10. Further medical use claims

In a further medical use claim, the claimed therapeutic effect is a functional technical feature of the claim, i.e. the claims are commonly limited to a known substance or composition for use in a new therapeutic application (G‑VI, 6.1).

In order to meet the requirements of Art. 83, the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. An insufficiency in this respect cannot be remedied by post-published evidence (G 2/21).

It is therefore necessary that, at the date of filing, the application render it credible that the known substance or composition is suitable for the claimed therapeutic application and that the therapeutic effect arises as a result of the therapeutic measures defined in the claims. Mere verbal statements are not sufficient to render the therapeutic effect credible. The application as filed must provide either suitable evidence in which the therapeutic effect is demonstrated or scientific reasoning based on known effects for the claimed substance or composition. While it is not necessary for every conceivable treatment falling within the scope of the claims to be therapeutically effective, an undue amount of research should not be needed for the skilled person to arrive at therapeutically effective treatments.

A claim directed to a further medical use wherein the active pharmaceutical agent is defined only in terms of functional features meets the requirements of Art. 83 if all of the following conditions are met:

(a)specific compounds achieving the claimed function are part of common general knowledge or are known from the prior art or are disclosed in the application as filed in such a way that it is credible that the compounds achieve the claimed function;

(b)the claimed function can be verified by tests or procedures which are adequately specified in the description or known to the skilled person and which do not require undue experimentation; and

(c)the application as filed shows that the claimed function is causal for the solution of the problem underlying the invention, such that it is credible that any compound achieving the claimed function is suitable for the claimed therapeutic application.