The patent relates to a bone regenerative material for use in methods of treating patients suffering from bone degeneration, such as osteopenia and osteoporosis and more particularly, by replacing at least a portion of the degenerated bone material.
Brief outline of the procedure
The patent was revoked by the OD and the proprietor appealed.
In its decision the OD came to the conclusion that claim 1 of the granted patent could not benefit from the novelty exception in Art 54(5); the claim had to be interpreted as being directed to a material suitable to be used in the method defined in the claim. The claim thus lacked N over D3 (Not mentioned in the ISR established by the EPO) and a variety of other documents. The same applied to the independent claims of AR 1, 2 and 7-9. The independent claims of AR 3-6 and 10-13 lacked an inventive step under Art 56 starting from D3 as closest state of the art.
The board held that claim 1 as granted was clearly drafted in the format provided for in Art 54(5), generally called second medical use.
Under this premise, the board held that claim 1 as granted indeed lacked N over D3, but that the patent could be maintained in amended form according to AR2. The case was thus remitted to the OD, inter alia for adaptation of the description.
The case in interesting when it comes to consideration that the claim at stake relates to a substance or composition and defines a surgical (and therapeutic) method
Claim 1 as granted reads
A bone regenerative material comprising calcium sulfate, calcium phosphate, or demineralized bone matrix (DBM), or a combination thereof, for use in a method of treating a patient suffering from a degenerative bone condition that can be characterized by a loss of bone mineral density (BMD), the method comprising:
- forming a void in a localized area of intact bone by clearing degenerated bone material and optionally removing a portion of the degenerated bone material; and
- at least partially filling the formed void with a bone regenerative material that facilitates formation of new, non-degenerated bone material in the void.
The OD’s position
In its decision the OD came to the conclusion that claim 1 as granted could not be read as a medical use claim under Art 54(5). The method defined in the claim did not involve a new technical teaching, as required by decision G 02/08, and was thus not novel.
Therefore the claim had to be read as defining compositions suitable for this method. The materials defined in the claim are well-known. In fact, they are commercially available, cf.§ [0042] of the patent. The claim was then held to lack N over a variety of documents. N was denied over D3, a document which the OD found to disclose the composition used in the method defined in the claim, but also over other documents which disclosed the compositions as such.
Furthermore, in its decision the OD did not contest that calcium sulfate and the other materials mentioned in the claim qualify as “substance or composition”.
Novelty under Art 54(5) – Two different approaches possible
The OD’s approach
The approach of the OD for assessment of N of this claim is based on the second part of Art 54(5), “provided that such use is not comprised in the state of the art”. The N exception defined in Art 54(5) only applies under this condition.
Following this approach, in order to assess whether the N exception applies, it is first examined whether the specific use of the substance or composition defined in the claim is already known or not. If the use is already known, the claim cannot benefit from the N exception. The claim was not novel since the composition as such was already known.
The proprietor’s approach
The approach followed by the proprietor is to read the claim in the format provided by Art 54(5). After assuring that the method defined in the claim falls under the exclusion of Art 53(c), the use and the method steps are considered as limiting features of the claim. Following this approach it then has to be examined whether the specific use of the substance or composition defined in the claim is novel or not. If this specific use is already known, the claim is not novel over the document disclosing the specific use of the substance or composition defined in the claim.
The board’s position
For the board, claim 1 as granted is clearly drafted in the format provided for in Art 54(5).
The board held that if applied correctly, both approaches must lead to the same result. In both cases it has to be assessed whether the specific use of the substance or composition defined in the claim is already known or not.
This specific use includes the method steps, because “such use” in the last phrase of Art 54(5) refers to the “specific use in a method” of the previous phrase. If this specific use is already known, the claim is not novel and cannot be allowed.
For the board, the approach proposed by the proprietor, i. e. reading the claim as it is drafted, assuring that the method falls under Art 53(c), then considering the use and method features as limiting and assessing whether the specific use defined by them is already known from the prior art is, in the Board’s view, aligned with the wording of Art 54(5) and follows its logic.
For the board, the approach taken by the OD appears to be prone to errors, in particular when the specific use includes various method steps to be taken into account.
Lack of novelty of claim 1 as granted
The opponent argued that the therapeutic use defined in the claim, i. e. the use of the bone grafting materials defined therein for the treatment of degenerative bone conditions, was already known as such. These materials were commercially available, see paragraph [0042] of the patent, and were, in the end, designed and marketed for this very purpose. This therapeutic use did not depend on the details of the surgical steps defined in the claim.
The Board did not agree. The claim defines a method for treating a patient suffering from a degenerative bone disease comprising two steps, firstly creating a void in an intact bone, and secondly filling the void with bone regenerative material.
This is the “specific use in a method” referred to in Art 54(5) EPC, and this use needs to be compared with the disclosure of the prior art. The surgical step of the present claim is clearly a part of the therapeutic method. Without the surgical step the bone grafting material could not deploy its therapeutic activity. The method defined in the present claim has to be assessed as a whole.
For the board, the surgical method steps cannot be ignored when assessing novelty of the claim.
It was uncontested that the material used in D3 is according to the claim. It was likewise uncontested that the method used in D3 is according to the claim. The proprietor defended N of the claim arguing that D3 failed to disclose the formation of “non-degenerated bone material” as required by the claim.
For the board, this feature cannot establish novelty of the claim as D3 clearly discloses the formation of new bone material in the void.
The proprietor argued that the feature “non-degenerated bone material” in the claim not only required the formation of new bone material, but of new healthy bone, as opposed to the osteoporotic bone removed when creating the void.
The board held that Independent from the question of whether, under which circumstances and how far the description may be used to interpret features of the claim, the description does not state that the only possible interpretation of “non-degenerated bone material” is the one proposed by the proprietor.
The description of the patent does not support the interpretation of “non-degenerated bone material” as exclusively referring to bone material corresponding to a 30-year old healthy subject, or bone material having certain physical characteristics relating to the BMD or T-score.
Thus, the formation of new bone material disclosed in D3 anticipates the granted claim.
The same applied to AR1
Allowability of AR2
The method defined in claim 1 of AR 2 requires additional steps.
In particular the claim defines that the method comprises:
- forming a channel into the interior of a localized area of intact bone,
- using the channel as access, forming a void of dimensions greater than the channel in the localized area of intact bone by clearing degenerated bone material and optionally removing a portion of the degenerated bone material.
Based on G 2/08, the OD held this claim to lack N, as it did not consider the method steps to provide a “new technical teaching“.
G 02/08 was mainly concerned with the question of whether a specific dosage regime could provide N under Art 54(5) over a prior art document concerning the treatment of the same disease using the same active ingredient, but disclosing a different dosage regime, or none at all.
Requiring additional surgical steps clearly provides a new technical teaching compared to the disclosure of D3 already because additional physical actions must be undertaken. The method defined in the claim is thus not just verbally different from the method disclosed in D3, but differs in tangible, physical method steps.
D3 does not disclose forming a channel and using this channel as an access to form a void greater than the channel in the bone. In D3 a hole is drilled, and nothing more.
A skilled person, reading D3, would have had no reason to create a bigger void inside the bone, using the channel as an access. There is no indication anywhere in D3 that the drill hole alone could not accommodate the bone graft material injected into the bone, or that the amount of injected material was considered insufficient. On the contrary, it is indicated in figure 3 that the end of the drill hole remained unfilled after injection of the bone graft material.
Thus, a skilled person would not see any need for further enlarging the void, using the channel as an access.
Comments
The board made clear that, when it comes to a claim drafted according to Art 54(5) involving a surgical step, it is important to consider the claim as a whole.
This means that not only the use but also the method steps defined in the claim have to be taken into account.
This consideration might appear manifest for applicants/proprietors dealing with pharmaceutical substances, i.e. when it comes to therapeutic methods, it also applies to surgical methods. .
Any step going further than those known in the prior art cannot be ignored.
On the procedure
Claim 1 should not have been granted.
D3=S.R. Murali et al., “New bone formation in an osteoporotic patient treated by intraosseous injection of bioactive materials; a case report”; Cells and Materials 4(4), 337-346 (1994) appears to be a standard specialised magazine, and should have been found in during the original search.
The present decision of the OD is one more of those set aside by a board. More than 50% of decisions taken by ODs have been set aside since the beginning of 2023.
The OD concluded to a lack of N of claim 1 as granted for reasons which were not found convincing by the board.
it can be considered that, by ignoring the specific surgical steps in AR2 the patent was unnecessarily revoked.
https://new.epo.org/en/boards-of-appeal/decisions/t200558eu1.html
Comments
11 replies on “T 558/20 – On N (and IS) of a claim for a substance of composition defining as well a surgical method”
Daniel, please could you clarify whether “More than 50% of decisions taken by ODs have been set aside since the beginning of 2023” refers to 50% of all decisions of the ODs (i.e. including those are were not appealed), or 50% of the OD decisions that have been appealed? Thanks.
Dear Shere,
Thanks for your comment. My figure does indeed need an explanation.
The only freely and easily accessible source of information are the published decisions of the boards of appeal following an appeal after a decision of the OD.
It is certainly possible by looking in the public register to find out decisions of the OD which have not been appealed, but this is much too tedious. I think that by relying on published decisions, one can get a pretty good idea of the situation.
The figure of 50% represents thus only OD decisions which have been appealed.
If you have the number of decisions not appealed, I would be interested in the corresponding figure, preferably with the breakdown in opposition rejected, patent revoked and patent maintained in amended form.
There are certainly OD decisions which are not appealed. From my experience, I would guess that this number is relatively small, as in most of the cases the parties to an opposition appeal the decision of the OD. The trend observed by looking at published decisions of the boards is certainly indicative of the general situation and therefore worth looking at.
Up to yesterday, 23.08.2023, 809 decisions of a BA after appeal on opposition have been published and in 452 cases the decision of the OD has been set aside. This amounts to 56,1% of decisions set aside.
From those 809 published decisions 745 were final, i.e. the opposition was rejected (140-18,8%), the patent was revoked (358-48,1%) or the patent maintained in amended form (247-33,2%). A decision is not final if the corresponding case is remitted to the OD for further prosecution, other than the mere adaptation of the description.
Thanks Daniel for clarifying. I don’t have the number of decisions not appealed – as you say, this could be obtained from the public register, but it would be very time consuming to do so. I agree that the number of not appealed OD decisions is fairly low (in my personal experience, perhaps around 20% – typically because the opponent no longer has a commercial interest in the opposition rather than because the opponent thinks that the OD decision is unlikely to be changed).
Your point – that more than 50% of the appealed OD decisions have been set aside – is shocking. One could simply toss a coin and get a more reliable outcome!
Dear Shere,
Thanks for your comments and your guess about the cases in which a decision of an OD is not appealed. I can concur with your figure.
That decisions of the first instance can be set aside is always possible. A board is entitled to have a different opinion. However the percentage of decisions set aside is, I would say, inordinately high. It should certainly not be as high as it presently is. With the creation of directorates specialised in oppositions, one would think that the number of decisions set aside should be much lower. The contrary is true and this is worrying.
I want to make clear that I am not blaming examiners. They simply have to deal with a case in the time allocated. That this time is constantly reduced is not what they wish, but they have to cope one way or the other with the ever increasing production pressure.
Dear DXT
I am not sure I your numbers are accurate, because they neglect the number of inter partes appeals terminated without any decision.
In 2022, for example, according to page 31 the BoA’s annual report for 2022, only 60% (1375) of the 2305 inter partes cases were terminated with a decison on the merits. In 40 % of these the 1375 cases, the appeal was dismissed, i.e. the decision confirmed. In around 60% of said 1375 cases, the appeal was at least partly successfull. This percentage remained stable since 2016. This means that around in 36% (0,6×0,6) of the inter partes appeal, the decison of the opposition division is not confirmed.
In my opinion, the number of 50% you mentioned is overstimated, as it does not take into account the appeals terminated without any decision.
Addendum: The same number of around 65 % of opposition division’s decisions confirmed can be found in figure 43 of the EPO’s 2022 Quality report.
@Anonymous
I beg to disagree with you. I did not neglect anything. I have made clear what the figure actually represents.
I fully agree that a certain number of inter partes appeals are terminated without any decision.
The partial reimbursement of the appeal fee when an appeal is withdrawn is there to encourage parties to withdraw their appeals.
The % I have indicated is relative to PUBLISHED decisions of the boards of appeal.
Indeed, I did not take into account the absolute number of appeals ever filed.
Even if the absolute number is lower, which I can fully agree with, the trend revealed in PUBLISHED decisions is notable and does not necessarily bode well for the quality of the work delivered by ODs, in spite of what is said in various publications of the EPO.
When a board had a look at the decision of an OD, the boards set aside more than 50% of OD’s decisions.
Thus in cases in which a decision has been taken by a board, I maintain my figure.
Hiding behind decisions which have not been taken is a good trick to try to hide or belittle the problem or even claim that there are no problems. The problems are however real and all presentation tricks will not make them less acute.
When looking at the divergences the following are examples of different categories:
Maintenance-Maintenance in a different form
Maintenance-Revocation
Maintenance-Remittal for further prosecution
Rejection opposition-Maintenance
Rejection opposition-Revocation
Rejection opposition-Rejection for different reasons
Revocation-Maintenance
Revocation-Remittal for further prosecution
Revocation-Revocation for different reasons
I invite you to look at PUBLISHED decisions of the boards. This source is open and available to any interested person.
When no decision has been taken, it is easy to claim that there has been no problem.
This decision is of note in that it provides guidance as to how the provisions of A54(5) are to be interpreted. The practice at the EPO has been to require that the substance or composition exhibits a therapeutic effect such that an inert substance could not benefit from the provisions of A54(5) even if the method were to be considered novel and inventive. The decision of the OD did not explicitly refer to this but it is implicit in the reasoning, see E3.1.3 and the reference to an “additional technical effect”.
The reasoning in T 0588/20 rejects this “unwritten” requirement, see e.g. 2.6, “Whether the claim is novel over the prior art must be assessed in the usual way, i. e. by comparing the features of the claim, the nature of the substance or composition as well as the use and method steps, with the disclosure of the prior art.”
@Kant
Thanks for your comment. It is highly pertinent and I can subscribe to it.
It is the essence of Art 54(5) that the substance or composition at stake is necessarily used in a method according to Art 53(c). Without a specific medical method under Art 53(c), there is no protection possible under Art 54(5). The method in which the substance is used has to be considered as a functional limitation of the claim.
In the present case, claim 1 as granted as well as claim 1 of AR1 were lacking N as the substance as such and the medical use were disclosed in combination in the prior art D3. The result of the OD might have been the right one, but for the wrong reason. Claim 1 at stake was clearly a claim under Art 54(5) and the comment of the board in Reasons 2.6 is highly pertinent.
For AR2 the OD accepted implicitly that claim 1 was a claim under Art 54(5). In this respect, the reference to G 2/08 was rather odd, to say the least. Claim 1 of AR2 goes, in combination, clearly further than what is disclosed in D3. As the method was different of that of D3, there was necessarily a new technical teaching.
It actually reminds me of the attitude of ED/OD before the Vicom decision on CII (T 208/84). The program is not patentable and the computer is known, so that nothing is patentable.
Here the substance was known as such and the use was known as such so that both features being known as such there is an overall lack of N. Vicom for CII, and the present decision for second medical use claims, remind that a claim cannot be arbitrarily cut in pieces. It would never occur to attack a claim under Art 54(5) for lack of IS due to partial problems! A claim under Art 54(5) is to be taken as a whole.
In your fourth paragraph you refer to AR2 being accepted by the OD to be a claim under A54(5). You may have meant to refer to the BoA. AR2 was not accepted by the OD to be a claim under A54(5), see part VI of the BoA decision. In the preliminary opinion of the OD at 4.3 the position of the OD was indicated, i.e a claim is only novel if the claimed use provides a new therapeutic effect. The BoA in this case did not indicate that such a new therapeutic effect was a requirement for a claim under A54(5).
@Kant
I apologise again for my mishap. You are right. By stating that the claim is only novel if there is a new therapeutic effect, boils again for the OD to not looking at the claim as a whole.
That the board did not indicate that such a new therapeutic effect was a requirement for a claim under Art 54(5) is understandable. Art 54(5) applies also in case of a new group of patients or a different dosage regimen.