6.1.2 7.1.2 Therapeutic uses pursuant to Art. 54(5)

The treatment of a disease with a substance or composition which is already known to be used for treating said disease, where the only difference from the known treatment is in the dosage regime, is a specific further medical use within the meaning of Art. 54(5) (see G 2/08). Thus, therapeutic uses of a substance/composition may be based not only on the treatment of a different disease but also on the treatment of the same disease by a different therapeutic method differing for example in the dosage, administration regime, group of subjects or route of administration (G 2/08).

A claim directed to the further therapeutic use of a substance/composition must indicate the illness/disease to be treated, the nature of the therapeutic compound used for that purpose and, if relevant for establishing novelty and inventive step, the subject to be treated. If the further therapeutic use relates to a different therapy of the same disease using the same substance/composition, the claim must also define all technical features of the therapy giving rise to the desired technical effect (G 2/08).

An independent claim directed to a further therapeutic use of a substance/composition which is based on the use of said product in the treatment of a different disease must be formulated as follows:

The presence of the term "for use" is mandatory, to closely adhere to the wording of Art. 54(5).

If the independent claim is directed to a composition, the definition of the composition may be inserted before or after the term "for use". For example: "Composition comprising X for use in the therapy of Y" or "Composition for use in the therapy of Y comprising X".

If the further therapeutic use is based on the use of the same product in a different treatment of the same disease, the independent claim must be formulated as follows:

Purpose-related product claims which do not define exclusively (see claim 4 in the table below) a medical use excluded from patentability under Art. 53(c) are construed as claims directed to a product per se which is suitable for the claimed use.

The table below shows some examples of claims which do not define a further medical use within the meaning of Art. 53(c).

If the prior art discloses either the product per se in a form which could be considered suitable for the claimed use, or its first medical application, claims 1 to 4 would lack novelty. The novelty objection could be overcome by reformulating the claim as described above (first table).

These amendments may be proposed by the examining division in the Rule 71(3) communication without the need to consult the applicant beforehand (see C‑V, 1.1, point (f)).

The following are examples of claims which would not be considered novel:

Example 1

Composition comprising X for use by topical treatment/application

It is assumed that a composition comprising X is already known in the prior art.

Reasons for objection: Since the claim fails to identify the specific therapeutic indication for X, the feature "for topical treatment/application" remains de facto purely illustrative and does not limit the scope of the claim to that specific application.

Furthermore, the term "topical treatment/application" does not necessarily relate to use in a method referred to in Art. 53(c) since it could refer to a cosmetic treatment. Consequently, the subject-matter of the claimed composition would be anticipated if said composition comprising X is already known in the prior art.

Example 2

Composition comprising X for use in therapy by topical administration

It is assumed that a composition comprising X is already known in the prior art for a medical use.

Reasons for objection: The mode of administration may be a critical factor in a medical treatment and has been considered as a limiting feature, but only in relation to a further (specific) medical indication (T 51/93). "Topical administration" specifies only the mode of delivery, but does not relate to any therapeutic effect obtained thereby. Consequently, since the claim fails to identify the specific therapeutic indication, the feature "by topical administration" is merely illustrative and not a restrictive technical feature capable of establishing novelty. The subject-matter of the claimed composition would thus be anticipated if said composition comprising X is already known in the prior art for any medical use.

Example 3

Product X for use in a method of contraception

Reasons for objection: Such a claim would not be considered novel over the disclosure of product X per se because pregnancy is not a disease. This claim can usually be reformulated as a method of contraception using product X. Reformulation may not be possible in so far as the contraception method involves the personal and private sphere, i.e. it does not fulfil the requirement of industrial application (T 74/93).