Medical Diagnostic Methods More Freely Patentable in Europe

In G1/04 the Enlarged Board of Appeal stated that, to sustain a rejection for non-patentable subject matter, a claimed method must include steps from all of the following categories:

(i) an examination phase, during which data is collected;

(ii) a comparison of the data to standard values;

(iii) detection of a significant deviation in the course of the comparison; and

(iv) an attribution of the deviation to a particular clinical picture (i.e., a deductive decision phase).

Steps (i) to (iii) include technical and/or non-technical steps for making a diagnosis ' i.e., for collecting information and determining the way or ways in which the data differ from standard data representing, for example, characteristics of individuals free from a condition. That is, step (iii) may represent the identification of a symptom, while step (iv) is regarded as the diagnosis stricto sensu, involving the identification of a particular condition as the cause of the determined deviation or symptom. The step or steps constituting this diagnosis stricto sensu may be performed by a medical practitioner or automatically through the implementation of a device.