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Olanzapine
The Olanzapine Patent Dispute: German court grants a preliminary injunction on a patent invalidated by the first instance Federal Patent Court
Gerhard Barth and Dr. Franz-Josef Zimmer
The recent olanzapine case has caused a furor in Germany. For the first time in history, a German court allowed a preliminary injunction based on a patent that was found invalid by the first instance Federal Patent Court. The Olanzapine patent (DE 691 12 895) owned by Eli Lilly was attacked by several generic companies filing invalidation complaints with the Federal Patent Court. By decision 3Ni 21/04 (EU) combined with 3Ni 41/06(EU), the Federal Patent Court declared the Olanzapine patent invalid for lacking novelty. Nevertheless, the patentee filed a request for a preliminary injunction inter alia with the first instance Civil Court in Düsseldorf, which rejected the request; surprisingly, however, the second instance Appeal Court granted the preliminary injunction. This is all the more noteworthy since the infringement court of second instance, composed of “non-technical” judges found the underlying patent to be valid, contrary to the opinion of the Federal Patent Court having technical judges deciding on the case.
The Decision of the Federal Patent Court to invalidate the Olanzapine
The patent contains 22 claims inter alia
patent was a publication by Chakrabarti et
al. in J. Med. Chem. 23 (1980), pages 878
ff of which disclosed a group of compounds allegedly having neuroleptic
activity and being defined by the following lead structure:
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
Chakrabarti et al. the Federal Patent Court
neuroleptic compound (R1 is H, R2 is Me).
wording, the skilled person would “read
Chakrabarti, a skilled person would further
into” (read between the lines of) the literal
Olanzapine, all requirements for a novelty-destroying disclosure of Olanzapine would
to the disclosure of Chakrabarti, the Federal Patent Court further considered,
Moreover, in the Patent Court’s opinion,
content of Chakrabarti should be defined.
neuroleptic activity of the compounds. This in turn would directly tell the skilled person
that the compounds are useful for treating
compounds with lead structure of formula I
Therefore, also the use of Olanzapine for
with neuroleptic activity. Based on this
treating inter alia schizophrenia would lack
starting point in Chakrabarti et al., the
Patent Court’s further considerations may
the Court invalidated the patent for lack of
Chakrabarti would clearly disclose to the
The influence of validity questions in German patent litigation
falling under formula I with R1 occupying position 7 and being selected from H, Cl
To understand the Olanzapine decision of
the Düsseldorf Court of Appeal, it is helpful
to understand the limited influence of validity questions in German patent
only 12 compounds clearly disclosed by the lead structure (R1 being H, Cl, F; and
A core feature of German patent litigation
R2 being H, Me, Et, i-Pr). The residues R1
is the strict separation of the infringement
infringement court has to accept the patent
(leading to 12 possible combinations, i.e.
12 compounds with the desired activity). Further, Chakrabarti would disclose 3
The jurisdiction for all questions relating to
infringement of a patent is vested with the
so-called ordinary courts, i.e. the District
Courts (Landgerichte) for the first instance
relationships for all 12 compounds and the
“neighbouring” Olanzapine, the Court concluded that the skilled person would
1 See Federal Supreme Court in “elektrische
Steckverbindung” (electrical plug-in connector)
914, 916 – Kontaktfederblock; BGHZ, 134,
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
infringement courts must accept the patent
Düsseldorf requires that a patent either seems to lack novelty or that the inventive
The jurisdiction for invalidity suits is vested
with a special court on the first instance
of the prior art presented by the infringer
level, the Bundespatentgericht or Federal
favor of validity left 5. The infringement
judge forms his opinion on the basis of the
Federal Supreme Court. The appeal is not
exception, also to the finding of facts. In
fact, the Federal Supreme Court regularly appoints a court expert to assist the court
proceedings, it usually waits until a final
understanding and to deal with questions
however, the courts may also stay up to a
and invalidity cases are dealt with by the
first instance decision in the invalidity case
same judicial panel, an infringement case
in an invalidity suit concerning one and the
patent has been upheld by a first instance
same patent will not be tried as one case
decision of the Federal Supreme Court or,
by the Federal Supreme Court even if both
Patent Office or the German Patent Office.
delayed by questions of validity and in fact progress as rather swiftly, providing an
In preliminary injunction proceedings, the
patentee, even after a first instance judgment. In other words, invalidity of the
patent is not a defense in an infringement
infringement court has to accept the patent
suit. On the other hand, the majority of all
patent infringement suits run parallel to an
a final ruling in an invalidity case, it is
invalidity suit filed by either the defendant
company, for example the licensor or supplier of the defendant. The defendant
of the infringement suit will of course bring
an invalidity suit filed by itself or a third party to the attention of the infringement
court. The infringement court may, under German
infringement proceeding at its discretion if it comes to the conclusion, summarily weighing the pros and the cons of the invalidity suit, that the invalidity suit has a
Transportfahrzeug; Court of Appeals Mitt., 97,
In law suits to the merit, there is only
one appeal in preliminary injunction cases
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
parties are weighted against each other,
Appeals, there is a rule that a preliminary
taking into account doubts with respect to
injunction can be denied even if the prior
the validity of the patent and the swiftness
art would not be strong enough to warrant
of the patent owner in enforcing his rights.
preliminary injunction proceeding would be
inconsistent with its character as a means
opposition as such, or even any new type
of swift justice. Therefore, doubts with
respect to the validity of a patent cannot,
excludes a preliminary injunction. At least
contrary to the practice in lawsuits to the
when the alleged infringer has had enough
time to produce relevant prior art against
proceeding and waiting for the result of an
injunction proceeding the preliminary injunction will be denied only if the
It follows that the request for a preliminary
infringer demonstrates a strong likelihood
injunction will be denied if the validity of
that the patent will be invalidated. The
likelihood would then be the same as it would be to convince a court in a lawsuit
There is no strict standard as to when the
validity of a patent can be regarded to be sufficiently
preliminary injunction against an infringer.
an infringement court can never judge with
binding effect but can only give a forecast
(prognosis) as to the result of an invalidity
considered to be sufficiently clear if the
infringement courts usually refrain from
patent has already been upheld in either
making their own prognosis if and when a
an opposition or an invalidity suit, at least
first instance ruling took place on validity,
by a first instance decision. However, this
either by the Federal Patent Court in an
rather strict standard, which would imply
reason behind this attitude is the principle
procedure, is not even applied in all cases
interfere with the findings of the Federal
has, albeit only on a first instance level,
ground that a preliminary injunction will not
sole jurisdiction to decide on the validity.
However, first instance decisions of the
infringement court, the prior art cited in an
opposition or invalidity suit comes so close
to the patent that the court would stay a
patents are upheld. The District Court of
lawsuit on the merits.6 If the prior art upon
which the invalidity suit or opposition is
based is not strong enough to warrant the
Court – upholding a patent can still leave
doubts, for example if the Federal Patent
standards of different courts vary. In the
Court failed to address a relevant legal
Düsseldorf Mitt. 96, 87; Court of Appeals Frankfurt, GRUR-RR 2003, 263.
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
question or if conflicting decisions existed
decision of the Federal Patent Court which
to parallel intellectual property rights, for
would be inconsistent with the appellate
jurisdiction of the Federal Supreme Court.
However, the Düsseldorf Court of Appeal
emphasized that, in an exceptionalcase, where the nullification of the patent by the
Federal Patent Court is evidentlywrong
court replaces a first instance decision
in the view of the infringement Court, this
court is free to make its own assessment
prognosis to the contrary as the Court of
of the validity and consequently would also
Appeals of Düsseldorf chose to do in the
be free to grant a preliminary injunction.
Moreover, the Düsseldorf Court of Appeal
preliminary injunction proceeding. Simple
pointed out that one must consider that if
logical considerations underscore just how
the underlying patent were to expire in the
unique this decision is: Since a preliminary
near future, it would constitute a refusal of
injunction is granted only if there is no
reasonable doubt with respect to validity,
decision upholding a patent still leaves
convinced that the first instance decision
invalidating a patent is so clearly wrong
and, moreover, that the claimed invention
that no reasonable doubts as to its validity
Specifically, the Appeal Court concluded
The Decision of the Appeal Court
that the Federal Patent Court applied too
Düsseldorf to grant a Preliminary Injunction
the skilled person to take the compound Olanzapine from the Chakrabarti art.
considerations applied by the Patent Court
requires that the underlying patent is valid
in interpreting the teaching of Chakrabarti
and, in general, that this validity has been
as extending far beyond those relevant for
the assessment of novelty. In addition, the
decision in a contentious proceeding such
Appeal Court clearly rejected some of the
as opposition or nullification proceedings.
findings of the Federal Patent Court, in
This in turn would mean that in general a
particular, that residues R1 and R2 would
preliminary injunction has to be refused if
opposition or nullification proceedings are
desired pharmaceutical activity, and that
still pending and rely on prior art which
leads to concerns regarding the validity of
the underlying protection right. This holds
falling under formula I. This, in turn, would
all the more so if the first instance has
mean that predicting the function based on
would be possible only by “trial and error”.
the infringement judge may not disregard
Moreover, contrary to the Federal Patent
the nullification of a patent, even if only in
Court’s opinion, the Appeal Court saw the
tantamount to a de facto supervision of the
person that a halogen substitution for R1 is mandatory in position 7 in order to achieve
1996, 51; Court of Appeals Düsseldorf InstGE
Therefore, the skilled person would have
to depart from the teaching of Chakrabarti
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
in order to arrive at Olanzapine as a useful
mechanism of preliminary injunctions. One
cannot conclude from the decision of the Düsseldorf Court of Appeals that in the
future it will be easy, much less the rule, to
the Federal Patent Court’s finding that
obtain a preliminary injunction where the
validity of the patent is doubtful or has
convinced of the inventive step underlying
the claimed invention, in particular, in view
of the replacement of the halogen atom in
emphasized by the judge presiding in the
position 7 by hydrogen in Olanzapine. In
Düsseldorf Court of Appeals decision. On
the court’s view, the skilled person would
the other hand, the decision is a signal
not have expected the observed activity as
that the patentee must not give up if he
a result of such a replacement. Moreover,
feels that there really exists clear and
the Appeal Court was of the opinion that
convincing evidence that the decision in
several other indications would support the
inter alia, the fact that it took more than ten
cases where the validity of the patent has
publication date of Chakrabarti to the priority date of the Olanzapine invention
patentable and there were only a few years left before the patent expired, they decided not to wait for a second instance following the invalidation proceedings but rather issued the preliminary injunction.
Further Considerations
The latter consideration is in compliance with the principle that in preliminary injunction cases the interests of both parties have to be balanced. The Düsseldorf Court of Appeals took specific account of the long duration of German invalidity cases, especially in the second instance. In the Court’s opinion, it would be unlikely that the Federal Supreme Court would hand down its decision on the appeal of the patent owner before the patent expires. In view of this, denial of the preliminary injunction would be, in the view of the Düsseldorf Court of Appeals, refusal of justice (Rechtsverweigerung).
Conclusion
The Olanzapin case is certainly an exceptional
GRÜNECKER KINKELDEY STOCKMAIR & SCHWANHÄUSSER
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