Pursuant to article 53 (c) EPC methods for the treatment of the human or animal body by surgery are excluded from patentability in Europe. According to EPO’s Enlarged Board of Appeal decision G 1/07, a method is excluded from patentability, if
a) maintaining the life and health of the subject is important and
b) it 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,
If method claims comprising surgical steps are objected to under Article 53 (c) EPC, the applicant often succeeds in rescuing the claim by deleting the problematic surgical aspects (see News of June 17, 2011). Generally, it is a prerequisite for such an attempted rescue that an embodiment lacking the surgery is disclosed in the original application documents in order to comply with the disclosure requirements of Article 123 (2) EPC. Otherwise, the only remaining solution presented in decisions G 1/03 and G 2/03 by EPO’s Enlarged Board of Appeal is to exclude the subject matter excluded from patentability by Article 53 (c) EPC by inserting a highly precise disclaimer into the claim wording.
The difficulty in practise, however, to find such an appropriate disclaimer wording is illustrated by EPO’s Board of Appeal decision in the case T 2102/12 of April 30, 2013. The applicant tried to rescue a method claim by introducing a disclaimer the wording of which corresponded to the “surgical method” in G 1/07 according to features a) and b) mentioned above. However, this proposed wording borrowed from G 1/07 has been rejected by the Board of Appeal for lack of clarity (Art. 84 EPC). According to the Board of Appeal the chosen wording leaves open the question, if actually all methods excluded by Article 53 (c) EPC are covered by the wording of the disclaimer, which should be clear from the disclaimer itself.
In the absence of a generally applicable standard solution it is still the task of the applicant or, respectively, his representative to find creative individual case solutions in order to forestall or prohibit collisions of a method claim with Article 53 (c) EPC.