Monday, 5 August 2013

T 1955/09 – Indirectly

Another decision dealing with novelty in the medical realm …

Claim 1 of the request refused by the Examining Division (ED) read:
1. The use of a peptidic compound for the manufacture of a medicament for the prophylactic or therapeutic treatment of a bacterial or fungal infection of a mammal by killing said bacteria or fungi, wherein the compound comprises an amino acid sequence X1KEFX2RIVX3RIKX4FLRX5LVX6, wherein
X1 represents the N-terminal part;
X2 is K or E;
X3 is Q or E;
X4 is D or R;
X5 is N or E;
X6 represents the C-terminal part;
wherein one or more of the amino acids of the core sequence are optionally derivatized, and wherein
(a) the N-terminal part is acetylated, and/or
(b) the C-terminal part is amidated, and/or
(c) the amino acid sequence is different from
X1KEFX2RIVX3RIKX4FLRX5LVX6. (emphasis added)
Contrary to the ED, the Board found this claim to be novel:

[2] Claim 1 refers to a therapeutic application in the form allowed by the Enlarged Board of Appeal (EBA) in decision G 5/83, i.e. in the form of the use of a substance or composition for the manufacture of a medicament for a defined therapeutic application. The board considers that this claim form is also allowable when taking into consideration the findings of the EBA in its decision G 2/08 [7.1.4 ; order, last paragraph].

3. The ED denied the novelty of the subject-matter of claim 1 over the disclosure in document D1, a document relevant under A 54(3). Document D1 disclosed the use of the same peptidic compounds for the “diagnosis/prevention/therapy of a disease or condition involving, or resulting from, a fungal or bacterial infection, or the exposure to a fungal or bacterial toxin”, whereby the infection was of the upper airways or the respiratory system. The feature “by killing said bacteria or fungi” of claim 1 had no limiting effect on the scope of the claim. Furthermore, the presence of bacterial/fungal cells and the secretion of toxins by these cells were concomitant events and the application did not identify a new distinguishable sub-group of patients unlike the situation underlying decision T 836/01.

[4] Document D1 is concerned with the use of the peptidic compounds “for the diagnosis, prevention or therapy of a disease or a condition involving, or resulting from, a fungal or bacterial infection or the exposure to a fungal or bacterial toxin” […]. The underlying action of the peptidic compounds in these uses is their “affinity for toxins and especially for fungal and bacterial toxins such as lipopolysaccharide (LPS) or lipoteichoic (LTA)” and their ability to “inhibit or neutralize such toxins” […].

[5] The board notes that the appellants have not denied that document D1 concerns the same compounds as those defined in claim 1 and furthermore, that the ED has not argued that document D1 discloses antibiotic activity of these compounds. The attained therapeutic effect of the use of the compounds defined in claim 1, namely the killing of bacteria or fungi, is not described in document D1.

[6] The attaining of a new technical effect is considered as a functional technical feature of a claim referring to the new use of a known substance. If that technical feature has not been previously made available to the public, then the claimed invention is novel, even though such technical effect may have inherently taken place in the course of carrying out what has previously been made available to the public (see decisions of the EBA G 2/88 and G 6/88 [9]).

[7] This principle has been followed in a large body of case law of the boards on claims relating to second or further medical uses of a known substance, inter alia in decisions T 290/86, T 542/96, T 509/04 and T 1229/03, which all acknowledged novelty in the case at issue or in decisions T 254/93; T 486/01 and T 384/03 which all denied novelty in the case at issue.

[8] Since document D1 and claim 1 are both concerned with the same peptidic compounds for treating the same disease, it needs therefore to be decided whether the use now claimed represents a further and different therapeutic use from the disclosure in document D1.

[9] Document D1 disclosed the use of peptidic compounds for the purpose of inhibiting or neutralizing toxins produced by bacteria or fungi. Document D1 thus teaches a direct effect of the compounds on the toxins produced. This is in clear contrast to the technical effect relied on by the claimed invention, namely the indirect influence of the peptidic compounds on the production of the toxins via their antibiotic action against the toxin producing bacteria or fungi.

[10] The conclusion cannot be drawn that the technical effect relied upon by the claimed invention, i.e. the antibiotic effect, is a mere explanation of how the compounds inhibit or neutralize toxins. Rather, this effect identifies a new clinical situation, namely one in which it could be preferable to target the infection itself, not merely the toxins produced by the bacteria or fungi causing the infection […].

[11] The board notes that the above reasoning is analogous to the reasoning in two further decisions, i.e. T 836/01 and T 1642/06, on claims relating to second or further medical uses of a known substance and which acknowledged novelty in the case at issue based on the differentiation of a direct and indirect effect.

[12] In view of the foregoing, the board is satisfied that the subject-matter of claim 1 at issue fulfils the requirements of A 54(1) and A 54(3) vis-à-vis the disclosure in document D1.

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