In decision G1/07, released 15 February 2010, the Enlarged Board of Appeal (EBoA) has attempted to shed some light on the exclusion from patentability of Article 53(c) EPC (previously Article 52(4) EPC) relating to methods of treatment of the human or animal body by surgery.
The invention in question was perhaps a difficult case through which to clarify the law. The claimed methods included the step of delivering polarized 129Xe to a subject, in some instances via direct injection into the heart. The methods were, however, imaging methods, primarily diagnostic in nature, to provide feedback on the effects of both surgical and therapeutic procedures. Three questions were referred to the EBoA. The first was:
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 practiced 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?
The EBoA answered as follows:
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.
The jurisprudence of the Technical Boards of Appeal had apparently diverged with regard to whether it was the nature of the physical intervention or its purpose which was determinative with regard to Article 53(c) EPC. Ironically, in finding it is the nature of the intervention that is key, the EBoA relied heavily on the alleged purpose of the statutory exclusion, namely to protect medical practitioners from their activities being impinged by patents in the interests of public health.
The EBoA concluded that a method claim will fall foul of the exclusion from patentability “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”. The Appellant had argued that such a broad view of the exclusion was not necessary to give effect to the intended purpose of the exclusion. In particular, if a surgeon performs only one surgical step of a multi-step method there will be no infringement of the claim
and hence no need for a statutory exclusion. The EBoA was not convinced by this reasoning and indicated that the exclusion could not be dependent upon whether or not there would be infringement of the claim. This seems to be at odds with the purpose of the statutory exclusion as identified by the EBoA.
The answer to question 1 relied upon a lengthy discussion of the meaning of “surgery”. The EBoA was convinced that in today’s usage, non-curative treatments, if carried out by surgery, are regarded as surgical treatments. This was apparently assisted by looking at the legal history of the provision, which actually provided very little specific guidance on the term. The EBoA also held that on a normal reading the presence of three alternatives in Article 53(c) EPC meant that each must be different in scope. In particular, “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”. It could equally be argued, however, that a detailed consideration of what is meant by “therapy”, in particular that it would have been interpreted to encompass surgical methods, was needed to reach this conclusion. The late inclusion of “surgery” when the EPC was drafted may simply have been to ensure that therapeutic surgical methods were encompassed by the exclusion. Certainly, there is nothing to suggest that cosmetic surgical methods were even contemplated at the time.
The EBoA reviewed the jurisprudence of the Technical Boards and identified the difficulties and potential inconsistencies if the purpose of the method was used to determine whether the exclusion applied. Nonetheless, a similar issue arises in trying to differentiate a cosmetic method of treatment from a therapeutic method of treatment. It is arguably difficult to justify an exclusion from patentability that prevents patents inhibiting the commercial activities of a surgeon involved in purely cosmetic surgery. However, following a brief review of the corresponding national law, the EBoA concluded that treatment by surgery should not be confined to solely therapeutic methods.
Whilst this conclusion appears to leave the exclusion rather broad, the EBoA then moved on to consider exactly what, by their nature, should be considered as surgical activities. The EBoA admitted that the breadth of definition given in G 1/04 was too broad and could go beyond the overriding purpose of the exclusion. The EBoA indicated that it could not “give an authoritative once and for all definition of what the term ‘treatment by surgery’ may comprise…”. However, in the context of the referral and taking into account the President’s summary of the first instance regarding a “non-insignificant” intervention qualifying as “treatment”, the EBoA suggested that “treatment by surgery” would comprise “an invasive step representing substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a health risk”. Thus, whilst the non-therapeutic purpose of the step cannot be used to avoid the exclusion of methods of treatment by surgery, the nature of the treatment itself may still provide applicants with some room to argue in support of their application. This seems to be one major area of uncertainty moving forward, particularly with regard to where to draw the line on the question of the requirement for professional medical expertise and an associated health risk. Notwithstanding this definition, admittedly taken from the wording of the referred question, the EBoA explicitly indicated that whether or not a method is excluded from patentability cannot depend upon the person carrying it out. There are clearly issues to be resolved with this “new concept” proposed by the EBoA. The EBoA acknowledged this, but indicated that addressing the previous “unsatisfactory” approach to assessing the nature of “treatment by surgery” justified the legal uncertainty, which would be clarified through future jurisprudence.
Question 2 was contingent upon an affirmative answer to question 1. The EBoA answered the question in three distinct parts.
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 to disclaim it, or let the claim encompass it without being limited to it?
The first part was answered:
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.
The EBoA dealt with this issue rather swiftly, indicating that it is established law that a claim encompassing an embodiment which is excluded from patentability under Article 53(c) EPC cannot be left unamended. The appellant had referred to G 1/98 which permitted a claim embracing plant varieties but not explicitly claiming the varieties themselves as supporting their position. The EBoA drew a sharp distinction between the purpose of the provisions of Article 53(b) and 53(c) EPC in reaching their conclusion.
This then left the issue of whether the embodiment could be disclaimed. The EBoA found:
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.
The EBoA clarified that a disclaimer is an amendment to a claim to incorporate a negative technical feature, in accordance with their earlier decisions. Interestingly, the EBoA commented that the omission of the surgical step from the claim, for example by employing terms such as “pre-delivered” and “pre-implanted” would not represent a disclaimer. This may be relevant to Examining Division practice with respect to diagnostic methods, where inclusion of the term “in vitro” is often demanded by Examiners to avoid the exclusion from patentability of Article 53(c) EPC. Strictly speaking, this is not a negative technical feature either and could therefore potentially be objectionable under Article 123(2) EPC.
The EBoA had no real issue with the possibility of disclaiming specific embodiments that would be excluded from patentability, but was at pains to stress that the claim as amended must meet all requirements of the EPC, including any relevant conditions defined in G 1/03 and G 2/03.
On the question of omitting the step, the EBoA found that:
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.
As a general remark, the EBoA indicated that “whether or not a step being or encompassing a surgical step excluded from patentability can be omitted either by using positive wording for such omission like “pre-delivered” or by simply leaving it out from the claim depends on whether the claimed invention is fully and completely defined by the features of the claim without that step”. This depends upon the facts of the case.
The EBoA did, however, indicate that inventions only concerning the operation of a device could represent a class of cases in which the invention could be completely defined without requiring inclusion of a surgical step. This was with the proviso that there was no functional link between the claimed methods and the effects produced by the device on the body. This is in agreement with existing case law.
The EBoA was again at pains to stress that a claim following the omission of a step would need to fulfil all other requirements for patentability, in particular there would need to be a complete disclosure of how to perform the invention over the remaining claim scope.
The final question followed on from the earlier questions in the sense of asking whether, even if the claims were not excluded from patentability for those reasons, there could still be an issue due to the method in question allowing a surgeon to determine how to proceed on the basis of the result obtained by the method. It specifically asked:
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 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?
The EBoA decided:
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.
The EBoA did not seem overly impressed with this question. In summarising the earlier parts of the judgement the EBoA confirmed that “Article 53(c) EPC prohibits the patenting of surgical methods and not the patenting of any methods which can be used in the context of carrying out a surgical method”. Thus, simply because a method, in this case an imaging method, would allow a surgeon to make an intervention this does not exclude the method from patentability.
In summary, the EBoA has on the one hand addressed the questions posed to provide limited guidance with respect to the exclusion from patentability of methods of treatment by surgery. It is the nature of the step which will determine whether the exclusion applies, rather than its intended purpose. Embodiments that fall foul of the exclusion may be disclaimed or omitted in certain circumstances depending upon the facts of the case and taking into account the various requirements for patentability. On the other hand, the EBoA has also attempted to soften the strict interpretation applied in the case law with respect to the nature of surgical steps. So, back to nature. But exactly what type of nature? Only time will tell.