In its decision of 15 February 2010, the EPO Enlarged Board of Appeal (EBA) considered three questions referred to it by the EPO Technical Board of Appeal concerning Medi-Physics, Inc’s patent application, which claimed a method for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarised 129Xe.
The EBA initially noted that Article 52(4) was transferred to Article 53(c) by the EPC 2000, and that the referred questions should be answered in terms of Article 53(c).
The first question was whether a claim, such as the one at issue, which comprised or encompassed a step consisting of a physical intervention practised on a human or animal body was to be excluded from patent protection pursuant to Article 52(4) EPC if such step was not per se aimed at maintaining life and health.
The EBA answered this first question in the affirmative. Article 53(c)’s legislative history did not show that its purpose was to be limited to surgical methods pursuing a therapeutic purpose. Instead, the purpose of the exclusion is, in the interests of public health and patients, to free the medical profession from constraints which would be imposed on them by patents granted on methods for surgical or therapeutic treatment.
The EBA stated that the exclusion should be interpreted to make its purpose effective, but should go no further. However, it refused to give a more precise definition of ‘treatment by surgery’, stating that a clear line could not easily be drawn and that ‘surgery’, as understood in the medical sense, was largely a matter of convention which would change with time as technology progressed. It noted that new inventions had to be given the protection they deserved and each case would have to be assessed on its merits.
The second question referred was whether the exclusion could be avoided by amending a claim’s wording to omit or disclaim the step at issue, or let the claim encompass it without being limited to it. The EBA reasoned that it was difficult to imagine how there could be a problem under Article 53(c) if the claimed invention no longer contained excluded subject-matter. However, the overall patentability of any such claim had to be assessed on the basis of the overall circumstances of the particular case. It would depend on the claim fulfilling the remaining requirements of the EPC (in particular Article 84) and, where applicable, the fulfilment of the conditions as defined in decisions G1/03 and G2/03.
The third and final question referred asked whether the claimed imaging method for a diagnostic purpose was excluded from patentability by Article 52(4) if the data obtained by the method immediately allowed a surgeon to decide on a course of action to be taken during a surgical intervention.
The EBA stated that Article 53(c) did not prohibit the patenting of methods which could be used during a surgical intervention. Otherwise, many methods for operating devices used in context with surgical activities would be unpatentable. Although one of the possible and described uses of the claimed imaging method was its use by a surgeon, it was a complete teaching per se and a diagnosis was not constitutive of the invention; accordingly it was not excluded by Article 53(c).