5 October 2016
On 5 October 2016, the Court of Justice of the European Union's handed down its decision in F. Hoffman-La Roche AG v Accord Healthcare OÜ, C-572/15. The decision has confirmed how the term of Supplementary Protection Certificates ("SPCs") in accession countries should be calculated. In doing so, it has effectively upheld the Tallinn Court of Appeal's decision and cleared the way for Accord to launch its capecitabine product in Estonia.
The case started in December 2014, following approval from the Ministry of Social Affairs for the inclusion of Accord’s capecitabine in the list of medicinal products provided by the national legislature. Roche claimed that the SPC for capecitabine would expire in June 2016. By order of 15 December 2014, the Harju District Court allowed Roche’s application for protective measures against Accord. This decision was reversed by the Tallinn Court of Appeal, but following an appeal by Roche, the Supreme Court referred the case to the CJEU for clarification.
The SPC Regulations provide originators with the benefit of extended periods of protection to compensate for delays in obtaining marketing authorisations ("MAs"). For policy reasons, where an originator has both a patent and an SPC, this period is capped at 15 years from the first MA in the European Union.
In this referral, the Court of Justice confirmed earlier case law (Merck Canada v Accord Healthcare, C 555/13) that the holder of both a patent and an SPC should not be able to enjoy more than 15 years of exclusivity from the time of the first MA. Following earlier case law (AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, C 617/12), the Court also confirmed that MAs granted by the Swiss Confederation constitute a "first MA" for the purposes of the SPC Regulations. Although Switzerland is not a member state, Swiss MAs are automatically recognised by the Principality of Lichtenstein, which is a member of the European Union.
With regard to calculating the term of an SPC, the Court of Justice addressed the issue of whether the "first MA" for the purposes of the SPC Regulations should be the first MA in any member state of the European Union (as set out in the legislation) or whether special rules apply in accession countries, such that the SPC term is calculated by reference to the first MA in that accession country. In the present case, the issue arose because the first MA in the European Union for capecitabine was granted by Switzerland in 1998. However, Estonia also granted a capecitabine SPC in 2001, before it became a member of the European Union in 2004.
Therefore, the question for the Court of Justice to decide upon was, should the maximal protection period in Estonia be calculated from 1998 or 2001? The Court held that the transition provisions of the SPC Regulations (Article 21) provide a complete answer - so that the extended protection period expires at the same time in all member states (and therefore upholding the free movement of goods), the "first MA" should be interpreted as the first MA in any member state.
Finally, the Court of Justice also addressed the issue of whether Community legislation that potentially has retroactive effect (in this case, the re-calculation of an SPC term) is invalid. As SPCs take effect only on the expiry of the basic patent and in this case after Estonia had already acceded to the Union, the Court held that there was in fact no retroactive effect. In any event, the transition provisions in the SPC Regulations had been agreed between the acceding member and the Community, and the Court of Justice has no jurisdiction to opine on the legality of such arrangements.
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