On 17 February 2010, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) issued the decision G 1/07 (“Method for treatment by surgery”) concerning the ban on patenting methods for treatment of the human or animal body by surgery.

In short, the decision states that a method which comprises an invasive step representing a substantial physical intervention on the body, and which:

• requires professional medical expertise to be carried out, and
• entails a substantial health risk even when performed by a person with medical expertise,
  

is excluded from patentability. The European Patent Convention (EPC), Article 53(c), states that

“..patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body..”.

This ban on patenting methods for treatment by surgery has up to now been interpreted to prevent patenting methods which included just one feature or element defining a physical activity/action that constituted a method step for treatment of the body by surgery, i.e. a quite specific interpretation which is focused more on the nature of the surgical method step than on the purpose of the surgical method.

However, the case law of the Boards of Appeal of the European Patent Office has recently not been entirely consistent on this interpretation by allowing patents on method claims that include steps of a surgical nature but with a purely cosmetic purpose.

The G1/07 decision reintroduces the legal reasoning behind this exception of patentability i.e. it was, and still is, considered non-ethical and damaging to public health to prevent a medical professional in performing his work. The decision applies the legal reasoning to interpret Article 53 (c) by bringing into consideration who is applying the method in combination with the purpose of it.

Thus, the decision seems to indicate that non-critical but nevertheless surgical method steps with a non-therapeutic purpose, and which does not require medical expertise may be patentable, for example in connection with cosmetic procedures like tattooing or piercing, though the distinction between surgery with a therapeutic purpose, and, on the other hand, surgery with a cosmetic purpose can be quite difficult to make.

The case prompting the decision by the EBA relates to magnetic resonance (MR) imaging where the disputed patent had method claims with the step of: “…delivering polarized ¹³⁹Xe to the patient….” where the description included injection, inhalation, and oral intake as different means of delivering the isotope ¹³⁹Xe as contrast agent to the patient. Thus, administering the ¹³⁹Xe by inhalation or oral intake do not include a surgical method step, whereas the injection necessarily involves a surgical step of some kind, possibly even a dangerous injection into the heart. The EBA therefore suggests the claims could have been drafted differently with expressions like pre-delivered or pre-injected contrast agent, or by a disclaimer. Thus, the exclusion from patentability may in some situations be avoided by reformulation of the claims provided that the claimed invention is fully and completely defined by the features of the claim without that step and the amended claims fulfill all the requirements of the EPC.

The G1/07 decision emphasizes the importance of carefully drafting your European patent application in the area of medical technology.

Contact Anne Schouboe or Peter Sørensen for more information about the G1/07 decision or read the official documnet on the matter here