EPO Enlarged Board issues decision on surgical methods
The European Patent Office has handed down its decision on Enlarged Board ofAppeal case G1/07. This decision relates to the interpretation of “methods for treatment of the human or animal body by surgery”. Such methods are excluded from patentability in Europe in order to allow medical professionals to treat their patients freely without fear of patent infringement.
This case stems from European patent application number 99918429.4, which relates to a method for magnetic resonance imaging of the pulmonary and/or cardiac vasculature, one embodiment of which involves the injection of 129Xe directly into the heart. This application was initially refused as it was considered that performing an injection directly into the heart constitutes a method of treatment by surgery and therefore excluded from patentability. An appeal against this decision (T992/03) was filed by the applicant.
The central issue of the appeal was the scope of the exclusion of methods of treatment by surgery from patentability, and in considering this issue the Technical Board of Appeal found that the previous interpretation of this exclusion had been inconsistent. The matter was therefore referred to the Enlarged Board of Appeal for clarification, in particular whether the exclusion applies only to methods that aim at maintaining the life and health of the subject.
The Enlarged Board of Appeal eventually defined a method of treatment by surgery as a method in which “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”. It was also concluded that the exclusion should apply to any method comprising or encompassing such a step.
This decision confirms that the exclusion of methods of treatment by surgery from patentability is not confined to surgical methods directly aimed at maintaining the life and health of the subject. This appears to broaden the scope of this exclusion to cover other methods encompassing an invasive step. However, the Enlarged Board of Appeal also confirmed that this exclusion may be avoided by disclaiming the offending subject matter, provided the disclaimer complies with the conditions laid down in previous decisions G1/03 and G2/03and the relevant requirements of the EPC.
8 March 2010