Patentability of Diagnostic Methods in Europe
Under Article 52(4) EPC, diagnostic methods practised on the human or animal body are excluded from patent protection. The purpose of this exclusion is to prevent patent rights standing in the way of the use of such methods by medical practitioners in the diagnosis of humans or animals.
The Boards of Appeal of the EPO have been required to consider this exclusion but have not always found common ground. Two appeal decisions in particular have caused the President of the European Patent Office to refer matters to the Enlarged Board of Appeal for clarification These two decisions are T 385/86 and T964/99.
According to T385/86, the exclusion was interpreted narrowly so that methods excluding the actual step of diagnosis and which is typically performed by a physician or nurse, i.e. methods whose results do not make it possible to decide on a particular course of medical treatment, could be claimed.
Later, the Board of Appeal in decision T964/99 considered whether obtaining a sample from the human or animal body and analyzing the same was a diagnostic method excluded by Article 52(4) EPC. Although in this case the sampling was to be carried out by the patient rather than a physician or nurse, the Board held that this was immaterial. The decisive factor for the Board was that the method claims included the step of taking a body sample for the purpose of diagnosis.
The President of the European Patent Office has consequently referred points of law relating to the interpretation of the term "diagnostic methods practised on the human or animal body" within the meaning of Article 52(4)EPC to the Enlarged Board of Appeal. The case is pending under reference no. G 1/04.
Until the Enlarged Board of Appeal has issued its decision, all proceedings before the EPO departments of first instance (examination and opposition divisions) where the conclusion of the Enlarged Board of Appeal may be material will be suspended.