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 exceptional case,
where the nullification of the patent by the
Federal Patent Court is evidently wrong
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

Source: http://www.grunecker.eu/files/olanzapine_article.pdf