FINLAND Trends and Developments Contributed by: Rainer Hilli, Mikael Segercrantz, Johanna Lilja and Johanna Flythström, Roschier
cancelled by the Supreme Court. Finnish courts have traditionally applied a so-called strict lia- bility regime when it comes to damages to be awarded if a PI has been unnecessarily granted. On 14 July 2022, the Market Court referred the case of Mylan v Gilead (C-473/22) to the CJEU, requesting the CJEU to respond to questions addressing whether a strict liability damages regime, such as the one in force in Finland, is compliant with Article 9(7) of the Enforcement Directive. In the aforementioned court proceedings, the PI was cancelled by the Supreme Court due to the CJEU ruling in Teva UK (C-121/17), which led to the Supreme Court finding it likely that the relevant SPC was invalid. Mylan has claimed that Gilead should compensate Mylan for the alleged damages caused by the PI. The Market Court found that it was unclear if it could apply the strict liability regime in light of the CJEU rul- ing in Bayer Pharma (C-688/19). The advocate general’s opinion concluded that a strict liability regime would not be in line with Article 9(7) of the Enforcement Directive. However, in its judg- ment announced on 11 January 2024, the CJEU concluded that Article 9(7) does not preclude national legislation that provides for a strict lia- bility-based damages regime in which the court has the possibility to reduce the amount of the damages to be awarded, taking into account all the relevant circumstances of the case, includ- ing the potential contribution to the damage by the defendant. The CJEU started its response by first noting that the Enforcement Directive provides for the protection of IP rights and allows right-holders to claim provisional measures that can directly prevent the infringement of an IP right; howev- er, if these measures are revoked or lapse due to the applicant’s own conduct, or if it is later
established that no infringement has occurred, the defendant is entitled to claim compensation for the damage suffered. The court noted that it follows from Article 9(7) of the Enforcement Directive that it is up to the competent court to examine whether three con- ditions of said provision are met – namely: • whether the provisional measures have indeed been revoked or lapsed due to the applicant’s own conduct, or whether it has been established that no infringement has occurred in the first place; • whether any damage has been caused to the defendant; and • whether there is a causal relation between the damage and the provisional measures. To answer the question of whether member states are obliged to apply a certain compen- sation regime under Article 9(7), the CJEU pointed out that it is important to consider the context and history of said provision as well as the aim pursued by the Enforcement Directive as a whole. In this respect, the court stressed that the Enforcement Directive is not intended to regulate all aspects of IP rights, but instead to oblige member states to provide for effective remedies. The CJEU noted that Article 9(7) of the Enforcement Directive, in light of Article 50(7) TRIPS, gives member states discretion as to the system of liability of the applicant for provisional measures, and this may be based on either strict liability or fault [34–36]. The CJEU noted that in Bayer Pharma it had held that the Enforcement Directive does not, in principle, preclude such national legislation as does not require the defendant to be compen- sated for the damage because they failed to act in a manner which was normally expected in the
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