Enlarged Board decisions are usually reported and commented on IP blogs even before the ink is dry on the signatures. The present decision is no exception; although brand new, it has already been reported here and here. I for one have not yet found the time to delve into this 80-pages decision, but here are the questions referred to the Board in interlocutory decision T 992/03 and the corresponding answers of the Enlarged Board:
Question 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 A 52(4) if such step does not per se aim at maintaining life and health?
Answer : A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to A 53 (c).
Question 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?
Answer: 2a. A claim which comprises a step encompassing an embodiment which is a “method for treatment of the human or animal body by surgery” within the meaning of A 53(c) cannot be left to encompass that embodiment.
2b. The exclusion from patentability under A 53(c) can be avoided by disclaiming the embodiment, it being understood that in order to be patentable the claim including the disclaimer must fulfil al1 the requirements of the EPC and, where applicable, the requirements for a disclaimer to be allowable as defined in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal.
2c. Whether or not the wording of the claim can be amended so as to omit the surgical step without offending against the EPC must be assessed on the basis of the overall circumstances of the individual case under consideration.
Question 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 A 52(4) 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?
Answer: A claimed imaging method is not to be considered as being a “treatment of the human or animal body by surgery” within the meaning of A 53(c) merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.
Answer: A claimed imaging method is not to be considered as being a “treatment of the human or animal body by surgery” within the meaning of A 53(c) merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.
Should I find something of particular interest in the decision, I will report on it later.
NB: To download the decision, click here.
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