7.2.1 Introduction

A substance or composition for which a first medical use is already known may nevertheless be patentable under Art. 54(5) EPC for a second or further use in a method under Art. 53(c) EPC if that use is novel and inventive. According to G 5/83 (OJ 1985, 64), a further medical use claim is a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified therapeutic application. Such a claim is novel if the therapeutic application, i.e. the therapeutic effect obtained by the claimed use, is novel. The Enlarged Board explained the legal and historical background to the patentability of further medical uses in G 2/08 date: 2010-02-19 (OJ 2010, 456).

Under the EPC 1973 a patent for a further medical application could, pursuant to a line of case law first set out in decision G 5/83 (OJ 1985, 64), be granted for a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified therapeutic application ("Swiss-type claim"). The novelty of the subject-matter of such a claim could be derived not only from the novelty of the substance or of the method of manufacture, but also from the new therapeutic application (G 5/83). This "special approach to the derivation of novelty" constituted a narrow exception to the general novelty requirement and was not to be applied in other fields of technology.

Under Art. 54(4) EPC (former Art. 54(5) EPC 1973), known substances or compositions are deemed to be new, provided they are used for the first time in such a medical method ("first use in a medical method"). In the early 1980s, the Enlarged Board was asked to decide whether any further medical use could receive patent protection under the EPC in spite of the wording of Art. 54(5) EPC 1973 (now Art. 54(4) EPC) which seemed to limit patentability to the first medical use. The Enlarged Board extended the notional novelty provided for in former Art. 54(5) EPC 1973 to apply to each further medical use in the so-called "Swiss type claim", i.e. to a claim "directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application" (G 5/83, OJ 1985, 64; legal advice from the Swiss Federal Intellectual Property Office, OJ 1984, 581).

During the course of the revision of the EPC 2000, former Art. 54(5) EPC 1973 ("first use in a medical method") was renumbered to become Art. 54(4) EPC and a new Art. 54(5) EPC was introduced to provide protection for second medical uses. The new Art. 54(5) EPC eliminates any legal uncertainty on the patentability of further medical uses. It unambiguously permits purpose-related product protection for each further new medical use of a substance or composition already known as a medicine.

Claims to a second medical use would be drafted as product claims relating to a specific second or further medical use (see T 1599/06).

In T 1758/07 the board stated that G 5/83 only applies to second (and further) medical indications. It followed from this that the legal fiction behind G 5/83, namely that the therapeutic treatment according to Art. 52(4) EPC 1973 was a limiting feature, was applicable only if a therapeutic treatment was indeed a second (or further) medical indication. If, however, the claimed subject-matter related to the first medical indication, G 5/83 provided no legal basis for additionally claiming the same subject-matter as a second medical indication.

In T 558/20 the board had to decide on the proper assessment of novelty under Art. 54(5) EPC, in particular when a claim defines a combined surgical and therapeutic method. The board stated that Art. 54(5) EPC did not, as such, define any criteria to be applied for assessing whether a claim drafted according to the wording of the article was novel or not. It held that novelty of the claim over the prior art must be assessed in the usual way, i.e. by comparing the features of the claim, the nature of the substance or composition as well as the use and method steps, with the disclosure of the prior art. The board held that the claim defined a method for treating a patient suffering from a degenerative bone disease comprising two steps, firstly creating a void in an intact bone, and secondly filling the void with bone regenerative material. This was the "specific use in a method" referred to in Art. 54(5) EPC, and this use needed to be compared with the prior art. The surgical step was clearly a part of the therapeutic method. Without it, the bone grafting material could not deploy its therapeutic activity. The method defined in the present claim had to be assessed as a whole. Thus, the surgical method steps could not be ignored when assessing novelty of the claim. Novelty was established in the case in hand.