T 0780/89 (Immunostimulant) 12-08-1991
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1. General immunostimulation or stimulation of the body's own defences by the use of particular compounds, in conjunction with specific prophylaxis against certain infections, is to be classed as therapeutic treatment and therefore as not susceptible of industrial application in accordance with Article 52(4) EPC (point 6 of the Reasons for the Decision).
2. If an increase in meat production is merely the consequence of improved health and a lower death rate because of therapeutic treatment with a specific substance, this secondary effect does not deprive the use invention of the character of a therapeutic treatment excluded from patentability in accordance with Article 52(4), first sentence, EPC (point 7 of the Reasons for the Decision).
Therapeutic treatment
Prophylaxis
Immunostimulation
I. European patent application No. 85 102 045.3 (publication number 0 158 075) was refused by the Examining Division. The decision was based on Claims 1 to 4, filed on 28 October 1989, which read as follows:
"1. Use of compounds of
formula (i)
where R stands for alkyl; R1 for hydrogen, alkyl, halogen, alkyl halide, alkoxy; R2 for hydrogen, alkyl, halogen, alkyl halide, alkoxy; R3 for substituted aryl or heteroaryl, if any; X for O or S; and Y for O or S,
for non-therapeutic immunostimulation in poultry and non-human mammals.
2. Use of compounds of formula (i), as defined above, for the manufacture of an immunostimulant.
3. Use of compounds of formula (i), as defined above, for non- therapeutic stimulation of the body's own defences in poultry and non-human mammals.
4. Use of compounds of formula (i), as defined above, for the manufacture of agents for stimulating the body's own defences."
II. The Examining Division refused the application essentially on the grounds that Claims 1 and 3, relating to use of the triazine derivatives defined therein for non-therapeutic immunostimulation or stimulation of the body's own defences, did not fulfil the requirements of Article 52(4) EPC.
It took the view that the claimed uses were prophylactic, since immunostimulation or stimulating the body's own defences also served to prevent disease; such measures therefore came under the concept of "treatment of the human or animal body by ... therapy", which according to Article 52(4) EPC was not patentable.
In particular, the therapeutic/pharmacological effect of the active substance could not be cancelled out by a change of phraseology. Furthermore, Article 52(4) EPC did not differentiate between the therapeutic treatment of a human or an animal body, which the applicants were trying to do in an indirect way with their reference to "non-human" mammals.
The Examining Division had no objections however to Claims 2 and 4 relating to the use of triazine for the manufacture of certain agents, since these claims were in keeping with the Enlarged Board of Appeal's decision G 1/83 (OJ EPO 1985, 60).
III. The appellants appealed against this decision.
IV. In their statement of grounds and the oral proceedings on 12 August 1991 the appellants argued essentially as follows:
Decisions T 19/86 (OJ EPO 1989, 25) and T 116/85 (OJ EPO 1989, 13) had been concerned with treatment focused on a specific syndrome entailing vaccination: prophylactic treatment of a specific disease and treatment of specific ectoparasites. Both treatments were therefore classed as therapeutic. Immunostimulation on the other hand was not directed against any specific disease. The present case, for example, revolved around a purely commercial consideration - an increase in meat production. In T 36/83 (OJ EPO 1986, 295) and T 144/83 (OJ EPO 1986, 301), moreover, the Boards of Appeal had found certain applications carried out under medical supervision to be non- therapeutic, while in similar borderline cases such as T 81/84 (OJ EPO 1988, 207), T 290/86 of 13 November 1990 (OJ EPO 1992, 414) and T 582/88 of 17 May 1990, the Boards had decided differently each time. In such an unclear situation the consequences of choosing a specific category of claims could not possibly be foreseen. Dispensing with either Claims 1 and 3 or 2 and 4 might mean forfeiting protection, particularly given the legal validity of European patents before national courts, whose decisions were bound to be just as different. Examples of this could be seen in decisions delivered by an appeal division of the Netherlands Patent Office (OJ EPO 1988, 405), a revocation division in the German Federal Patent Court and the British High Court which were not in keeping with the practice of the Boards of Appeal of the European Patent Office. In any case the applicant clearly had an interest in reducing the risk of loss of rights.
On the subject of industrial applicability, the appellants further argued in particular that the subject-matter of the invention no longer included the prevention of coccidiosis and that the only objective was an increase in meat production for the farmer's financial benefit.
In the course of the oral proceedings the appellants filed two new claims as an auxiliary request. These correspond to Claims 2 and 4 of 28 October 1988.
V. The appellants request that the contested decision be set aside and a patent granted on the basis of Claims 1 to 4 of 28 October 1988 or, alternatively, Claims 1 and 2 filed during the oral proceedings on 12 August 1991.
1. The appeal is admissible.
2. The appeal is about whether granting Claims 1 and 3 runs counter to Article 52(4) EPC. In the contested decision Claims 2 and 4 were considered grantable. The appellants do not contest this point since it is in their favour. Nor does the Board see any reason to examine this matter itself.
3. It remains therefore to be established whether the claimed use of compounds of formula (i) for immunostimulation or stimulating the body's own defences counts as therapeutic treatment of the human or animal body within the meaning of Article 52(4) EPC. The Board can base its answer to this question on existing case law.
3.1 Decision T 36/83 dealt with the question whether a use was therapeutic or non-therapeutic if the effects of a substance or combination of substances differed. In that particular case, the description expressly disclosed two very different properties of a compound used in the treatment of comedones, i.e. its anti- bacterial and its hygienic action. Since the latter was non- therapeutic, use of this substance for purely hygienic purposes was not excluded from patentability.
3.2 Similar observations were made in T 144/83, in which the Board found that no clear distinction could be made between the cosmetic treatment in question for improving bodily appearance and the medical treatment for curing obesity. Article 52(4) EPC was, however, to be construed narrowly so that it did not work to the disadvantage of an applicant seeking patent protection for the cosmetic treatment only. In that case too, the chemical substance used had both a purely cosmetic and a therapeutic effect, and therefore clearly displayed two types of action.
3.3 If the properties of a product did not differ, however, the claim was not considered grantable since the therapeutic use could not be distinguished from the non-therapeutic use. T 81/84 concerned the relief of pain, discomfort or incapacity. The application related to the treatment of dysmenorrhoea and claimed a method for treating uterine cramps, a method for relieving menstrual discomfort in humans and a composition for such use. The applicants took the view that relieving menstrual discomfort in humans was not treating a disease.
The Board on the other hand found that it was neither possible nor desirable to distinguish between basic and symptomatic therapy, i.e. healing or cure and mere relief. The use of medicaments might be called for whenever the human body was suffering from a disease, illness, pain or discomfort or incapacity, and the administration thereof could provide or contribute to either full or partial healing, or relief or restoration of fitness.
This conclusion sprang from the observation that the biochemical effects and mechanisms which medicaments generated in order to restore the body to a normal, functioning, painless state were often very similar or even identical, irrespective of causes.
3.4 There was a similar situation in T 116/85, in which it was found that under Article 52(4) EPC it was not possible as a matter of law to distinguish between the uses of a particular pesticide in methods for the treatment of ectoparasites and endoparasites. A corresponding claim for the use of a pesticidal composition to control ectoparasitic infestations was therefore refused. The applicant argued, however, that while endoparasites constituted a disease, the treatment of ectoparasites was not a medical treatment since it was normally carried out by farmers as a matter of routine.
3.5 In T 19/86, too, the Board assumed that classification as therapeutic within the meaning of Article 52(4) EPC was not dependent on the form or type of treatment. Here the question was whether the use of a known vaccine in a new class of pigs, namely sero-positive pigs that were still maternally immune, constituted a new use of the vaccine. The Board assumed that the vaccine's use on sero-positive animals was a prophylactic rather than a curative measure. Both forms of treatment had the same objective, i.e. the maintenance or restoration of health, and therefore came under the provisions of Article 52(4) EPC. Since no fundamentally different action could be demonstrated for the vaccine other than its therapeutic property, only claims for the second medical use were admissible.
3.6 In T 582/88 of 17 May 1990 (cited in the 1990 case law report, OJ EPO 1991, supplement to issue 6, page 19) the claims did contain the words "non-therapeutic treatment" or "non- therapeutic use", but a distinction was made between a purely therapeutic property of the agent used (an antibiotic) and a measurable result (an increase in the milk production of a ruminant). However, this increase in milk production - achieved by influencing fermentation in the rumen - can be clearly distinguished from the bactericidal effect of the antibiotic used. The Board did not therefore consider applying Article 52(4) EPC.
3.7 T 290/86 again demonstrated that where a treatment has overlapping and therefore indistinguishable effects (i.e. the apparently purely cosmetic removal of dental plaque and the prevention of periodontal disease), which are inextricably linked with therapy, a claim for anything other than a second medical use is excluded from patentability.
4. It follows from the case law cited that a method which constitutes a therapeutic treatment cannot be patented. If it has more than only a therapeutic effect, however, then under Article 52(4) EPC it counts as an invention susceptible of industrial application within the meaning of Article 52(1) EPC, for which a patent may be granted if the usual requirements for patentability are met. The principle that only those methods of therapeutic treatment are unpatentable which are carried out wholly outside the industrial sector and are therefore not susceptible of industrial application is also supported by the case law of national courts (cf. for example the Bundesgerichtshof [German Federal Court of Justice] "Hydropyridine" decision, OJ EPO 1984, 26, 31 under point 3(d)). Nor does a decision of the Netherlands Patent Office's appeal division (Octrooiraad, Afdeling van Beroep, 30 September 1987, No. 16673), which is cited by the appellants, say anything different on this matter. The Board upholds the existing case law - not least in the interests of harmonising European and national case law on identical provisions.
5. The question therefore is whether the compounds of formula (i), in addition to coccidiocidal action and effectiveness against toxoplasmosis, i.e. their therapeutic effects, also have other effects on the immune systems of poultry and mammals that are unconnected with this therapeutic treatment.
6. It is true that immunostimulation is not always employed in order to prevent a specific disease. It does not follow, however, that it is not a therapeutic treatment, for it does generally serve to prevent or alleviate potential ailments. It is therefore to be classified as a therapeutic measure, since all prophylaxis serves to maintain health and therefore comes under the provisions of Article 52(4) EPC. Furthermore, immunostimulation or stimulation of the body's own defences using compounds of formula (i), a measure classified by the applicants as non- specific, is always accompanied simultaneously by specific prophylactic measures against infection with coccidiosis and toxoplasmosis. The Board at any rate has no information and the application documents say nothing specific on why this particular prophylactic measure should not be carried out. This too demonstrates that the treatment is prophylactic and has to be classified as therapeutic.
7. The applicants assert that immunostimulation increases meat production. If true, however, that would still not alter the legal position, since even if more meat is produced because fewer animals become sick or die the method for which patent protection is claimed remains a therapeutic treatment. The increase in meat production is merely a consequence of the therapeutic treatment. A purely secondary effect of successful therapeutic treatment does not deprive the latter of its character as a therapeutic treatment within the meaning of Article 52(4) EPC (for case T 582/88, which was decided differently, cf. point 3.6 above).
8. Referring to decisions in the Contracting States the applicants felt that the EPO ought to allow use claims for immunostimulation. The Board is not aware of any decisions in the Contracting States that deem claims of this type to be patentable. Nor does this follow from the decisions cited by the applicant. But even if it were the case, the Board would not be released from its obligation to apply Article 52(4) EPC in the present circumstances.
9. The Board therefore considers that the use of compounds of formula (i) for immunostimulation or stimulating the body's own defences in accordance with Claims 1 and 3 of the main request constitutes therapy or therapeutic use within the meaning of Article 52(4) EPC and accordingly cannot be patented. This provision is no obstacle to the grant of Claims 1 and 2 of the auxiliary request, which correspond to Claims 2 and 4 of the main request; the matter is therefore to be referred back to the Examining Division.
ORDER
For these reasons it is decided that:
1. The contested decision is set aside.
2. The matter is referred back to the Examining Division with the request that it grant a patent in accordance with the auxiliary request and an amended description.