7.2.6 Medicament directed to a specific group of patients

T 1491/14 concerned a medicament whose novel feature was that it was directed to a specific group of patients. A lack of sufficiency was alleged on the basis, in particular, that the skilled person was not able to identify the group of patients. Contrary to the opponent's arguments, it was not necessary to measure a physical or chemical parameter to identify the patients. This view was confirmed by the expert declarations (standard practice for a physician to question the patient). The fact that there were no standard questionnaires for this purpose did not create an impasse (anamnesis). While there might sometimes be uncertainty, this amounted to a lack of clarity rather than a lack of sufficiency. As the technical features in question (definition of the patient group) were already present in the claims as granted, and the cause of uncertainty was not the amendment, this issue was not within the scope of the opposition appeal proceedings (see G 3/14).

In T 166/22 independent claims 1 and 6 as granted were directed to the use of a combination of at least four components for maintaining or increasing body weight in an elderly human above 65 years of age. Examples 3, 4, 9 and 10 of the application as filed contained evidence related to the effect. It was common ground that age-related body weight development is parallel in mice and humans. The matter of dispute between the parties arose from the fact that the application as filed provided evidence of a body weight increase in adult mice while the effect required by claims 1 and 6 was to stop or reverse body weight decline in elderly humans. There was no evidence on file that, on the priority date, the mice tested in examples 3, 4, 9 and 10 constituted established or generally recognised models for body weight development in elderly humans. The respondent (patent proprietor) referred to D19, but in the board's view the skilled person would not assume that such an effect was credible from the evidence in the application as filed. The respondent also referred to D18, however D18 did not constitute common general knowledge, nor was it cited in the application as filed. Therefore, the content of D18 would not affect the skilled person's assessment of whether the claimed subject-matter was sufficiently disclosed on the filing date. The board therefore concluded that there existed serious doubts substantiated by verifiable facts. In accordance with the finding of G 2/21 (point 77 of the Reasons), the proof of the effect recited in claims 1 and 6 had to be provided in the application as filed. A deficiency in this respect could not be remedied by post-published evidence. Therefore, the evidence in post-published D24 (clinical study filed in response to the board's preliminary opinion) could not be taken into consideration.