IPKat friend Rodolfo Bretscher reported on the case of the Swiss Federal Patent Court 2018/004 dated 22 October 2018.
The Swiss case
In the case of ViiV v.
Sandoz, the Swiss Federal Patent Court ruled in favor of a request for a preliminary injunction, prohibiting Sandoz
from marketing a generic version of ViiV's Kivexa in Switzerland. The case
concerned the combination product of abacavir and lamivudine for the treatment
of HIV, Swiss SPC C00817637/01, based on EP 081 637 B1. In its defense, Sandoz objected to the validity of the
basic patent, but not to the question of infringement. It contested the validity of ViiV’s patent on the
basis that it was not entitled to the claimed priority date, arguing lack of novelty (prior art WO 96/06844) and
lack of inventive step in light of prior publications in the scientific field.
Taking into consideration that a previous ruling from
the German Federal Patent Court on the same case reached a different
conclusion, the Swiss Federal Patent Court found that it had to explain the
discrepancy. He reasoned that the
discrepancy is justified on the basis of the different manner by which novelty is
determined in Germany, and under the framework of the EPO case law, respectively.
In the case law
of the German Federal Patent Court, the novelty of selection invention is
subject to a more strict examination than in that of the EPO. In particular, a
citation from prior art is more prone to be novelty destroying than under the
case law of the EPO Boards of Appeal. By contrast, the Swiss court follows the case law of the EPO(see EPO
Guidelines for examination (Part V, Chapter VI Article 8.)
Regarding examination
of inventive step, the Swiss court did
not consider the citation referred to by Sandoz sufficient to provide a motivation to the skilled person
in the art to use abacavir as one of the two compounds for the treatment of HIV
(the prior art referred to in this case was limited to the use of lamivudine
and zidovudine).
What is interesting is that the court discusses the
differences between the EPO and German caselaw in the field of the examination of
selection patents, and that the Swiss court
treated the matter with considerable speed (the ruling came some three weeks
after the oral hearing).
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Preliminary injunctions in Switzerland or in Sweden? Same case but different |
The Swedish
ruling
This IPKat notes that the Swiss court refers to the ruling of the Swedish
Patent and Market Court in the same case.
The reason why the court makes reference to the Swedish ruling is
because this has been claimed by the defendant (Sandoz) in support of its
defense for injunctive relief.
The ruling of the Swedish Patent and Market Court of Appeal (in the same
case) (PMÖ 3565-17, ruling of the 26th of June
2017) overturned the decision of the Swedish
Patent and Market Court, which had
previously granted Viiva a preliminary injunction. The ruling of the Court of
Appeal was based on a preliminary examination of novelty and inventive step, reaching the conclusion that it is probable that the patent will be
invalidated in the infringement proceedings.
The Swedish ruling includes an extensive review of the rules for
determining whether the requirements for a preliminary injunction were met,
and more specifically what is required
to base such a ruling upon lack
of inventive step and novelty of a granted patent. The Court of Appeal concluded
that the patent holder failed to show that the patented invention (even after
the changes proceeded by means of the post-grant delimitation of the patent
claims), would survive a thorough examination of novelty and inventive step in
the infringement proceedings. Unlike the
Swiss ruling, the Swedish Court of Appeal did not include an elaborate
discussion on how these two patentability requirements are applied in Sweden
(or for that matter how they are applied in other jurisdictions and in the EPO).
The most important and most valuable contribution of the Swedish case lies with
the pedagogic discussion on the requirements for the grant of a preliminary
injunction, the burden of proof and how/when this may be shifted. Somehow the
Swedish way of structuring a preliminary injunction ruling makes more sense and
is more valuable in terms of understanding its legal and factual grounds.
The clash of the German and Swiss assessments re novelty is discussed in a bit more detail here: https://www.patentlitigation.ch/generic-kivexa-interim-injunctive-relief-granted-appeal-pending/
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