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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