T 1554/11 - Second medical use of antibiotics

T 1554/11
Link  (online 28.09.2015)

Key points

• The Board allows as second medical use claim:
  Use of an antibiotic for the manufacture of a medicament for the treatment or prevention of a bacterial infection in an animal, wherein the medicament is to be injected subcutaneously in the posterior of the ear of the animal, wherein the medicament is an injectable suspension of a sparingly water-soluble antimicrobial agent in a sterile oil.
• Board: " when a claim is correctly drafted in the format foreseen for second (further) medical use claims, the question of whether a specific feature or technical effect can be recognised as conferring novelty or inventive step are matters to be considered under Articles 54 and 56 EPC. This is also emphasised in section 6.3 of decision G 2/08, in the context of claims characterised by a dosage regime." 

Summary of Facts and Submissions

I. European patent No. 0 969 844, with the application number 98 912 889.7, is based on the international application published as WO 98/41207. It was granted on the basis of one independent and eleven dependent claims; claims 1 and 8 read as follows:

"1. Use of an antibiotic for the manufacture of a medicament for the treatment or prevention of a bacterial infection in an animal, wherein the medicament is to be injected subcutaneously in the posterior of the ear of the animal, wherein the medicament is an injectable suspension of a sparingly water-soluble antimicrobial agent in a sterile oil.

8. The use of any preceding claim, wherein the antibiotic is selected from procaine penicillin, benzathine penicillin, ceftiofur crystalline free acid, ceftiofur hydrochloride, ampicillin trihydrate, amoxicillin trihydrate, oxytetracycline, erythromycin, tylosin, tilmicosin, florfenicol, enrofloxacin, danofloxacin, premafloxacin, ceftiofur sodium and lincomycin hydrochloride."

Reasons for the Decision

6. Article 53(c) EPC

The present claims are second medical use claims in Swiss-type format, as instituted by Enlarged Board of Appeal decision G 5/83 (OJ EPO 1985, 64). It was not disputed by the appellants that this is a valid format for the present patent (cf. Enlarged Board of Appeal decision G 2/08, OJ EPO 2010, 456, paragraph 7.1.4 of the Reasons).

The central argument brought forward by the appellants was that the characterising feature of present claim 1 relating to a specific site for subcutaneous injection, namely, "in the posterior of the ear", did not represent a true therapeutic feature, and therefore fell foul of Article 53(c) EPC.

However, in decision G 2/08 (point 5.10.9 of the Reasons) the following position taken in decision T 1020/03 (OJ EPO 2007, 204, point 36 of the Reasons) was specifically endorsed (emphasis added; note: the applicable law in T 1020/03 was Article 52(4) EPC 1973, rather than corresponding Article 53(c) EPC 2000 applicable to the present case):

"... there is a seamless fit, either a method of using a composition is not a treatment by therapy and therefore falls outside the provision of Article 52(4) EPC [1973] first sentence, and so is patentable subject to compliance with the other provisions of the EPC, or else a method is a treatment by therapy and therefore inside the provision of Article 52(4) EPC [1973] first sentence, and so not itself patentable, but use of a composition for making a medicament for use in such treatment by therapy is patentable for unspecified therapy as a first medical indication or for a specified therapy as a further medical indication, again subject to compliance with the other provisions of the EPC, in particular novelty and inventive step."

In other words, when a claim is correctly drafted in the format foreseen for second (further) medical use claims, the question of whether a specific feature or technical effect can be recognised as conferring novelty or inventive step are matters to be considered under Articles 54 and 56 EPC. This is also emphasised in section 6.3 of decision G 2/08, in the context of claims characterised by a dosage regime.

In view of this clear rationale, the appellants' reading of decision G 2/08 is untenable:

In particular, no basis can be derived therefrom for imposing additional restrictions on the types of features that may be used to characterise a Swiss-type claim. In section 5.10.7, referred to by the appellants, "well-established case law" is reviewed, including cases relating to "a novel group of subjects treated" or "a new route or mode of administration". However, the list provided is not presented as being in any way exhaustive, nor is it implied that a particular type or level of detail with respect to the treatments concerned is required in order to be eligible for protection as a Swiss-type claim.

The appellants further sought to derive support for their position, with reference to section 7.1.2 of decision G 2/08, from the use of the term "specific" in Article 54(5) EPC. However, as analysed in detail in section 5.9.1 of G 2/08, this article "does not define any degree of distinctiveness the new use would be required to have in order to qualify as a specific use". Moreover, the board notes that Article 54(5) EPC refers to "any substance or composition" (emphasis added). There is no basis in the wording of this article to support the contention that the medicament employed must be defined with a particular degree of specificity. Therefore, the significance that was attached by the appellants to the use of the singular in the passage cited in decision G 2/08, point 7.1.2, is not justified (cf. also, e.g., point 5.9, first paragraph, where the plural is used).

Finally, in view of the fact that the site of injection is clearly an integral technical element of the overall administration of the medicament to the animal, the board concurs with the opposition division that the issue of whether this feature produces further effects, which are not therapeutic, has no impact on the question of whether the Swiss-type claim format is suitable to overcome the exclusion from patentability under Article 53(c) EPC.

For the above reasons, the board concludes that the subject-matter of the main request is not excluded from patentability pursuant to Article 53(c) EPC.

7. Novelty (Articles 52(1) and 54 EPC)

As set out above in point 6, the feature "in the posterior of the ear" is to be taken into account when assessing the novelty of the claimed subject-matter. The conclusion in the decision under appeal (point 3.4 of the Reasons), according to which documents (1) and (2) do not disclose this feature, was not challenged by the appellants in the written appeal proceedings.