7.1
FirstSecond or further medical use of known pharmaceutical products

Where a substance or composition is already known, it may still be patentable under Art. 54(4) if the known substance or composition was not previously disclosed for use in a method referred to in Art. 53(c).

Where a substance or composition is already known to have been used in a "first medical use", it may still be patentable under Art. 54(5) for any second or further use in a method according to Art. 53(c), provided that said use is novel and inventive.

Art. 54(4) and (5) thus provide for an exception from the general principle that product claims can only be obtained for (absolutely) novel products. However, this does not mean that product claims for the first and further medical uses need not fulfil all other requirements of patentability, especially that of inventive step (see T 128/82).

A claim in the form "Use of substance or composition X for the treatment of disease Y..." will be regarded as relating to a method for treatment explicitly excluded from patentability under Art. 53(c) and therefore will not be accepted. A claim in the form "Substance X for use as a medicament" is acceptable, even if X is a known substance, but its use in medicine is not known. Likewise, it is acceptable to have a claim in the form "Substance X for use in the treatment of disease Y", provided that such a claim involves an inventive step over any prior art disclosing the use of X as a medicament.

If an application discloses for the first time a number of distinct surgical, therapeutic or diagnostic uses for a known substance or composition, normally in the one application independent claims each directed to the substance or composition for one of the various uses are may be allowed; i.e. an a priori objection of lack of unity of invention should is not, as a general rule, be raised (see F‑V, 7).

Where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, the claim may no longer have the format of a so-called "Swiss-type" claim as instituted by decision G 5/83 ("Use of a substance or composition X for the manufacture of a medicament for therapeutic application Z") if the application has a filing or earliest priority date of 29 January 2011 or later (see the Notice from the EPO dated 20 September 2010, OJ EPO 2010, 514).

The effect of the different claim formulations on patentability is summarised in the table below:

Examples

#

Claim

Patentable?

Article

A

Use of product X for the treatment of asthma

No

53(c)

B

1. Product X for use as a medicament

[X known as e.g. herbicide]

2. Product according to claim 1 for use in the treatment of asthma

Yes

(even if X is a known product, but its use in medicine is not known)

Yes

54(4)

C

Product X for use in the treatment of cancer*

Yes

(even if case B is prior art, provided that such a claim is inventive over B and any other prior art)

54(5)

D

Product X for use in the treatment of leukaemia*

Yes

(even if cases B and C are prior art, provided that D is inventive over B and C and any other prior art because leukaemia is a specific type of cancer)

54(5)

* Note: The corresponding Swiss-type claims for cases C and D (required under EPC 1973) would be "The use of Product X for the manufacture of a medicament for the treatment of cancer/leukaemia".

In cases where an applicant simultaneously discloses more than one "subsequent" therapeutic use, claims of the above type directed to these different uses are allowable in the one application, but only if they form a single general inventive concept (Art. 82). Regarding use claims of the above type, it should is also to be noted that a mere pharmaceutical effect does not necessarily imply a therapeutical application. For instance, the selective occupation of a specific receptor by a given substance cannot be considered in itself as a therapeutic application; indeed, the discovery that a substance selectively binds a receptor, even if representing an important piece of scientific knowledge, still needs to find an application in the form of a defined, real treatment of a pathological condition in order to make a technical contribution to the art and to be considered as an invention eligible for patent protection (see T 241/95). See also F‑IV, 4.22, for the functional definition of a pathological condition.

A claim in the format of a Swiss-type claim is a purpose-related process claim, whereas a claim drafted in accordance with Art. 54(5) is a purpose-related product claim. Therefore, such claims have different categories. This has the following consequences:

(i)
If a parent application has been granted with a Swiss-type claim, granting a patent on the basis of the purpose-related product claim in its divisional application would not lead to double patenting (T 13/14, see also G‑IV, 5.4).
(ii)
Since a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se (G 2/88, reasons 5.1), a Swiss-type claim confers less protection than a claim formulated according to Art. 54(5). Therefore a change from a Swiss-type claim to a claim drafted in accordance with Art. 54(5) contravenes Art. 123(3) (T 1673/11, see also H‑IV, 3.5).

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