Tuesday, 9 March 2010

G 1/07 – What Is A “Treatment By Surgery”?


The present decision of the Enlarged Board of appeal (EBA) also deals in detail with the question as to what a “treatment by surgery” - excluded from patentability by A 53(c) - is meant to be.

The EBA first answers the question if the exclusion only concerns therapeutic surgery. It comes to the conclusion that this cannot be the case, for the following reasons:

First, the wording of A 53(c) does not suggest so.

The word ‘surgery’ as such appears to comprise non-curative action:

In decision T 182/90 [2.2-4] the Board explored the meaning of the term “surgery” in general and found that in today’s medical and legal linguistic usage, non-curative treatments are, if carried out by surgery, regarded as surgical treatments. This statement has not been put into question as such in the later decisions. [3.3.1, 1st §]

Moreover, the arrangement of A 53(c) does suggest that the surgical methods under consideration do not have to be therapeutic:

[…] In order to be patentable a claimed invention must fulfil all requirements for patentability and must not be excluded from patentability by any of the exclusions foreseen in the EPC. The three alternative exclusions in A 53(c) are thus cumulative requirements. In order to be patentable a claimed method must neither be a therapeutic nor a surgical nor a diagnostic one. [3.3, 3rd §]

[…] The fact that the exclusion of methods of treatment by surgery from patentability is one of three alternative exclusion conditions prima facie indicates that the situations covered by each of the alternatives were not meant to be identical since the inclusion of the term “by surgery” in A 53(c) would be pointless if the meaning of that alternative was already entirely contained in the exclusion from patentability of the other alternative, i.e. the “treatments by therapy”. [3.3.1, 2nd §]

The Board notes that the exclusion of surgical methods was not initially contained in the draft EPC but was introduced later than the exclusions relating to therapeutic and diagnostic methods. It therefore explores the legislative history and the purpose of the insertion. The above mentioned understanding is found “rather to be supported by the course of the preparatory work for the EPC 1973 and by the outcome of later legislative initiatives”.

The EBA also studies the jurisprudence of Board 3.2.02 and finds that there have been diverging decisions. The Enlarged Board concludes:

[…] The foregoing considerations, in particular also the comparison between the cases as decided in T 1172/03 on the one hand and T 383/03 on the other hand, show how inconsistent the decisions to be made may become, if the term treatment by surgery is seen as limited to therapeutic surgery only. Admittedly, it is often also difficult to precisely delimit excluded therapeutic from patentable cosmetic treatments. However, in this context the problem cannot be avoided, since it is the express wording of A 53(c) that only therapeutic methods are excluded from patentability (and thus cosmetic methods are not) and the exclusion cannot be extended to treatments which are not therapeutic in character (T 1172/03, [2.2], making reference to T 144/83). [3.3.8.6]

The question as to whether A 53(c) only excludes therapeutic surgery therefore receives a very clear answer:

Summarising the above, neither the legal history nor the object and purpose (“ratio legis”) of the exclusions from patentability in A 53(c) justify a limitation of the term “treatment by surgery” to curative surgery, contrary to what the ordinary meaning of the word “surgery” implies and contrary to the fact that A 53(c) defines three separate alternative exclusions thereby suggesting that these are not merely identical in scope.

Hence, the Enlarged Board concludes that the meaning of the term “treatment by surgery” is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose. [3.3.10]

What then is the scope of the exclusion?

The EBA first deals with the question as to whether the involvement of medical or veterinary practitioners can be decisive. It relies on the findings of G 1/04 [6.3] and confirms that “whether or not a method is excluded from patentability under A 53(c) cannot depend on the person carrying it out.”

So is it the nature of the interventions that determines whether they are surgical or not?

The EBA presents the broad construction that has been used by several Boards in the past:

[…] The broad construction of the kind of interventions being of a surgical nature developed in decision T 182/90 [2.2-3], that it covers any non-insignificant intervention performed on the structure of an organism by conservative (“closed, non-invasive”) procedures such as repositioning or by operative (invasive) procedures using instruments including endoscopy, puncture, injection, excision, opening of the bodily cavities and catheterisation, has not as such been challenged by decision T 383/03 and the later decisions following it having additionally required a therapeutic purpose in order for the exclusion to apply. [3.4.2.1, 1st §]

The EBA considers that this broad construction is no more justified. This is where the decision takes a rather pragmatic turn:

This broad view of what should be regarded as surgical activities excluded from patentability has in the Enlarged Board’s view rightly been criticised by the appellant as being or having 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.

If so, that can also not be ignored when it comes to the application of routine interventions in the medical field.

Today, numerous and advanced technologies do exist in the medical field concerning the use of devices which in order to operate must in some way be connected to the patient. Methods for retrieving patient data useful for diagnosis may require administering an agent to the patient, potentially by an invasive step like by injection, in order to yield results or at least they yield better results when using such a step.

Considering this technical reality, excluding from patentability also such methods as make use of in principle safe routine techniques, even when of invasive nature, appears to go beyond the purpose of the exclusion of treatments by surgery from patentability in the interest of public health.

Insofar the definition given in opinion G 1/04 [6.2.1] that “any physical intervention on the human or animal body” ... is a method of surgery within the meaning of A 52(4) EPC 1973 appears too broad. [3.4.2.2]

The EBA then gives some “elements of a narrower understanding”:

Hence, a narrower understanding of what constitutes by its nature a “treatment by surgery” within the meaning of A 53(c) is required. It must allow the purpose of the exclusion to be effective but it must also not go beyond it. The exclusion serves the purpose of, in the interests of public health and of patients, specifically freeing the medical profession from constraints which would be imposed on them by patents granted on methods for surgical or therapeutic treatment, thus any definition of the term “treatment by surgery” must cover the kind of interventions which represent the core of the medical profession’s activities, i.e. the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility.

These are the physical interventions on the body which require professional medical skills to be carried out and which involve health risks even when carried out with the required medical professional care and expertise. It is in this area that the ratio legis of the provision to free the medical profession from constraints by patents comes into play. Such a narrower understanding rules out from the scope of the application of the exclusion clause uncritical methods involving only a minor intervention and no substantial health risks, when carried out with the required care and skill, while still adequately protecting the medical profession.

One amicus curiae observed that the administration of diagnostic agents often causes negative side effects. It is therefore convenient to clarify that there is an exclusion from patentability as a surgical method only if the health risk is associated with the mode of administration and not solely with the agent as such. It was also remarked that it would be absurd if administering a diagnostic agent by an injection was excluded from patentability but administering by inhalation was not. It is not for the Enlarged Board to decide whether a method involving the injection of a contrast agent is in fact excluded from patentability under the definition of “treatment by surgery” given here. As a matter of patent law, however, this argument does not hold good, since, by contrast to one early draft version of A 52(4) EPC 1973, neither its final version nor A 53(c) stipulate an overall exclusion of medical methods from patentability. Both provisions only exclude the therapeutic, diagnostic and surgical methods listed in the Articles. Hence, where a step is neither a therapeutic nor a diagnostic nor a surgical method the legal situation was and is that it is not excluded from patentability. [3.4.2.3]

However, the Board refuses to go much further; it decides to let the first instance bodies and the Boards of appeal do the rest of the work.

Clearly, it is not possible for the Enlarged Board in the context of the present referral when trying to redefine the meaning of the term “treatment by surgery” to give a definition which would, once and for all, also delimit the exact boundaries of such a new concept with respect to the whole comprehensive body of technical situations which might be concerned by it.

Assuming such a task would go far beyond the scope of present referred question 1. The set of circumstances underlying the referral has been determined in the referring decision as encompassing 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. Hence, what the Enlarged Board must do in answering question 1 [referred to it by T 992/03], is to define the scope of the term “treatment by surgery” to an extent which allows the referring Board to decide whether or not the step claimed in the application-in-suit falls under that definition. This will also indicate the direction in which further practice and jurisprudence should develop. The required new direction is that the exclusion from patentability should not be applied to methods in respect of which the interests of public health, of protection of patients and as a counterpart to that of the freedom of the medical profession to apply the treatment of choice to their patients does not call for their exclusion from patentability.

The first instance bodies and the boards of appeal are much better suited to define the boundaries of a more narrowly construed concept of “treatment by surgery” in situations other than the one underlying the present referral, based on the technical reality of the individual cases under consideration.

This includes that the required medical expertise and the health risk involved may not be the only criteria which may be used to determine that a claimed method actually is a "treatment by surgery" within the meaning of A 53(c). The referring decision and the President have mentioned the degree of invasiveness or the complexity of the operation performed but these do not appear to be issues in the case underlying the referring decision. At least, the referring decision contains no statement of fact establishing the presence of such circumstances which the Enlarged Board would have to consider when determining the scope of its answer given. Although it appears likely that interventions involving a high degree of complexity and/or a high degree of invasiveness would normally also be such as to require professional medical expertise and entai1 health risks even when carried out with the required care and expertise, the Enlarged Board does not wish to rule out from the outset that, depending on the circumstances of the individual case under consideration, other criteria could not also determine that a physical intervention on the human or animal body is a "treatment by surgery" within the meaning of A 53(c). [3.4.2.4]

The Board terminates its considerations by referring to the fluidity of concepts:

Another reason why the Enlarged Board cannot, in the context of the present referral, give an authoritative once and for all definition of what the term “treatment by surgery” may comprise is that in the ever changing technical and medical reality the term “surgery” itself does not appear to have a once and for all fixed meaning, either. There appears to be no general common concept for the acts which are commonly regarded as surgical in the medical sense. Rather, it appears that what is to be understood by “surgery” in the medical sense is to a large extent a matter of convention. Thus, in order to be surgical, it is not necessary that the intervention be invasive or that tissues be penetrated (T 5/04 [2]). Repositioning body limbs or manipulating a body part is traditionally considered surgical. The mere catheterisation or the insertion of components of a device into the body is already regarded as prohibited as being a surgical step even if it does not require the penetration of tissues (T 5/04). All this implies that the scope of what is surgery may change with time and with new technical developments emerging, as was already acknowledged in decision T 182/90 [2.4]. [3.4.2.5]

As to this last point, I am tempted to object that a decision of the EBA is not the law of the Medes and the Persians either … If the wise (wo)men of the EBA only decided on matters they could fix once and for all times, they would have to resign to silence. However, let us not be ungrateful - the Enlarged Board has gone well beyond the original question referred to it and opened new horizons.


Summing up, I would say that this decision constitutes an interesting mix of legal precision (as far as the separation between therapy and surgery is concerned) and pragmatic eagerness not to let legal precision stand in the way of patentability. I have the feeling that the EBA to some extent adds to the EPC when developing its “narrower understanding” of surgery, but the Enlarged Board has almost always chosen to favour patentability and, therefore, this orientation is all but a surprise.

To download the decision, just click here.

2 comments:

Anonymous said...

hi

Oliver G. Randl said...

Hi. Thanks for your thoughtful comment! ;-)