Brussels, 21/02/2014 (Agence Europe) - On 20 February, the European Court of Justice said that a court such as the Portuguese Tribunal Arbitral Necessario responsible for compulsory rulings on appeals cases may refer questions to the Court of Justice for a preliminary ruling. The Court of Justice also ruled that “the holder of a patent and a supplementary protection certificate for a medicinal product may not enjoy more than 15 years of exclusivity from the first marketing authorisation issued in any member state.'
The Portuguese court asked for clarifications about the duration of patent protection for a medicine because EU law provides patent holders with 20 years of protection, but under EU Regulation 469/2009, it notes that the duration of patent protection, combined with an additional protection certificate, may not exceed 15 years from the first time the product was given authorisation to be marketed in an EU member state. The Portuguese court was hearing a case involving pharmaceutical company Merck Canada, which has held a patent in Portugal since October 1998 for an active principle found in its anti-asthma medication, along with an additional protection certificate. Merck was taking various generic medicine manufacturers to court. The company was demanding exclusive use of its active principle until August 2014 under its protection certificate, but the generics manufacturers argue that the protection conferred by the patent and extra certificate expired in August 2012 because the first sales authorisation for the medicine containing the active principle in question was issued in Finland in August 1997.
In the ruling, the Court of Justice says that the Portuguese court “meets all of requirements to be considered a court or tribunal. Its jurisdiction stems not from the will of the parties, but from Portuguese legislation and this confers compulsory jurisdiction upon the tribunal to determine, at first instance, disputes involving industrial property rights pertaining to reference medicinal products and generic drugs. In addition, if the arbitral decision is not subject to an appeal before the competent appellate court, it becomes definitive and has the same effects as a judgment handed down by an ordinary court. Furthermore, the arbitrators are subject to the same obligations of independence and impartiality as the judges of the ordinary courts. Lastly, the Tribunal Arbitral necessario observes the principle of equal treatment and the adversarial principle in the treatment of parties and decides on the basis of the Portuguese law on industrial property”. The Court of Justice agrees with the generic manufacturers' arguments that the medicine was protected for 15 years from the first authorisation issued in any member state (Finland in this case) rather than the first authorisation issued in the member state where the request was made (Portugal). (FG/transl.fl)