IP Cases & Commentary – Details
19 July 2011
Surgical Methods in the Wake of G1/07 – Technical Board of Appeal Decision T0663/02
What is a 'surgical method'? In the wake of Enlarged Board of Appeal (EBA) decision G1/07 which supposedly provided clarity on this point, many patent attorneys have had sleepless nights when formulating claims which require a step of 'injecting' a compound into a subject.
Do we have guidance now on how to assess if a method falls within the exclusion of a surgical method?
A recent Technical Board of Appeal decision T0663/02 promises hope!
[Note from author: Yes, this is recent! Don’t be fooled by 2002 designation, this decision was only issued on 17 March 2011 after long delays first awaiting the outcome of G1/04 (diagnostic methods) and then G1/07 (surgical methods)].
In G1/04 the EBA confirmed that:
"a method claim falls under the prohibition of Article 52(4) EPC  if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy".
Therefore, the surgical or therapeutic nature of a method claim can be established by a single method step.
In G1/07 the EBA pleaded for a narrow construction:
“Hence, a narrower understanding of what constitutes by its nature a 'treatment by surgery' within the meaning of Article 53(c) EPC is required” (Reasons 126.96.36.199).
The wording used by the EBA in G1/07 ("is required") was suggested in T0663/02 to underline the necessity of a new definition consistent with the today's technical reality in the medical field.
In order to find elements of a “narrower understanding”, the EBA in G1/07stated that: "any definition of the term 'treatment by surgery' must cover the kind of interventions which represent the core of the medical profession's activities, ie, the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility" (Reasons, 188.8.131.52). [emphasis added]
However, specific guidance was lacking in G1/07 of how to assess whether an action belongs to the “core of the medical profession’s activities”.
In T0663/02 it was necessary to assess whether the injection of a magnetic resonance contrast agent into a vein belongs to this core, because claim 1 of the granted patent EP 0 812 151 B (the subject of T0663/02) included the following step:
“…injecting the magnetic resonance contrast agent into a vein remote from the artery…”
In practice, this step would be carried out by the placement of an intravenous catheter through which the contrast agent may then flow into the vascular system.
It must be borne in mind that the point of the exclusion is to free the medical profession from constraints by patents and differentiation must be made between major physical interventions on the body which should be excluded from patentability and uncritical methods for which the exclusion clause should not apply.
T0663/02 makes it clear that when assessing what is the “core of the medical profession’s activities” this must be made in the light of the technical development in the medical field at that time.
In the present case, the placement of an intravenous catheter is one of the most common invasive procedures performed in hospitals and consulting rooms.
An intravenous injection can today be delegated by a physician to a qualified paramedical professional.
In T0663/02 it was decided that this gives an indirect hint at the fact that such an injection may be considered as representing a minor routine intervention which does not imply substantial health risks when carried out with the required care and skill.
As such, it was not considered as an intervention which represented the “core of the medical profession’s activities” as required by G1/07 and thus was not excluded by A53(c) EPC.
Importantly T0663/02 provides a possible way of assessing health risks by using a 'risk matrix'. The matrix combines the levels of likelihood and health impact of a complication of a medical act with regard to a large number of patients, so as to obtain statistical health risk scores.
The Board described the so-called risk matrix as follows:
“The likelihood that a complication of an intravenous injection may happen is represented on a first scale (x-axis). The health impact of that complication is represented on a second scale (y-axis). According to a simple model, the likelihood is subdivided in three levels, ie, 'unlikely', 'likely' and 'very likely'. The health impact is also subdivided in three levels, ie 'minor', 'moderate' and 'major', wherein 'minor' would cover negligible effects which do not need any treatment, 'moderate' reversible effects which can be easily treated, and 'major' serious irreversible effects or even death. The risk matrix thus permits to combine the levels of likelihood and health impact of a complication with regard to a large number of patients so as to obtain statistical health risk scores which may be used to decide what action should be taken, for instance whether or not the intravenous injection may be delegated to a paramedical professional.
Due to its definition, the risk matrix is subdivided in various sectors. A first sector is defined by the levels 'unlikely' and 'minor', a second sector by the levels 'likely' and 'minor', and so on up to the last sector corresponding to the levels 'very likely' and 'major'. The heath risk score assigned to each sector increases when moving from the first to the last one.”
In T0663/02 the Board suggested that such an assessment based on the risk matrix would be in agreement with the understanding of the EBA in G1/07. In particular, the sectors with low health risk scores, at least that with the levels 'unlikely' and 'minor', would correspond to the uncritical methods involving only a minor intervention and no substantial health risks. The sectors with high health risk scores, at least that with the levels 'very likely' and 'major', would correspond to the physical interventions on the body which require professional medical skills to be carried out, which involve substantial health risks even when carried out with the required medical professional care and expertise, and for which the physicians assume a particular responsibility.
The Board used the risk matrix to confirm that intravenous injections may be considered as minor routine interventions involving no substantial health risks. Confirming their decision that the claim was not excluded as a surgical method.
A further point of interest in T0663/02 is that during the appeal proceedings a serious complication of intravenous injections of a specific magnetic resonance contrast agent was mentioned. Patients with acute or chronic renal insufficiency who receive a gadolinium-based contrast agent appear to be at an increased risk for developing a Nephrogenic Systemic Fibrosis (NSF). This complication, however, only depends on the injected substance. As a further complication, allergic reactions may be mentioned which also depend on the injected substance.
In this respect, T0663/02 confirmed that there was an exclusion from patentability as a surgical method only if the health risk was associated with the mode of administration and not solely with the agent as such (confirming G1/07). Therefore, the complications concerning NSF and allergies are irrelevant for the issue of assessing whether the claimed method should be excluded from patentability under Article 53(c) EPC.
This decision provides guidance on how to determine whether or not a method would be excluded as a surgical method. From the decision two interrelated aspects should be assessed. Firstly whether the action belongs to the “core of the medical profession’s activities” and secondly the health risk associated with the intervention. In T0663/02 a risk matrix is provided for determining the latter. It is clear from this decision that when making the assessments it is important to consider the actual technical developments in the medical field and whether a procedure can be delegated by a physician to say a qualified paramedical professional.