Cases Update: International roundup of recently filed cases and noteworthy rulings

摘要

The Court of Justice of the European Union handed down a decision to clarify that the TRIPS Agreement falls within the exclusive competence of the EU and held that “[a] patent granted before the entry into force of the TRIPs Agreement for the process of manufacture of a pharmaceutical product does not, after its entry into force, cover the actual invention of the product.” The EU approved the TRIPS Agreement by Council Decision 94/800/EC of 22 December 1994. The decision was made in a case between Daiichi Sankyo Co. Ltd (‘Daiichi Sankyo‘), Sanofi-Aventis Deutschland GmbH (‘Sanofi-Aventis‘) and DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon (‘DEMO‘), in which the marketing by DEMO of a generic medicinal product whose active ingredient is a substance allegedly protected by patent rights of Daiichi Sankyo. The Grand Chamber of the Court of Justice of the European Union ruled that: “1. Article 27 of the Agreement on TRIPS Rights, constituting Annex 1C to the Agreement establishing the World Trade Organisation (WTO), signed at Marrakesh on 15 April 1994 and approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986–1994), falls within the field of the common commercial policy; 2. Article 27 of the Agreement on TRIPS Rights must be interpreted as meaning that the invention of a pharmaceutical product such as the active chemical compound of a medicinal product is, in the absence of a derogation in accordance with Article 27(2) or (3), capable of being the subject-matter of a patent, under the conditions set out in Article 27(1); and 3. 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 TRIPS Rights, have to be regarded from the entry into force of that agreement as covering the invention of that pharmaceutical product.”