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The German Federal Supreme Court in
a groundbreaking decision dated 16 December 2008 has upheld the validity of Eli
Lilly's patent DE 691 12 895 (from EP 0 454 436) covering olanzapine (Zyprexa®),
a drug used in treating schizophrenia and bipolar disorders. The Federal
Supreme Court ruling brings German case law regarding so called “selection
inventions” broadly into line with that of the European Patent Office (EPO), the
United Kingdom and most other European countries, confirming that a specific
compound can be held patentable over a prior art generic formula encompassing
the compound.
Eli Lilly's olanzapine patent had
been deemed invalid by the first-instance German Federal Patent Court in 2007,
on the basis that olanzapine was anticipated by a generic structure disclosed
in a prior art document. The Federal Patent Court had said that even though
olanzapine was not described in express terms in the prior art, the disclosure
content of a prior art document should not be limited to its literal
description - in accordance inter alia with an earlier Federal
Supreme Court decision “Electric plug-in connection” (1995). Rather, the
disclosure content was stated by the Federal Patent Court to include also those
modifications that are suggested or readily apparent to the person skilled in
the art by the full scope of the writing. This very broad concept of disclosure
content contradicted the EPO approach which when considering novelty requires a
concrete disclosure in the prior art.
Prior to the Federal Supreme
Court’s olanzapine ruling, the Düsseldorf Court of Appeal in May 2008 granted a
preliminary injunction to Eli Lilly against a distributor of a generic version
of olanzapine - even though at that stage Eli Lilly's olanzapine patent was
still deemed to be invalid following the Federal Patent Court's 2007 decision.
This was apparently the first time in patent law history that a German court
had granted a preliminary injunction based on a patent found invalid by a first
instance Federal Patent Court. The Düsseldorf Court of Appeal said this was an
exceptional case because the Federal Patent Court was evidently incorrect. Fortunately
for the Court of Appeal judges, the Federal Supreme Court has now affirmed
this.
The Federal Supreme Court’s
olanzapine decision means that it is likely that the EPO’s practice regarding
selection inventions will be followed in Germany in respect of inventions
relating to chemical formulae. However, the impact of the Federal Supreme
Court’s decision could also extend to other areas of technology when the
disclosure content of a prior art document is assessed.
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