New dosage regimen 

Some boards of appeal have considered recognising specific therapeutic uses as patentable in principle to be problematic where they differ from the prior art merely in terms of the dosage regimen. In G 2/08 (OJ 2010, 456), the Enlarged Board addressed this issue in detail.

With reference to the case law and the danger of a collision with Art. 52(4) EPC 1973, decision T 584/97 denied patentability for a claim directed essentially to the administration of nicotine in increasing doses. In T 317/95, T 56/97 and T 4/98 (OJ 2002, 139) the issue was discussed, with answers tending towards the negative, but ultimately left undecided. In all of these cases, the grant of a patent would anyway have been refused on other grounds – i.e. lack of novelty or inventive step – so that the outcome of a decision on this issue was immaterial (see also T 1319/04, OJ 2009, 36)

In T 1319/04 (OJ 2009, 36), the board referred to the Enlarged Board of Appeal the question whether medicaments for use in methods of treatment by therapy, where the only novel feature was a dosage regime, are patentable under Art. 53(c) and 54(5) EPC. The Enlarged Board answered in G 2/08 (OJ 2010, 456) as follows:

1. Art. 54(5) EPC does not exclude a medicament which is already used in the treatment of an illness being patented for use in a different treatment by therapy of the same illness. Art. 53(c) EPC, which lists as an exception to patentability 'methods for treatment of the human body ... by therapy' is clear and unambiguous, and draws a borderline between unallowable method claims directed to a therapeutic treatment on the one hand and allowable claims to products for use in such methods on the other. The two concepts of a method of treatment by therapy and of a product to be used in such a method are so close to each other, that there is a considerable risk of confusion between them unless each is confined to its own domain as allocated to it by the law. Art. 53(c), second sentence, EPC, is not therefore to be interpreted narrowly; on the contrary, it is appropriate to give both provisions (Art. 54(5) and Art. 53(c) EPC) the same weight and conclude that, in respect of claims directed to therapy, method claims are absolutely forbidden in order to leave the physician free to act unfettered, whereas product claims are allowable, provided their subject-matter is new and inventive. By virtue of a legal fiction, Art. 54(4) and (5) EPC acknowledge the notional novelty of substances or compositions even when they are already comprised in the state of the art, provided they are claimed for a new use in a method which Art. 53(c) EPC excludes from patent protection. The notional novelty, and thus, non-obviousness, if any, is not derived from the substance or composition as such, but from its intended therapeutic use. Art. 54(5) EPC refers to "any specific use" [emphasis added] and thus, in conjunction with the stated intention of the legislator to maintain the status quo of the protection evolved in the case law of the boards of appeal under G 5/83 (OJ 1985, 64) in this respect, this use cannot be ex officio limited to a new indication stricto sensu (approving T 1020/03, OJ 2007, 204).

2. The Enlarged Board went on to hold that such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art. Given the answer to the first question, and, since Art. 54(5) EPC may be used in cases of the treatment of the same illness, the "specific use" in the sense of that provision may reside in something other than the treatment of a different illness, the Enlarged Board held that there is no reason to treat a feature consisting in a new dosage regime of a known medicament differently from the one given to any other specific use acknowledged in the case law. However, it stressed that the whole body of jurisprudence relating to the assessment of novelty and inventive step also applies. The jurisprudence on this continues to apply (see T 290/86; OJ 1992, 414; T 1020/03, OJ 2007, 204; T 836/01; T 1074/06).

In T 1020/03 (OJ 2007, 204) a pure dosage regimen was for the first time recognised as not excluded from patentability. The claims were directed to the use of insulin-like growth factor-I in the preparation of a medicament for administering to a mammal in a specific discontinuous administration pattern. In the headnote, the board stated that any use to which Art. 52(4) EPC 1973, first sentence, applies in circumstances where the composition has already been suggested for some therapeutic use, allows a second medical use claim to the preparation of the composition for that second medical use, irrespective of in what detail that use was specified, subject to the use being novel and inventive. For the purposes of novelty also under Art. 54(5) EPC this depends on whether use for therapy is novel, irrespective of the detail with which the therapy is stated in the claim.

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