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News
16 February 2010
New EPO Decision on the Patentability of Methods of Treatment
New Decision of Enlarged Board G01/07
The EPO has just released their decision on the patentability of methods of treatment relating both to the exclusion of surgical methods and of diagnostic methods.
The referral concerned an imaging method in which a radioactive compound was "delivered" to a patient. The imaging allowed blood flow to be seen, which was useful in various contexts including during surgery and during drug delivery. Delivery of the compound could be either by inhalation (which is not surgical) or by injection, for example directly to the heart (which is surgical in nature). The claim language was broad enough ("delivery") to cover both options.
The Enlarged Board was asked whether claims of this type were excluded from patentability if they encompassed the surgical option (question 1); whether various strategies to get around this by disclaimer or limitation were valid (question 2); and whether an imaging method which allowed the surgeon to immediately decide on a course of action was an excluded "diagnostic method".
The answers are as follows:
1. 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 Article 53(c) EPC.
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 Article 53(c) EPC cannot be left to encompass that embodiment.
2b. The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming the embodiment, it being understood that in order to be patentable the claim including the disclaimer must fulfil all 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.
3. 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 Article 53(c) EPC 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.
