Tuesday, 16 March 2010

G 1/07 - Treatment by surgery

Case: G1/07, Medi-Physics, Inc.

The Enlarged Board of Appeal of the European Patent Office has recently issued their decision in referral G1/07, about the interpretation of the expression "methods for treatment of the human or animal body by surgery". Such methods are excluded from patentability according to Art. 53(c) EPC 2000. The application which is the subject of the referring decision is about an imaging method in which Xe-129 is used as a contrast agent. The scope of the claims encompasses an injection of polarized Xe-129 into the heart.

In the decision, the Enlarged Board makes some interesting remarks First, it is stated in the decision that the Vienna Convention does not provide a general principle of narrow interpretation of exclusions from patentability. Rather, the Vienna Convention gives the general rule that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

Second, a method claim falls under the prohibition of patenting methods for treatment by therapy or surgery if it comprises or encompasses at least one feature defining a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy. Moreover, the three alternative exclusions in Art. 53(c) EPC are cumulative requirements: a claimed method must neither be a therapeutic nor a surgical nor a diagnostic one. Consequently, the exclusion of “treatments by surgery” cannot be seen as limited to surgery which is performed for a therapeutic purpose, since it would then already be entirely covered by the exclusion of therapeutic methods from patentability. This point of view is further confirmed by legal history and the object and purpose of the exclusions.

According to the Enlarged Board, the jurisprudence should develop in a direction in which the exclusion from patentability should not be applied to methods in respect of which the interests of public health, of protection of patients and as a counterpart to that of the freedom of the medical profession to apply the treatment of choice to their patients does not call for their exclusion from patentability. The first instance departments and boards of appeal should further define the boundaries.

In the decision, the Enlarged Board indicates that a method is excluded from patentability if
- maintaining the life and health of the subject is important
- it comprises or encompasses an invasive step representing a substantial physical intervention on the body
- which intervention 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.

Also, a claim encompassing an embodiment falling under the exclusion, cannot be left to encompass that embodiment. It may be possible to disclaim the forbidden embodiment.

The third question asked in the referring decision was whether a claimed imaging method would be considered as a treatment by surgery merely because the data obtained by the method allows a surgeon to decide on the course of action to be taken during a surgical intervention. This question was answered in the negative.

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