Key points
- Claim 1 is a second medical use claims, "1. A cancer therapeutic drug, which is a composition comprising[ the compound FTD] and [another compound] in a molar ratio of 1:0.5, for use in the treatment of cancer in a human patient in need thereof by orally administering the drug at a dose, as a dose of FTD, of 20 to 80mg/m**(2)/day twice daily.""
- The filing date was in 2006. (!)
- D11 is D11|Summary of clinical data filed on 19 March 2018 |
- "5. Sufficiency of disclosure - claim 1 of the main request
- 5.1 The appellants questioned whether the skilled person could carry out the subject-matter of claim 1 without undue burden. They argued that the use defined in claim 1 could not credibly treat every type of cancer, let alone at any dose within the range defined in claim 1. The Board disagrees. ... Example 2 and Figure 2 (Trials 3 and 4) of the English translation of the application as filed showed that the oral administration of TAS-102 at a total daily dose of 60 or 50mg/m**(2) FTD, provided in two daily doses, effectively treated more than 70% of breast cancer patients for whom standard therapy had not worked. In this context, effectively treating meant that at least tumour progression was stopped and the disease remained stable.
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The Board agrees with the respondent that, due to the direct action of FTD on DNA, TAS-102 could be expected to have a general effect on tumours and not to be limited to a single cancer type. Therefore, the consideration of the post-published evidence in document D11 confirming this effect on additional tumour types was in line with the principles established in G 2/21 (Reasons 77 and 93), namely that the purported effect is encompassed by the technical teaching of the application as filed and that it is embodied by the same originally disclosed invention."
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"The Board therefore concludes that the appellants did not raise serious doubts that the skilled person could carry out the subject-matter of claim 1 without undue burden. Consequently, claim 1 of the main request fulfils the requirements of Article 83 EPC."
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On inventive step: "In summary, the skilled person wanting to improve the efficacy and safety of the therapeutic indication disclosed in D4 would turn to D6. This combination would lead them to provide TAS-102 in multiple doses as an obvious solution. In particular, the skilled person would administer TAS-102 thrice daily, which is the regimen found in D6 to be optimum. The skilled person would have expected that administration twice daily, which was neither disclosed nor explicitly suggested in D6, would not be as good as thrice daily. It is even less likely that they would have expected twice daily administration to exhibit a comparable level of anticancer efficacy while considerably reducing the level of side effects. Therefore, the solution to the objective technical problem proposed in claim 1 was not obvious from the combination of D4 with D6. It constituted the selection of an undisclosed embodiment which was unexpectedly advantageous."
source http://justpatentlaw.blogspot.com/2023/12/t-273519-post-published-evidence-for.html
