PORTUGAL Trends and Developments Contributed by: António Andrade, Manuel Durães Rocha and Ana Panão, Abreu Advogados
lem–solution approach, as per the case law of the Boards of Appeal of the European Patent Office. Appeals before the Court of Appeal of Lisbon regarding decisions of the Intellectual Property Court are also being argued, with some of them still pending. In order to obtain a preliminary injunction, if there is no actual launch onto the market of a generic product that infringes a patent, the patent holder must evidence irreparable harm within the legal concept of periculum in mora. Conversely, if the generic is launched onto the market, the patent holder should only evidence the existence of the patent right and the infringement, which is what the Directive 2004/48/EC of the European Parlia- ment and of the Council of 29 April 2004 on the enforcement of intellectual property rights (the “(IPR) Enforcement Directive”) expressly states. As to the mandatory legal action before the Intel- lectual Property Court under the amended Law 62/2011, if no voluntary arbitration has been agreed by the parties, the jurisprudence of the Court of Appeal of Lisbon remains stable regard- ing the legal standing and procedural interest of a patent holder in filing such action. In other words, the patent holder has an explicit proce- dural interest in filing this specific legal action to legitimately enforce its patent rights. Supplementary protection certificate cases As far as supplementary protection certificate (SPC) litigation is concerned, the pending cas- es are still focused on the fulfilment of the legal requirements established by Article 3(a) and Article 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary pro- tection certificate for medicinal products (the
“Supplementary Protection Certificate Regula- tion” (SPCR). The tendency of the Intellectual Property Court and the Court of Appeal of Lis- bon is to follow the ECJ – notably, its decisions in MIT (C-431/04), GSK (C-210/10), Fosgren (C-631/13), Bayer Cropscience (C-11/13), Eli Lilly (C-493/12), Gilead (C-121/17) Santen (C-673/18) and Royalty Pharma (C-650/17). The Intellectual Property Court has decided that a product protected by an SPC is protected: • where the active principle is claimed in the basic patent; and • where the active principle is not directly claimed in the basic patent but the functional definition formulae of the claims, interpreted in light of the description of the basic patent, implicitly contain and necessarily identify the active principle in a specific form. In addition, a very important decision from the Court of Appeal of Lisbon granted an SPC based on the following assumptions: “If it is demon- strated that a non-active principle (excipient) – combined with an active principle – produces a pharmacologic, immunologic or metabolic effect per se covered by the therapeutic indica- tions contained in the marketing authorisation. An excipient can be included in the definition of the product established by Articles 1(b) and 3(a) of [the SPCR] in the [event] that the excipient of a pharmaceutical product per se has therapeu- tic efficacy on its own covered in the marketing authorisation.” This is a landmark judgment not only because it reverted the refused SPC decision from the European Patent Office and the Intellectual Property Court decision rendered in an appeal, but also because the authors believe that it was
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