This appeal was filed against the refusal of the application under consideration by the Examining Division (ED). The ED considered claim 1 of the main request (request A) to lack novelty over D1.
Claim 1 of the main request before the Board (request F) read (in English translation):
A strip (1) made from biocompatible material for a use in the treatment of female urinary incontinence, wherein the treatment comprises the following steps:
- Making a median paraurethral (paraurétale) incision essentially at the level of the middle third (tiers moyen) of the urethra measured from the meatus such as to allow for said strip to pass between the Halban’s fascia (le facia [sic] de l’Halban) and the periurethral fascia (facias [sic] périurétaux); and
- Extending each of the free ends (3,4) of said strip (1) at the level of the two obturating holes of the iliac wing and their outlet (sortie) into the groin opposite the corresponding hole such as to form a V the tip of which passes below the urethra without changing its position.
Claim 1 of the first auxiliary request before the Board was identical to claim 1 of request A and read (in English translation):
Use of a biocompatible material for manufacturing a strip (1) for the treatment of female urinary incontinence by means of a method comprising the following steps:
- Making a median paraurethral (paraurétale) incision essentially at the level of the middle third (tiers moyen) of the urethra measured from the meatus such as to allow for said strip to pass between the Halban’s fascia (le facia [sic] de l’Halban) and the periurethral fascia (facias [sic] périurétaux); and
- Extending each of the free ends (3,4) of said strip (1) at the level of the two obturating holes of the iliac wing and their outlet (sortie) into the groin opposite the corresponding hole such as to form a V the tip of which passes below the urethra without changing its position.
The appellant also requested the Board to refer the following questions to the Enlarged Board (EBA) – again in English translation:
A1) Is the patentability of products for use in any of the methods concerned by A 53(c) limited to substances or compositions?2) If the answer to the first question is yes, what characterises a substance or a composition?4) If the answer to the first question is no, is the product also patentable if the sole new feature of the treatment consists in the surgical steps envisaged?5) Is it sufficient for a substance, a composition or a medicament to be patentable pursuant to A 54(5) if it is consumed during its use according to a method according to A 53(c)?6) If the answer to the first question is no, what are the criteria to be applied for distinguishing a substance or a composition according to A 54(5) from a product which in itself has a therapeutic effect when it is used in a method according to A 53(c)?
The appellant argued, inter alia, that the method for the treatment of female urinary incontinence was not known. Admittedly, the strip according to claim 1 used in the method was not distinct from strips used in prior art methods for the treatment of female urinary incontinence. However, being inserted into the body and having a physiological interaction with the body, the strip had to be considered to be a composition. Therefore, its novelty could be acknowledged within the framework of A 54(5). Even if the strip was not to be considered to be a substance or composition, it would still be patentable within this framework. A 53(c) established that products for use in methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body were not excluded from patentability. Given this wording, it was clear that A 54(5) was not limited to substances or compositions but was applicable to all products for use in methods covered by A 53(c). This also resulted from G 2/08 [5.10.9] …
Here is the verdict of the Board :
*** Translation of the French original ***
Request F
[3.1] A strip made from biocompatible material for a use in the treatment of female urinary incontinence is known, e.g. from D1 (claim 1).
However, even if, as admitted by the appellant itself, the prior art strip is suitable for use in a method such as the method of claim 1, this method as such is not known from D1. Therefore, it has to be established whether this use, which constitutes a method for treatment of the human body by surgery or therapy, confers novelty to the claimed subject-matter.
[3.2] According to A 54(4), it is possible to acknowledge the novelty of a “… substance or composition, comprised in the state of the art, for use in a method referred to in A 53(c), provided that its use for any such method is not comprised in the state of the art” (emphasis added).
According to A 54(5) it is also possible to acknowledge the novelty of a “… substance or composition referred to in paragraph 4 for any specific use in a method referred to in A 53(c), provided that such use is not comprised in the state of the art.”
Article 53(c), to which A 54(4) and A 54(5) refer, provides 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 practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods” (emphasis added).
[3.3] It can be seen from the wording of the three articles that there is an explicit difference between the wording chosen by the lawmaker for A 53(c) and the wording of A 54(4) and A 54(5). First of all, as a consequence of the use of the expression “in particular” (notamment), A 53(c) in itself indicates that the products are not limited to substances or compositions. Moreover, whereas A 53(c) mentions the products, in particular substances or compositions, A 54(4) and A 54(5) only mention substances or compositions. Thereby, the legislator has made a distinction between the products that can be qualified as substances or compositions – which are patentable within the framework of A 54(4) and A 54(5) – and other products, which do not fall under the exceptions provided by those articles.
It is true that, as pointed out by the appellant, A 53(c) provides that products – among which the products which are neither substances nor compositions – for use in any of the methods concerned by this article are not excluded from patentability on the basis of this article. However, this provision simply means that said products are not excluded from patentability in application of A 53(c) and not that their novelty can be established on basis of their use within the framework of A 54(4) and (5).
The appellant’s argument referring to decision T 1020/03, according to which there was no difference between substances and compositions, cannot play any role in establishing the field of application of A 54(4) and A 54(5) because the lawmaker’s distinction is not between substances and compositions but rather between products that are substances or compositions and products that are not.
Decision G 2/08 does support a different point of view either because it does not deal with the patentability of products in general but only with the patentability of substances and compositions that are already known as medicaments.
Therefore, it directly and unambiguously follows from the provisions of the EPC that A 54(4) and A 54(5) only apply to products that are substances or compositions, whereas products that are neither substances or definitions are not patentable within the framework of those articles.
[3.4] In order to establish whether the strip according to claim 1 is patentable within the framework of A 54(5), as submitted by the appellant, it has to be decided whether it may be considered to be a substance or composition.
The strip under consideration is a finished product having a certain shape and certain dimensions. In the present case, it is for example the polypropylene used for manufacturing the strip disclosed in paragraph [0029] of the application that constitutes a substance or a composition.
Considering the context of A 54(4), it is impossible to interpret the terms “substance” and “composition” in a way that would encompass a finished product such as said strip. In particular, as this article does not require or mention any physiological interaction, there is no reason to interpret it as if it also referred to finished products, provided that they had such a physiological interaction with the human body, as argued by the appellant.
Therefore, the strip according to claim 1 cannot be considered to be either a substance or a composition. Therefore, it is excluded to acknowledge its novelty within the framework of A 54(5). As a consequence, the subject-matter of claim 1 of request F lacks novelty over D1.
Request A
[4.1] Claim 1 of request A concerns the use of a biocompatible material for manufacturing a strip for the treatment of female urinary incontinence by means of a method corresponding to a method according to claim 1 of request F.
It is therefore necessary, also in this case, to establish whether the indication of this use, which constitutes a method for treatment of the human body by surgery or therapy, may confer novelty to the claimed subject-matter.
[4.2] As far as claims covering a method or a use are concerned, the EPC does not contain any explicit provision analogous to those applying to substances or compositions according to A 54(4) and A 54(5). However, decision G 6/83 [2] has acknowledged the possibility of using Swiss-type claims. Accordingly, a European patent may be granted on the basis of claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.
[4.3] In order to establish whether novelty can be acknowledged on this basis it is necessary to consider whether the strip that is manufactured in accordance with claim 1 can be considered to be a medicament.
The appellant has submitted that said strip is a medicament because it has a physiological interaction linked to the treatment of female urinary incontinence. However, claim 1 only requires the material of the strip to be biocompatible, which is not limitative at all in the present case. Therefore, said therapeutic effect cannot stem from the nature of said material as such in the present case. Quite to the contrary, as acknowledged by the appellant itself, it depends on the geometry and the positioning of the strip.
However, the therapeutic effect of a medicament, within the ordinary meaning of this term, has in principle its origin in at least one substance or composition that is used, generally referred to as the active principle of the medicament. It is true, as pointed out by the appellant, that other factors, such as the posology of the medicament, can be essential for its therapeutic effect to be obtained. However, this effect is never independent of said active principle. Moreover, the posology is of no concern in the present invention.
Moreover, even the possibility introduced by decision G 6/83 [headnote 2] concerns claims “directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application” (emphasis added). Therefore, this decision does not offer any basis for considering that a product the therapeutic effect of which is not associated to a substance or a composition used, could be a medicament.
In view of the above considerations the strip the therapeutic effect of which does not result from the nature of the biocompatible material, i.e. of the substance or composition that is used for its manufacture, cannot be considered to be a medicament.
As a consequence, it is not necessary for the present decision to decide whether, in agreement with the considerations of decision T 227/91 [5.1], a medicament is necessarily consumed when it is used and can only serve once. Nor is it necessary to establish whether the observations made in decisions T 775/97 and T 1314/05 concerning the use of Swiss-type claims for the manufacture of a device can be applied to the present case.
Consequently, the subject-matter of claim 1 of request 1 lacks novelty with respect to D1. […]
Referral to the EBA
[7.1] A 112(1)(a) provides that in order to ensure uniform application of the law, or if a point of law of fundamental importance arises, a Board of appeal shall, during proceedings on a case and either of its own motion or following a request from a party to the appeal, refer any question to the EBA if it considers that a decision is required for the above purposes. According to this article, it is within the discretion of the Board to decide whether a referral is necessary or not. Such a need can only exist if the decision to be taken by the Board depends on the question that is to be referred to the EBA and if the Board cannot decide itself without difficulty the question that is to be referred.
[7.2] The Board is not aware of any divergence in the case law concerning the point raised by question 1 of the appellant, i.e. whether the patentability of products for use in any method concerned by A 53(c) is limited, within the framework of A 54(4) and 54(5), to substances or compositions. As far as this point is concerned, there is, therefore, no problem of uniform application of the law.
Moreover, as explained above under [3.3], the Board is of the opinion that the answer to this question can be derived clearly and explicitly from the provisions of the EPC itself. Therefore, it is not necessary to refer this question to the EBA.
[7.3] Although it is necessary in the present case to decide whether the strip according to the invention is a substance or a composition, the Board can decide on this question without there being any need for a complete definition of what defines a substance or composition. Therefore, the decision to be taken by the Board does not depend on question 2 and this question must not be referred to the EBA.
[7.4] It is not necessary to refer questions 4 and 6 either because they only had to be considered if the answer to question 1 was “no”.
[7.5] As the Board has established that said strip was neither a substance nor a composition, nor a medicament, question 5 plays no role whatsoever in the present decision and must not be referred to the EBA either. […]
The appeal is dismissed.
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