On December 16, 2008 the Federal Supreme Court gave its judgment determining the validity of the Olanzapine patent, this was further to its revocation by the Federal Patent Court at first instance.

This marked the end of the hardfought battle between almost 20 generic companies and the originator in Germany.

In June 2007, at first instance, the Federal Patent Court revoked the patent due to lack of novelty. The prior art reference did not expressly disclose Olanzapine, but a generic chemical formula encompassing it. The court determined that the person skilled in the art would have read the formula for Olanzapine in the article when carefully reviewing it. He would have chosen the relevant substituents in the formula leading to Olanzapine. In addition, the court found that Olanzapine could have been reproduced on the basis of the publication describing the synthesis for the respective group of compounds and was therefore disclosed.

The decision was found in accordance with the Supreme Court’s “Fluoran” judgment of 1988. According to this judgment, a generic chemical formula encompassing a claimed compound was held to be novelty-destroying, in cases where the document contained a concrete indication for that compound. This would require the person skilled in the art to be able to synthesise the claimed substance. The formula subject to that decision encompassed about 2000 reproducible compounds.

Generics, encouraged by the favourable revocation judgment pushed into the market at the end of 2007/beginning of 2008. The originator reacted by filing preliminary injunction proceedings with different courts in Germany despite the patent’s nullification. At first instance all courts rejected the preliminary injunction request, assuming the patent to be invalid.

However, to the surprise of all parties involved, the originator was successful in one case in second instance: the Higher Regional Court Düsseldorf granted a preliminary injunction holding the Federal Patent Court decision to be obviously incorrect. This decision was very exceptional since German infringement courts usually respect decisions of the Federal Patent Court being the competent court for deciding a patent’s validity.

In light of the further preliminary injunction proceedings pending against various defendants, and the different outcomes of the proceedings, the Federal Supreme Court speeded up the trial. It scheduled an oral hearing within one and a half years after the filing of the appeal.

The Federal Supreme Court found that the patent is in fact valid, particularly claiming a new and inventive technical teaching. It expressly limited its former case law based on the “Fluoran” decision.

The Federal Supreme Court emphasised that “Fluoran” was found on the basis of the former Patent Act of 1968. They noted that the decision should no longer be applicable to the extent that it did not require further information to be disclosed in the prior art reference individualising the claimed compound in order to qualify as novelty-destroying.

With this the court also intended to harmonise its case law in respect of anticipation of chemical formulae with the EPO’s practice to which it expressly referred to in its judgment. It emphasised that also the High Court of Justice (Floyd J.) had found its revocation decision regarding the British part of the Olanzapine patent ([2008] EWHC 2345 (Pat)) on these principles developed by the EPO’s boards of appeal.

The decision is final. The generics immediately stopped distributing their products and will now have to wait before expiration of the corresponding SPC in 2011 before entering back into the market.