T 0426/89 (Pacemaker) of 28.6.1990

Summary of Facts and Submissions

I. The respondents are the proprietors of European patent No. 0 108 360 (filing No. 83 110 823.8).

II. The appellants opposed the grant of this patent on the grounds that, in the light of the following documents, its subject-matter lacked inventive step: ...

III. The Opposition Division rejected the opposition.

IV. The appellants appealed against this decision.

V. Oral proceedings were held.

VI. The appellants (opponents) request that the contested decision be set aside and the European patent revoked.

VII. The respondents (patent proprietors) request that the appeal be dismissed and the patent maintained with the following amendments (main request):

Claim 1 to be replaced by Claim 1 as submitted during the oral proceedings held on 28 June 1990, which is worded as follows:

"1. Method for operating a pacemaker for arresting a tachycardia in the following stages:

(a) detection of a tachycardia

(b) initiation of a routine for arresting it by

1. generating at least one first sequence having a number n (n > 1) of stimulating pulses within an n-dimensional space spanned by the possible times S1 ... Sn of the said stimulating pulses,

2. monitoring the heart's reaction to the stimulation,

3. varying the times in the sequence and/or the number n of the pulses in such a way that at least a part of the n-dimensional space is scanned until an effective sequence for arresting the tachycardia is found,

characterised by

(c) storage of N (N > 1) effective sequences in N (N > 1) registers of a memory,

(d) use of the available register values as initial sequences for stimulating pulses, in the event of a renewed occurrence of tachycardia, in a prescribed order which is followed once again, if all sequences are ineffective, by the routine for arresting the tachycardia, and

(e) exchange of a stored sequence for an effective sequence obtained in a renewed routine, if all stored sequences were ineffective."

In the alternative, the respondents request that the patent be maintained with the following amendments (auxiliary request I): Claims 1 to 15 to be replaced by Claims 1 to 13 as submitted during the oral proceedings held on 28 June 1990; the title and description column 1, line 1 to column 10, line 19 to be replaced by the title and description column 1, line 1 to column 10, line 19 filed on 5 June 1990.

The only independent claim in the set of claims under alternative request I is worded as follows:

"1. Pacemaker for arresting a tachycardia ..." (then as Claim 1 under the main request).

The respondents' further auxiliary request (II) was rendered invalid by the decision.

VIII. The arguments used by the appellants in support of their request can be summarised as follows:

1. Claim 1 under the main request defined a method for treating the human body by therapy, which under Article 52(4) EPC was not regarded as an invention susceptible of industrial application. This method arrested a tachycardia by therapy involving the transmission to the heart of stimulating pulses whose number and timing was precisely determined and directly influenced the therapeutic effect. Decision T 245/87 - 3.4.1 (OJ EPO 1989, 171) relating to a method for using an implanted device to administer a drug fluid, instead of the electrical pulses in the case in suit, stated that a therapeutic method was covered by the exclusions of Article 52(4) EPC if it was clearly determined when what volume of which drug fluid was fed to the body within what period of time. In that case the controlling action claimed, when featured in the implanted device, would have a functional connection with the quality and quantity of the drug dose and a direct causal influence on the therapeutic effect produced. Patent protection granted on that basis would thus hinder the doctor in the exercise of his professional skills. Since the case in suit fulfilled all these conditions, the use of the same criteria clearly indicated that the claimed method was not patentable in the light of Article 52(4) EPC. The same applied to the subject-matter of Claim 1 under alternative request I, whose wording referred to a pacemaker even though it was actually a disguised method claim designed to circumvent the provisions of Article 52(4) EPC. It was quite conceivable, moreover, that freely programmable pacemakers would become available in the near future, so that patent protection granted for a pacemaker defined simply by an operating method could restrict the programming freedom of such pacemakers and consequently also hinder the doctor inadmissibly in the exercise of his professional skills. ...

IX. The respondents, on the other hand, contest that the method according to Claim 1 of their main request is a method for the treatment by therapy of the human or animal body, since in their opinion it is simply an operating method for a device, i.e. a purely technical method not requiring the involvement of the doctor but simply addressed to the manufacturer. Since Claim 1 of alternative request I clearly related to a pacemaker, its subject-matter was not covered by the exclusions set out in Article 52(4) EPC, which did not apply to products (or devices) used to implement a therapeutic method. Patentability ...

Reasons for the Decision

1. The appeal is admissible.

2. Respondents' main request

2.1 The Board of Appeal cannot agree with the respondents' argument that any method for the operation of a device must necessarily be a technical method not covered by the exclusions set out in Article 52(4) EPC. There is no support for this interpretation in Article 52(4) EPC itself. On the contrary, its last sentence, which states that it does not apply "to products, ..., for use in any of these methods", indicates that the products (e.g. apparatuses) are patentable as such but that the methods in which they are used are not. In the present case, therefore, an actual operating method for a pacemaker for arresting a tachycardia would necessarily be a method for treating the human (or animal) body by therapy using a pacemaker, and would not be patentable. However, the respondents have maintained that Claim 1 under their main request refers to the steps in a technical method which do not define a method of treatment but rather, in functional terms, the structural features of a pacemaker. The Board agrees. If correctly interpreted in accordance with Article 69(1), second sentence, EPC, Claim 1 does not define a method but rather an apparatus (pacemaker) in terms of the functions of its components. Thus, Article 52(4) EPC does not prejudice the patentability of the subject-matter of Claim 1 under the main request.

2.2 The respondents' main request, however, is for the maintenance of the patent as amended. Under Article 102(3) EPC, such a request can only be granted if the European patent (and not only the invention to which it relates) also meets the requirements of the EPC. Following the amendments made to the patent documents by the respondents, therefore, it will also be necessary to establish whether Claim 1 conforms to Article 84 EPC with regard to the clarity of the claims. Although the subject-matter of Claim 1 is described as a "method" for the operation of a pacemaker, the Board takes the view - as set out under point 2.1 - that Claim 1 does not define an actual act to be performed with the pacemaker itself or during its manufacture. Since in particular the characterising portion of the claim refers exclusively to features which are concerned with the handling of register values in a memory (storage of sequences in a memory's registers, use of the available register values in a specifiable order, exchange of a stored sequence), and which consequently indicate the function of a pacemaker, the content of Claim 1 is to be seen as a functional definition of a pacemaker and the claim itself, therefore, as a product claim. Since the reference to a method in the designation of the subject- matter of Claim 1 does not make this explicit, the Board regards Claim 1 as not "clear" within the meaning of Article 84 EPC. For these reasons the respondents' main request cannot be allowed.

3. Respondents' first auxiliary request

3.1 Apart from the deletion of the granted dependent Claims 11 and 12 and the corresponding re-numbering of the subsequent claims, the only essential differences between the patent according to auxiliary request I and the granted version were that in Claim 1 the title of the invention, "Method for the operation of a pacemaker", was replaced by "Pacemaker", and section (c) of the characterising portion specified that N (N > 1) effective sequences were stored in N registers of a memory, instead of only one effective sequence in one of N registers. The description was amended accordingly.

These amendments cannot be questioned under the terms of Article 123(2) EPC, since the documents originally filed, and particularly the description in conjunction with the drawings, actually disclose a pacemaker capable of arresting a tachycardia by means of the steps indicated in Claim 1 (a) to (e). The use of N registers or groups of registers in which, in each case, one of N effective sequences is stored, is mentioned in particular in the penultimate paragraph of the description. Nor does the amendment of Claim 1, including its change of category, contravene Article 123(3) EPC. For the reasons stated under point 2 above with regard to Claim 1 of the respondents' main request, Claim 1 as granted is already a product claim containing a functional definition of a pacemaker. So the seeming change of category does not alter the content of the claim but simply serves to clarify it (cf. also T 378/86 - 3.2.2., OJ EPO 1988, 386).

Given this clarification of the definition of the subject-matter of Claim 1 as a pacemaker capable of arresting a tachycardia (by means of the steps indicated in the claim), Claim 1 can no longer be contested on the basis of Article 84 EPC. Thus, the patent documents according to the respondents' auxiliary request I meet the formal requirements of the EPC.

3.2 Under Article 52(4) EPC, methods for treatment of the human or animal body by therapy are not regarded as inventions which are susceptible of industrial application. However, this provision concerning therapeutic methods expressly excludes products for use in such methods (Article 52(4) EPC, last sentence). Consequently, Article 52(4) EPC does not prejudice the patentability of the claims under the respondents' auxiliary request I, which now clearly relate to such a product, namely a pacemaker for arresting a tachycardia.

The Board cannot agree with the appellants' argument that enforcement of the rights ensuing from the present claims could hinder a doctor from programming a legitimately acquired freely programmable pacemaker so as to perform the claimed steps of the method and could thus restrict him inadmissibly in the exercise of his professional skills. The programming of a pacemaker is no more than an act performed on an apparatus. And although that act can be performed by a doctor in the exercise of his professional skills, it does not constitute direct treatment by therapy of the human or animal body, which alone is excepted from patentability by Article 52(4) EPC. Equally, every valid patent for a product for the treatment by therapy of the human or animal body can prejudice the manufacture of this product by a doctor without automatically constituting an inadmissible restriction on the exercise of his professional skills. 3.3 Novelty ... The subject-matter of Claim 1 is therefore new within the meaning of Article 54 EPC.

3.4 Inventive step ... The subject-matter of Claim 1 therefore involves an inventive step within the meaning of Article 56 EPC. 3.5 On account of their dependence on Claim 1, the remaining Claims 2 to 13, like Claim 1, relate to a patentable invention. Following the amendments made by the respondents under their alternative request I, therefore, the European patent and the invention to which it relates satisfy the requirements of the Convention. The patent can thus be maintained as amended.

4. Auxiliary request II ....

ORDER

For these reasons it is decided that:

1. The contested decision is set aside.

2. The matter is remitted to the first instance with the order that the patent according to the respondents' auxiliary request I be maintained with the following amendments: Claims 1 to 15 to be replaced by Claims 1 to 13 as submitted during the oral proceedings held on 28 June 1990; the title and description column 1, line 1 to column 10, line 19 to be replaced by the title and description column 1, line 1 to column 10, line 19 filed on 5 June 1990.