Make no bones about it: The "credibility test" has no place in the novelty assessment of second medical use claims (T 0558/20)

A recent decision relating to bone regeneration therapy from the Boards of Appeal considered the correct approach to the assessment of second medical use claims. The Board of Appeal in T 0558/20 favoured an approach whereby the novelty of a second medical use should be assessed as a whole and not be restricted to the direct "medical use" steps of the claimed composition. The Board of Appeal also rejected the approach of the Opposition Division requiring a "credible" technical effect of the claimed use for novelty under Articles 54(4) and (5) EPC.

Legal Background: Second medical use claims

Medical methods are excluded from patentability in Europe (Article 53(c) EPC). This exclusion was included in the EPC 1973 to ensure there was no impingement of doctors' freedom to treat patients (G 01/07). However, in Europe, it is possible to patent "substances or compositions, for use" in a method of treatment. Particularly, a previously known substance or composition may be patented for a medical use if this specific use of the composition is new (Articles 54(4) and (5) EPC). 

Articles 54 EPC thus singles out "substances and compositions" as a special category of product. A known product for a new non-medical use cannot generally be patented, as this would be considered to lack a technical contribution to the art, or "technical teaching" (G 2/88). Particularly, a claim for a product for a non-medical use would be construed as a product "suitable for" the claimed use. If the product is already known, then the claim is thus anticipated by the product itself. It is therefore not possible to claim a hammer for use in hammering a new type of object, such as cheesecake, even if the prior art contains no reference to the use of hammers to hammer cheesecake. The prior art hammers will be considered to have been "suitable for" hammering cheesecake. 

By contrast, it is recognised that providing sufficient disclosure of a known "substance or composition" for a new medical use requires substantial research and development. The identification of a known "substance or composition" for a new medical use is therefore considered a technical contribution worthy of patentability. A second medical use claim is thus construed as including the functional effect of the claimed use. The new medical use of a known substance or composition is therefore considered novel (G 02/88Articles 54(4) and (5) EPC). 

T 0558/20Case background

Getting to the bones
of the matter

The patent (EP2588154) in T 0558/20 related to a bone tissue regeneration product for use in the treatment of degenerative bone diseases, such as osteoporosis. The question on appeal was whether the granted second medical use claim was novel in view of the fact that the claimed compositions and their general use in the treatment of bone disease was known. The only distinguishing features of the claim from the prior art were surgical method steps that, the Opponent argued, should not be considered a specific use of the composition falling under Article 54(5) EPC.

The correct approach to assessing novelty of a EPC 2000 second medical use claim

The Board of Appeal noted that it was self-evident that the method steps referred to in the granted claim related to a method of treatment. The method per se was thus excluded from patentability under Article 53(c) EPC. Claim 1 was also clearly drafted in the format provided for in Article 54(5) EPC, generally called "second medical use" (r. 2.5). 

The Board of Appeal noted that Article 54(5) EPC does not, as such, define any specific criteria to be applied when assessing the novelty of such a claim. For the Board of Appeal, the novelty of a second medical use claim over the prior art must therefore be assessed in the usual way. In other words, it is necessary to assess whether the specific use of the substance or composition defined in the claim is already known or not (r. 2.9). The Board of Appeal, however, identified two different approaches to this assessment. 

The Board of Appeal favoured an approach whereby it is first established whether the method referred to in the claims falls under the Article 53(c) EPC exclusion, i.e. is it a method of treatment of the human or animal body. It is then considered whether the specifically claimed use of the substance or composition in such a method is novel. For the Board of Appeal this approach was aligned with the logic of Article 54(5) EPC (r. 2.9). 

The Opposition Division (OD) in T 0558/20, on the other hand, had followed a different approach to the novelty assessment of second medical use claims. The OD reversed the steps and first assessed whether the specific use of the substance or composition defined in the claim was novel. Following this approach, if the specially claimed use is already known, the claim cannot benefit from the novelty exception. As such, the claim is not novel and it is then not necessary to assess whether the use falls under the Article 53(c) EPC exclusion or not. 

The Board of Appeal accepted that both approaches, if properly followed, should reach the same conclusion regarding the novelty of a second medical use claim. Nonetheless, it was the Board of Appeal's view that the OD's approach would be more prone to error (r. 2.10), which the Board felt was illustrated by the OD analysis in the case in question. 

The "specific medical use" of the composition should be considered as a whole 

Claim 1 of the patent specified materials for use in a method of treating a patient suffering from a degenerative bone condition. The method included surgical steps, such as creating space in the bone of the patient for filling with the bone regenerative material. The claimed materials were marketed for use in treatment of bone degeneration at the priority date. The new "characterising" part of the method thus solely resided in the surgical steps. 

The Opponent argued that these surgical steps did not specifically relate to the claimed materials. As such, the Opponent argued, the surgical steps could not contribute to the novelty of the claimed therapeutic use. 

The Opposition Division (OD) agreed with this argument. For the OD, the novelty of the claim was further dependent on the patentee making it "credible that a new technical teaching was provided" by the medical use. In doing so, the OD essentially incorporated a plausibility/credibility test into novelty analysis of second medical use claims (IPKat). Given the use of the materials for the treatment of bone disease was already known, the OD concluded that a new technical effect over the prior art could not be recognised, and thus the claim could not be considered novel under Article 54(5) EPC.

For the Board of Appeal, however, the surgical steps specified in the claim did form part of a "specific use in a method of treatment" as required by Article 54(5) EPC. The Board of Appeal particularly found that it was the method as a whole, i.e. the use of the materials in the treatment of bone disease comprising the surgical steps, that should be compared to the prior art disclosure. The Board of Appeal thus rejected the Opponent's argument that the surgical method steps of the claim should be excluded from the novelty analysis under Article 54(5) EPC

For the Board of Appeal, the claimed "additional physical actions" and "tangible, physical method steps" of the surgical steps could also be considered a technical teaching. The Board of Appeal therefore did not follow the OD approach requiring the patentee to demonstrate a "credible technical effect" of the claimed therapeutic use in order to establish novelty under Article 54(5) EPC.  The Board of Appeal reversed the OD decision and found an auxiliary request novel under Article 54(5) EPC on the basis of specific surgical steps not disclosed in the prior art with respect to the claimed materials. 

Final thoughts

For this Kat, the Board of Appeal interpretation of the requirement that a second medical use invention contribute a "technical teaching" (G 2/88) is in line with the case law on the patentability exclusion of abstract ideas. According to this case law, a patentable invention cannot be an abstract idea, but must have technical character (Case Law of the Boards of Appeal, I-A-1.1G 2/88). The Board of Appeal did not follow the approach of the Opposition of Division, whereby the phrase "technical contribution" was interpreted as a credibility requirement for the treatment effect of the second medical use claim.

In recent years, the Boards of Appeal have moved progressively away from "special" tests for the novelty of certain types of invention. Particularly, Boards of Appeal have rejected the "purposive selection" criteria for novel sub-ranges (IPKat) and the requirement for purity by "unconventional means" for the novelty of purity inventions (IPKat). Boards of Appeal are increasingly rejecting these "special" novelty tests for being incompatible with the gold standard novelty test, whereby novelty is only destroyed by a clear unambiguous disclosure of the claimed invention in the prior art (G 2/88, G 2/10). 

In this Kat's view, the decision in T 0558/20 confirms that the gold-standard approach to novelty also applies to an assessment of novelty under Article 54(5) EPC. The requirement for a second medical use invention to possess "technical character" can therefore be considered a low bar. Whether the claimed medical use is inventive and can be performed over the full scope of the claim, remain considerations for sufficiency and inventive step analysis. 

Further reading

Make no bones about it: The "credibility test" has no place in the novelty assessment of second medical use claims (T 0558/20) Make no bones about it: The "credibility test" has no place in the novelty assessment of second medical use claims (T 0558/20) Reviewed by Rose Hughes on Wednesday, August 30, 2023 Rating: 5


  1. I would allow myself to add that not only novelty has to be assessed as a whole, but this applies as well to assessing inventive step.

    Should one cut the claim in two parts, the substance and the use, then it could be dealt with with partial problems and it could be rather easy to conclude to a lack of inventive step.

    After all the medical use is a limiting functional feature of the claim which cannot be dealt with separately from the substance.

    T 558/20 has also been dealt with in another blog.

  2. Here is the claim:
    "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."

    Cleary the appeal board decision is correct. At the EPO the use of a known substance in a new method of treatment is patentable. That is a very established policy, and there is no reason to change as it continues to protect medical practitioners from being sued. Whether the invention (novel feature) lies in a surgical step is irrelevant at the EPO. However I know that a lot of UK Examiners (working at the UK IPO) would have a lot of problems with this decision as the UK still likes to focus on the nature of the distinguishing feature, and whether the distinguishing feature falls into an exclusions (especially for example for mental acts, business methods, etc)

  3. Question : what is the commercial value of the patent as upheld by the Board ? Anybody can sell the substance if the specific use covered by the claims is not labelled.

    1. The claim is a medical use claim covering the product when intended for the medical use. So the manufacturer, importer, advertiser, supplier, etc, all infringe when dealing with it. Courts across Europe will have different tests for what level of evidence is needed to establish what type of 'intention' by each party that is sued, which is complicated, but that is how the system works. Whether or not the product is labelled is only one component of the test. In the UK at least non-labelling would not protect you from infringing. Potentially the claim can therefore provide very effective protection (and also I suspect very interesting case law if it was litigated)

  4. Dear Santa,

    The claim you mention is the claim as granted which has been considered lacking N over D3, but for other reasons than that of the OD.

    The claim considered allowable by the board is claim 1 of AR2 and 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 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, at least partially filling the formed void with a bone regenerative material that facilitates formation of new, non-degenerated bone material in the void.

    In this claim, the void created for receiving the bone regenerative material is greater than the channel. As 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. This difference was enough for the board to consider the subject-matter of claim 1 of AR2 novel and inventive.

    Dear F. Hagel,

    The commercial value of a patent as upheld by the Board is irrelevant when considering the allowability of the claim in matters of sufficiency, N and IS. If the subject-matter of the claim is inventive over the CPA, and there are no other obstacles, the EPO has no legal reason to refuse a patent. What the proprietor does with its patent is none of the business of the EPO. Patents not coming on the market are often considered as the hidden part of an iceberg.

    There is no doubt that the substance is known, otherwise we would not be in presence of a second medical use. Second medical use has often been belittled as being a patent on the leaflet accompanying the substance. It has at least he merit to exist and has also been the source of some quite arduous litigation, cf. the in the UK.

    1. Francis asked a reasonable question. The world doesn't revolve around the EPO and patents are obtained by businesses for business reasons. It was these business reasons that Francis was asking about. Luckily, Santa was able to answer without being condescending.

      Pity, of course, the EPO doesn't understand it exists for purposes other than its own self-interests.

    2. I never said that Mr Hagel’s question was not reasonable. It was simply out of bounds. What would be the legal basis for the EPO to refuse a patent for lack of commercial interest? This question has not been answered, neither by Mr Hagel, nor by yourself.

      EPO is there to grant patents if the conditions set up by the EPC are met. The rest is indeed irrelevant and has nothing to do with EPO’s self-interests. For instance, if the patent certificate ends up on the wall of inventor’s lounge, there is nothing to say.

      If an applicant/proprietor is prepared to fork out money for a patent of little commercial value, this is his problem, not that of the EPO. By the way, the patent can always been brought to lapse by not paying annual fees.

      I have granted or maintained patents, the value of which was prima facie doubtful. In view of the EPC there was no alternative.

      Once, the representative, a former colleague, told me that the “invention” was that of the head of R&D. It was anticipated to 90% by a publication in IBM Technical Disclosure Bulletin, not even a patent! If the representative would not have got a patent, he risked having a hard time. As the conditions of the EPC were met, there was no reason to refuse the application.

  5. @Anonymous
    @DX Thomas

    I posted the following comment yesterday but for some reason it has not been published, so I redo it. Sorry for the unconvenience.

    Thank you for your replies. My question somehow reflected the surprise of somebody who is not a pharma specialist at the content of claim 1 of the patent as granted : the « substance or composition » recited in claim 1 (calcium phosphate etc) being nothing more than bone tissue, and the « method » being a surgical step excluded under Art 53(c) EPC, how come features so clearly devoid of any patentable character can have been granted ?
    It is to be noted that the patentee holds another EP patent (2987507) in which claim 1 as granted contains much more specific information regarding the composition. The patentee has not put all their eggs in one basket.
    I also have to stress that the value of patents is not limited to their enforcement against infringing activities. Patents can be very effective in non-contentious relationships including to attract third party investments and partnerships.
    I fully concur with Mr Thomas that the EPO has no reason to worry about the value of the patent in infringement proceedings. This is why I also think that the concern about legal certainty cited by the EPO as motivation for the requirement to adapt the description to the claims is beyond its remit.

    1. Dear Mr Hagel,

      I can agree with most of what you said, but it will not come as a surprise that I cannot agree with your last comment. This is however an old story and there is no need to dwell on it.

    2. Dear Mr Thomas,

      The adaptation of the description is not the subject of this post and I agree there is no reason to discuss this issue now. I am only surprised that you call it an old story since a referral to the EBA is suggested by the Board of case T 56/21. If it happens, the issue will be a very hot topic again and there will be ample opportunity for debates.

      From the Board’s communication of June suggesting the referral, I take this robust policy statement : « It is not for the Office to harmonise the extent of protection conferred by European patents (and applications) by bringing the description and/or the drawings the amended claims held allowable. » (Reason 3.2.3).

    3. Dear Mr Hagel,

      The suggestion of the board simply shows that the legal member, who has drafted the communication under Art 15(1) RPBA in T 56/21, did not want to take the decision and is actually trying to hide behind the applicant. The applicant should take the decision for him.

      It could also be interpreted that the other members of the board might not be absolutely convinced by a referral, but should the applicant want, it, they will not oppose it.

      In view of the mind set of the EBA, such a referral might not have the effect hoped by yourself and many other people thinking alike. Have G 3/19 and G 1/21 not been a warning?

  6. One aspect of this decision which caught my eye is that it seems to go against the established practice of the EPO of requiring the substance or composition to play an active role in the treatment of the patient in order for the provisions of Article 54(5) to apply.
    In its preliminary opinion, the opposition division had indicated that a claim is only novel under 54(5) if the use of the substance or composition provides a new therapeutic effect. In the absence of such a therapeutic effect, the claim was to be interpreted as a material suitable for use in the recited method. This reasoning was not articulated in the OD's decision.
    Looking at the Board's decision, the requirement for a therapeutic effect is not mentioned, and at 2.8 the Board interprets how a claim under 54(5) is to be assessed, where the only requirement is to assess whether the specific use is novel.
    Can we at last say goodbye to the practice of the EPO of requiring a therapeutic effect, inherited from the days of Swiss-type claim formulations, although the EPC does not state such a requirement?

    1. Kant, you make an excellent point, but I remind you of T2003/08, which 'stretched' a Swiss-style medical use claim to cover use of particular column to treat a patient’s plasma outside the body. See the relevant claim below:

      ‘1. Use of a specific ligand for human immunoglobulin in the manufacture of a column having said ligand coupled thereto for the treatment of a patient suffering from dilated cardiomyopathy, said treatment comprising passing plasma of the patient over the column under conditions which effect the binding of said specific ligand to immunoglobulin in the patient's plasma, thereby removing a significant portion of the immunoglobulin from the patient's plasma, and reinfusing the plasma to the patient.’

      [Also discussed in old IPKat article here]

      So my belief is that the substance does not need to provide the therapeutic effect. Only the medical method as a whole needs to do that as recited in the claim. I believe T1020/03 established that ANY method of treatment can be expressed as an allowable medical use claim if a substance is somehow involved. The in vivo diagnostics case law for contrast agents for use in MRI also supports this approach with the invention often being in the MRI method, and not in a new contrast agent.

    2. But what about T 1758/15 and T 2136/15 where collagen, hyaluronic acid, alginates, etc., were characterised as "initially viscous devices" rather than substances because they did not take an active role in therapy?

  7. I must admit, the title of the article confuses me. The decision to my understanding does not reject the test from G2/08 which requires that the new use must in fact include a new teaching. Instead, this is expressly acknowledged in 5.3 of the reasons. There is no discussion of a “credible effect” in this context. The surgical steps are then in 5.4 simply considered a new technical teaching in view of those steps being tangible new physical steps. This is then sufficient for novelty. Effects associated with these new features were discussed under inventive step. Since no effects were proven, inventive step was discussed in view of an alternative solution. This alternative was considered unobvious in view of a lack of suitable hints towards such a solution. I would assume that still not every use language which is verbally different will automatically pass the test of G2/08. In this decision it was simply clear that the new steps are a new teaching. If I have missed an important part of the decision, I would be thankful for a further explanation.


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