T 2003/08 – It’s A Substance

This opposition appeal contains quite a lot of interesting material. I have, therefore, decided to split it in two posts.

Claim 1 of the second auxiliary request read:

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.

In what follows Board 3.3.04 examines whether this claim is to be interpreted as a claim to a second medical use in the sense of G 5/83:

Interpretation of claim 1

[6] In seven parallel decisions of 5 December 1984, all with corresponding texts in the different official languages of the EPO and of which decisions G 1/83, G 5/83 and G 6/83 were published in the Official Journal of the EPO, the Enlarged Board (EBA) decided that a claim in the form of a “use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application” was the appropriate form of protection for inventions pertaining to a second or further new and inventive use in the medical domain (see point [23] of the reasons). This type of claim is known as a “second medical use claim” or “Swiss-type claim”. (Hereinafter reference will be made to G 5/83, published in English, the language of the present proceedings.)

[7] It is not disputed by the parties, and the board agrees, that claim 1 of auxiliary request 2 […] has the format of a second medical use claim as envisaged by G 5/83. It is furthermore uncontested that the specific ligands for immunoglobulin referred to in claim 1 and a process for their generation were known in the art, as were the ligands when bound to a column and the manufacture of such a column. By way of example reference is made to the Therasorb-Ig column disclosed in document E10 which is in fact the column used in the examples of the present patent. Hence, the present invention is of the type considered in G 5/83, i.e. one where the feature in claim 1 relating to the treatment of DCM patients is decisive for the patentability of the claimed invention.

 [8] The appellant-opponent has argued that claim 1 does not fulfil one prerequisite to qualify as a second medical use-claim in accordance with G 5/83, namely that a “medicament” is used in the treatment. Indeed the means used in the treatment were a “column”, which is not a “medicament”, but a “device”. Therefore, despite it being drafted in the format of a second medical use claim, claim 1 should not be interpreted as such and therefore the treatment-feature should be neglected when assessing novelty.

[9] Accordingly it needs to be decided whether or not claim 1 is to be construed as a second medical use claim. In the decision under appeal this question was answered in the affirmative […]. The board comes to the same conclusion, although for different reasons which are set out below.

[10] The board considers it helpful in this context to highlight the reasons that led the EBA in G 5/83 to allow patent protection for further uses in the medical domain.

[10.1] At the time when G 5/83 was taken A 54(5) EPC 1973 provided patent protection for inventions pertaining to the first use in the medical domain of a known substance or composition in the form of a purpose-limited product claim. A 54(5) EPC 1973 stipulated: “[...] shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in A 52, paragraph 4, provided that its use for any method referred to in that paragraph is not comprised in the state of the art”.

[10.2] In G 5/83 [22] the EBA stated however that it “does not deduce from the special provision of A 54(5) EPC [1973] that there was any intention to exclude second (and further) medical indications from patent protection other than by a purpose-limited product claim”. Thus, the EBA considered that protection for further “medical” uses should be possible by analogy to the protection provided by A 54(5) EPC 1973 for first “medical” uses.

[10.3] The EBA considered that the adequate form of protection for these inventions would be a claim to a “use” or a “method”, but that this form of protection would be “in direct conflict with the provisions of A 52(4) EPC [1973]” (points [12-13] of the Reasons).

A 52(4) EPC 1973, to which the new A 53(c) EPC 2000 in substance corresponds (see for example G 1/04 [10]), stipulates: 

“Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.”

However, […] the EBA in G 5/83 [23] found it “legitimate” to allow claims which are directed to the “use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application”.

[11] Accordingly, this board judges that the expression “for the manufacture of a medicament” was considered by the EBA as a way to remove from the exclusion from patentability for lack of industrial applicability the sort of claim that the EBA in substance intended to allow, namely the use of a substance or composition for any of the methods recited in A 52(4) EPC 1973.

[12] It can be taken from the distinction made in the second sentence of A 52(4) EPC 1973 […] that the meaning of the term “products” is not identical to the meaning of the terms “substances or compositions”. Rather, according to the wording of A 52(4) EPC 1973 “substances or compositions” are cited as a subgroup of the larger group of “products”. Thus, (i) in view of the fact that A 54(5) EPC 1973 relates to “substances and compositions” only, (ii) in view of the link made in A 54(5) EPC 1973 to A 52(4) EPC 1973 and (iii) in view of the connection established by the EBA to A 54(5) EPC 1973 […], this board concludes that the EBA intended to allow the special form of protection only for those uses in the medical domain which concern products which qualify as “substances or compositions”.

[13] Moreover, again in view of the link made by the EBA to A 54(5) EPC 1973 […], the present board is convinced that the term “therapeutic application” in the wording of the claim allowed by the EBA is to be interpreted as referring to any of the methods referred to in A 52(4) EPC 1973. In fact, the EBA states in point [21] of the Reasons: “It is clearly understood that the application of this special approach to the derivation of novelty can only be applied to claims to the use of substances or compositions intended for use in a method referred to in A 52(4) EPC [1973]”.

[14] It follows from the observations and considerations in points 10 to 12 above, that in the light of G 5/83 it is therefore of pivotal importance to establish whether or not the means used in the treatment of DCM according to the present claims constitute a “substance or composition”, rather than to establish whether or not it constitutes a “medicament”.

[15] In G 5/83 the EBA does not give an explicit definition of what is encompassed by the terms “substance” or “composition”. Yet, in view of the claims at stake in the referring decision T 17/81 – they were essentially directed to the use of 1,4-dihydro-2,6-dimethyl-4-(3’-nitrophenyl)-pyridin-3-ß-methoxyethylester-5-isopropylester to treat pathologically decreased cerebral functions – this board deduces from the gist of G 5/83 as a whole, and in particular from the specific reference to “chemical substance or composition” in point [10] of the Reasons […] that in the context of G 5/83 “substance” or “composition” refers at least to products which qualify as “chemical” entities or compositions of “chemical” entities.

[16] A “device”, as for example a stent or a catheter, would not normally be denoted as a chemical entity. Therefore, G 5/83 ([…] and A 54(5) EPC 2000, which according to the EBA in G 2/08 [5.9 ff.] is considered to fill the lacuna in the EPC 1973 which had been filled in a praetorian way by the EBA with G 5/83 and the case law based on that decision) has consistently been interpreted by the boards as not providing for the patentability of uses in any of the methods recited in A 52(4) EPC 1973 (or A 53(c) EPC 2000) involving means that are a “device” (see for example T 1314/05 [3.2]; T 213/07 [3]; T 1099/09 [3.2-3; 7.2], where the relevant claims related to the use of a “device” in a treatment by therapy; or T 775/97 [2.6, second paragraph], where the relevant claim related to the use of a “device” in a treatment by surgery).

[17] In the present board’s view, it also emerges from the whole reasoning of G 5/83 that it is the “substance” or “composition” which is responsible for the “medical” - in the case of a treatment by therapy the “therapeutic” – effect, i.e. that the “substance” or “composition” is the active agent in the medical use. Reference is made in particular to the statement in G 5/83 [23]: “For these reasons, the EBA considers that it is legitimate in principle to allow claims … even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.” (emphasis added). A similar view on the interpretation of G 5/83 as regards this aspect was expressed in decision T 1099/09 [4.3].

[18] Consequently, in accordance with the reasoning in G 5/83 and in view of the claim at issue here which relates to the treatment of patients by therapy, the board considers that it is decisive for determining whether or not a “substance” or “composition” is used in a treatment to establish (a) the means by which the therapeutic effect is achieved and (b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities.

[19] In the present case the therapeutic effect on which the treatment according to claim 1 is based is the removal of immunoglobulin from the plasma of patients suffering from DCM. This effect is achieved by the “specific ligand for human immunoglobulin” which is undisputedly a chemical entity. The “column” serves as a carrier for the ligand and is not instrumental in achieving the therapeutic effect. In fact, the ligand could also bind immunoglobulin, if it was not bound to the column, i.e. if it was free in solution. Accordingly, the board judges that the means used for the treatment in accordance with claim 1 is to be considered as a “substance” or “composition” in the sense of G 5/83.

[20] Several decisions were considered in the context of the issue raised by the appellant-opponent’s argument.

[20.1] In T 138/95 [2,4] a claim to the “Use of a polypeptide selected from growth factors and cytokines for the manufacture of a device for delivering to the blood stream of a patient a therapeutic dose of the peptide by systemic delivery by pulmonary adsorption [...]” was considered by the board without any observations or comments as a second medical use claim within the meaning of G 5/83 […].

In T 138/02 [2.5-7] the claim under consideration was to the “Use of a material comprising a porous water insoluble carrier and a compound covalently immobilized onto said carrier, [...] for the manufacture of an adsorbent for the treatment of a disease selected from the group consisting of [...] by removing at least one cytokine selected from the group [...] from body fluid [...].” (emphasis added). The board concluded that this claim was not directed to a second medical use in line with G 5/83, because the means actually used in the treatment after the manufacture were not a “medicament”. The board defined “medicament” as characterized by “it be administered to a patient’s body in order to treat a disease”.

Thus, in both those decisions the relevant claims related to the use of “means” for a treatment by therapy and it was decisive for the interpretation of the claim – as for example in T 213/07 and T 1099/09 – whether or not the “means” were to be considered as a “substance” or “composition”. The board notes that in none of decisions T 138/95, T 138/02 and T 213/07  was it decided whether or not the means used in the claimed treatment were “substances or compositions” within the meaning of G 5/83. Therefore, the board considers that these decisions do not help to elucidate the issue at stake here. In this board’s view, T 1099/09 [3.4, 4.3] supports its view on the present issue.

[20.2] T 227/91 and T 775/97 were cited by the appellant-opponent because they give a definition of the term “medicament” with which the subject matter of claim 1 would – in the appellant-opponent’s view – not comply. In the first of those decisions, T 227/91, the board dealt with the following claim:

“1. [...] Use, in the manufacture of a laser surgical instrument for intercepting an incident laser beam having a particular wavelength after the laser beam has energised a desired surgical target site but before the laser beam energises material adjacent to the surgical target site, of: substrate means (16) adapted to transmit energy received from said laser beam away from said surgical target site, said substrate means having a high thermal conductivity and an exterior surface; and coating means (18) adapted to absorb laser energy at said wavelength, said coating means covering substantially the entirety of the exterior surface of the substrate means, having a high absorptivity for energy at that wavelength and having a thickness in excess of one quarter of the wavelength of the laser beam; characterized by said coating means having a thickness substantially equal to 0.1 (a.t)0.5, where a = thermal diffusivity of the coating means t = effective pulse time of the laser beam.” (emphasis added).

In T 775/97 the following claim was at issue:

“29. Use of a mutually connected first tube (160A) and first tubular member (166A) and a mutually connected second tube (160B) and second tubular member (166B), as defined in any one of claims 1 to 26, for the manufacture of a device for use in a surgical method in which the tubular members and tubes are intraluminally delivered in the first diameter condition of the tubular members into a body passageway (152) to be repaired, to be disposed therein substantially even and on the same level as each other, and the tubular members are subsequently expanded and deformed, by the application from the interior of the tubular members of a radially outwardly extending force, from the first diameter to the second, expanded and deformed, diameter with portions of the first and second tubular members being in a substantially flat adjacent relationship, whereby the adjacent portions are substantially flattened towards each other to substantially close off and substantially remove any gaps that may otherwise be present within the body passageway between the tubular members; to form a bilateral passageway in the body passageway to repair the body passageway.” (emphasis added).

The board notes that in neither of these decisions did the board express any doubt that the means used in the treatment were a “device” and did not decide on the issue of whether what was used was a “substance” or “composition” within the meaning of G 5/83.

Furthermore, as already observed in point [14] above, the board considers that in order to decide whether or not a claim complies with the requirements set out in G 5/83 an assessment of whether or not a “medicament” is used is not in fact needed. Instead it is necessary to decide whether or not a “substance” or “composition” within the meaning of G 5/83 is used. However, even if it was necessary to decide whether or not a “medicament” was used, the board notes that in T 227/91, T 775/97 and also in T 138/02 different boards even had different views on the essential characteristics of a “medicament” which demonstrates in this board’s view that it would be undesirable to take any one of those definitions as being generally applicable.

[20.3] The appellant-opponent has furthermore relied on decision T 144/04 where the claim at issue was directed to “A method for the extracorporal removal of lipids selected from cholesterol, triglycerides and other lipids from animal plasma, serum or other suitable blood fractions, said method comprising: providing plasma, serum or other suitable blood fractions, mixing with an extraction solvent (mixture) which extracts the said lipids from the fraction, wherein the extraction solvent is removed from the delipidated fraction by mixing the delipidated fraction with an adsorbent specific for the extraction solvent.” (emphasis added).

The appellant-opponent has argued that this claim related to a treatment-method very similar to that of present claim 1, i.e. the extracorporal removal of unwanted blood components, and that the board held that the claimed method was not a method of treatment by therapy in the sense of A 52(4) EPC [1973] because it was carried out extracorporally, i.e. not “on” the body. By analogy, it was argued that the column used extracorporally according to the present claim 1 could not be considered as a “medicament”.

The board notes first, that the claim at issue in decision T 144/04 was not a second medical use claim, but a claim to a method and that the relevant issue was whether or not the claimed method of treatment by therapy fell within the ambit of subject-matter excluded under A 52(4) EPC 1973, i.e. whether or not the treatment by therapy was to be considered as such a treatment in the sense of A 52(4) EPC 1973 (see also T 329/94 and T 789/96 where the same issue was considered). Therefore, T 144/04 is prima facie not relevant for the specific issue arising here in relation to a second medical use claim, namely if the used “means” are a “substance” or “composition” in the sense of G 5/83. Moreover, the board in decision T 144/04 gave no opinion – explicit or implicit – on what is considered to be a “medicament”, whether in a general sense or in the sense of G 5/83.

[20.4] For the present board a question which could rather arise from T 144/04 or T 329/94 and T 789/96 and in the light of G 5/83 is whether or not the feature in present claim 1 relating to the treatment “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” is to be considered as a “method referred to in A 52(4) EPC [1973]”.

Decision T 144/04 held that the claimed method was not a method according to A 52(4) EPC 1973 because the removal of the lipids took place “extracorporally”, i.e. the blood when it was treated was “unlinked” to the patient’s body, see (i) the steps in claim 1 of decision T 144/04 of mixing plasma, serum or other suitable blood fractions with an extraction solvent and of mixing the delipidated fraction with an adsorbant, and see (ii) in point 2 of the Reasons (a) the originally present feature that the removal of lipids happens in a discontinuous flow system and (b) the disclosure in the application that it was an object to provide a method whereby a patient’s plasma or serum can be treated remote from a patient.

In the present case the treatment referred to in claim 1 is a so-called immunoapheresis which achieves the therapeutic effect extracorporally, i.e. the unwanted components in the plasma, immunoglobulins, are removed spatially separated from the patient’s body. Yet here the patient’s plasma, the patient’s body and the means achieving the therapeutic effect, i.e. the ligand bound to the column are linked in a continuous circuit. Therefore, the treatment in the present case is different from the treatment dealt with in decision T 144/04. Hence, the board sees no reason based on decision T 144/04 not to consider the treatment defined in claim 1 as a treatment by therapy in accordance with A 53(c) (or A 52(4) EPC 1973). The treatment-feature therefore does not preclude the interpretation of claim 1 as a second medical use claim.

Other decisions also support the board’s view in this respect. In T 1075/06 the board decided that the claimed blood processing method for the removal of certain blood components which that board qualified as “blood component therapy” or “therapeutic plasma exchange” was a method of treatment of the human body by therapy and thus refused the claim pursuant to A 53(c). In T 1695/07 the board considered a blood manipulation process involving the continuous removal of blood from a patient, its subsequent flowing through a circulating line of an extracorporal circuit and its re-delivery to the patient as a method of treatment of the human body by surgery. The claim was therefore excepted from patentability pursuant to A 53(c).

[21] In view of the considerations above, the board judges that claim 1 and its dependent claims 2 to 8 are to be interpreted as claims to a second medical use in the sense of G 5/83. Accordingly, the indication of the purpose “for the treatment of a patient suffering from dilated cardiomyopathy [...]” is not merely descriptive and needs consideration when assessing the patentability (here in particular the novelty and inventive step) of the claimed subject-matter.

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