T 0714/13 - Second use not medical

EPO T 714/13

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Key points

• The applicant asserts that claim 1 specifies a second medical use. The claim is directed "a composition for use in the induction of selective apoptosis of human tumour cell types comprising ...".
• Board "The wording of claim 1 of the main request does not require that the technical effect is achieved only in and for a medical treatment under Article 53(c) EPC 2000. The purpose stated in feature i) of claim 1 "for use in the induction of selective apoptosis of human tumor cell-types" does not mention any method of treatment as required by Articles 54(5) and 53(c) EPC 2000, but merely relates to a technical effect which may also be attained in vitro.
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Reasons for the Decision
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5. Main request

5.1 Claim construction

5.1.1 The subject-matter of claim 1 of the main request relates to
i) a composition for use in the induction of selective apoptosis of human tumour cell types comprising
ii) a mineral ascorbate; and
iii) a secondary compound selected from the group consisting of 4-hydroxy-5-methyl-3(2H)furanone and 3-hydroxy-kojic acid,
iv) wherein the amount of secondary compound is from 0.01 to 1.0% by weight of the total composition.

5.1.2 EPC 2000 allows purpose-related product claims for any substance or composition comprised in the state of the art for any specific use in a method referred to in Article 53(c) EPC 2000, provided that it is not comprised in the state of the art (Article 54(5) EPC 2000). The methods mentioned in Article 53(c) EPC 2000 are methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (emphasis added).

5.1.3 Hence, what needs to be assessed is whether the purpose-related claim 1 is in fact a claim for a product which is limited by the medical treatment in which it has to be used.

5.1.4 The wording of claim 1 of the main request does not require that the technical effect is achieved only in and for a medical treatment under Article 53(c) EPC 2000. The purpose stated in feature i) of claim 1 "for use in the induction of selective apoptosis of human tumor cell-types" does not mention any method of treatment as required by Articles 54(5) and 53(c) EPC 2000, but merely relates to a technical effect which may also be attained in vitro.

5.1.5 Moreover, according to Article 84 EPC the claims shall define the matter for which protection is sought and they shall be clear, concise and supported by the description.

The only passage in the application as originally filed concerning the technical effect stated in claim 1 appears on page 2, second paragraph:

"In addition to the normal utility of the Vitamin C component, these compositions will induce improved dose-dependent, selective apoptosis of diverse human tumor cell-types, even though the concentration of the secondary component in these compositions is very low, i.e., from about .01 to about 1.0% by weight of the total composition".

There is, however, no mention in the application as filed as to which are the tumour cell-types which undergo apoptosis, nor are any data displayed concerning the tumour cytotoxic activity of the compositions claimed. Moreover, in the whole description there is no single test method or assay mentioned, which could have served as a valid model for supporting a claim directed to a purpose-related product for use in a medical treatment against tumours.

Hence, the application as originally filed does not provide a basis for claiming a composition for use in the treatment of cancer. Furthermore, even taking into account the whole content of the application as filed, there is a lack of support for considering the purpose stated in feature i) of claim 1 "for use in the induction of selective apoptosis of human tumor cell-types" to be equivalent to the treatment of cancer.

5.1.6 Therefore, claim 1 of the main request is a product "per se" claim which is not restricted by the stated use, except as regards the suitability of the composition for the intended technical effect.

5.1.7 As regards the appellant's argument based on technical board of appeal decision T 290/86, it cannot succeed for the following reasons.

Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83), OJ EPO 1985, 60 introduced the "Swiss-type" claim form in consideration of the fact that the provisions of EPC 1973, and in particular of its Article 54(5), allowed purpose-related product claims only for the first (generic) medical use of a known substance or composition. There was, however, an absence of provisions in EPC 1973 allowing purpose-limited product claims for further specific medical indications (see G 5/83, OJ EPO 1985, 64, point 15 of the Reasons and G 2/08, OJ EPO 10/2010, 456, points 5.8 and 5.9 of the Reasons).

By virtue of the legal fiction in accordance with the praetorian rule introduced with Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83), the format of a "Swiss-type" claim, by definition, allowed claims directed to subject-matter referring to particular situations in which the "invention" for which protection was sought relied upon a new use of a substance or composition in a method of treatment referred to in Article 52(4) EPC 1973 (Article 53(c) EPC 2000).

Decision T 290/86 deals with claims in Swiss-type form. Apart from the fact that this claim format belongs to a different category than a purpose-limited product claim, the claim's format requires explicitly the feature "for the manufacture of a medicament" in order that the legal fiction conferring novelty on the subject-matter may be applied.

As the subject-matter of claim 1 of the main request is not in a "Swiss-type" format but in that of a purpose-related product claim, the findings in decision T 290/86 do not directly apply to the present case.

5.2 Novelty, Article 54(2) EPC

Document D2 discloses a liquid vitamin C concentrate composition comprising mineral ascorbate and at least 4-hydroxy-5-methyl-3(2H)-furanone and/or 3-hydroxy-kojic acid, each present in amounts of 0.001 wt.% to upwards of about 0.1 wt.% or more (D2 column 2, lines 41 and 58-60, column 3, lines 8-39, column 4, lines 14-19, column 11 second and third paragraphs). The upper value of 0.1 wt.% described for the secondary compound in the compositions of document D2 thus falls within the range of 0.01 to 1.0% by weight defined in claim 1 of the main request.

Hence, the compositions disclosed in document D2 comply with the definitions given in claim 1 of the main request for the features ii) to iv).

As regards feature i) in claim 1 of the main request, the compositions disclosed in document D2 are suitable for the intended purpose, as acknowledged on page 3 (end of first paragraph) of the present application as filed, where document D2 is referred to as an example for the preparation of stable liquid compositions according to the "invention".

Consequently, the subject-matter of claim 1 of the main request lacks novelty vis-à-vis the disclosure of document D2 (Articles 52(1) and 54(2) EPC).