 2012. Shortly before adoption, those challenges were the subject of Advocate General Bot’s Opinion, which was that they were without merit. A decision of the CJEU itself is expected later this year, but it would be surprising if the Court arrived at a different decision than the Advocate General. Now, perhaps spurred on by the negative opinion, Spain (this time alone) has launched challenges at the CJEU against the Regulations themselves.

The basis for Spain’s new challenges is as yet unknown, but is likely to focus in part at least on the lack of legal basis for the Regulations. If so, some sections of the Commission should logically agree with the Spanish, because the Commission’s position had been that the controversial Articles 6 to 8 in the draft were essential to the legality of the unitary patent Regulation, whereas they were deleted following UK insistence that the CJEU should not be given extensive jurisdiction to decide on the meaning of infringement. Doubtless, however, the Commission’s previous position will be swept under the carpet and the position taken that Article 5 (the successor to Articles 6 to 8) provides an adequate legal basis. However, Article 5 is curious in its effect: it makes the applicable law of infringement of unitary patents depend on the domicile of the patentee at the date of the patent application. Hence, the scope of a patent with identical claims would seem to be different in the hands of, for example, a German patentee than a British one, when it comes to the scope of the experimental use exception and what clinical trials are lawful and which are patent infringing. In short, whatever the merit of the previous challenges to the enhanced cooperation procedure, these new challenges may have greater impact, and potentially threaten the whole Unitary Patent and Unified Patent Court (UPC) regime.

Such a challenge was probably inevitable at some stage, and is perhaps better dealt with now, rather than once the system is up and running. At least some certainty can then be obtained in advance that the regime is lawful and not liable to be struck down at a future date when massive investment has been made in setting up the UPC, and indeed when unitary patents have been granted and other patents litigated in the UPC. The challenges have no suspensive effect on implementation of the new regime, but what remains to be seen is whether, as with the challenges to the legality of the enhanced cooperation process, the participating states will simply ignore this latest development and carry on regardless, or whether instead they will slow the process down. In any event, in reality there is virtually zero prospect of the UPC opening for business before the CJEU reaches a decision on this latest Spanish challenge, which is likely to be some time in the first part of 2015.