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Intellectual Property

TRIPS and product claims before 7.10.1992. Case-Law of the ECJ

For the past months, the Court of Justice of the European Union (ECJ) has issued some key decisions on patent law, in particular on the interpretation of TRIPS Agreement in relation to States like Spain that made reservations to the EPC on the patentability of pharmaceutical products. Until the 7 October 1992 pharmaceuticals products could not be protected as such in Spain so, in consequence, the patents requested up to that date could not validly protect pharmaceuticals. This legislation allowed the Spanish manufacturers develop alternative processes both for the manufacture of medicines and for their active ingredients.

Since late 2005, it is well known in the pharmaceutical industry that certain judicial actions of particular patent holder companies, led to national courts to apply a sort of supervened patentability and validity of matter not protected by patents that: (a) either have been requested with product claims that could not be protected in Spain; (b) or have been validated by means of modifications made through translation reviews to incorporate protection granted for other countries of the European Patent Organization.

The ECJ by judgement of 18 July 2013 and two orders of January 30, 2014, has made clear that TRIPS Agreement does not confer product protection to what could not be validly protected in Spain. The latter has been said in the two orders mentioned above with respect to the atorvastatin patent, for which the Spanish courts had conferred validity by enforcement of the TRIPS Agreement. The patent in question had been asked for in 1990 and published by the EPO in 2001.

 

The result of this circumstance is that a U-Turn is to be expected in the tendency of the Spanish courts, making possible that pharmaceutical manufacturers use alternative processes not protected by patents.