Enlarged Board of Appeal Clarifies Exclusion from Patentability of ‘Methods of Treatment by Surgery’

Summary
In decision G1/07, the Enlarged Board of Appeal of the European Patent Office have set out a new approach to be used in determining whether inventions are excluded from patentability as methods of surgery under Article 53(c) EPC.

Background
The referral to the Enlarged Board of Appeal comes from a Technical Board of Appeal decision to refuse the grant of European Patent Application number EP99918429.4 on the grounds that it related to a surgical method.  Article 53(c) of the European Patent Convention (EPC) prohibits the patenting of ‘…methods for the treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body.’

The method claims included the step of administering polarized ¹²⁹Xe to the subject as an imaging agent, either by inhalation or by injection. The Technical Board of Appeal held that methods involving the step of injecting the imaging agent were excluded from patentability since they related to a ‘surgical method’.

1. The Board of Appeal considered the matter, and referred the following questions to the Enlarged Board:Is a claimed imaging method for diagnostic purpose…, which comprises or encompasses a step comprising in a physical intervention practiced on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a ‘method for treatment of the human or animal body by surgery’ pursuant to Article 52(4) EPC if such a step does not per se aim at maintaining life and health?
   
2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?
   
3. Is a claimed imaging method for a diagnostic purpose…to be considered as being a constitutive step of a ‘treatment of the human or animal body by surgery’ pursuant to article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

In answering question 1, the Board rejected arguments in favour of a narrow interpretation of the exclusion of "tratments by surgery" meaning only purely theraputic methods were excluded. Instead, they looked to the object and purpose of the exclusion in order to give it meaning.

After considering the legislative history and the object and purpose of the exclusions from patentability, the term ‘surgery’ was held not to be limited to surgery for therapeutic purposes. On the other hand, the broad construction, taken in previous Enlarged Board decision G1/04 and subsequent Board of Appeal decisions, of ‘treatment by surgery’ covering essentially any ‘non-insignificant intervention’ performed on the structure of an organism, was also rejected. Instead, the Enlarged Board attempted to steer a middle course between these extremes.

In answering the first question, the Enlarged Board set out that a method involving ‘…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.’ Thus it appears that methods involving only a minor intervention or no substantial health risks may not be excluded from patentability. However, due to the constant evolution of medical technology the Board was reluctant to give any concrete guidelines.

In the case of the injection of an imaging agent into the heart, it was decided that since this step represents a substantial intervention on the body which requires professional medical expertise to carry out, question 1 was answered in the affirmative and the claimed method was excluded from patentability as a ‘surgical method’.

The Enlarged Board confirmed the established practice of prohibiting the patenting of a method if it contained a single step of treatment by surgery in a multi-step process.

Question 2 was answered by stating that in principle, a disclaimer can be used to overcome the prohibition on patenting of surgical methods (in line with earlier decisions G1/03 and G2/03) provided that the remaining claim complies with the other requirements of the EPC, in particular clarity and sufficiency.

Question 3 was answered in the negative, stating that imaging methods are not excluded as ‘surgical methods’ solely because they may be usefully employed during surgery.

Effect on Practice
This decision has broad implications as to how the EPO will assess the patentability of surgical methods in future. Prospects look better for applicants in the field, despite the lack of a bright-line test in the decision. We expect that decisions following G1/07 will provide guidance as to the applicability of these principles to specific circumstances.