30 May 2018

T 1819/13 - Claim for injecting antibiotic

Key points

  • Claim 1 is in Swiss-type format and includes the feature " for use in treating or preventing a bacterial infection in an animal by injection of the medicament subcutaneously at the junction of a pinna with the cranium of the animal" . The Board decides that this feature of injection at a specific site does not make that the claim violates Article 53(c) EPC. 
  • Furthermore, the feature provides for novelty.
  • As a comment, note that the claim refers to "an antibiotic"  in general. I am not sure if that is a substance or composition in the sense of Article 54(4) EPC.


EPO T 1819/13 - link

X. With letter of 21 December 2017, the respondent filed amended sets of claims: auxiliary requests 1 to 9.
Auxiliary request 1 consists of fourteen claims. Claim 1 reads as follows:
"1. Use of an antibiotic for the manufacture of a medicament for use in treating or preventing a bacterial infection in an animal by injection of the medicament subcutaneously at the junction of a pinna with the cranium of the animal, wherein the animal is selected from cattle, swine, sheep and goats."

2. Exception to patentability (Article 53(c) EPC)
2.1 From 13 December 2007, Article 52(4) EPC 1973 (see point II above) was superseded by Article 53(c) EPC 2000 which also applies to European patent applications pending at the time of its entry into force and to European patents already granted at that time (see Article 1 of the Decision of the Administrative Council of 28 June 2001 on the transitional provisions under Article 7 of the Act revising the EPC of 29 November 2000). Hence, Article 53(c) EPC 2000 (hereinbelow: Article 53(c) EPC) applies to the patent in suit (see point I above).


2.2 Pursuant to Article 53(c) EPC, "European patents shall not be granted in respect of [...] methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods."
2.3 Claim 1 of auxiliary request 1 (see point X above) is however not directed to a method for treatment as defined in Article 53(c) EPC, but to the use of a substance (namely an antibiotic) for the manufacture of a medicament for a therapeutic application (namely treating or preventing a bacterial infection in an animal by subcutaneous injection at a specified injection site).
2.4 Thus the wording of the claim conforms to the so-called "Swiss-type" format as instituted by decision G 5/83 of the Enlarged Board of Appeal, which ruled (see G 5/83, Order: 2) that "a European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application". The appellant did not dispute that this is a valid claim format for the patent in suit (see Enlarged Board of Appeal decision G 2/08, OJ EPO 10/2010, 456, Reasons: 7.1.4).
2.5 The appellant essentially argued that the characterising feature of claim 1 relating to the specific site for subcutaneous injection (namely the junction of a pinna with the cranium) did not represent a true therapeutic feature because it could only give rise to non-therapeutic effects, and therefore it did not result in a new therapeutic application or use of the antibiotic. For that reason, the exception mentioned in Article 53(c) EPC ("this provision shall not apply to products, in particular substances or compositions, for use in any of these methods") did not apply, and consequently the claim was not patentable pursuant to Article 53(c) EPC.
2.6 This argument cannot succeed, for the following reasons:
(a) It is self-contradictory: If it were indeed correct that the claim relates to a non-therapeutic use, then it could not be in violation of Article 53(c) EPC.
(b) Actually, the claim does however relate to a therapeutic use but is correctly drafted in the Swiss-type format which is not prohibited by Article 53(c) EPC. The Swiss-type format is valid for the patent in suit and is established as a patentable claim format for second (or further) medical uses (see point 2.4 above), subject to compliance with the other provisions of the EPC, in particular novelty and inventive step under Articles 54 and 56 EPC (in this context, see also decision T 1554/11 of 23 July 2015, Reasons: 6).
(c) The therapeutic application mentioned in claim 1 is the treatment of an animal by injection of a medicament comprising an antibiotic. The site of injection is an integral technical element of the administration of the medicament and thus of the therapeutic application. Whether this feature might also give rise to non-therapeutic effects has no impact on the established eligibility of the Swiss-type claim format for overcoming the exception to patentability under Article 53(c) EPC.
(d) Points (a) to (c) equally apply to the dependent claims.
2.7 In view of these considerations, the board concludes that the subject-matter of the claims of auxiliary request 1 is not excluded from patentability pursuant to Article 53(c) EPC.
3. Novelty (Articles 52(1) and 54 EPC)
3.1 As established in point 2.6(c) above, the purpose defined in claim 1 of auxiliary request 1 (namely "treating or preventing a bacterial infection in an animal by injection of the medicament subcutaneously at the junction of a pinna with the cranium of the animal, wherein the animal is selected from cattle, swine, sheep and goats") is a therapeutic application within the meaning of Enlarged Board of Appeal decision G 5/83.
3.2 According to that decision and the established case law of the Boards of Appeal of the EPO, the therapeutic indication addressed in a Swiss-type claim relating to a second or further medical use is regarded as a functional technical feature, to be taken into account in the assessment of novelty and inventive step (see G 5/83, Reasons: 20 and 21; Case Law of the Boards of Appeal of the European Patent Office, 8th edition 2016, I.C.7.2.1: "special approach to the derivation of novelty", and I.C.7.2.4). In that context, a different mode of administration can render such a claim novel.
3.3 Hence, contrary to the appellant's view, a disclosure in a prior-art document of a medicament which is merely suitable for subcutaneous injection at the junction of a pinna with the cranium, without a disclosure of that same injection site, does not anticipate the subject-matter of claim 1.
3.4 The appellant did not contest the fact that neither document D2 nor document D11 discloses the junction of a pinna with the cranium as the injection site.
3.5 The appellant's argument that the alleged technical effect concerning a reduction in drug residue levels in the animals after slaughter was not therapeutic (since it did not result in a therapeutic benefit for the treated animal) is not relevant in the context of novelty. The assessment of novelty merely consists in establishing whether the claimed combination of technical features is anticipated in the prior art.
3.6 Thus, the therapeutic indication specifying that the injection takes place at the junction of a pinna with the cranium establishes the novelty of the claims of auxiliary request 1 relative to documents D2 and D11, since the bacterial infection is to be prevented or treated by injection at an injection site which is not anticipated in those documents.

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