At the beginning of April 2021, a decision was given by the Supreme Court of Justice ruling on whether the general criterion for the assessment of procedural interest is derogated by Article 3 of Law No 62/2011 of 12 December 2011, namely as amended by Decree-Law No 110/2018 of 10 September 2018.
To recall, Law No 62/2011 (amended by Decree-Law No 110/2018) created a system for the resolution of compulsory litigations arising from the claiming of industrial property rights, including injunction proceedings, relating to reference medicines, namely medicines that are authorised on the basis of complete documentation, including the results of pharmaceutical preclinical and clinical trials, and generic medicines, irrespective of whether process, product or use patents or supplementary protection certificates are involved.
In accordance with Article 3(1) of the said Law No 62/2011, within a 30-day term counted from the publication on the website of the Portuguese Drug Agency INFARMED of all applications for marketing authorisation or registration for generic medicines, any interested party who wishes to invoke its industrial property right within the terms of the preceding article must do so before the Court of Intellectual Property or, upon agreement between the parties, before the institutionalised arbitration tribunal or must request the submission of the litigation to non-institutionalised arbitration.
In a recent decision of the Court of Intellectual Property, following the filing of an action under the system created by Law No 62/2011, the non-specific plea of lack of legal interest in bringing proceedings was deemed admissible and the court ruled that “the plaintiff has the exclusive right to work the patents that it owns and the right to prevent third parties not having its consent from manufacturing, commercialising or making it available to third parties. However, there is nothing in the proceedings to indicate that there is any infringement or threat of infringement and there is no obligation to lodge actions of this nature, which were devised for a certain set of circumstances that no longer exist, with the compulsory use of an arbitration tribunal.”
An appeal was lodged at the High Court of Lisbon, which upheld the abovementioned decision.
The plaintiff did not agree with this decision and appealed to the Supreme Court of Justice, defending that the start or imminence of the manufacturing, commercialisation, storage, export or any type of provision of medicines containing the active substance under discussion is not a condition or requirement for the action lodged under Law No 62/2011.
In a first analysis, the Supreme Court recognised the plaintiff’s right to file an exceptional appeal on a point of law, highlighting the controversy caused by the issue of patent protection for medicines for which marketing authorisation is sought in respect of generic medicines. The court deemed that, notwithstanding the private interest of the appellant in accessing the third degree of jurisdiction, what would be decided in this case would affect the resolution of other industrial property litigations regarding which a single court of first instance has competence, meaning that this intervention of the Supreme Court of Justice would contribute to certainty and safety in the application of the law.
Subsequently, in its decision, the Supreme Court clarified the issue, stating that “The owners of intellectual property rights can file the special action provided for in Article 3 of Law No 62/2011 of 12 December 2011, namely as amended by Decree-Law No 110/2018 of 10 September 2018, following the publication of a simple application for marketing authorisation.”
The Supreme Court quoted the words of Professor Evaristo Mendes, “Patentes de medicamentos. Arbitragem necessária. Comentário de jurisprudência. Súmula da Lei No 62/2011”, Propriedades Intelectuais 4, 2015, pp. 26-40, ruling that “(…) the proceedings provided for in Article 3 of Law No 62/2011 of 12 December 2011 must represent (and continue to represent) a ‘special proceeding’ of ascertainment of rights: i) which can be started in view of the publication of a simple MA request (when, as a rule, there is still no infringement or imminent threat of an infringement of industrial property rights); ii) which the owners of rights may or may not file, depending on their interest in it; iii) which can only be filed within one month counted from the said publication, because this is in accordance with the nature of a swift proceeding, intended to ideally be concluded before Infarmed issues a decision on the MA request; and iv) involving a single appeal body.”
