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Estonia / Supreme Court, Civil Law Chamber / 3-2-1-88-15

F. Hoffmann-La Roche AG v Accord Healthcare OÜ

Policy area:
Deciding Body type:
National Court/Tribunal
Deciding Body:
Civil Chamber of the Supreme Court
Decision date:

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.