Enlarged Board of Appeal: Surgical Methods (G1/07)

Article 52(4) of the European Patent Convention states that:

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions which are susceptible of industrial application...

The Enlarged Board of Appeal has been asked to provide guidance on what constitutes a "surgical method" within the meaning of Article 52(4) EPC. This referral is pending as G1/07.

The Technical Board of Appeal in T0992/03 reviewed the case law on "surgical methods" and found that two distinct aspects could be identified in the definition of surgery, namely the nature of the physical intervention on the one hand and its purpose on the other hand. According to the Board, different conclusions have been drawn in respect of the exclusion under Article 52(4) EPC depending on whether the emphasis was put on the former or the latter aspect.

In view of the inconsistency in these two approaches the following questions have been referred to the Enlarged Board of Appeal:

Is a claimed imaging method for a diagnostic purpose (examination phase, within the meaning given in G1/04), which comprises or encompasses a step consisting in physical intervention practiced on the human or animal body (in the present case, an injection of a contrast agent into the heart) to be excluded from patent protection as a "method for treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if such a step does not per se aim at maintaining life and health?

If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G1/04) to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if the data obtained by the method immediately allows a surgeon to decide on the course of action to be taken during a surgical intervention?

This is not an exhaustive review. For further information please contact your usual D Young & Co adviser.