A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Wednesday 6 February 2019

Darunavir in Swedish Preliminary Injunction Proceedings

Recently, the Paris High Court decided for a preliminary injunction against the commercialisation of Darunavir by Sandoz, the SPC Blog report can be found here. In parallel proceedings, the Swedish Patent and Market Appeal Court has come to the opposite conclusion, and found that that the contested SPC would most likely be found invalid and thus denied a request for a preliminary injunction. Hampus Rystedt from Zacco has kindly provided the following summary of the case.

The first instance Patent and Market Court, which is quite experienced in SPC appeals originating from the examination at the Swedish Patent Office, granted a preliminary injunction. The Patent and Market Appeal Court however reversed the decision. The PMAC specifically referenced the Teva case from the CJEU (C-121/17; EU:C:2018:585) and found that the criteria set out in Teva should be applied when assessing the plausibility that an SPC will be considered valid. The PMAC finds that darunavir is not specifically identified in the claims, and indeed appears to have been first synthesized only after the priority date. The PMAC therefore finds that it is likely that the SPC will be considered invalid in the main proceedings and that a preliminary injunction cannot be granted.

Of interest to note is that the decision in PMAC was split 3 to 2, with the chairwoman and the only chemical expert dissenting. The two dissenting judges found that the case law is not clear on how Art 3(a) of 469/2009 should be applied when the basic patent defines the invention by means of a Markush-formula. These judges were thus of the opinion that it had not been sufficiently shown that the SPC would likely be held invalid, and that the preliminary injunction granted by the lower court should be upheld.

The main proceedings will now continue in the first instance court.

Many thanks Hampus!

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