Guidance on the therapeutic methods exclusion
15 January 2018
The therapeutic methods exclusion is often problematic to navigate. In T 0699/12, the Technical Board of Appeal (TBA) of the European Patent Office has provided some useful guidance on its application.
In an opposition before the Opposition Division, the division held that the patent in suit (which was for a method for performing in vivo dosimetry) was invalid pursuant to Art 53(c) of the European Patent Convention (EPC).
Art. 53(c) of the EPC states: “European patents shall not be granted in respect of: ... methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body ...”
On appeal the Technical Board of Appeal, considering the effect of this provision, referred to decision G 01/04 and explained that it “... clarified that a method claim falls under the prohibition of patenting methods for treatment by therapy or surgery under Art. 53(c) EPC if it comprises or encompasses at least one feature defining a physical activity of action that constitutes a method step for treatment of a human or animal body by surgery or therapy ...”
It concluded that Art 53(c), therefore, did not exclude methods from patent protection that are used during a therapeutic or surgical treatment of a human or animal body, but methods that are therapeutic or surgical treatments of a human or animal body.
Applying this claim 1 of the patentee’s main request, this read as follows:
“1. Method for enabling quantification of dose delivery in radiotherapy treatment, characterized in that it comprises the steps of:
- irradiation of a phantom following a treatment plan of a patient,
- measurement of the irradiation in said phantom,
- collecting information regarding the irradiation by information means arranged between the phantom and the radiation source, wherein said measurements are divided in time-intervals, and
- analysing the measurements for obtaining information regarding the relationship between the measurements in the phantom and measurements in the information means between the phantom and the treatment source at each time-interval,
- using said relationship information during verification of the treatment of the patient.”
The patent specification further explained that the "invention is thereby a method to calibrate the detectors to be used in vivo (during treatment) in a time-efficient and accurate way to achieve high quality, reliable dose measurements during treatment".
The Technical Board of Appeal concluded that the wording of claim 1 did not include any step that could be considered as being of surgical or therapeutic nature, since no actual irradiating step was claimed. It reasoned that the "verification" (namely, ‘quantification of the dose delivery’ of the treatment) had no therapeutic or surgical effects as such. Rather, it only determined (verified) the radiation dose during a treatment.
Expressed another way, the claimed method only concerned the technical operation of a device (the radiation/ treatment source and the information means/detectors) without any functional link to the effects of the device on the body.
Case details at a glance
Jurisdiction: European Union
Decision Level: European Patent Office
Citation: T 0699/12 (ECLI:EP:BA:2017:T069912.20171113)
Date: 30 November 2017
Link to full decision: http://dycip.com/t069912