EPO Enlarged Board decides which surgical methods should be cut out

The recent decision from the EPO Enlarged Board of Appeal (EBA), G1/07, sheds new light on the patentability of surgical methods, particularly those forming part of diagnostic methods, in Europe. The exclusion of surgical methods from patentability has caused consternation for patentees for some time, with varying approaches being taken by a number of different Technical Boards of Appeal (TBA) of the EPO and by the UKIPO. Fortunately, G1/07 provides some guidance on how surgical methods should be judged.

G1/07 arose following the consideration of European Patent Application 99918429.4. The application included claims to a method of diagnosis which comprised the step of administering polarised 129Xe to a patient, either by inhalation or injection. One possible route of administration encompassed by the invention, though not specifically claimed, was injection into the heart. The application was refused, amongst other reasons, for lack of patentability under Article 52(4) EPC 1973 for being a diagnostic method and for including a surgical step. On appeal of this case to the Technical Board of Appeal (TBA) EPC 1973 still applied, but by the time the EBA considered the matter, EPC 2000 had come into force. In EPC 1973, methods of treatment by surgery or therapy and methods of diagnosis were excluded under Article 52(4) as lacking industrial applicability. This legal fiction was removed by EPC 2000, in which methods of treatment and diagnosis are specifically excluded from patentability by Article 53(c).

The TBA referred a number of questions to the EBA for clarification of the law relating to the patentability of diagnostic methods containing surgical steps. Specifically, the questions related to the patentability of the surgical aspects. The questions and answers provided by the EBA are as follows:

Q 1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), 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" pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?

A 1. A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses 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 as a method for treatment of the human or animal body by surgery pursuant to Article 53(c) EPC.

Q 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?

A 2a. A claim which comprises a step encompassing an embodiment which is a "method for treatment of the human or animal body by surgery" within the meaning of Article 53(c) EPC cannot be left to encompass that embodiment.

2b. The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming the embodiment, it being understood that in order to be patentable the claim including the disclaimer must fulfil all the requirements of the EPC and, where applicable, the requirements for a disclaimer to be allowable as defined in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal.

2c. Whether or not the wording of the claim can be amended so as to omit the surgical step without offending against the EPC must be assessed on the basis of the overall circumstances of the individual case under consideration.

Q 3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) 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 of the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken  during a surgical intervention?

A 3. A claimed imaging method is not to be considered as being a "treatment of the human or animal body by surgery" within the meaning of Article 53(c) EPC merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.

In answering the first question, the EBA made it clear that the exclusions in Article 53(c), surgery, therapy and diagnosis, are independent of each other. A surgical step carried out in a diagnostic method is still a surgical step and should be judged under the surgical exclusion. The Board then went on the consider the meaning of the term "method of treatment by surgery", finding both merit and fault with the definitions used previously. The EBA acknowledged that it was not possible, certainly within the bounds of the referral, to provide an exact definition that would delimit the precise boundaries of the exemption. Nevertheless, a new concept was devised. As defined in answer 1, a surgical method is to be excluded if it:

1. includes an invasive step;
2. represents a substantial physical intervention;
3. requires professional medical expertise to be carried out; and
4. entails a substantial health risk.

The question of a disclaimer was answered as expected. It may be possible to disclaim surgical steps, either by way of a specific disclaimer, omitting the step or using positive wording effectively to exclude the step. Indeed, practitioners have been drafting claims excluding surgical steps for some years now, such as diagnosis claims in which the steps are practised on a sample from a patient, but the step of obtaining the sample is omitted. Clearly, as before, any claim in which the step is disclaimed or omitted must of course still fully define the invention and be novel and inventive. This may be difficult where the novelty or inventiveness lies at least partially in the surgical step.

The presence of question 3 seemed to slightly confuse the EBA, but it was probably included because the claimed method was intended to be used to provide real-time feedback during surgery and so the diagnostic method could be considered to be intrinsically linked with a separate surgical method. In effect, the question asked whether surgical steps carried out after a diagnostic method and influenced by the diagnosis should be considered when examining the patentability of the diagnostic method. The EBA clarified that the diagnosis and surgery would be considered to be separate actions and the later surgical steps would not affect patentability.

Whilst the EBA's decision does not provide absolute clarity on the definition of surgery, it is hoped that the position is now significantly clearer and more positive for at least some patentees in this field. Given the EBA's indication that the surgical and diagnosis exemptions are entirely separate, it would appear that, although the case in point related to surgical steps in diagnostic methods, the EBA's conclusion ought to be applicable to any surgical method whether related to diagnosis or not. It seems that at least some methods that would have faced objections under the surgical exemption will now be considered potentially patentable. The EBA made it clear that the injection into the heart described in EP99918429.4 would certainly be considered to meet the criteria for exclusion from patentability. It may be queried, however, whether less invasive injections might be patentable. We may even be seeing a step away from the position held in a number of cases that any method in which the skin is broken is "surgical". As the EBA itself explains in the Decision, an absolute definition cannot be provided and the judgement on whether a method is surgical will have to be made on a case-by-case basis. The door has been left wide open for further argumentation and we will have to wait and see how G1/07 is applied before we know whether things have really changed.
 
Rachel Wallis
Life Sciences & Chemistry Group