New EPO practice on the patentability of surgical methods

February 17, 2010

The Enlarged Board of Appeal of the European Patent Office has in its latest decision G 1/07 of 15 February 2010 provided guidelines on the exception to patentability on methods for treatment of the body by surgery. The purpose of this exclusion is to free the medical profession from constraints by patents. The context of this decision relates to methods for MRI imaging of lung and heart vasculature, involving as one of many steps the administration of an imaging agent to a patient’s body. One embodiment involves injection of the imaging agent into the heart.

It has been questioned whether the current practice that the presence of a single surgical step in a multi-step method excludes this method from patentability is appropriate. The present decision makes it clear that a method is excluded from patentability if it involves at least one method step for treatment of a body by surgery or therapy.

Until now, the lower instances have developed two different lines of interpreting the exception to patentability on methods for treatment of the body by surgery. The first, and dominating, interpretation has been that it is the nature of the intervention that is decisive, i.e. what actual operations are performed on the body. The second, dissenting interpretation has been that it is the purpose of the intervention that is relevant, or more precisely whether or not the method is intended to, or suitable for maintaining or restoring health, physical integrity or physical wellbeing.

The present decision emphasizes that it is the nature of the intervention that is decisive, but it is also recognized that this should not be so broadly interpreted so as to exclude safe routine techniques, such as hair removal by optical radiation, from patentability. When determining its nature, a guiding factor may be the complexity of the invasive step, including the required medical expertise and the health risks involved. In this particular case, however, the invasive step represents 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. This step is therefore of a surgical nature regardless of its purpose, and methods comprising this step are as a consequence excluded from patentability as methods for treatment of the body by surgery.

Although some remedies, such as disclaimers, may be available if a claimed method is held to be a method for treatment of the body by surgery, this decision reinforces the rather strict European view on the patentability of inventions involving a step that is surgical in its nature. It therefore remains of key importance to word the specification and the claims carefully when setting out to protect such inventions by a European patent.

Mikael Henriksson
European Patent Attorney