T 0017/81 (Nimodipin) of 30.5.1983

Summary of Facts and Submissions

I. The European patent application No. 79 100 968.1 filed on 30 March 1979 under publication number 0 004 650, claiming priority from the prior application (DE 2 815 578) of 11 April 1978, was refused by decision of the Examining Division of the European Patent Office dated 20 March 1981.

II. That decision was based on four claims, which are still being maintained, of which the first (at present also the first, but referred to as Claim 7) is for the use of 1,4 - dihydro - 2,6 - dimethyl - 4 - (3' - nitrophenyl) - pyridine - 3 - ß - methoxyethylester - 5 - isopropyl ester as a cerebral agent.

III. The subsequent claims (currently Claims 8 to 10) are claims of the same kind defining the cerebral indication more closely. The introductory part of the patent application states inter alia that the above-mentioned compound is already described as a coronary agent in a United Kingdom patent specification (GB-A-1 358 951).

IV. In this decision the compound described in the claim above according to the chemical nomenclature will be referred to by the short title "Nimodipin", which is the international generic name for this compound in pharmacological writings.

V. The principal reason given in the decision of 20 March 1981 for refusing the patent application with those claims is that the claims as currently worded are directed to a treatment of the human body by therapy. Such treatment is not susceptible of industrial application and, pursuant to Article 52(4) and Article 54(5) EPC, is not patentable.

VI. By letter dated 13 May 1981, received on 20 May 1981, the applicant filed an appeal against that decision, at the same time paying the appeal fee and filing the Statement of Grounds.

VII. In the course of the appeal proceedings, the Board of Appeal indicated in interlocutory communications that it doubted whether use claims of the kind in question could be granted. The appellant, on the other hand, expressed the opposite view in a number of written submissions. In a letter dated 29 November 1982 (p. 171 of the file), the appellant requested that, pursuant to Article 112(1) EPC, the question whether inventions relating to the "second medical indication" are patentable be referred to the Enlarged Board of Appeal. This was an important point of law to which an unambiguous answer is not given in the Convention. Viewpoints were to be found in national case law and in the learned writings that might cast doubt on the views previously expressed by the Board of Appeal.

VIII. The claims submitted by the appellant have been amended in the course of the appeal proceedings and are currently not numbered consecutively. The current version is as follows: Use claims (four claims, currently Claims 7 to 10, cf. pp. 21 and 317 of the file): Use of "Nimodipin" - (7) as a cerebral agent; - (8) in the treatment of pathologically reduced cerebral functions and vitality deficiency; - (9) in the treatment of cerebral insufficiency; - (10) in the treatment of cerebral circulatory and metabolic disturbances. There are also currently two product claims for pharmaceutical formulations (currently Claims14 and 15, cf. p. 317 and pp. 435 and 436 of the file). The original Claims 1 to 6 and 11 to 13 are no longer maintained.

Reasons for the Decision

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

2. With the above-mentioned Claims 7 to 10 the appellant is seeking the grant of a patent with claims for the use of a chemical substance for a therapeutic purpose. From the form of those claims the invention appears to be a method for treatment by therapy within the meaning of Article 52(4), first sentence, EPC. As such it would not be susceptible of industrial application and thus, pursuant to Article 52(1) EPC, not patentable.

3. The question as to claims for the use of a substance or mixture of substances for one of the purposes mentioned in Article 52(4), first sentence, EPC being admissible is an important point of law within the meaning of Article 112(1) EPC. That is already clear for the following reason alone: Use claims represent a category of claim in principle allowed by the Convention (cf. Rule 30(a) EPC). In the field of biochemistry it is often the category particularly suited to that type of invention, since in that field inventions are frequently centred on the teaching that a certain effect is achieved with a certain substance. But in view of Article 52(4), first sentence, EPC, use claims in the field of therapy appear not to be allowable, particularly because, under Article 52(4), second sentence, EPC, products but not uses are patentable and because Article 54(5) EPC provides for product claims for substances or compositions known per se - on condition that the use of the substances or compositions for any method referred to in Article 52(4) is not comprised in the state of the art.

4. The question of the admissibility of use claims in the field in question is of major significance, particularly for the patenting of pharmaceutical inventions. The answer to that question has become the subject of public controversy. Since it is, furthermore, purely a point of law, the Board considers that a decision of the Enlarged Board of Appeal is required on this question under the terms of Article 112(1)(a) EPC.

ORDER

5. For these reasons, pursuant to Article 112(1)(a) EPC in conjunction with Article 17 of the Rules of Procedure of the Boards of Appeal (OJ EPO 1983, p.7), it is decided that the following point of law be referred to the Enlarged Board of Appeal for decision: Can a patent with claims directed to the use be granted for the use of a substance or composition for the treatment of the human or animal body by therapy?