T 1278/12 - Second use not medical

EPO T 1278/12

For the decision, click here

Key point

• Claim 1 is not a medical use claim :" Use of [a composition] for the manufacture of a composition for enteral administration to an infant delivered via caesarean section". Board: "An enteral administration to an infant delivered via caesarean section only specifies the mode of delivery to the patient, but does not relate to any therapeutic effect obtained thereby. Therefore, the format of claim 1 is not the one prescribed by G 5/83 for further medical use claims."
• Adding as feature " to the increase of the biodiversity of microorganisms in the intestinal flora of infants born via caesarean section" renders the claim a valid second medical use claim.

Reasons for the Decision

3. Novelty

3.1 Claim 1 refers to the use of at least one microorganism and at least one indigestible oligosaccharide for the manufacture of a composition for enteral administration to an infant delivered via caesarean section, wherein the composition contains at least one species of Bifidobacteria selected from the group consisting of B. breve, B. infantis, B. bifidum, B. catenulatum, B. adolescentis and B. longum, and wherein the composition comprises an indigestible oligosaccharide selected from the group consisting of transgalactooligosaccharides, indigestible dextrins, xylooligosaccharides, arabinooligosaccharides, glucooligosaccharides, mannooligo-saccharides, isomalto-oligosaccharide and fructopolysaccharides.

3.2 As not disputed by the appellant, a composition containing the components required by claim 1 is disclosed in each of D6, D26 and D36. More specifically,

- example 3 of D6 discloses the use of B. longum (corresponding to the Bifidobacteria of claim 1) and fructooligosaccharides ("FOS") (corresponding to the indigestible oligosaccharide of claim 1) for the manufacture of a starter formula for infants;

- example 4 of D26 discloses the use of B. breve (corresponding to the Bifidobacteria of claim 1) and galactooligosaccharides and polyfructose (corresponding to the indigestible oligosaccharide of claim 1) to prepare an infant formula; and

- example 1 (the only example) of D36 discloses the use of B. breve (corresponding to the Bifidobacteria of claim 1) and transgalactooligosaccharide (corresponding to the indigestible oligosaccharide of claim 1) to prepare an infant nutrition.

Since the compositions disclosed in the above examples of D6, D26 and D36 are infant formulae, they must be suitable for enteral administration to infants delivered via caesarean section.

3.3 However, the appellant argued that claim 1 constituted a further medical use claim (also denoted as "Swiss type claim"), where the reference to the patient group of caesarean section infants implicitly indicated a therapeutic effect. Since the use of the claimed composition for this patient group was not disclosed in any of D6, D26 or D36, the implicit therapeutic effect rendered the subject-matter of claim 1 novel over these documents.

It has thus to be decided whether the reference to "an infant delivered via caesarean section" qualifies claim 1 as a further medical use claim.

3.3.1 According to G 5/83, 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 (headnote II and points 19 to 21). Such a claim is novel according to G 5/83 if the therapeutic application, i.e. the therapeutic effect obtained by the claimed use, is novel.

3.3.2 In the present case, claim 1 relates to the use of a composition for enteral administration to an infant delivered via caesarean section. An enteral administration to an infant delivered via caesarean section only specifies the mode of delivery to the patient, but does not relate to any therapeutic effect obtained thereby. Therefore, the format of claim 1 is not the one prescribed by G 5/83 for further medical use claims.

3.3.3 While this was not disputed by the appellant, it argued that according to T 1020/03, the therapeutic effect did not need to be specified in a claim to qualify it as a further medical use claim.

3.3.4 The Board does not share the appellant's view.

Firstly, T 1020/03 refers to a case where the relevant claims (claim 1 and 13) read as follows:

"1. Use of insulin-like growth factor-I (IGF-I) in the preparation of a medicament for administering to a mammal so as to sustain its biological response in the treatment of a chronic disorder in the mammal wherein ..." (emphasis added by the board);

"13. Use of insulin-like growth factor-I (IGF-I) in the preparation of a medicament for treating chronic renal failure in a mammal wherein ..." (emphasis added by the board).

Consequently, the claims underlying the case in T 1020/03 specify therapeutic effects, namely the sustainment of a biological response in the treatment of a chronic disorder in a mammal (claim 1) and the treatment of chronic renal failure in a mammal (claim 13). The case underlying T 1020/03 thus is not comparable to the present one where no therapeutic effect at all is specified in claim 1.

Secondly, contrary to the appellant's assertion, the board in T 1020/03 did not hold that no therapeutic effect is needed in a claim to qualify it as a second medical use claim. More specifically:

- In point 7 of that decision, the board held that a claim to the preparation of a composition for a further medical use was allowable, irrespective of the detail in which that use was specified, subject to the use being novel and inventive.

The Board then went on to discuss three specific cases, in all of which the claims specified a therapeutic effect.

- In subsequent passages of T 1020/03, the Board referred numerous times to the claim format approved by G 5/83. For instance, in point 12, the board stated that "it considers that a claim formulated in the way approved by the Enlarged Board of Appeal in decision G 0005/83 prima facie cannot be considered as producing any results contravening Article 52(4) EPC [1973], ...". The way approved by the Enlarged Board of Appeal in G 5/83 can only be the one defined in headnote II of this decision, namely of the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.

- In point 18, the board held that claims "which take the form of the use of a composition for the preparation of a medicament for a specified therapeutic use, will thereby avoid being in conflict with Article 52(4) EPC [1973], irrespective of the degree of detail with which the therapeutic use is stated" (emphasis and insertion in square brackets added by the present board).

Consequently, there can be no doubt that the claims which the board in T 1020/03 had in mind and on which its decision was based were claims in which the therapeutic use was specified to some extent. In fact, the board even explicitly stated in point 34 of its decision that in a further use claim "... the further medical indication must be specified in the claim with some degree of specificity" (emphasis added by the board).

3.3.5 Since claim 1 of the main request does not specify any therapeutic effect at all, it represents a non-medical use claim. Therefore the wording "for enteral administration to an infant delivered via caesarean section" limits claim 1 only in so far as the composition has to be suitable for the enteral administration to caesarean section infants. Since this suitability is given in the above examples of D6, D26 and D36 (see point 3.2 above), these are novelty-destroying for the subject-matter of claim 1.

[...]

Auxiliary request 1

8. Novelty

Unlike the claims of the main request, all independent claims of auxiliary request 1 refer with some degree of specificity to a therapeutic effect, namely to the increase of the biodiversity of microorganisms in the intestinal flora of infants born via caesarean section. Hence these claims constitute second medical use claims, so that the novelty objection made with regard to the main request no longer applies, and novelty over the cited prior art is to be acknowledged. Indeed, the respondents did not raise any novelty objection.