09 April 2021

Protecting non-therapeutic methods at the EPO

Like many patent offices, the EPO does not allow applicants to claim methods for treatment of the human or animal body by surgery or therapy (Article 53(c) EPC). Such exclusions are historically founded upon the principles of free exercise of the medical profession. The EPO has, nevertheless, allowed applicants to navigate around such exclusions by protecting new and innovative medical treatments by means of purpose-limited product claims (i.e. “compound X for treatment of disease Y”), where the use to which the claim is directed determines patentability.

The claiming of non-therapeutic (e.g. cosmetic) methods (rather than purpose-limited product claims) is allowed at the EPO. However, such claims have not always been so readily accommodated under EPO practice, specifically where there is the potential for a non-therapeutic method to have an underlying (even if unintended) therapeutic benefit. Once there is considered to be an inevitable therapeutic element to any such method, the exclusions relating to methods of treatment have often prevented applicants successfully pursuing such claims at the EPO, even if there is a legitimate intent not to cover a therapeutic treatment.

However, a recent decision from the technical Boards of Appeal of the EPO – T1916/19 – suggests that the EPO may be becoming more accepting of such claims, which will be welcome news to certain innovators, particularly those operating in the cosmetic, functional food or nutraceutical fields, for instance. This article discusses the background and some of the more interesting developments in EPO case law around non-therapeutic method claims, particularly where the non-therapeutic application is accompanied by a possibility for a potential therapeutic benefit.

In general, a method may only be considered to be therapeutic at the EPO if it involves the curing of a disease or malfunction, or has a prophylactic (i.e. preventative) effect (EPO Board of Appeal Decision T 19/86 holding that both prophylactic and curative treatments of diseases are within the meaning of the word “therapy”). Historically, the EPO has allowed applicants to exclude unpatentable therapeutic treatments from a non-therapeutic method claim by means of a disclaimer. In Board of Appeal decision T 36/83, for instance, a claim directed to “Use as a cosmetic product of thenoyl peroxide” was found to be allowable – the Board considering the “cosmetic” disclaimer to be sufficient to separate the subject-matter of the claim from the medical use of thenoyl peroxide. In particular, the Board in that case commented:

“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.”

The Board’s decision in T 36/83 was influenced by the distinction, clearly set out in the description of the application as filed, between the therapeutic and non-therapeutic methods (Reasons for the Decision point 6).  It may therefore, on first sight, seem that there should be no great barrier to the protection of various non-therapeutic methods, if the applicant can rely on disclaimers to exclude any potential non-patentable methods of treatment. However, complexity arises when a method potentially provides for both therapeutic and non-therapeutic effects.

Established EPO case law (e.g. Board of Appeal decision T 290/86) has historically stipulated that non-therapeutic methods must be directed solely to a non-therapeutic effect so as not to encompass anything that falls foul of the exclusions directed towards therapeutic methods. In T 290/86, a cosmetic treatment relating to the removal of plaque from teeth was not considered allowable as this method was considered to inevitably have a therapeutic effect of preventing tooth decay. In taking this line, the Board deviated from an earlier decision – T 144/83 – which concerned a weight loss drug that was able to provide both a cosmetic weight loss effect, as well as a therapeutic cure for obesity. Whilst the Board in T 144/83 acknowledged that the two uses were “adjoined”, it was felt that this should not be allowed to work to the disadvantage of an applicant claiming protection for the cosmetic method.

One notable difference in the formulation of the claims in T 144/83 (appetite suppressant) and those of T 290/86 (plaque removal) was a reference to attaining a “cosmetically beneficial” result in the earlier case, which may have helped the Board reach the conclusion it did. Nevertheless, the use of disclaimers to carve out non-therapeutic methods has had mixed results before the EPO, where there has been the potential for therapeutic effects to accompany the non-therapeutic benefits of an invention. Where non-therapeutic and therapeutic uses have been considered to be “inseparably associated” with each other (T 1635/09), a disclaimer to the therapeutic use in a claim has either been considered to have no effect in isolating the non-therapeutic use or has been considered to mean that the whole subject-matter of the claim is in effect disclaimed so as to be completely void (T 767/12) – leading to a fundamental lack of clarity in either case.  

Decision T 1635/09, for instance, concerned use of an oral contraceptive for a woman of fertile age making use of a low oestrogen dosage. Whilst it is worth noting that the EPO does not consider contraception to be a medical method, use of the low oestrogen contraceptive in question was nevertheless seen to encompass a medical treatment because the technical problem solved by the invention was one of reducing harmful side effects, as compared to a higher oestrogen dosage, rather than an increased efficacy of contraception. Thus, although the claim related to a contraceptive use which is non-therapeutic per se, the selected concentrations of active substance defined in the claim simultaneously prevent pathological secondary effects likely to arise in the case of that contraceptive use (and passages in the applicant’s own application outlining the advantageous reduction in pathological side effects were considered particularly relevant). The presence of a “non-therapeutic” disclaimer in the claim was thus considered to be insufficient to overcome an objection under Article 53(c) EPC in view of the inseparable association with an unpatentable method of treatment.

These cases demonstrate that separating therapeutic and non-therapeutic methods in a claim is not always straightforward, and this is particularly the case where the potential therapeutic benefit relates to prophylaxis (i.e. preventative treatment). In decision T 780/89, claims to the use of certain compounds for non-therapeutic immunostimulation were found not to be allowable. The Board in that case took the view that immunostimulation, or stimulation of the body’s own defences, constituted a prophylactic treatment because infection is prevented. Since the therapeutic use could not be separated from the non-therapeutic use, the inevitable therapeutic/pharmacological effect of the active substance could not be cancelled out by the use of the “non-therapeutic” disclaimer.

Nevertheless, in decision T 358/09, use of a “non-therapeutic” disclaimer was allowable and considered able to differentiate a claim directed to a non-therapeutic method of cooling cows to lure them to a milking stall from an excluded medical method of cooling cows as a treatment for overheating. The Board in that case opined that the purpose of therapy was invariably to restore the organism from a pathological state to its original condition, or to prevent pathology in the first place, whereas a non-therapeutic improvement of performance took as its starting point a “normal state”.

However, it is not clear how much consideration was given to the potential prophylactic benefit associated with the method in T 358/09. If prophylaxis is to be defined as preventing a pathological state by maintaining the “normal state”, it would seem that there is a far greater opportunity for overlap of non-therapeutic and prophylactic uses, and in some cases it may be more of challenge to carve out the non-therapeutic use in a claim. Does it, for instance, matter how much at risk a subject might be of developing a disease/pathology, when considering whether a potential prophylactic benefit may also arise as a result of a non-therapeutic method?

Recent decision T 1916/19 could therefore be a welcome development to certain innovators, since it appears to signal that there must be a real possibility of a prophylactic benefit for a healthy subject in order for this to prevent the legitimate claiming of a non-therapeutic method (i.e. for therapeutic and non-therapeutic effects to be considered genuinely “inseparable”). In this decision, the claimed invention related to a non-therapeutic method comprising the application of an anti-microbial composition to the skin for the purpose of improving body odour. Whilst this method is primarily a cosmetic treatment, the Examining Division refused the application at first instance on the basis that pathogenic bacteria would be removed as an inevitable result of carrying out the method. As a consequence, the claim scope was seen to impermissibly cover prophylaxis against infectious agents by the Examining Division, meaning the claim impermissibly embraced a method of treatment.

In following this line, the Examining Division saw therapeutic and non-therapeutic effects of the anti-microbial skin treatment as being “inextricably linked”, i.e.one would occur as an inevitable result of carrying out the other. Nevertheless, on appeal the Board in T 1916/19 ultimately reversed the decision of the Examining Division, accepting the appellant’s arguments that removal of pathogenic bacteria from a healthy person’s skin does not in fact constitute a prophylactic treatment. In reaching its decision, the Board acknowledged (point 4.6.1 of the Reasons) that:

“Undoubtedly, at least some realisations of the claimed method of providing an anti-microbial effect on skin are therapeutic in nature, e. g. in case the composition is applied to individuals suffering from a bacterial skin infection or a wound. There may be also realisations of the method which, depending on the circumstances, may be of a therapeutic/prophylactic nature or not,  e. g. applying the composition to the hands…”

The Board, however, went on to state (point 4.6.2 of the Reasons) that:

Even in case potentially pathogenic bacteria are present on its skin a healthy individual is not likely to develop a pathological state only because of the presence of such bacteria. Not disinfecting one’s armpits or feet may have unpleasant consequences, but will not, as such, lead to a pathological condition.

Whilst it could of course be argued that the presence of a pathogen on the body poses a non-zero degree of risk in developing a pathology, the Board clearly felt this risk to be negligible, meaning that the claimed method was not “inseparably associated” or “inextricably linked” with a method of prophylaxis and the Board went on to conclude (point 4.6.3 of the Reasons):

Thus, the Board does not share the reasoning of the Examining Division that the claims only define methods in which non-therapeutic and therapeutic effects are inextricably linked.

The Board comes to the conclusion that there are realisations of the claimed methods that are of a non-therapeutic nature, others that are of a therapeutic nature, and others that may be mixed.

In this scenario, the Board considered the disclaimer in the claim limiting to non-therapeutic methods to be allowable and also capable of excluding therapeutic methods, thereby avoiding contravention of Article 53(c) EPC, and the Board remitted the case back to the Examining Division for further examination accordingly.

This case is interesting in as much as the Board acknowledged that there are certain “realisations” of the claimed method that involved therapy/prophylaxis, but it seems that the Board was satisfied that there are alternative “realisations” of the method that do not, ostensibly where the method is applied to a “healthy individual” (presumably exhibiting the “normal state” as referred to in T 358/09 (cow cooling case)).

One question that arises as result of T 1916/19 is to what extent the possibility of prophylaxis can exist before there can be considered an “inextricable link” between the claimed method and a therapeutic/prophylactic treatment. In other words, what proportion of the possible “realisations” of the claimed method need to necessarily involve a prophylactic element, for prophylaxis to be “inextricably linked” with the method? This seemingly puts a focus on the scope of the “healthy individual” to which the non-therapeutic method is applied and whether prophylaxis would be inherent having regard to that subject.

It therefore seems that further development in the case law might be required to understand the full impact of T 1916/19 on the assessment of non-therapeutic methods going forward. Nevertheless, this case offers some reassurance to applicants that the possibility of a prophylactic benefit to a claimed non-therapeutic method does not automatically preclude the allowability of the non-therapeutic method, particularly where any prophylactic benefit might be remote or would not be enjoyed by a healthy subject to which application of the non-therapeutic method is intended. This seems like a pragmatic approach to the assessment of non-therapeutic methods in order to avoid applicants being unfairly disadvantaged and so as not to stifle legitimate innovation.

Another consideration that T 1916/19 opens up is whether applicants can more freely claim a non-therapeutic method, as well as a therapeutic use in treating a specific patient group that could feasibly take a prophylactic (or other therapeutic) benefit (i.e. in certain “realisations” of the method) in the same patent application. The current state of EPO case law does support this possibility. For instance, in decision T36/83, it was stated:

“A product’s first use in a method of treatment of the human or animal body by therapy and also its use cosmetically may therefore be claimed in one and the same patent application”

However, as discussed above, such allowability would appear to be conditional on the therapeutic and non-therapeutic uses not being “inextricably linked” or “inseparably associated” with each other. It also remains to be seen whether the existence of such medical use claims in the same patent application could potentially undermine arguments that any possible prophylaxis in the case of the non-therapeutic method claimed was sufficiently remote from the “healthy individual” to which the non-therapeutic method was directed. Consequently, it is likely that in such cases careful construction of the patent application at the drafting stage will be of paramount importance in placing the application in the best possible position in order for non-therapeutic and therapeutic uses to be successfully claimed in the single application.

We at Mathys & Squire have seen several examples of such cases nevertheless making it through EPO examination. For instance, EP3316876 B1 (“Arginine Silicate Inositol for Improving Cognitive Function”) granted with the following claims:

Inositol-stabilized arginine silicate for use in treating and/or preventing a cognitive disorder in a subject”; and

A non-therapeutic method of improving cognitive function in a subject comprising administering inositol-stabilized arginine silicate to the subject”.  

In this case, the treatment of a subject in need of cognitive enhancement in order to return to, or maintain, a “normal state”, e.g. patients suffering from dementia, can be separated from healthy individuals simply making use of a method of improving cognitive function over the normal state, meaning that both claims were found to be allowable in the same patent application.

Clearly, the specific technical facts underpinning inventions having both therapeutic and non-therapeutic elements will play a large part in whether a claim to the non-therapeutic method is allowable (and whether therefore an alternative therapeutic use may be claimed in the same patent application). Nevertheless, applicants may be encouraged that the EPO will take a more pragmatic approach to assessing such claims in the future, to the benefit of innovation.

For further information, visit our Life sciences & chemistry page, or contact the author, Michael Stott, directly.