一覧に戻る New Medical Use of a Known Medicament

In its decision X ZR 68/08 – “Memantin”, dated June 9, 2011, the Federal Court of Justice in Germany heard a case concerning the use of a known medicament for treating a particular disease. In the case underlying the above decision the validity of a Supplementary Protection Certificate (SPC) providing protection for the use of Memantin as an active ingredient for treating Alzheimer’s disease was challenged. The appellant requested nullification of the SPC based this request on prior art which anticipates the claimed use.

One document cited by the appellant discloses a clinical study, wherein a group of patients with Alzheimer’s disease and a group of healthy patients forming a control group were treated with Memantin. The outcome of this study was that no significant difference in the therapeutic response of patients having Alzheimer’s disease and patients in the control group could be detected. While the Federal Patent Court as the first instance court found this document to be detrimental to the novelty of the claimed subject matter, the Federal Court of Justice reversed this decision. According to the Federal Court of Justice, this document does not teach that Memantin is pharmaceutically active in patients having Alzheimer’s disease. Thus, this document does not disclose a novelty-destroying use of Memantin as an active ingredient for treating Alzheimer’s disease.

Another document cited by the appellant discloses the treatment of patients having a common syndrome, called organic brain syndrome, with Memantin. Organic brain syndrome can be caused by a variety of diseases including encephalitis, alcoholism and Alzheimer’s disease. At the priority date of the patent underlying the SPC, diagnosis of Alzheimer’s disease was not very well-established. It can be concluded that a number of patients having Alzheimer’s disease were among the patients having organic brain syndrome who were treated with Memantin. In contrast to the cited document, the patent application underlying the SPC provides detailed scientific explanations as to how the damages caused by Alzheimer’s disease in the patient’s brain are remedied by administering Memantin. However, although the Federal Court of Justice acknowledges the scientific merits of the above explanations, it does not consider the provision of the biological mechanisms of action as a new technical teaching. Accordingly, the Federal Court of Justice revoked the SPC due to lack of novelty or the underlying patent.

As a consequence of the above it can be concluded that when it comes to the novelty of a second medical use of a known medicament, it has to be shown that no prior art document discloses the successful treatment claimed. If the successful treatment of a disease by a medicament has been published prior to filing the respective patent application, the resulting lack of novelty cannot be remedied by identifying a particular biological mechanism of action of the medicament in the claims.

Download the full text of the decision X ZR 68/08 – “Memantin” of the German Federal Court of Justice under:

http://www.mueller-bore.de/tl_files/Decisions_BGH/X_ZR_68_08.pdf

Should you have any questions, please feel free to contact lenhard@mueller-bore.de

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