We successfully represented Mylan AB before the Supreme Court in a case concerning the presumption of validity of a supplementary protection certificate (“SPC”) in a preliminary injunction matter. The Supreme Court handed down its ruling on 11 April 2019 overturning the Market Court’s decision, accepting Mylan’s appeal and cancelling the preliminary injunction ordered by the Market Court. This landmark ruling has great importance for preliminary injunction proceedings involving IPR.
In accordance with the Market Court’s established case law, the starting point for assessing the likelihood of a patent infringement in preliminary injunction matters is that a patent that has been granted or validated in Finland is presumed to be valid. In practice, this so-called presumption of validity has made it close to impossible to defend against a preliminary injunction by invoking the invalidity of the applicant’s right especially in patent cases. This has been the case even where the respondent has presented several foreign decisions dismissing the application for a preliminary injunction or even invalidating the right on which the preliminary injunction is based. The Market Court’s approach has also varied in terms of different types of IP rights.
In this case decided by the Supreme Court, the Market Court had granted a preliminary injunction at the end of 2017. Following the European Court of Justice’s preliminary ruling in case C-121/17 (Teva UK and Others), in which the CJEU clarified its interpretation of Article 3 a of the SPC regulation by setting a two-limb test, Mylan requested the Market Court to cancel the preliminary injunction’s enforcement. The request was made on the basis of a change of circumstances in consequence of which there were no longer prerequisites for the preliminary injunction’s preservation, as the CJEU had noted in its preliminary ruling e.g. that it seemed that the first limb of the test was not met.
The Market Court rendered its decision on the cancellation of the preliminary injunction’s enforcement in October 2018. The Market Court referred to the presumption of validity as the starting point for its assessment and noted that the burden of proof in terms of the invalidity of the SPC lies with the party invoking invalidity. The Market Court noted that the parties had presented contradictory evidence and therefore it was impossible to determine whether it was more likely that the SPC was valid or invalid. As such, the Market Court considered that the presumption of validity was not sufficiently undermined and dismissed the request for cancellation.
Supreme Court’s decision
Mylan successfully sought a leave to appeal from the Supreme Court at the end of 2018 requesting the Market Court’s decision to be overturned and the preliminary injunction to be lifted.
The Supreme Court considered that the CJEU’s preliminary ruling that clarified the interpretation of Article 3 a of the SPC regulation is to be considered as a change of circumstances on the basis of which it is to be reassessed whether the prerequisites for granting a preliminary injunction still exist. The Supreme Court noted that if it is to be considered that the SPC is no longer likely to fulfil the requirements set out in the CJEU’s preliminary ruling it can be concluded, despite the presumption of validity, that the prerequisite of claim will no longer be met.
The Supreme Court noted that the CJEU has in its preliminary ruling set an additional specified requirement for the SPC to be valid, which did not exist in the CJEU’s practice at the time of granting the SPC in 2009. The Supreme Court considered that this additional requirement together with what was presented in the proceedings undermined the assumption of the validity of the SPC.
As regards the burden of proof, the Supreme Court noted that proving that the first limb of the test was met required the presenting of evidence and held that, for this issue, the burden of proof lies with the party that applied for the preliminary injunction and not with the party who invoked invalidity.
In conclusion, the Supreme Court held that based on a summary assessment carried out in connection with preliminary injunction proceedings, it could not be considered likely that the requirements set in the CJEU’s ruling were met. As such, the Supreme Court held that the prerequisite of claim was no longer met and as a result of that the preliminary injunction must be cancelled.
The implications of the Supreme Court’s decision
This landmark ruling given by the Supreme Court has great importance for preliminary injunction proceedings involving IPR. The Supreme Court’s decision unifies practices adopted for different types of IPR and confirms the invalidity argument’s position as a defence equal to that of the non-infringement defence.
Furthermore, the Supreme Court’s decision offers the following important clarifications as regards the burden of proof in preliminary injunction matters:
- The rules of burden of proof applied in preliminary injunction proceedings involving IPR are no different to other preliminary injunction proceedings.
- Even established rules on the burden of proof are not cast in stone, but the burden of proof may shift when the other party has sufficiently proved its grounds.
- Preliminary injunction proceedings are summary by nature, which has to be taken into account in the evaluation of proof; full proof cannot be required to overturn the presumption of validity.