T 2157/21 - Embodied by the same originally disclosed invention

Key points

• The Board  applies G2/21, hn.2, the part about  "would derive said effect as being [...] embodied by the same originally disclosed invention." (without mentioning the decision).
• A crystalline form of a compound is claimed. After some amendments, the claim meets Article 123(2) EPC and defines the crystalline form quite specifically in terms of XRD peaks.
•  "Claim 1 of auxiliary request 12, which is identical to claim 1 of auxiliary request 12A, claims a crystalline form designated as "Form II" which is characterised by an XRPD pattern comprising lines at 2Theta values measured using CuKa radiation, wherein the X-ray powder diffraction pattern is the same as that shown in Figure 7." (i.e. the claim refers to Figure 7 that is also included in the claim and shows the XRD spectrum as an image.
• "Thus, the question that is decisive for the acknowledgement of an inventive step is whether the claimed polymorph provides an unexpected advantage in comparison with forms disclosed in the prior art. The patent proprietors relied, in this regard, on the data presented in Examples 14 to 16 of the patent in suit."
• "Examples 14 and 15 of the patent in suit compare "Form II" of the patent in suit with the so-called "patent form" disclosed in US8877938B2 (i.e. the US equivalent of D3) in terms of moisture uptake and flowability. It was not in dispute that the comparative experiments reported in Examples 14 and 15 represent a comparison of "Form II" with the crystalline form of trisodium valsartan sacubitril as disclosed in document D3. The reported outcome is that "Form II" showed better flowability (Example 15) and less moisture uptake when exposed to humidity (Example 14). "
• So far, so good.
• "However, it is not disclosed in the patent specification whether the samples tested according to Examples 14 to 16 were obtained according to the process of preparation described in Example 6, or according to the process described in Example 7. In both Examples 6 and 7, the respective product that was prepared is designated as "Form II"."
• "it cannot be confirmed on the basis of the available evidence that the crystalline products of Example 6 and Example 7 are indeed identical, as argued by the patent proprietors. As a consequence, the exclusive use of the term "Form II" in Examples 14 to 16 does not permit the reader to infer that, specifically, the product according to Example 6 and corresponding Figure 7 and Table 4 was tested in these examples. For this reason, it cannot be confirmed that the specific product claimed in claim 1 of auxiliary requests 12 and 12A, which is characterised by the diffractogram in Figure 7, indeed exhibited the favourable properties described in Examples 14 to 16."
• Inventive step is denied.
• For the lower-ranking auxiliary request, the claim refers to Figure 8 instead of Figure 7.
• "By analogy, the same reasoning applies: since it cannot be confirmed that the crystalline product prepared according to Example 7, as characterised by Figure 8 (and Table 5), was used in the experiments described in Examples 14 to 16, it has not been conclusively shown that the claimed product has superior properties in comparison with the crystalline form of D3. Accordingly, the same objective technical problem and the same conclusions regarding obviousness apply as those set out above with respect to auxiliary requests 12 and 12A."
• In other words, likely the compound of Example 14 was either the one of Figure 7 or Figure 8, but the ambiguity prejudices basing inventive step on the effects shown in Example 14. 

EPO 

The link to the decision and an extract of it can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t212157eu1