EPO: In Vivo Process Requiring “Professional Medical Expertise” Excepted From Patentability

Fig. 1 aus EP 95902560.2

Recently the European Patent Office (EPO) has published Decision T 1695/07 – 3.3.07 of one of the Boards of Appeal dealing with the exception from patentability under Article 53(c) EPC. The catchword reads as follows:

I. A blood manipulation process involving the continuous removal of blood from a patient, its subsequent flowing through a circulating line of an extracorporeal circuit and its re-delivery to the patient is a method of treatment of the human body by surgery excepted from patentability under Article 53(c) EPC. It does not belong to the kind of methods which should not be covered by the exception clause according to the “narrower understanding” suggested by the Enlarged Board of Appeal in decision G 1/07, because the process is not performed in a “non-medical, commercial environment” and cannot be considered as a “minor intervention” being performed on “uncritical parts of the body” (Reasons, 8 to 10).

II. Such an in vivo process requires “professional medical expertise” and belongs to the kind of interventions representing the “core of the medical profession’s activities”, even when performed by paramedical support staff (Reasons, 11).

III. Even when the process is carried out with the required medical professional care and expertise, it involves ”substantial health risks” for the patient. A health risk is considered to qualify as “substantial” whenever it goes beyond the side effects associated with treatments such as tattooing, piercing, hair removal by optical radiation, micro abrasion of the skin as mentioned in G 1/07. A factual analysis of absolute or relative risks and their likelihood of occurrence based on objective evidence is hardly feasible and should therefore not be required.

In the Decision the Board argues the claimed process does not fall under the “narrower understanding”, i.e. does not belong to the kind of methods which should not be covered by the exception clause according to the criteria developed in G 1/07 because of it comprises the steps of

• “continuously removing blood from a downstream location in the shunt (12) …” and
• “delivering the removed blood flowing in said circulating line by way of an outlet connected to an outlet side of said circulating line to an upstream location of said shunt, …”.

Furthermore and again according to the Board, It has been established that these steps are invasive and represent 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. ccording to the established jurisprudence of the Boards of Appeal, a multi-step method falls under the exception clause of Article 53(c) EPC, if it includes at least one feature that constitutes a method step for the treatment of the human body by surgery. The possible technical contribution of the invention as mentioned by the proprietor appellants is not a criterion to be taken into consideration in this context.