EU: General Cruz Villalon conclusions regarding article 27 TRIPS to patents affected by reservation under article 167


This is a short summary of the Conclusions of the Advocate General Pedro Cruz Villalon given on 31 January 2013 in the case C-414/11, referred to him in the preliminary ruling from the Polimeles Protodikio Athinon (Greece) lodged on 8 August 2011 - Daiichi Sankyo Company Limited, Sanofi-Aventis Deutschland GmbH v. DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon-.

The questions referred by the Polimeles Protodikio Athinon where:

Does Article 27 of the TRIPS Agreement setting out the framework for patent protection fall within a field for which the Member States continue to have primary competence and, if so, can the Member States themselves accord direct effect to that provision, and can the national court apply it directly subject to the requirements laid down by national law?

Under Article 27 of the TRIPS Agreement are chemical and pharmaceutical products patentable subject matter provided that they satisfy the requirements for the grant of patents and, if so, what is the scope of their protection?

Under Articles 27 and 70 of the TRIPS Agreement, do patents covered by the reservation in Article 167(2) of the 1973 Munich Convention which were granted before 7 February 1992, that is to say, before the above agreement entered into force, and concerned the invention of pharmaceutical products, but which, because of the aforementioned reservation, were granted solely to protect their production process, fall within the protection for all patents pursuant to the provisions of the TRIPS Agreement? If so, what is the extent and content of that protection, that is to say, have the pharmaceutical products themselves also been protected since the above agreement entered into force?

Does protection continue to apply to their production process only? Or must a distinction be made based on the content of the application for grant of a patent, that is to say, as to whether, by describing the invention and the relevant claims, protection was sought at the outset for the product or the production process or both?

The Advocate General (AG) held that the Court of Justice of the European Union (CJEU) does not have jurisdiction to deal with this issue. In any event, the AG analysed the questions and concluded that Article 27 of TRIPS is an Article directed to the legislator and can not be considered to have direct effect. Notwithstanding the foregoing, in case the CJEU has a different opinion, the AG also analysed the substantive issue, concluding that “the sole entry into force of that Agreement [TRIPS] does not produce the consequence that anyone who owned pharmaceutical process patents in that moment pursuant to a legislation that did not allow patents on pharmaceutical products themselves, would have acquired a patent on the product itself, even if at the time of the patent application procedure the applicant had applied for a patent on the same product (see point 114).” In any event, the AG asserted that even in the case that the CJEU shares his opinion; the CJEU’s judgment “should have effects only as of the publication of the judgment”. Further, the AG expressly declared “the intangibility of the previous final judicial decisions with the force of res judicata on the date of publication of the judgment from the CJEU” (vid. punto 121).

The AG began his conclusions with the analysis of the jurisdiction of the CJEU to analyse this question according to Article 207.1 of the Treaty on the Functioning of the European Union (TFEU). This reads: “the common commercial policy shall be based on uniform principles, particularly with regard to changes in tariff rates, the conclusion of tariff and trade agreements relating to trade in goods and services, and the commercial aspects of intellectual property (…) The common commercial policy shall be conducted in the context of the principles and objectives of the Union’s external action”. In this regard, the AG analysed if Article 27 TRIPS can be considered as a “commercial aspect of intellectual property” and concluded that it is not possible to consider the content of Article 27 TRIPS as “commercial aspects of intellectual property” and, therefore, “it still holds the doctrine of the Court of Justice that links the scope of jurisdiction of the Court of Justice to interpret the provisions of international treaties to the substantive jurisdiction over issues already governed” (see points 80 and 81 of the Conclusions), i.e., “at this point in the development of Community law, the Member States remain principally competent, they may choose whether or not to give direct effect to that provision” (Judgment of the CJEU issued on 11-IX-2007, C 431/05, Merck).

Notwithstanding the foregoing, the AG continued the analysis of the question in the event that the CJEU reaches a different solution. First, the AG analysed whether Art. 27 TRIPS has direct effect or not, and concluded that, based on the doctrine of FIAMM case (Judgment of the CJEU issued on 9-IX-2008, C-120/06 P y C-121/06 P), where the CJEU stated that “direct effect is only admitted when the international rule in question complies with a two-fold prerequisite: ‘given their nature and structure, those agreements are not in principle among the possibility of alleging them and that the invokes rules are in light of the object and purpose of the Agreement and its context, sufficiently precise and unconditional, i.e., encompass a clear and precise obligation that, in its execution of effects, it is not subordinated to the adoption of a subsequent act’” (see point 88), “Article 27 of TRIPS and, via connection, also Article 70 of the same Agreement are not ‘sufficiently precise and unconditional’, i.e., they do not contain a ‘clear and precise obligation’ that is not subordinated ‘in its execution and effects to the adoption of a subsequent act’” (see point 89).

The AG referred to case-law from Slovenia, Finland, Portugal, Austria, Spain and Greece, noting the lack of homogeneity of their decisions on the issue. Further, it explains that, in his view, Article 27 of TRIPS is a provision directed to the legislators and it is not a provision to be directly applied (see point 104).

In any event, in case the CJEU did not share his opinion, the AG analysed the third question, i.e., if existing material according to Article 27 of TRIPS has retroactive effect. The conclusion of the AG reads as follows:

113 I understand that TRIPS does not envisage, in any case, the ‘automatic extension’ of process patents to product patents on pharmaceutical products, as requested by Daiichi Sankyo. Also, in my opinion, TRIPS does not include a ‘deferred granting’ of patents on medicines that were applied in a time when they could not be granted. To sum up, for basic certainty reasons in an area as sensitive as patents and commercialization of medicines, it should be interpreted that a patent given to a pharmaceutical product can only be the result of a specific examination and control that should begin by an explicit request.

114. In conclusion, in case the CJEU considers that he has jurisdiction to interpret Article 27 of TRIPS – and, via connection, of Article 70 of the same Agreement-, and that the mentioned provision is of direct application, I suggest the CJEU to declare that the sole entry into force of the cited Agreement has not the consequence that the owners of process patents on pharmaceutical products in this moment according to a legislation that did not allow patents on pharmaceutical products as such, had acquired a product patents on the pharmaceutical product, even in the case that at the time of the patent application on the process the applicant had applied for a patent on the same product”.

Other articles related to the Life Sciences Update for February 2013: