IP-Fälle und Artikel

G 1/07 Interpretation:Method for Treatment By Surgery

The European Patent Convention contains a specific exclusion from patentability of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body.

Much case law from the Technical Boards of Appeal has been delivered which attempts to define the terms of this exclusion and how far it should be extended. The breadth of the exclusion concerning diagnostic methods has been clarified in decision G 1/04 of the Enlarged Board of Appeal. Until now, however, somewhat less consistent guidance was available in relation to methods for treatment by surgery.

Previously, the Technical Boards of Appeal had produced divergent case law as to the breadth of the surgical exclusion. In particular, whilst some decisions have considered that it is the nature of the physical intervention that is decisive, e.g. intervention by injection etc, others have considered that it is the purpose of the surgery that is decisive, e.g. that the surgery should aim to maintain or improve health, as opposed to some other non-health related goal, such as cosmetic enhancement.

G 1/07 provides a ruling as to which approach should be taken, as well as to setting out other indications of when a method can be considered to be a “method for treatment by surgery”.

The background to the case in question concerns magnetic resonance methods for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarized 129Xe. When considering whether the claimed methods in relation to this subject matter were to be excluded from patentability, the following 3 questions were referred to the Enlarged Board of Appeal:

  1. Is a claimed imaging method for a diagnostic purpose, which comprises or encompasses a step consisting in a physical intervention practised 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” if such a step does not per se aim at maintaining health and life?
  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 “method for treatment of the human or animal body by surgery” 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 Enlarged Board was careful to stress that the answer applied to the specific situation of the imaging method of the present case. However, in coming to its conclusion, the Enlarged Board set out that:

treatment by surgery is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose.

Thus, the Enlarged Board have decided that just because a surgical method is not aimed at maintaining, restoring or improving health, does not mean that it is not “treatment by surgery”

This outcome can be seen as negative for many applicants in the field of medical method and device research. Previously, it may have been arguable that where some methods of surgery did not aim to maintain or improve health, but instead only had an industrial or cosmetic goal, they would not be methods of “treatment by surgery”. This, however, no longer appears to be the case.

Although this apparent broadening of the exclusion can be seen as negative for applicants, in an attempt to provide a ruling which can adapt as technology advances, it may be that the Enlarged Board have left open a window for pursuing certain types of method claims.

The Enlarged Board have noted that:

[the] broad view of what should be regarded as surgical activities excluded from patentability has in the Enlarged Board’s view…become overly broad when considering today’s technical reality. The advances in safety and the now routine character of certain, albeit invasive techniques, at least when performed on uncritical parts of the body, have entailed that many such techniques are nowadays generally carried out in a non-medical, commercial environment like in cosmetic salons and in beauty parlours and it appears, hence, hardly still justified to exclude such methods from patentability. This applies as a rule to treatments such as tattooing, piercing, hair removal by optical radiation, micro abrasion of the skin.

Accordingly, whereas the Enlarged Board have broadened what can be considered to be “treatment by surgery”, it seems that they have also narrowed what is to be considered “surgery”.

Although still limited to the specifics of the present case, the Enlarged Board indicated that when judging whether a method is a “method for treatment by surgery” what will be assessed is whether the method includes an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a health risk even when carried out with the required professional care and expertise.

Clearly, this “test” contains many relative terms and how far it reaches will no doubt be the subject of further case law. However, it may be that certain other uncritical methods involving only a minor intervention and no substantial health risks, when carried out with the required skill and care, are not excluded from patentability.

Whether this turns out to be the case will of course depend on the interpretation of this decision by the departments of first and second instance of the EPO (Examining Divisions/Opposition Divisions/ Technical Boards of Appeal).

The answers to questions 2 and 3 were relatively straight forward.

With particular reference to question 2, the Enlarged Board confirmed that a claim which encompasses a step which encompasses a “method of treatment of the human or animal body by surgery” cannot be left to encompass that embodiment. Instead, it was possible to use a disclaimer to such a step, or to amend the claim so as to ensure that the step no longer formed part of the claim. In both instances, the disclaimer and the amendment must meet the other requirements of the EPC and case law, and will be assessed on a case-by-case basis.

In summary, whilst the Enlarged Board have broadened the interpretation of what can be considered to be “treatment by surgery” and thus has been largely unhelpful to applicants, they have acknowledged that as surgical research advances, some uncritical methods involving minor interventions may “come through the other side” so as to be potentially patentable.