Clarity sought for interpreting the exclusion from patentability of 'methods for treatment of the human or animal body by surgery.'

A new referral to the Enlarged Board of Appeal of the EPO (case number G 1/07) has been made including questions to clarify how the term “treatment by surgery” within the meaning of Article 52(4) EPC is to be interpreted.

Article 52(4) EPC sets out that 'Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application'.

Such methods are therefore excluded from being patentable in Europe, the exclusion being based on socio-ethical and public health considerations: a health professional should not be inhibited or prevented from using methods to provide medical treatment to humans or animals because of a patent. The exclusion intends to protect patients.

What exactly should be excluded has been debated and discussed in numerous cases before the EPO. The meaning of the terms “treatment” (curative, preventative?) and “treatment by therapy” (prophylactic, relief, curative, cosmetic?) have been determined in various cases over the years while the limits of the exclusion of “diagnostic methods” was clarified in an earlier referral to the Enlarged Board of Appeal, G 1/04.

In a new development, the question of what is meant by “treatment by surgery” has been raised.

The case in question relates to magnetic resonance methods for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarized 129Xe. During examination before the EPO, the Examining Division held that the claimed methods, in so far as they comprised the step of administering polarized 129Xe as an imaging agent to a subject by injection, were excluded from patent protection as they involve a surgical step.

The Patentee argued that, in the field of imaging, there were procedures where no contrast agent was required (e.g. x-ray imaging of the skeleton) and procedures where a useful image could only be obtained by injecting a contrast agent (e.g. x-ray imaging of the vasculature). It did not seem reasonable that a method related to in vivo imaging of one part of the body should be patentable and another similar method related to a different part of the body should be excluded from patent protection because it required the introduction of a contrast agent.

In addition, one of the advantages of the methods claimed in this case is that they provide real-time feedback during surgery to verify the success of the treatment. This raised the question of whether an imaging method providing information of diagnostic value should be considered as being a constitutive step of a treatment by surgery.

The following questions have been referred to the Enlarged Board:

1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised 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 step does not per se aim at maintaining life and health?

2. 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?

3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) 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 allow a surgeon to decide on the course of action to be taken during a surgical intervention?

The Enlarged Board will now consider these questions and issue a decision to clarify the interpretation.

(Note in EPC 2000, which comes into force 13 December 2007, the wording of Article 52(4)EPC reappears in Article 53(c) EPC2000. A change in the EPO’s current practice regarding these inventions is not envisaged).

01 Jan 2007

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