By Thomas Becher, German and European Patent Attorney, Hoffmann Eitle
From a first read, Decision T 1731/12 may have a tremendous impact on the patenting of medical devices at the European patent office. The EPO itself seems to attach quite some importance to the decision because it has provided an official headnote which serves to summarize the relevant content. In our translation, the headnote reads
“A device which is defined by a feature that can only be obtained by means of a surgical or therapeutic step is excluded from patentability.”
So where is the expected impact of this decision? Medical devices are frequently defined by resorting to so-called functional features. Functional features impart a particular clinical context to medical devices, apparatus or systems. The context is often used to argue in favor of patentability over the prior art, which may be structurally extremely similar but used in a different clinical context. The functional features are almost always expressed in method-like language. The method-like language then relates to what the medical device can do in clinical terms, i.e. how it is to be employed or what helps cure.
So what happened in T 1731/12?
European patent EP 1 613 394 had a single independent claim to a device for the desynchronization of activity of pathologically active brain areas. While the opposition was initially based on lack of novelty and inventive step (obviousness) and inadmissible extension (added matter), the opposition division of the EPO (“OD”) introduced the opposition ground “exception to patentability” (patent eligibility) on its own motion. The opposition ground was introduced because the claim was thought to relate to a method for treatment of the human or animal body by surgery or therapy. After having introduced the ground, the OD dismissed it. Opponent appealed. In the appeal Opponent also argued patent eligibility. Board of Appeal 3.4.01 (a Physics board) provided a provisional opinion in which it provisionally dismissed the opposition ground raised under patent eligibility, but introduced yet another opposition ground. At such a late stage, case law from the enlarged Board of appeal makes the admissibility of this still other opposition ground be contingent on proprietor consenting. Proprietor did not consent. At the beginning of the oral proceedings, the BoA confronted the proprietor with a reversal of opinion on eligibility. The Board said that the claimed subject matter would likely, after all, lack patentability. In support, the Board pointed to Art. 53(c) EPC and to T 775/97 (issued by another BoA). The Board ultimately revoked the patent entirely as relating to non-eligible subject matter.
The invention relates to a device for the treatment of Parkinson’s disease, essential tremor, dystonia, or the like. This is a group of neurological disorders which the patent said is due to unwanted synchronization of the activities of pathologically active areas of the brain. The device for treating these conditions was claimed to be one for desynchronizing the activities of these areas. The device comprises at least two electrodes and control means. Claim 1 recites that the control means are designed such that, during operation, they control the at least two electrodes such that these stimulate at least two sub-populations of a neuron population to be desynchronized. The stimuli are further defined with reference to phase resets of the sub-populations, and the claim concludes with a functional statement that the stimuli are “such that the at least two sub-populations have different neural-activity phases after the phase resets produced by the stimuli”. So in summary and at the risk of over-simplifying, claim 1 contained a requirement that there be control means which is designed such that it emits certain stimuli causing the activity of the sub-populations in the brain to change.
On the face of it, claim 1 is thus directed to a device, not a method; in a typical manner, the device is defined by means of a functional clause relating to the clinical effect. Art. 53(c) EPC, which governs exceptions to patentability or patent eligibility, conversely, is directed to methods, not devices. It says that European patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. From this wording alone, one can clearly take that claims to products ought not to fall under the exception. Apparatus, device, or system claims are typically construed as product claims. Furthermore, Art. 53(c) EPC continues by clarifying in its last sub-clause that the provision recited in the first sub-clause “shall not apply to products, in particular substances or compositions, for use in any of the [non-patentable] methods”.
There is a sizeable body of case law discussing Art. 53(c) EPC as an opposition ground with respect to apparatus, device, or system claims. The overwhelming majority of cases handled by the EPO found the opposition ground not to apply to these claims. There seems to be one exception, and this exception is also mentioned as authority in T 1731/12. That one exception is T 775/97. After analyzing the function of Art. 53(c) EPC, the prior decision cited as authority, some commentaries on the EPC, further case law, and some of the national statutes on possibly infringing acts, the Board of Appeal in T 1731/12 then came to the conclusion that the device of claim 1 of the opposed patent is non-patentable subject matter. The primary reason for this finding was that the last functional feature of claim 1 (control means which is designed such that it emits certain stimuli causing the activity of the sub-populations in the brain to change) can only be met once the electrodes emitting the stimuli have been implanted. Making devices meeting the functional limitation would therefore require carrying out a step of implantation which, in turn, is a surgical step and which has the consequence that the device itself is not patentable.
On the facts, the board relied on the description of the opposed patent teaching that the control means is to be adapted to the conditions found post-implantation so that the phase reset of sub-populations can be carried out. Adapting the control means, in turn, would be necessary for the proper functioning because the parameter of the stimuli are determined by positioning the electrodes. The specification would distinguish between cases in which the electrodes are placed directly in the neural tissue to be stimulated, and cases in which at least one of the electrodes does not lie in the neuron population to be desynchronized. In the latter cases, the latency of the stimuli from the electrodes to the neuron population would have to be taken into account and, to this end, be measured. The board could not see how such a measurement can take place prior to implanting the electrodes. Moreover, the specification would mention advantages, and that the position of the implanted electrodes would have to be taken into account so as to achieve these advantages. Again the Board concluded from the specification that the position can only be determined post-implantation so that the control means cannot be configured pre-implantation such that the functional feature is fulfilled.
On the basis of these facts the Board concluded that the claimed device is defined by at least one feature which can only be obtained by way of implantation, i.e. by means of a surgical step.
On the law, the Board recognized the function of Art. 53(c) EPC, namely, that the exceptions to patentability of methods is to protect the medical and veterinary practitioners’ freedom to use the best available treatments to the benefit of their patients is uninhibited by any worry that some treatment might be covered by a patent, by excluding these activities from patentability. The board went on to stipulate that decision T 775/97 would have transferred this approach to certain products. T 775/97 would have treated a patent claim reciting a new product which was made by means of a surgical step in the human body. T 775/97 would have decided that a European patent must not be granted to products that are defined by means of a design that can only be made by means of a surgical step in a human or animal body. Further, the Board in T 1731/12 agreed with the consideration it saw in T 775/97, that a product which is defined by means of a surgical step cannot exist without this step so that the surgical step is part of the claimed product.
If one disregards what we think are clear errors in understanding the decision T 775/97 cited as authority, for instance that T 775/97 dealt with a use claim and construed the use to be an activity and the activity to contain a surgical step, that T 775/97 only found the activity non-patentable but found the corresponding product claim patentable, and that the statement that a European patent must not be granted to products that are defined by means of a design that can only be made by means of a surgical step in a human or animal body was only an obiter dictum in the midst of the discussion of an activity, the approach of T 1731/12 to the law is still interesting with respect to how the Board reasoned that excluding products from patentability is not in contradiction to the last sub-clause of Art. 53(c) EPC.
As previously stated, the last sub-clause reads that the exclusion of surgical and therapeutic activities under the EPC shall not apply to products for use in any of the exempted methods. The board took a particular approach in identifying the term “use” as recited in Art. 53(c) EPC. The Board reasoned that this “use” relates to possibly infringing acts. The board then distinguished between “use” as a possibly infringing act versus “making” or “manufacturing” as a different possibly infringing act. For patented products both these acts would be reserved to the patent proprietor.
The decisive difference between these acts would, however, be that using a patented product would generally be allowed once the product has been legally acquired. The proprietor of the patent would then have received the reward he deserves for the invention and the party having acquired the product can freely use it. The Board interpreted the last sub-clause of Art. 53(c) EPC as permitting the patenting of products which can, after acquisition in proper form, be used in a surgical or therapeutic method. The only constraint imposed on medical personnel would then be the obligation to acquire the patented product in conformity with the law.
Manufacturing a patented product, conversely, would necessitate that the medical personnel obtain a license to the method of manufacturing. If there were a surgical or therapeutic step in the method of manufacturing, the medical and veterinary practitioners’ freedom to use, which is to be safeguarded by Art. 53(c) EPC, would be impacted. Interestingly, in this connection the Board pointed to the guidelines for examination before the UKIPO where it reads that, pending clarification from the courts, it remains the practice of the UKIPO that if a claimed product can only be manufactured by performing a method of surgery then the claim to the product is objectionable under the UK section on exceptions to patentability. In such a case it will not be possible to work the invention without performing an excluded method.
So in summary, in T 1731/12 Board of Appeal 3.4.01 has terminated a long tradition of defining medical devices by means of functional statement, by giving much weight to a statement in a single EPO decision and by relying on guidelines for examination of a national patent office, if the functional statement results in defining the product such that it can only be obtained by means of a step of surgery or therapy.
For us, this decision creates uncertainty. It also leaves us with a few practice points until the uncertainty has been resolved. The problem with the functional statement was identified in the perceived fact that the claimed function could only be delivered in vivo and in situ. So as to avoid the problem, one could, of course, avoid such functional statements in a claim. In a further step, specifications could be drafted so that they describe alternative ways of delivering the function ex situ, possibly in a machine environment, for instance for testing or calibration purposes. Doing so, however, may well result in a claim which the EPO understands to embrace both, patent eligible and non-eligible subject matter. The current EPO approach to such claims is to request that the non-eligible subject matter be excised from the claim, possibly by means of a disclaimer. It will need to be evaluated if the resulting scope is still of commercial interest.
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It may be noted that board 3.4.01 is a physics board and not normally dealing with medical devices. So please do not attach too much importance to this decision until it is confirmed by the boards that usually work in this field.
Whilst I understand that the author is alarmed by the fact this decision could mean that contrary to Art 53, c) devices could also be submitted to the exception to patentability, I find the decision perfectly correct and understandable.
The device at stake can only be implemented after implantation of an electrode and in this respect it is not possible to distinguish the surgical part from the non-surgical part of the device. In this respect T 755/97 shows that even for a device, if it cannot be obtained in another way than by a surgical step, it also falls under the prohibition of Art 53, c), at the time Art 52(4).
T 2369/10 a second or further medical use for a device was denied and a referral to the Enlarged Board dismissed. One of the claims at stake was as follows: “Neurostimulator system for treating a patient having a substance addiction to alleviate a symptom of the substance addiction, the neurostimulator system comprising an electrode configured for directly coupling to a cranial nerve of the patient and applying an electrical signal to said cranial nerve.” The independent claim of Alternative B is directed to essentially the same subject matter, but is drafted as a Swiss-type claim.
T 1314/05 is also interesting. Point 2 of the catchword says: “The use of a device (here: microelectrode arrangement) for the manufacture of a device used for medical purposes (here: implant) constitutes a method of surgical treatment of the human or animal body covered by the exclusion of Article 53c) EPC (Article 52(4) EPC 1973) if the manufacture of the device necessarily involves surgical operations.”
In T 1005/98, the method for manufacturing a prosthesis fell under the prohibition of Art 53, c), at the time Art 52(4) since it could not be obtained other than by a surgical step. The nub of the invention was to manufacture the prosthesis by comparing two ray images before and after resection, so that the prosthesis was “custom made” for the patient.
The manufacture of the prosthesis was certainly carried outside the body, but here again the direct product of the method, could only be obtained by a surgical step. The product, i.e. the prosthesis, was not claimed as such, but in view of the method used to determine the exact features of the prosthesis, a surgical step was needed exactly as in the case of T 755/97.
The author of the blog must have overlooked the catchword of T 755/97 in which it is stated expressis verbis that “This [i.e. the prohibition under Art 53, c), at the time Art 52(4)] is equally true for product claims defined by a construction which is only arrived at in the human or animal body following a surgical method step”.
T 1731/12 is thus by far not a one-off decision which “has terminated a long tradition of defining medical devices by means of functional statement”.
T 836/08 would be more of the liking of the author. T 836/08 relates to a method and a device for identifying the position of the distal end of a bone guide wire. In this decision the BA simply disregarded the fact that one marker had to be fixed on a bone as this step was neither claimed in the method and in the device.
The Board held: “The fact that the procedure is performed after or even during a surgical procedure on the body (attachment of the reference device to the bone or insertion of the wire into the bone) does not mean that the claimed position finding procedure as such is a surgical treatment procedure”.
For the Board “it is a purely “passive” and non-invasive measurement and evaluation procedure that has no effect on the human body and the medical treatment performed”. Both statements are quite daring. By further stating that “no device-induced therapeutic effect on the body [that] could be functionally related to the process steps claimed, the Board really tries to justify the unjustifiable. The reference to T 245/87, OJ 1989, 171, appears totally misplaced.
As far as the method was concerned, the same Board, in a different composition, rectified its position in a later decision, T 2438/11, whereby the (same) applicant referred to T 806/08.
One aspect which is also to be kept in mind, is that under substances and compositions only pharmaceutical products are meant and not devices as such. The oldest decision in this respect is T 227/91, OJ 1994, 491
In Point 1 of the catchword of the above cited decision T 1314/05, it was stressed that devices used in medical procedures cannot be equated with substances and compositions and therefore Swiss-type claims are not available for devices! See also the above mentioned T 2369/10. Last but not least T 1099/09 confirms the restriction to substances and compositions of the benefit of Art 53, c) and excludes devices.
Sorry Hermann D. but I disagree. Your position is siloed. This is a very interesting decision and the comments are insightful.
What I find quite interesting, beyond the specific field of medical devices and its interaction with the exclusion of medical treatments, is the notion that a step implying human intervention in a patent claim, whether in method or product form, raises a patentability issue. This is true in computer-implemented inventions, in which a step performed by a user generates the so-called “broken chain fallacy”.
In the case of medical devices, the comment suggests that the problem could be avoided by excising from the claim any subject matter implying human intervention. This would lead to a functional definition of the device worded as an outcome in response to specified inputs.
@ Hermann D.
A far as medical devices are concerned, there are three BA competent depending on the IPC class. Source: Special Edition of the OJ 2019, N° 2, Boards of Appeal.
Board of Appeal 3.2.02 A61 (exc. C, F, K, L, N, Q)
Board of Appeal 3.2.08 A61C, F (exc. 13-17); Dentistry and stents
Board of Appeal 3.4.01 A61N; Electrotherapy, magnetotherapy, radiation therapy and ultrasound therapy
Board 3.2.02 is the BA which has the biggest part as it only deals with medical devices. Like Board 3.2.08 it is a mechanical Board. Only a relative small part of the duties of Board 3.2.08 has to do with medical devices.
Board 3.4.01 is indeed a physics board, but it deals with important devices like pacemakers, defibrillators lithotripters and the like. Like Board 3.2.08, only a relative small part of the duties of Board 3.4.01 has to do with medical devices.
Claiming that not too much importance is to be given to the decision at stake, and waiting until the decision is confirmed by the boards that usually work in this field is anything but helpful. There is no other BA dealing with this topic, so no confirmation from BA 3.2.02 is to be expected.
It might have been better to concentrate all medical devices in one and the same BA, but as this is not the case, one cannot deny other Boards any competence to deal with such topics.
The proposal to delete any “naughty” step is an old one. However, be it in a claim to a method or to a device, it is not possible to circumvent the prohibition by merely deleting the “naughty” step. The proposal to delete any step which could imply an interaction with the human or animal body is thus not helpful. There are clear decisions in this respect. See for instance T 1005/98, where the applicant has willingly deleted the resection step.
But even some Boards have played this game. In T 948/95, Board 3.4.01, the original method claim comprised a step relating to insertion of an ultrasonic transducer into the body. The amended claim, suggested by the Board, mentions a step of energising the transducer to generate ultrasonic signals, whereby the transducer is merely “located” in the body. In my opinion this claim offended Art 123(2), as there was no other alternative to the surgical step of insertion. At the time, Art 123(2) was not considered as strictly as nowadays, but this is a different story. It was in B. T 948/75 was a one-off. T 1731/12 is the best proof to the contrary.
A claim in which such a step directly linked with the human body would be deleted would lack essential features and should not be granted. Even in G 1/04, diagnostic methods, which is very liberal as barely nothing can be refused under this heading, this point is clearly stated.
The comment about the human intervention in CII is very interesting and is food for thoughts.
Dear Attentive Observer,
Thanks for your answer. I understand I have to clarify my suggestion.
I see no need to delete what you call the “naughty step” if it is possible to draft a claim drawn to the device in which the claimed features are limited to the components of the medical device considered in itself i.e. components suitable for interaction with the environment of a human body, defined by the nature of their input(s) and output(s) and how the outputs are derived from the inputs. I am not knowledgeable about medical device patents, I do not know whether and to what extent this is possible.
The advantage of such a definition is that the manufacture or sale of the device can be an infringing activity.
So what about a claim directed to “Artifical heart valve for controlling the blood flow in a human heart, comprising the very elborate mechanical structure with features A,B,C,D that are clearly not related to any surgical step.”
According to general claim construction, the “for controlling the blood flow in a human heart” merly means “suitable for”. Nevertheless the valve is defined by this feature to a certain extent….
The Board erred in my opinion. On the other hand, a single T decision should not make us panic….
The claim as proposed by P. Parker is in its generality OK. That a heart valve is for controlling the blood flow, is manifest and hence the feature which is superfluous.
Adding that the features are not achieved by a surgical step is inducing a lack of clarity. It is a negative feature which should be avoided. If no surgical step is needed, this should be apparent from the original disclosure. Then the sentence is superfluous as well.
If, in order to obtain the final heart valve, there is necessary a surgical step, the we are in the situation of T 775/97.
The Board has, in my humble opinion not erred.
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