T 1457/09 - Speculative prior art medical use

T 1457/09 - 17.01.2014

Link [C]

Key points

• A decision from 2014, that seems still worthwile to report. 
• According to established case law, "a  disclosure in a prior art document is novelty-destroying only if the teaching it contains is reproducible. This need for an enabling disclosure is in conformity with the principle expressed in Article 83 EPC. Thus, the requirements of sufficiency of disclosure are identical for a prior art document and a patent." (T 1437/07)
• In T 1457/09 applies this decision to an Art. 54(3) prior right mentioning the now claimed second medical use (compound + disease), however without experimental evidence (in the priority application): this document was not novelty destroying. 

T 1457/09

Novelty - Article 54(3) EPC - claim 4

34. Claim 4 is drafted as a second medical use claim (see section XI above for the complete wording of the claim).

Document (D1)

35. In the decision under appeal (see reasons, section 2.3) the opposition division held that the subject-matter of claim 14 of auxiliary request 1 before it, which corresponds to the subject-matter of present claim 4, was anticipated by the intermediate document (D1). The opposition division considered that both documents (D1) and (D1a) disclosed pharmaceutical compositions comprising the peptide RMFPNAPYL and their use as a cancer vaccine. Appellant I appealed this decision.

36. Pursuant to established case law, a disclosure destroys novelty only if the teaching it contains is reproducible, in other words if it can be carried out by the person skilled in the art (see Case Law of the Boards of Appeal of the European Patent Office, 7th edition 2013, section I.C.3.11, and in particular decision T 1437/07 of 26 October 2009, reasons, points 25 and 26 cited in that section). For the requirement of reproducibility to be considered as fulfilled in relation to a medical use it is necessary - following the principles developed by the case law in the framework of the evaluation of Article 83 EPC in the case of a second medical use claim (see decision T 609/02 of 27 October 2004, reasons point 9) - that the disclosure in the prior art document is such as to make it credible that the therapeutic effect on which the disclosed treatment relies can be achieved. Thus, in the present case a prior art document is novelty-destroying only if it discloses not only the product referred to in the claim - here RMFPNAPYL - for the claimed therapeutic application - here treatment of cancer - but also that the claimed product is indeed suitable for the claimed therapeutic application.

37. In the present circumstances (see point 26 above), for document (D1) to anticipate the subject-matter of claim 4, the suitability of RMFPNAPYL for the therapeutic application must be disclosed in both the priority document (D1a) and in document (D1). This follows from Article 89 EPC in combination with decision G 2/98 (OJ EPO 2001, 413, reasons, point 9) wherein the Enlarged Board endorsed a narrow or strict interpretation of the concept of "the same invention", limiting the right to priority to subject-matter which the person skilled in the art can derive directly and unambiguously, using common general knowledge, from the previous application as a whole, see also decision T 107/09 of 12 July 2012 (reasons, points 7 to 10).

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40. Its priority document (D1a) differs from document (D1) in that document (D1a) only comprises examples 1 to 3 of document (D1) and in particular in that document (D1a) does not comprise example 6 of document (D1). Further, document (D1a) does not contain any evidence that CTLs specific for the peptide RMFPNAPYL are able to lyse cancer cells endogenously expressing WT-1 protein. Document (D1a) also does not contain any evidence that cancer cells endogenously expressing WT-1 protein produce the peptide RMFPNAPYL and present said peptide on their surface in the context of MHC class I antigens. The experimental results disclosed in document (D1a) are therefore not sufficient to make it credible that the RMFPNAPYL peptide is suitable for the treatment of cancer (cf decision T 609/02, supra, reasons, point 9).

41. Appellant II argued that document (D1a) taught the use of WT-1 derived peptides as cancer vaccines and provided an enabling disclosure of the medical use because the killing of cells pulsed with the peptide having the sequence RMFPNAPYL, as shown in the examples 1 to 3 of document (D1a), was evidence of a direct and specific effect. Moreover, document (D1a) stated (see page 17, lines 15 to 18) that the results demonstrated that the D**b 126 peptide functioned indeed as a tumor antigen and that it induced the growth of killer T cells against tumor cells.

42. The board is not persuaded by this argument. Document (D1a) does indeed state on page 17, lines 15 to 21 that "The above results demonstrated that the peptide of the present invention indeed functions as a tumor antigen and that it induced the growth of killer T cells (tumor cell-toxic T cells) against tumor cells. Therefore, the tumor antigen peptide of the present invention is useful as a cancer vaccine for leukemia and solid tumors that are accompanied by increased expression of the WT1 gene". However, the observation that cells pulsed with a peptide in vitro are killed by cells raised against this very peptide does not allow any conclusion as regards the in vivo processing and presentation of the peptide on tumor cells endogenously expressing WT-1 protein. Therefore the above statement is a mere assertion uncorroborated by experimental data. As a matter of fact, the induction of CTLs against tumor cells has not been shown in document (D1a). Consequently, the suitability of the peptide RMFPNAPYL for the treatment of cancer is not disclosed in document (D1a), and document (D1) does not destroy the novelty of the subject-matter of claim 4.

T 1437/07 - 26.10.2009 

Link

Enabling disclosure in document R21

25. A disclosure in a prior art document is novelty-destroying only if the teaching it contains is reproducible. This need for an enabling disclosure is in conformity with the principle expressed in Article 83 EPC. Thus, the requirements of sufficiency of disclosure are identical for a prior art document and a patent.

26. In accordance with the principles developed by the case law in the framework of the evaluation of the requirements of Article 83 EPC in the case of a medical use, the skilled person should not only be able to carry out the teaching of document R21, but it should also be credible that the effect at issue - here relief of pain - has been achieved. It is stated, for example, in decision T 609/02 of 27 October 2004, point 9 of the Reasons: "Where a therapeutic application is claimed in the form allowed by the Enlarged Board of Appeal in its decision G 5/83 (OJ EPO 1985, 64), ie in the form of the use of a substance or composition for the manufacture of a medicament for a defined therapeutic application, attaining the claimed therapeutic effect is a functional technical feature of the claim (see G 2/88 and G 6/88, OJ EPO 1993, 93 and 114, Headnote III. and point 9 of the reasons; for non-medical applications, see also T 158/96 of 28 October 1998, point 3.1 of the reasons). As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application." (emphasis added).

26.1 Evidence that the requirements are indeed fulfilled may come in different forms. If, as in document R21, data from a particular patient are reported, the later identical repetition of the teaching is of course not an option.

26.2 In the present case it is argued neither that the skilled person did not have botulinum toxin type A at its disposal, nor that he/she did not know how to apply it. In fact, the instructions in document R21 are detailed: "20 units (2cc) of BoTx was injected with a 5mm sclerotherapy needle in 0.5cc increments in a longitudinal axis from the superior border of the bile duct orifice to the horizontal fold of the papilla."

As to the therapeutic effect, the board has prima facie no reason to doubt in view of the disclosure in document R21 that the treatment results in a relief of pain in response to a lowering of the sphincter pressure.

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27. Thus, the board concludes that no case of lack of enabling disclosure in document R21 has been made out.

28. The subject-matter of claim 1 is thus not novel in view of document R21. The requirements of Article 54 EPC are not fulfilled.