Wednesday 30 November 2011

T 1642/07 – Prophets Welcome


The applicant filed an appeal against the decision of the Examining Division (ED) refusing his application.

Independent claims 1 and 8 before the Board read:
1. A combination of a herpes simplex virus (HSV) and an effective amount of a chemotherapeutic agent which induces DNA damage for simultaneous, separate or sequential use in a method of treatment of the human or animal body.

8. Use of a herpes simplex virus (HSV) for the manufacture of a medicament for the therapy of tumors, wherein the virus is administered simultaneously, separately or sequentially in combination with an effective amount of a chemotherapeutic agent which induces DNA damage.
The Board found this request to comply with the requirements of A 123(2) and to be novel. It then determined document D3 to be the closest prior art and found that the problem to be solved over D3 was to provide an alternative potentiated virus-based combination therapy for killing (cancer) cells. The proposed solution lay in the replacement of radiation with a chemotherapeutic agent which induces DNA damage. 

The Board then dealt with the question whether the problem had indeed been solved:

[14] In the decision under appeal, the ED considered that the formulated technical problem had not been solved.

[15] However, as explained in detail below […], the ED’s negative arguments […] in relation to the failed solution of the technical problem do not (or no longer) apply to the formulation of the technical problem set out by the board. This formulation is now the provision of an alternative potentiated virus-based combination therapy (wherein “potentiated” means additive until synergistic, or in other words “at least additive”) […].

[16] One of the ED’s lines of argument […] was that the patent application as filed did not comprise experimental data showing the synergistic effect.

[17] Firstly, the board cannot agree with the approach adopted by the ED which unjustifiably turned its original formulation from “the provision of an alternative anticancer therapy using HSV” […] into “the provision of a synergistic anticancer combination therapy” […].

[18] Secondly, it is true that the patent application contains no experimental evidence in support of the claimed combination therapy but only theoretical statements that viral therapy in combination with a chemotherapeutic agent inducing DNA damage results in an additive until synergistic killing effect on cells/cancer cells […]. A “prophetic” Example III(3) disclosing mitomycin C at a dose of 20 mg/m**(2) to be used in conjunction with an adenovirus can also be found [… in] the published WO application. HSV viruses are dealt with […]. The patent application as filed thus addresses expressis verbis the claimed subject matter and potentiation (additive until synergistic killing effect on cells/cancer cells).

However, the board observes that there is no requirement in the EPC, let alone in A 56, that a patent application should include experimental evidence in support of patentability or a claimed technical effect. Hence, the fact that the disclosure in a patent application is merely theoretical and not supported by experimental data is in itself no bar to patentability or to the presence of a technical effect being acknowledged.

[19] Further, the ED, relying on decision T 1329/04, decided that post-published documents E7, E8 and E13 to E15 could not be taken into account for showing that the synergistic effect occurred, because the disclosure in the present application did not render plausible that its teaching indeed solved the problem of providing a synergistic anticancer combination therapy and did not render plausible that this synergistic effect occurred for all the possible combinations covered by claim 1.

[20] However, the formulation of the technical problem to be solved as set out by the board is less demanding than the ED’s, since it now only requires that the potentiating effect be additive until synergistic (in other words, “at least additive”) rather than “synergistic” for any combination.

Post-published document E7 (this document shows that HSV R1716 + mitomycin C = additive effect in 3/5 cells and synergistic effect in 2/5 cells and that HSV R3616 + cisplatin = additive effect), document E8 (HSV NV1066 + 5-FU or gemcitabine = synergistic effect in 3 cell lines), E13 (HSV NV1020 + 5-FU, SN38 or oxaliplatin = additive up to synergistic effect), document E14 (HSV NV1066 + cisplatin = synergistic effect in 6 cell lines) and document E15 (HSV NV1066 + mitomycin C = synergistic effect in 2 cell lines), submitted by the appellant, illustrate such an “at least additive” effect for all the combinations.

Therefore, the dichotomy noted by the ED between the disclosure in the patent application and the technical teaching in post-published documents E7, E8 and E13 to E15 no longer subsists. Rather, the post-published documents can be viewed as being a mere confirmation of the technical effect already announced (albeit at a theoretical level) in the application as filed.

[21] The board observes that such a dichotomy arose between, on the one hand, the disclosure in the patent application underlying decision T 1329/04 (lack of the seven cystein residues with their peculiar spacing required for a protein (in that case, GDF-9) to belong to the TGF-beta superfamily – see T 1329/04 [7] – and the lack of functional characterisation of GDF-9 – see ibidem, [9]) and, on the other hand, the teaching in post-published document D4 that GDF-9 was indeed a growth differentiation factor (see T 1329/04 [12]). Hence, the then competent board concluded that there was not enough evidence in the application as filed to make it at least plausible that a solution had been found to the problem alleged to be solved.

[22] In summary, the negative arguments produced by the ED no longer apply to the less demanding problem set out [by the board]. The board sees also no grounds for doubting that the combined administration of HSV and a chemotherapeutic agent inducing DNA damage is able to achieve an increase of the level of cell killing above that seen for a treatment modality alone. Under these circumstances, post-published documents E7, E8 and E23 to E15 can be taken into account.

[23] In view of the foregoing, the board concludes that the problem highlighted in point 13 supra has indeed been solved by the claimed subject-matter.

The Board then found the claims to be inventive and remitted the case to the ED for further prosecution.

To download the whole decision, click here. The file wrapper can be found here.

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