T 1819/13 21-02-2018

1. Amendments (Article 123(2) and (3) EPC)

1.1 Claim 1 of auxiliary request 1 is identical to claim 1 of the patent as granted, except that it additionally specifies that the animal is selected from cattle, swine, sheep and goats. Dependent claims 2 to 14 of auxiliary request 1 correspond to claims 3 to 15 of the patent as granted. Thus the amended set of claims has a more restricted scope than the granted version.

1.2 The basis in the application as filed for the amendment of claim 1 is found in the general disclosure of cattle, swine, sheep and goats on page 1, line 6, and page 4, lines 20 to 21, of the description.

1.3 Hence the board sees no reason for objection under Article 123(2) or (3) EPC.

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2.1 From 13 December 2007, Article 52(4) EPC 1973 (see point II above) was superseded by Article 53(c) EPC 2000 which also applies to European patent applications pending at the time of its entry into force and to European patents already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.

4. Inventive step (Articles 52(1) and 56 EPC)

Starting point for the assessment of inventive step

4.1 The board agrees with both parties that document D2 represents the closest prior art. According to document D2, an antibiotic is injected subcutaneously in the posterior of the ear of an animal, e.g. the middle third of the posterior of the ear (D2: see claims 1, 7; page 11). The animals targeted by D2 are, in particular, cattle, swine, sheep and goats (see D2: page 1, lines 4 to 5).

Technical problem and solution

4.2 As established above, the subject-matter of claim 1 of auxiliary request 1 differs from the disclosure of document D2 in the feature specifying that the site of subcutaneous injection is the junction of a pinna with the cranium of the animal.

4.3 While experimental data is provided in the patent in suit only with regard to one drug used on cattle (ceftiofur free acid in example 1, paragraph [0028]), the appellant did not contest that the antibiotic treatment is effective when the medicament is injected at the junction of a pinna with the cranium.

4.4 The respondent contended that the choice of the injection site according to the patent in suit, unlike that of D2, allowed the handler to grip the entire ear with one hand to stabilise the head of the animal, and to insert the needle with the other hand; furthermore, since the injection accessed a cavity which could accommodate the injection volume, no massaging of the bleb was required (unlike in D2: see page 12, lines 7 to 16), and the risk of self-injection was avoided. Finally, the risk of hitting blood vessels (which occupied a rather large proportion of the pinna), ear tags or implants was avoided. The board considers that these advantages relative to the injection method of document D2 are sufficiently plausible for the group of anatomically similar animals which consists of cattle, swine, sheep and goats. The appellant did not contest that the injection site at the junction of a pinna with the cranium provided improved ease of administration.

4.5 Hence, a technical problem to be solved when starting from the teaching of document D2 is the use of an antibiotic for the manufacture of a medicament for use in treating or preventing a bacterial infection in an animal by a method of administration which provides improved ease of administration.

4.6 The board is satisfied (see point 4.4 above) that the problem is solved by the choice of the junction of a pinna with the cranium as the site for subcutaneous injection of the antibiotic.

Obviousness of the solution

4.7 While document D2 focuses on the administration of antibiotics by injection into the posterior of the ear, document D11, which relates to the use of ceftiofur free acid - an antibiotic listed in the patent in suit - as a veterinary antibiotic, mentions subcutaneous injection without specifying an injection site (see D11: claim 11). Thus there is no incentive to be found in documents D2 or D11 to consider the junction of a pinna with the cranium as an injection site providing improved ease of administration.

4.8 Documents D6, D7, D8 and D10 are concerned with the administration of vaccines or antiparasitic drugs to cattle or swine and thus do not relate to the administration of antibiotics. While it is mentioned in those documents that the drugs in question are administered at the base of the ear, in the ear or behind the ear, these terms are, as conceded by the appellant, less specific than the definition "junction of a pinna with the cranium" employed in claim 1 of auxiliary request 1. Nor do documents D6, D7, D8 or D10 mention the issue of ease of administration. Hence the board considers that the person skilled in the art seeking to solve the above-mentioned technical problem would not necessarily have been guided to consult any of documents D6, D7, D8 or D10, and in any case would not have been able to derive from those documents the specific suggestion to consider the junction of the pinna with the cranium as an injection site which might be preferable for increased ease of administration.

4.9 Document D1 is an extract from a textbook on the diseases of swine. It teaches (see pages 694 to 695) that different methods for administering injections may be used for treating swine, including subcutaneous injection. The most common and practical sites of administration for subcutaneous injection are at the ear base, at the elbow and at the knee of the animal. The description of the injection site at the ear base, said to be the site most commonly used for treating larger animals, corresponds in the board's opinion to a location at the junction of the pinna with the cranium, since it is mentioned that the site is caudal to the ear base but very close to the pinna (see D1: page 694, column 2, paragraphs 1 to 3). On page 338 of D1 it is mentioned, in the context of infectious diseases and antibiotic treatment, that subcutaneous injection at the base of the ear has certain advantages in comparison with intramuscular injection in animals destined for slaughter.

Document D1 does not however discuss the issue of comparative ease of administration of different injection sites in and around the ear, and, as mentioned above, it discloses various routes for administering injections to swine, and several different locations deemed to be suitable for subcutaneous injection.

In view of this, the board comes to the conclusion that the information presented in document D1 does not contain a straightforward pointer and could thus not have suggested to the person skilled in the art seeking to solve the above-mentioned technical problem (see point 4.5) that subcutaneous injection at the junction of a pinna with the cranium would improve ease of administration in comparison with the injection site favoured in document D2.

4.10 As a consequence, the subject-matter of claim 1 of auxiliary request 1 and of the dependent claims involves an inventive step within the meaning of Article 56 EPC.

4.11 In view of this outcome, it is not necessary to examine whether the alleged advantages of short withdrawal times and low drug residue levels in the edible carcass are obtained over the entire scope of the claims.

5. Admission of document D15 into the appeal proceedings (Article 114(2) EPC, Article 12(4) RPBA)

5.1 Like document D7, document D15 relates to clostridial vaccinations. The opposition division did not admit document D15 into the proceedings, because the information it provided was not more relevant than the content of document D7 already on file, and its submission at a very late stage of the proceedings had not been occasioned by any new development in the case (see point VI above and point 2 in the decision under appeal).

5.2 Late submission and prima facie relevance are appropriate criteria for deciding whether new evidence should be admitted; thus the board concludes that the opposition division exercised its discretion correctly in not admitting document D15.

5.3 Moreover, in respect of prima facie relevance, the board takes the view that D15, if admitted into the appeal proceedings, would not make a difference in the assessment of inventive step: while using the term "base of the ear", D15 also states that "the injection is placed on the back of the ear in the bottom one-third". Thus D15 could at most corroborate the finding (see point 4.8 above) that the expression "base of the ear" as used in the prior art does not necessarily designate the junction of a pinna with the cranium.

5.4 In view of these considerations, document D15 is not admitted into the appeal proceedings.