T 0907/10 - Anticipation and experimental data

Key points

• The Board confirms that, also for second medical use claims, it is "established case law that the disclosure content of a prior art document anticipates claimed subject-matter only if the teaching it contains is reproducible. The criteria for assessing a reproducible disclosure in the context of novelty (Article 54 EPC) and sufficiency of disclosure (Article 83 EPC) are the same."

T 0907/10 -  link

Reasons for the Decision

12. Appellant I further argued that document D4 could not be regarded as anticipating the subject-matter of claim 1, because it did not disclose experimental data showing a therapeutic effect of anti-CD3 antibody F(ab')2 fragments in the treatment of rheumatoid arthritis. The disclosure of document D4 could therefore not be considered reproducible.

13. It is established case law that the disclosure content of a prior art document anticipates claimed subject-matter only if the teaching it contains is reproducible. The criteria for assessing a reproducible disclosure in the context of novelty (Article 54 EPC) and sufficiency of disclosure (Article 83 EPC) are the same.

A disclosure of a therapeutic use of a product is considered reproducible if it is at least plausible to the skilled person that the therapeutic effect at issue can be achieved. This is normally the case if evidence is available - either from the disclosure itself or from common general knowledge - that the product has, for example, a direct effect on the underlying metabolic mechanism specifically involved in the disease (see Case Law of the Boards of Appeal, 7th edition, I.C.3.11, last paragraph and e.g. decision T 609/02, point 9 of the reasons).

14. Hence, in view of the case law referred to in point 13 above, the absence of experimental data in a document relating specifically to the treatment of the disease under consideration does not inevitably mean that a therapeutic effect is not plausible. For this reason alone, appellant I's argument is not convincing.

15. Moreover, an analysis of the experimental data of document D4 reveals the following:

15.1 The document discloses a study which assesses the efficacy of anti-CD3 antibody F(ab')2 fragments in the treatment of overt, i.e. established, diabetes in non-obese (NOD) mice (see example 1). The treatment achieves a remission of the diabetes in the animals treated (see page 6, table 1 and page 7, lines 1 to 3).

15.2 At the priority date it was common general knowledge that NOD mice were an established model for human autoimmune insulin-dependent diabetes mellitus. It was moreover known that auto-reactive T-cells play a major role in this disease (see e.g. document D68a, page 337, column 1, fifth paragraph).

15.3 The involvement of auto-reactive T-cells in the pathogenesis of rheumatoid arthritis was also known from the prior art. Document D79, for example, reads: "Most researchers agree that RA [rheumatoid arthritis] is initiated by an antigenic or autoantigenic peptide complexed to the rheumatoid-associated major histocompatibility complex (MHC) class II molecules, HLA-DR4 or DR1, on the surface of an antigen presenting cell. This antigen-MHC complex is presented to CD4+ lymphocytes with the appropriate T-cell receptor, which become activated and increase their cell surface expression of many activation markers" (see page 484, column 1, second paragraph to column 2, line 7; "CD4+" is a surface marker that is specifically expressed on T-cells; note and emphasis added by the board).

15.4 In the board's view therefore, it was part of the common general knowledge of the skilled person that both rheumatoid arthritis and insulin-dependent diabetes mellitus in humans are T-cell-mediated autoimmune diseases, i.e that auto-reactive T-cells are the underlying mechanism involved in both diseases. Accordingly, in view of the results disclosed in document D4 in the treatment of insulin-dependent diabetes, the skilled person would have considered it plausible that the F(ab')2 fragments of anti-CD3 antibodies would also achieve a beneficial effect in the treatment of rheumatoid arthritis.

16. In view of the above considerations, the board concludes that the disclosure of document D4 is to be considered reproducible.

17. Consequently, document D4 anticipates the subject-matter of claim 1. Hence, the main request does not fulfil the requirements of Article 54 EPC.