Key facts of the case:
F. Hoffmann-La Roche AG held a patent and a supplementary protection certificate for capecitabine (Drug XELODA). It received the supplementary protection certificate on 24 October 2001, and the protection lasts according to the certificate until 8 June 2016. Applicant filed an action against Accord Healthcare OÜ and asked the court to oblige the respondent to avoid or stop violating its supplementary protection certificate for capecitabine, and, as for securing the action, prohibit the respondent from marketing, offering for sale, selling and promoting it generic drug Capecitabine Accord.
County Court settled the claim and secured the action by a ruling; it refused to grant the appeal against the latter ruling. The District Court satisfied the appeal and found that as the drug XELODA was first registered in the EU in 2001, its patent had expired, and the supplementary protection certificate could not be relied upon.
The applicant made an appeal to the Supreme Court and found that as the supplementary protection certificate was granted before the Estonian joining to the EU, the matter should be solved in accordance with Estonian legislation, not the EU law. The Supreme Court found that there are doubts about both the legality of the Regulation (EC) No 469/2009 and its compliance with the Charter.
Outcome of the case:
The Supreme Court asked for a preliminary ruling.
15. If the European Court of Justice finds that the answer relating to the interpretation of art 21 (2) of the regulation is “yes”, the chamber has a doubt about whether this provision is in compliance with the primary law of the EU or not.
This interpretation would mean that the rights of the applicant are directly affected, and the protection given through the supplementary protection certificate (that was prior the Estonian joining the EU) is shortened. This in turn, raises a question of the consistency of the art 21 (2) of the regulation with the EU law, general principles of protection of acquired right, prohibition of retroactivity, and rights protected in articles 16 and 17 of the Charter of Fundamental Rights. Article 16 of the Charter recognises freedom to conduct business in accordance with Union law and national laws and practices. According to art 17 (1) of the Charter, no one may be deprived of his or her possessions, except in the public interest and the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss. The use of property may be regulated by law in so far as is necessary for the general interest. Art. 17 (2) also protects intellectual property.
17.Deriving from the above, the Chamber finds it important to ask preliminary ruling also in the following question: “If the reply to the first question is affirmative, is art. 21 (2) of the regulation in compliance with EU law, in particular, general principles of the EU law on the protection of the acquired rights, prohibition of the retroactive force of the law, and the Charter of Fundamental Rights?