In the decision Carvedilol II (file X ZR 236/01), the Federal Supreme Court had to deal with the validity of the German part of a European patent that was defended with a main claim, the essential part of which reads as follows:
“Use of Carvedilol for the manufacture of a medicament […], wherein the medicament is administered in an initial dose of 3.125 mg […], daily for a period of 7- 28 days […].”
The Court dealt with Art. 52 (4) of the European Patent Convention according to which methods for treatment of the human body are not regarded as inventions which are susceptible to industrial application. The Court concluded that the determination of a therapy plan for a patient which includes the prescription and dosing of medicaments is a distinctive part of the activity of a medical doctor and therefore a method excluded from patentability pursuant to Art. 52 (4) EPC. The Court did not decide whether the claim as a whole is excluded from patentability, but concluded that the dosing recommendation specified in the claim cannot be considered for the assessment of novelty and inventive step of the claimed subject matter. Consequently, novelty and inventive step were evaluated as if the feature relating to the dosage regimen was absent. The claim was finally rejected for lack of inventive step.
As an auxiliary request, the patentee defended the patent with a claim in which the passage “whereby the medicament is administered […]” was replaced by “whereby the medicament is prepared for an administration […]”. According to this auxiliary request, the dosage regimen was defined as a feature of the medicament as such (“is prepared for administration”) and not as part of an administration scheme (“is administered”, see claim 1 of the main request). In the Court’s view, the patent claim of the auxiliary request did not conflict with the regulations of Art. 52 (4) EPC. The claim drafted in the “is prepared for administration” language was regarded as relating to the design of the medicament for this use, e.g. by designing a suitable size of the tablet, by adding an imprint on the package or on the package insert. Although the court was of the opinion that the claim complied with the requirements of Art. 52 (4) EPC, it was also rejected for lack of inventive step.
In summary, it should be concluded that features related to dosage regimens as such might not be considered in Germany for assessing novelty and/or inventive step of the subject matter of a second medical use claim. However, if the claim is redrafted to specify that the medicament is designed to be useful in a specific administration scheme, dosage features linked to the medicament will be taken into account.