Key points
- This opposition appeal concerns dasatinib. It is the (at least) the third appeal decision about dasatinib. It is the second appeal in the opposition proceedings. In the first appeal, T 0950/13, the Board found the recited medical use to be sufficiently disclosed without examples in the application as filed.
- " The patent in suit aims at treating certain types of cancer, in particular chronic myelogenous leukemia, by oral administration of [dasatinib]"
- The decision under appeal and all appellants [opponents] rely, inter alia, on either document (5) or (18) as closest prior art.
- It is common ground that the difference between the subject-matter of claims 1 or 3 of auxiliary request 2a and the disclosure of these two documents is the use of dasatinib as active agent.
- " it is common ground between the appellants and accepted as one possibility by the respondent that the technical problem is the provision of an alternative treatment for CML.'
- " The board draws attention to the primary finding of T 950/13, namely that the subject-matter of claims 1 and 4 of the then-main request, which is identical to the subject-matter of claims 1 and 3 respectively of auxiliary request 2a, is sufficiently disclosed. These claims define the treatment of CML with dasatinib. The board in T 950/13 found that there was a plausible technical concept to support this treatment. The fact that the board went on to find that such a plausible technical concept was not disclosed for the treatment of a specific patient group, i.e. patients suffering from a cancer resistant to imatinib treatment, does not change this general finding."
- The Board in T 950/13: Claim 2 is directed to treatment of CML cancer that is resistent to imatinib. " The application as filed contains no information at all, neither in the form of experimental data nor in the form of a plausible technical concept, that dasatinib is suitable in the treatment of those patients with imatinib-resistant CML. The functional analogy to imatinib as BRC-ABL kinase inhibitor is not helpful in this context and cannot explain why dasatinib should be active, when imatinib is, or has become, inactive." "
- The opponents argue that it is a problem that claim 1 encompasses this embodiment.
- The Board " According to [G1/03, point 2.5.2], the inclusion of non-working embodiments is of no harm if there are a large number of conceivable alternatives and the specification contains sufficient information on the relevant criteria for finding appropriate alternatives over the claimed range with reasonable effort. In T 950/13, the board did not state that the imatinib-resistant patient could not be treated, rather, it concluded that there was no technical concept for such a treatment in the application as filed. In the context of the discussion of inventive step, the following applies. A lack of a plausible disclosure for one group of patients in the application as filed does not automatically lead to the finding that the treatment does not work for this group of patients. It seems to be paramount to distinguish in this respect between the concepts of lack of disclosure and non-working embodiments."
- "While a plausible technical concept might not be disclosed in the application as filed for a specific embodiment (in the present case imatinib-resistant patients), this does not automatically imply that this specific embodiment has to be classified as a non-working embodiment, or, seen in the context of the problem-solution approach, as an embodiment that does not solve the technical problem."
- " In the case at hand, the board identified (the disclosure in the application as filed of) a technical concept for the general treatment in T 950/13. No such technical concept could be identified in the application as filed for the specific embodiment concerning imatinib-resistant patients. However, the reasons underlying the failure of a treatment are not necessarily linked to the reasons for not accepting the disclosure of a technical concept. From this, it follows directly that a lack of disclosure of this concept does not automatically equate with a failure of treatment. "
- " In sum, the lack of a plausible disclosure regarding the imatinib-resistant patients cannot be equated with a finding that the claimed subject-matter includes non-working embodiments. No non-working embodiments have been identified by the appellants. Consequently, the problem is to be considered as solved over the whole scope of the claims."
- " It remains to assess whether its solution would have been obvious to the person skilled in the art."
- " Document (1) relates to certain cyclic compounds and their use in treating protein tyrosine kinase (PTK)-associated disorders such as immunological and oncological disorders "
- " One of the cyclic compounds is dasatinib (example 455). In total, 580 compounds are exemplified and characterised by their HPLC retention time. For some of the compounds, information concerning the solid state and colour is given. Under the heading "utility", inhibition of members of the Src family is linked to diseases relating to immunological disorders, and inhibition of HER1 or HER2, which are receptor PTKs, is linked to anti-angiogenic uses such as the treatment of cancer and diabetic retinopathy (page 39, line 10 to page 40, line 9). A list of potential diseases to be treated is given on page 40, line 19 to page 43, line 25. It is stated that the compounds described in the examples have been tested in one or more of the enzyme assays (using Lck, Fyn, Lyn, Hck, Fgr, Src, Blk, Yes, Her1, Her2) and have "shown activity" (page 50, line 1 to page 51, line 30). The treatment of chronic myelogenous leukemia or the inhibition of Bcr-Abl is not disclosed. None of the exemplified compounds has been shown to have any activity for inhibiting any of the PTKs mentioned."
- " Document (1) [WO00/62778] lists various PTKs, belonging to both main families of PTKs. A Markush formula and several (580) specific compounds are disclosed. However, none of the compounds has been linked via its inhibitory activity to any of the kinases mentioned. Consequently, the person skilled in the art would have been faced with a screening project for "pairing" any of the compounds with one or more of the kinases mentioned. In the absence of any guidance as to which structure/compound might inhibit which PTK, such a screening project goes beyond the routine activities performed by a skilled person when trying to find alternative compounds inhibiting specific (either Bcr-Abl or dual Bcr-Abl and Src) kinases for the treatment of CML. The disclosure of document (1) can at best be seen as an invitation to perform a research programme."
- D1 was the PCT application leading to Dasatinib I, T0488/16, where the Board found the compound claim to lack inventive step for lack of plausibility.
- The claims are found to be inventive.
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/07/t-068919-dasatinib-iii-inventive-step.html
