T 0036/83 (Thenoyl peroxide) of 14.5.1985

Summary of Facts and Submissions

I. European patent application No. 79 400 198.2, filed on 28 March 1979 and published on 17 October 1979 (No. 0 004 810) claiming the priority of an earlier filing in France dated 31 March 1978, was refused by a decision of the Examining Division of the European Patent Office dated 15 October 1982. The decision was based on the claims received on 6 May 1981. Claims 1, 7, 9 and 10 read as follows:

"1. Medication characterised in that it is composed of thenoyl peroxide with the formula

SCO-O-O-CO S

7. Pharmaceutical compositions characterised in that they contain thenoyl peroxide as active principle.

9. Use of thenoyl peroxide as a cosmetic product.

10. Cosmetic compositions, characterised in that they contain thenoyl peroxide.

II. The application was refused on the grounds that Claims 1 and 7 contravened Article 54(5) EPC. The Examining Division considered that to meet that Article's requirements the claims would have had to be limited to the therapeutic indications described. III. The applicants filed an appeal against this decision on 6 December 1982 and paid the fee in due time. The Statement of Grounds was filed on 3 February 1983. The appellants contended that the EPC provisions cited, in particular Article 54(5) EPC, did not specify any limitation to a medication's scope.

IV. In its interlocutory communications the Board of Appeal proposed certain changes in the wording of the medical claims, principally to bring them into line with Article 54(5). The new wording was accepted by the appellants. The Board also raised the question of Claim 8's admissibility as it was finally worded, it being identical to Claim 9 of the set of claims refused. Claim 9 had not been contested by the first instance, but appeared to the Board to relate to a method of treatment by therapy (Article 52(4) EPC) since it was intended to treat acne, which is a disease.

V. In their reply received on 4 May 1984 the appellants rejected the idea that as finally worded Claim 8 constituted a method of treatment by therapy, and they cited French law as set out in "Droit pharmaceutique", Volume 5 (1978), page 7. They requested that the decision appealed from be set aside and a patent be granted with the following claims:

1. Chemical compound composed of thenoyl peroxide with the formula SCO-O-O-CO S for its use in a method of therapeutic treatment for the human or animal body.

2. Chemical compound according to Claim 1 for its antibacterial use.

3. Chemical compound according to Claim 1 for its antifungal use.

4. Chemical compound according to Claim 1 for its comedolytic use.

5. Chemical compound according to Claim 1 for its use in the treatment of acne.

6. Pharmaceutical compositions characterised in that they contain, as active principle, thenoyl peroxide, as well as an inert pharmaceutical excipient.

7. Compositions according to Claim 6, characterised in that they contain from 2 to 20% of active principle.

8. Use as a cosmetic product of thenoyl peroxide.

9. Cosmetic compositions, characterised in that they contain thenoyl peroxide.

10. Compositions according to Claim 9, characterised in that they contain from 0.2 to 20% of thenoyl peroxide.

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 64 EPC and is therefore admissible.

2. The claims' subject-matter does not extend beyond the content of the application as filed. The use of thenoyl peroxide as an active pharmacological substance and as a medication according to Claims 1 to 5 was disclosed in the application as filed (see page 1, lines 15 to 20; page 3, line 34; page 4, line 2 and Claim 1). Claims 6 and 7 are based on the original Claims 2 and 3 and on page 2, lines 11 to 22, of the description. Claims 8 to 10 are the original Claims 4 to 6.

3. The applicants have submitted to the specialist world the new teaching that thenoyl peroxide can be used as a therapeutic agent, particularly as a medication for treating acne. Thenoyl peroxide, the active principle claimed, has already been described in the prior art (see Monatshefte, Volume 80 (1949), page 739). However, its use in any method according to Article 52(4) EPC is not part of the state of the art and is considered new under Article 54(5) EPC.

4. Benzoyl peroxide, a product similar in structure to thenoyl peroxide, is already used for the treatment of acne in human beings, as has been acknowledged by the applicants (see original description, page 3, lines 1 to 13), citing J. Pharm. Sci,. Volume 66 (1977), page 718. Taking account of the closest prior art, the applicants set themselves the problem of finding not only a better medication than benzoyl peroxide for the treatment of acne, but also a product whose antibacterial, antifungal and comedolytic action permitted therapeutic and cosmetic uses. The applicants found in thenoyl peroxide a solution to this problem as set out in Claims 1 to 10. Having taken into consideration the article in Monatshefte, Volume 80 (1949), page 739, the Board sees no reason to question the novelty of the compositions nor of Claims 1 to 10. As regards inventive step, the Board accepts that the two closest prior art documents do not suggest the therapeutic and cosmetic properties shown by the applicants. The document relating to the treatment of acne in no way prompts the idea of looking for such properties in structurally similar products, not even a product like thenoyl peroxide, which has long been known. Moreover, comparative studies presented in the description are conclusive in showing that the solution proposed matches the problem posed. Consequently, in the absence of any other document pointing in this direction, the Board accepts, as did the Examining Division, that the subject-matter of Claims 1 to 10 involves an inventive step.

5. The reasons given by the Examining Division for refusing the application relate to Claims 1 and 6 only (corresponding to the refused Claims 1 and 7). It remains to be established for the purposes of the appeal whether the wording of Claims 1 and 6 indicating an extended use is admissible under Article 54(5) EPC.

5.1 In the decision T 128/82 Pyrrolidine derivatives/HOFFMANN- LA ROCHE (OJ 4/1984, page 164), the Board has already considered the question of a first medical indication. It concluded that where a known compound is for the first time proposed and claimed for use in therapy, the fact that a specific use is disclosed in the specification does not in itself call for a restriction of the purpose-limited product claim to that use.

5.2 The same conclusion applies to the case in suit. As in the other case, the use as a medication of the product claimed has been disclosed to a large extent from the outset in the description (see page 1, line 15 to page 2, line 26, of the description as filed). Claims 1 to 6 are therefore admissible.

6. Since the Board itself questioned the admissibility of Claim 8, it remains to be examined whether that claim may be accepted. In this context it also has to be established whether a cosmetic indication is distinct from a medical indication. Such a distinction is clearly set out in the description as filed (see page 2, lines 27 to 30).

6.1 It is clear from reading the description that the anti- bacterial and comedolytic activities that thenoyl peroxide has been shown to have are essential for the treatment of acne and are used in the application only in relation to a local remedy (description, page 6). However, the application shows that pharmaceutical and cosmetic preparations can have very similar, if not identical, forms (see description as filed, page 2, line 1 to page 3, line 6). Consequently, the cosmetic treatment according to the application may also incidentally involve a medical treatment.

6.2 However, the pharmacological study of thenoyl peroxide presented in the description includes a study of the comedolytic activity. This comedolytic study concentrates on the ratio between the orifice of comedones and their large diameter before and after applying thenoyl peroxide. It shows their transformation into open comedones, allowing the horny comedo matter to extrude (description as filed, page 5, lines 10 to 13). This operation assists in skin cleansing. The Board regards this activity of thenoyl peroxide as one clearly belonging to the field of non- medical body hygiene rather than that of therapy. The benefits gained by this activity in a cosmetic indication should not therefore be considered as being excluded from patentability under Article 52(4) EPC.

6.3 When considering the exclusions from patentability under Article 52(4) EPC the wording of Claim 8 is important. Having discovered for the first time the surprising properties of a chemical product already known in the state of the art and having shown those properties in various uses, the applicant has the right to have those uses protected. In the present case the uses are presented in the description as two methods: a method of medical treatment and a method of non-medical treatment. Under Article 52(4) a method of medical treatment is not patentable but a product for use in that method certainly is. Claims 1 to 7 have been worded accordingly. The method of non-medical treatment is one falling within the general field of patentable inventions. There can be no objection to the patentability of either use or method claims in general. The Enlarged Board of Appeal has held that it is a matter of preference whether any activity is claimed as a method of carrying out the activity or as the use of a thing for a stated purpose. There is no difference of substance (Gr 05/83, Second medical indication/EISAI, OJ 3/1985, page 64 et seq., points 11 and 12 of the Reasons for the Decision). The applicants have chosen the phrase "use as a cosmetic product of thenoyl peroxide". The Board considers that this form of claim is acceptable in the case in suit. In the Board's opinion the question of industrial application does not arise, since professional use of the invention in a beauty parlour is an industrial application within the meaning of Article 57 EPC.

6.4 The Board considers it useful to add the following remark concerning the wording of Claim 8: To avoid any possible conflict with the provisions of Article 52(4) EPC in a use or indication claim, it would have been possible to envisage the exclusion of the non-patentable invention within the meaning of that article by means of a disclaimer. In the present case the Board considers use of the term "cosmetic" to be sufficiently precise. Without the necessity of going into the provisions of national law in the various countries, which in any case largely point in the same direction (see point V), the term "cosmetic" is used adjectivally for a non-medical substance intended for use on the skin etc. (cf. Grand dictionnaire encyclopédique Larousse). The standard English- and German-language reference works support that definition.

7. In the circumstances there is no need to examine the alternative request maintained by the appellant.

ORDER

For these reasons, it is decided that

1. The decision of the Examining Division of the European Patent Office dated 15 October 1982 is set aside.

2. The case is referred back to the first instance with the order that a European patent be granted on the basis of the following documents: Description, pages 3 to 6 as filed, page 1 received on 3 October 1983 page 2 received on 4 May 1984 Claims1 to 10 received on 20 April 1985.