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The European Patent Organisation (“EPO”) has previously strictly prohibited protecting methods for medical treatment and diagnosis. However, a recent decision by the Enlarged Board of Appeals has clarified and restricted the grounds for rejection under Article 52(4) EPC on the basis of non-patentable subject matter. Thus, many diagnostic methods that were previously unprotectable in Europe may now be patented so long as they comply with the basic guidelines set forth in the opinion.

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.

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