Luxembourg, 05/02/2007 (Agence Europe) - On 23 January, Advocate General M.D. Ruiz-Jarabo Colomer presented his conclusions in a case concerning the violation, or otherwise, of the protection conferred by a pharmaceutical patent (Case C-431/05). In the case in hand, the injured party seeks to affirm the primacy of the World Trade Organisation (WTO) provisions on intellectual property over the national legislation of a member state, in this case Portugal. The question raised in this case is that of knowing whether one can directly call up an international agreement before a national court, without that agreement being transposed beforehand into the legislation of that country. Mr Ruiz-Jarabo Colomer considers that, in the case in hand, and given the vague nature of the WTO provision in question, the answer is “no”. In other words, the TRIPs Agreement (chapter of WTO provisions on intellectual property) is not directly applicable at national level in this case.
The patent in question covers the chemical composition of “Enalapril”, the active ingredient of “Enalapril Maleate”. The patent holder, Merck & Co. Inc. (“Merck”, Portugal), accuses Merck Genéricos-Produtos Farmaceuticos (“Merck Genericos”, Portugal) of having acted in violation of the protection conferred by the patent by placing the medicinal product, Enalapril Merck, on the market without authorisation in 1996.
Merck Genéricos noted that, as the patent had been granted in 1981, it had entered the public sphere after expiry of the 15-year protection time conferred upon it by national legislation (Article 7 of the 1940 Code and the transitional regime under Article 3 of the 1995 Code). Merck, for its part, acted under Article 33 of the TRIPs Agreement to support the patent that remained valid until 4 December 1999, in line with the provision of Article 33 that provides for a minimum 20-year period of protection for patents. The marketing of “Enalapril Merck” by Merck Genéricos in 1996 therefore constitutes infringement of the TRIPs Agreement but not of Portugal's regulation on intellectual property. It is therefore a matter of knowing which legal framework takes primacy.
The Court is faced with deciding an answer to the above question. After being found guilty by the Tribunal da Relação (Portuguese court of appeal), Merck Genéricos took the matter to the Supremo Tribunal de Justiça to challenge the applicability of Article 33 of the TRIPs Agreement (which, as it provides for 20-year protection for patents, would thus not rule in its favour). The Supremo Tribunal de Justiça referred the matter to the European Court of Justice, calling on it to decide whether the article should be applied or not.
The advocate-general's conclusions take the reader through an indepth and knowledgeable exploration of the case law on legal arguments, an analysis made more intricate by the flowery style so characteristic of it. First of all, one sees that a joint agreement (that is, signed by the European Community on behalf of its members but also by the member states themselves) may, despite not being expressly transposed into national legislation, be invoked before a national jurisdiction if this is done in all good faith.
Nonetheless, M. D. Ruiz-Jarabo Colomer considers that this interpretation is not valid here. The agreement, as it is, seems to require completion and to be transposed before it can be considered applicable. In particular, although it provides for a minimum period for the protection of patents, there is a failing, in that it does not provide for a maximum period of protection. Hence the incomplete nature of the agreement that it would therefore be erroneous to apply as it stands. Pending completion of the agreement and pending its transposition into national legislation, and given the lack of any case-law antecedent before the European Court, the current Portugal law is therefore the only legitimate legal framework for coming to a ruling in this affair. (cd)