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Propiedad Industrial e Intelectual

A landmark decision on TRIPS that will change the IP law in Europe

In a landmark decision of 18 July 2013 rendered in the case C-414/11, Daiichi Sankyo and Sanofi-Aventis vs Demo, the EUCJ has rendered a crucial decision concerning the application of the TRIPS Agreement. The Court has decided that it has jurisdiction to know on every aspect regulated in the agreement, including patent matters as it is the case of article 27. The court finds that the agreements falls within the field of the common commercial policy.

Subject to this statement, the court has interpreted article 27 in the sense that it must be construed as meaning that the invention of a pharmaceutical product such as the active chemical compound of a medicinal product is capable of being the subject-matter of a patent, under the conditions set out in Article 27(1).

In the specific case, the EUCJ has established that a patent obtained following an application claiming the invention both of the process of manufacture of a pharmaceutical product and of the pharmaceutical product as such, but granted solely in relation to the process of manufacture, does not, by reason of the rules set out in Articles 27 and 70 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, have to be regarded from the entry into force of that agreement as covering the invention of that pharmaceutical product. So far the Spanish Supreme Court had been reluctant to ask the EUCJ to render a preliminary opinion and has established a jurisprudence that is contrary to the current doctrine of the EUCJ.

More important however is the effect that this doctrine will have in the future. For years the big industry lobby has successfully tried to avoid the EUCJ having competence in patentability and infringement questions. The EU Regulations approved by the EU on the Unitary Patent deprived the EU law of establishing the acts of infringement.

Article 27 and 28 of the TRIPS Agreement establishes essential rules on patentability requirements (novelty, inventive step and industrial applicability), acts of infringement (of product and process patents), and 29 to 33 on the sufficiency of disclosure, exceptions to patent infringement, revocation, expiry and duration.

By this decision, the EUCJ has acknowledged its jurisdiction on patent fundamental issues. This is why certain interests are worried and some individual close to those lobbies has surprisingly, and in a certain way arrogant, criticized the court, pointing out that the EUCJ has no specific specialization on patent matters. Those apparently angry practitioners forget that no Supreme Court is specialized either in the UK, in Germany or in the USA.