Memantine: the Bundesgerichtshof speaks

From Cordula Tellmann (Freshfields Bruckhaus Deringer LLP, Düsseldorf) comes some helpful information concerning a judgment by the Bundesgerichtshof -- the German Federal Supreme Court -- regarding the supplementary protection certificate for memantine. The judgment was delivered in proceedings between Merz, as the owner of the SPC, against an entire bevy of companies which maintained that the SPC was invalid because the underlying patent was itself invalid: Neuraxpharm, Teva, Synthon, Pliva and Chemo Ibérica.

The Bundesgerichtshof held that the SPC was invalid, since the underlying basic patent was invalid for lack of novelty.

Cordula has kindly provided this weblog with a copy of the German original of the judgment. While the decision was issued following an oral hearing on 9 June 2011, it is only now that the written decision has been published only now.

According to Cordula, the Court held that the discovery that a certain active ingredient (here memantine) is effective against a pathological situation in a specific illness (in this case Alzheimer's disease) does not lead to a novel teaching if it was known in the state of the art that patients with this illness were treated with this active ingredient to alleviate such symptoms and if the patent does not teach a new way of dosage or a new group of patients which previously did not receive such treatment.

The decision must be read in the context of the decision of the Court of Justice of the European Union in Case C-195/09 Synthon on 28 July 2011 (noted by The SPC Blog here) regarding the validity of SPCs where there has been a pre-65/65 authorizations. In the German case, the Bundesgerichtshof did not have to address this question as the SPC was already invalid due to the invalidity of the basic patent.