Brussels, 19/07/2013 (Agence Europe) - A patent granted before the entry into force of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPs) for the process of manufacture of a pharmaceutical product does not, after its entry into force, cover the actual invention of the product, because the invention comes under trade policy, which is an exclusive competence of the European Union, ruled the European Court of Justice on 18 July in case C-414/11.
The Court of Justice was answering two questions from the Athens appeals court over a dispute between Daichi Sankyo Co. Ltd (of the United Kingdom), which, since 1986, has held a patent in Greece for the active component and manufacturing process for Tavanic, which was extended in 2006 until 2011 by an extra protection certificate (SCP), and DEMO AE (Greece), which was authorised in 2008 and 2009 to sell the Talerin generic drug in Greece that has the same active component as Tavanic. Daichi and its distributor in Greece, Sanofi-Aventis, want to stop the sale of Talerin and any other medicine having the same active component. The Greek court essentially asked the Court of Justice whether 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 only for the process of manufacture, must none the less, by reason of the TRIPs Agreement and from the date of its entry into force, be regarded as also covering the invention of the pharmaceutical product. It also asked to what extent the TRIPs agreement, which was concluded by the Community and the member states by virtue of shared competence, still falls within the competence of the member states.
On the second question, the Court of Justice says that, since the Lisbon Treaty, the common EU trade policy - which is within the context of the European Union's external action and relates to trade with non-member countries - also concerns the commercial aspects of intellectual property. If a European Union act is intended to promote, facilitate or govern international trade, it falls within the common commercial policy.
The rules in the TRIPs agreement have a specific link with international trade. The agreement itself forms part of the liberalisation of international trade, and its objective is to strengthen and harmonise the protection of intellectual property on a worldwide scale and to reduce distortions of international trade in the territory of the member states of the WTO. The agreement therefore now falls within the field of the common commercial policy and the exclusive competence of the European Union.
On the first question, the Court of Justice goes on to note that - according to the actual wording of the TRIPs agreement - any invention, whether a product or a process, which is new, involves an inventive step and is capable of industrial application is patentable, provided only that it belongs to a field of technology. Under EU Regulation 1768/92 on the creation of a supplementary protection certificate for medicinal products (1768/92), protection under an SCP is subject to the same limitations as those affecting the protection conferred by the basic patent. The reservation, permitted by the EPC, under which medicinal products were not patentable in Greece from 1986 to 1992, applied by analogy to national patents, such as that of Daiichi Sankyo. Similarly, the rule that the effect of the reservation continues throughout the term of the patent was also applicable by analogy to national patents. Consequently, Daiichi Sankyo's national patent and its SPC were of no effect as regards the invention of the pharmaceutical product, notwithstanding the patentability of pharmaceutical products in Greece from 1992.
The Court of Justice rules that “while the TRIPs agreement obliges the member states of the WTO to make it possible to obtain patents for pharmaceutical products, it does not oblige them to regard patents which were granted solely for processes of manufacture of those products as covering, after the entry into force of that agreement, the inventions of those products as such”. (FG/transl.fl)