Enlarged Board rules on surgical methods

01 April 2010

The Enlarged Board of Appeal (EBA) of the EPO has recently decided case G 1/07 dealing with the exclusion from patentability of surgical methods.

The EBA was asked whether a diagnostic-purpose method, which encompasses a step of physical intervention practised on the human/animal body, is excluded from patentability for being a surgical method when the step does not aim at maintaining life and health.

The case arose from an appealed refusal of a patent application, where all claims related to an MR imaging method where dissolved, polarised 129Xe is delivered to a subject and where the description contemplated direct injection of 129Xe into the heart of the subject.

Based on careful studies of the legislative history and the existing case law, the EBA concluded that treatment of surgery is not "...confined to surgical methods pursuing a therapeutic purpose...." but the EBA also found the exclusion should only apply in order to secure the interest of public health and protection of patients.

Consequently, the EBA held that any claimed 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..."

In answers to an additional question it was held that the exclusion may be avoided by means of a correctly drafted disclaimer or, under certain circumstances, via omission of a surgical step.

So the mere fact that a claimed method involves an invasive step does not exclude such a method from patentability. Rather, a method is excluded only if the method 1) encompasses an embodiment, where maintenance of life and health is "important" and 2) includes an invasive step, which represents a "substantial physical intervention" on the body, which requires professional medical expertise, and which is risky even when professional care is undertaken.

Applicants seeking protection for methods including steps of an invasive nature should therefore in the future face fewer problems in overcoming the patentability exclusion of surgical methods. At the very least, the EPO ought not to reject claims which do not relate to the medical field or which do not involve any danger to the subject which is subjected to the claimed method.