Article 53(c) of the European Patent Convention (EPC 2000) excludes methods of treatment of the human or animal body by therapy or surgery from being patentable at the European Patent Office (EPO). Similarly, section 25(11) of the South African Patents Act contains such an exclusion. The Enlarged Board of Appeal at the EPO usually decides on matters where case law of the EPO Boards of Appeal diverges, thus the most significant decision on methods of treatment by surgery was adopted in an Enlarged Board of Appeal case, G1/07 .
Prior to G1/07, the EPO was of the view that any physical intervention on the body was a surgical method and therefore excluded from patentability. However, in G1/07, it was held that the nature of physical intervention on the body was of more importance than the purpose of the physical intervention. The broad definition of a method of treatment by surgery was no longer suitable, and a narrower one was preferred. The Board of Appeal held that for a method of treatment by surgery to be excluded in terms of Article 53(c), it would have to include a step that is a substantial physical intervention on the body, requiring professional medical expertise, and entailing a health risk even when carried out with the required professional medical expertise. However, tests to define “substantial physical intervention” and “health risks” were not given. This left the door open for such determination on a case by case basis.
In two recent decisions, T663/02 and T1695/07 , the Board of Appeal had to then develop the criteria outlined in G1/07.
In T663/02, the Board of Appeal had to consider whether or not a method of magnetic resonance imaging which included a step of injecting a contrast agent into a vein, was a method of treatment by surgery, falling within the ambit of the exclusion. Under the EPO’s previous broad definition, the method may well have been considered an exclusion due to the physical intervention on the body by insertion of a catheter for injection of the contrast agent. However, the Board of Appeal held that the intravenous injection of a magnetic resonance contrast agent was a minor routine intervention which did not imply a substantial health risk when carried out with the required care and skill, and was therefore not excluded from patentability.
In its reasoning the Board of Appeal stated that placement of intravenous catheters was a common invasive procedure and did not require the involvement of a fully qualified doctor. As it was often delegated to less qualified medical staff, this implied a low level of risk to a patient’s health. In determining the health risk the Board of Appeal proposed a test based on the use of a risk matrix, taking into account the probability of a complication versus the seriousness of the impact to the patient’s health.
The case highlights the change in definition at the EPO. It can therefore be expected that similar methods of treatment by surgery may no longer be excluded from patentability at the EPO.
In T1695/07, the Board of Appeal had to determine whether a process for measuring the rate of blood flow in an arterio-venous shunt, by continuously removing blood from a downstream location, flowing the blood through an extra-corporeal circuit, and redelivering the blood to an upstream location of the shunt, constituted a method of treatment by surgery which should be excluded from patentability. In this case, the Board of Appeal held the method to fall within the ambit of the Article 53(c) exclusion.
In its reasoning, the Board used the criteria developed in G1/07, i.e. criticality of the part of the body concerned, degree of intervention, the environment in which the surgical method is carried out, medical staff required and health risks involved.
It was stated that as blood was a flowing organ of the body, performing essential functions, it could hardly be regarded as an uncritical part of the body. The continuous manipulation of a flowing organ in an extracorporeal circuit could also not be considered a minor intervention. The fact that the process required management by specialised medical staff that was specifically trained in the technique meant that professional medical expertise was required. In determining the health risks to a patient, it was stated that a health risk was substantial when it went beyond the side effects of harmless infections of superficial tissue due to non-sterile working conditions etc. Interestingly, the Board did not adopt the risk matrix approach outlined in T663/02, however, the reasoning adopted in T1695/07, in similarity to T663/02, flowed from development of the criteria given in G1/07.
Although these recent judgements provide some guidance on interpretation of the criteria set out in G1/07, uncertainty still exists, and will continue to exist until a vast body of case law is developed. It is evident that the criteria developed in G1/07 will have to be applied on a case by case basis. As South Africa is a non-examining jurisdiction, such case law of the EPO is of importance to us as our Courts are likely to follow the precedents of the EPO, if challenges to methods of treatment by surgery are pursued in South Africa. Previously, an attack to the validity of a European patent based on the argument of it containing a method of treatment by surgery falling within the exclusion of Article 53(c) would probably have been easily upheld due to the prior broad definition. The recent case law shows a move towards the narrower definition of a method of treatment by surgery, and attacks to validity of patents on this basis may very well need to be reconsidered. The South African approach however, remains to be seen.
Written by: Thamaray Govender- Professional Assistant, Patents Dept.
Approved by: Janice Galvad – Partner, Patents Dept.
1 South African Patents Act 57 of 1978, as amended.
2 G0001/07 of 15 February 2010.
3 T0663/02 of 17 March 2011.
4 T1695/07 of 28 September 2011.