Curated Content United States: The Silent Treatment: The EPO's Approach To Non-therapeutic Methods Encompassing Therapeutic Effects

Methods for treatment of the human or animal body by therapy (or surgery) are excluded from patent protection at the EPO under Article 53(c) EPC. The purpose of the exclusion is to avoid restricting the activities of medical and veterinary practitioners. In contrast, purely non-therapeutic methods of treatment, e.g. purely cosmetic methods, are permitted.

On face value, the EPO's approach seems clear and navigable. However, in practice the waters are murkier. The "treatment by therapy" exclusion of Article 53(c) EPC, often described as a narrow exclusion, is applied quite broadly in practice. Furthermore, certain method inventions can fall between the claim formats permitted by the EPO, meaning that protection may not be available without careful drafting at the outset.

"Therapeutic" treatments

As in most jurisdictions, the EPO considers that therapeutic treatments include prophylactic treatments as well as curative treatments (EPO Board of Appeal Decision T 19/86). Additionally, the term "therapy" is considered to include not only treatment of diseases, but also the alleviation of the general symptoms of pain and suffering (T 144/83). The pain or suffering need not actually result from a disease; methods of treating pain or suffering are excluded even if the pain/suffering is caused by natural circumstances such as age, pregnancy, menstruation, atmospheric conditions (e.g. temperature), etc. (T 81/84).

In contrast, treating discomfort of normal and healthy subjects might not be considered therapy. It is not immediately clear where discomfort (treatment permitted) ends and suffering (treatment excluded) begins. It is not sufficient to rely solely on a distinction between treating healthy and unhealthy subjects, since treatment of suffering caused by e.g. age or pregnancy, even in healthy subjects, is excluded. The key determining factor is whether the subjects are in, or are at risk of developing, a pathological state in the absence of treatment. If so, then the treatment is likely to be considered therapeutic rather than merely the non-therapeutic alleviation of discomfort (T 385/09).

Hidden (encompassed) therapeutic methods

A commonly encountered situation is when a claim reciting a non-therapeutic method nevertheless encompasses a therapeutic method. The EPO is particularly rigorous in spotting and objecting to such hidden therapeutic effects.

T 1635/09 provides a useful example. Methods of pharmaceutical contraception are not considered by the EPO to be methods of treatment by therapy because pregnancy is not a disease (see e.g. T 820/92 and T 74/93). In T 1635/09, the claims concerned uses of oral dosage forms comprising low doses of certain oestrogen compounds for contraception. Despite reciting contraceptive uses, and being entirely silent on any therapeutic treatment, the claim was deemed to fall foul of the Article 53(c) exclusion. This was because the claim was still considered to encompass an excluded therapeutic method within its scope. Specifically, the application taught that the low doses of oestrogen resulted in a reduction of harmful side-effects as compared to higher oestrogen dosages. This reduction/ prevention of harm was considered to be prophylactic therapy.

The risk of Article 53(c) objections on the basis of therapeutic methods that are not recited in a claim, but are nevertheless encompassed by it, is encountered frequently by cosmetic method claims. Methods for purely cosmetic treatments are straightforwardly patentable (see G1/07, affirming T 383/03). However, many cosmetic methods inherently comprise a therapeutic effect; positive superficial changes often go hand-in-hand with genuine health improvements.

For instance, in the well-known case T 290/86, the claim at issue was directed to a method of cleaning plaque and/or stains from human teeth. Although this method was intended to be cosmetic in nature, it was deemed to have the inevitable therapeutic effect of preventing tooth decay, and was therefore refused.

In many major cosmetic areas, claims intended to be directed to cosmetic methods risk encompassing therapeutic methods:

Inseparable associations

It has become established EPO practice to ask the key question of whether a claimed non-therapeutic (e.g. cosmetic) method can be clearly distinguished from any therapeutic effects that happen to result from that method. If so, then the claim will be deemed to encompass only non-therapeutic methods, and so avoid the Article 53(c) exclusion. But if the non-therapeutic method is "inseparably associated", or "inextricably linked", with a therapeutic effect, then the method will fall within the Article 53(c) exclusion.

The assessment of how tightly associated the non-therapeutic and therapeutic aspects are will of course need to be determined by the technical realities of the case in question. However, some useful insights are available from case law.

In T 469/94, the claim at issue was directed to the application of certain compounds to reduce the perception of fatigue in a person about to participate in major exercise, or in a person having completed major exercise. The claim recited that this was achieved by the compound raising the person's bloodstream choline level. This is a non-therapeutic application; the perception of fatigue is not a disease. However, the same steps were known to lead to the therapeutic treatment of muscular disease, muscular injury and epilepsy.

In this case, the Board considered the claimed non-therapeutic method to be clearly distinguishable from the therapeutic effect for two reasons. First, the recipients in either case would be different since the non-therapeutic method would be performed on healthy subjects, whereas the therapeutic effect would apply only to those with a muscular disease, muscular injury or epilepsy. Secondly, the two treatments would be effective over different timeframes: minutes/hours for the non-therapeutic effect in contrast to days for the therapeutic effect. The two effects were therefore not considered to be inseparably associated, and the claim was permitted.

T 385/09 (mentioned above) concerned a non-therapeutic method of cooling cows in a milking stall in order to motivate the cows to go there spontaneously; the desire to be made more comfortable by cooling thereby leading to increased milking. The method could also be used for the therapeutic treatment of a cow suffering from overheating. The Board considered the two effects were sufficiently separate given that they would be practiced on different groups of animals, i.e. healthy cows vs. those suffering from heat stress.

In T 1916/19, the claim at issue recited a non-therapeutic method of providing an anti-microbial effect to skin, the method comprising the steps of applying a particular composition thereto. This resulted in the reduction of unpleasant body odour, i.e. a cosmetic effect. The Examining Division had refused the claim under Article 53(c) EPC because the anti-microbial treatment was considered also to encompass prevention of several diseases (e.g. microbial infection). On Appeal, the Board disagreed, finding that removal of pathogenic bacteria from healthy skin is not necessarily prophylactic because a healthy individual is notlikely to develop a pathological state merely because of the presence of such bacteria. As the Board put it: "Not disinfecting one's armpits or feet may have unpleasant consequences, but will not, as such, lead to a pathological condition".

There is clearly some similarity between T 469/94, T 385/09 and T 1619/19. The non-therapeutic methods in these cases concerned application to healthy individuals, which is clearly not a curative treatment (which requires an unhealthy patient as a starting point). However, T 1916/19 teaches that consideration also needs to be given to the likelihood of the healthy individual developing a disease. If convincing arguments can be presented that a healthy individual is unlikely to develop a pathological condition without the claimed treatment, then it follows that the treatment of that individual is also not prophylactic in nature.

Precisely how unlikely the risk of developing a pathological state needs to be to pass this test is not well-established, and will most likely remain an issue to be determined on a case-by-case basis. There are however some cosmetic areas where the EPO's position is staunch, and not favourable to patentees. Methods comprising the application of UV sunscreen agents to the skin, and methods of oral cleaning/ care, are almost always objected to by the EPO for covering therapeutic methods, even if the claimed method is intended to be cosmetic. The EPO views methods involving the application of sunscreen to the skin to be therapeutic due to the prophylactic effect against sunburn that inherently and unavoidably occurs. Methods of oral cleaning/ care are almost always considered therapeutic due to the resulting effect on tooth decay, gum disease, etc.

T 2275/18 is an interesting exception. The claim at issue was directed to a non-therapeutic method of applying to human skin a "personal care composition" [comprising certain UV sunscreen agents]. During Opposition, in line with the usual EPO practice, it was found that the application of UV sunscreen agents resulted in a prophylactic effect against UV induced skin damage. Indeed, the application disclosed such therapeutic uses of the compositions. However, the application also disclosed situations in which application was not therapeutic; specifically when the personal care composition was a shampoo, hair conditioner, shower gel, or other product used indoors, absent UV exposure. On Appeal, the Board considered that sunscreen agents are active only when exposed to UV radiation, and in cases where no prevention against sunburn is needed, e.g. in the context of shower gels, applying the composition to the skin cannot be considered as a prophylactic therapeutic treatment. Since it was possible to carry out the method on human skin without preventing the likely development of a pathological state, the non-therapeutic and therapeutic aspects of the method were considered distinguishable and the non-therapeutic method claim was permitted.

Claims relating solely to methods of tooth whitening/ bleaching can be permitted (see e.g. T 2468/11). However, it must be the case that the method steps do not also result in any cleaning of the teeth or oral cavity. Claims encompassing the application of a bleaching agent in a standard toothpaste, mouthwash, etc. is likely to lead to the exclusion of the claim under Article 53(c) EPC, particularly if the description mentions generally positive effects of such compositions on oral health (see e.g. T 2664/17).

Practical advice

Applicants attempting to claim non-therapeutic methods that encompass a therapeutic effect certainly start on the back foot at the EPO. However, viable strategies for navigating the exclusion are available, as demonstrated in the cases discussed above.

A useful approach is to explain to the Examiner that there are specific situations in which the claimed method steps could be used without resulting in any therapeutic effect. Those situations might arise by treatment of a specific group of subjects (e.g. healthy individuals), treatment at a particular time, location, anatomical site, etc. Markedly different timeframes for non-therapeutic and therapeutic effects might also help to illustrate that purely non-therapeutic scenarios exist. It is not usually necessary to recite the specifics of the non-therapeutic situations in the claim itself; it is usually sufficient just to demonstrate that those situations do exist in reality, and are clearly separate from situations where a therapeutic effect results.

In this approach, if presenting situations based on the treatment of healthy subjects as not yielding a therapeutic result, it is also important to demonstrate convincingly that those subjects are unlikely to develop a pathological condition without the treatment.

It is worth remembering that under EPO practice, the claims are interpreted in light of the description. Since disclosure of therapeutic benefits in the description could undermine arguments that a claimed method has only non-therapeutic effects (see e.g. T 1635/09, above), omission of such disclosures is worth considering. Of course, this would not necessarily prevent therapeutic effects from being identified by the EPO or third parties.

It is important to note how disclaimers should be used in these claims. Applicants often try to present a claim reciting that the claimed method is "non-therapeutic". The rationale is that if the claim expressly recites "A non-therapeutic method...", or "A non-therapeutic cosmetic method...", then it cannot be interpreted as being directed to an excluded therapeutic method. Indeed, in many cases, such a disclaimer is essential: if the method steps could result in therapeutic effects in some scenarios, then it is important to limit the claimed subject-matter to the non-therapeutic methods. Such a disclaimer was essential in cases T 2275/18, T 1916/19 and T 385/09 above, and many others.

However, a "non-therapeutic" disclaimer might often be necessary, but it is not sufficient, for avoiding the objection in all cases. The presence of the disclaimer does not achieve the desired limitation to a non-therapeutic use if, as a matter of fact in practice, the non-therapeutic use is still inseparable from one or more therapeutic effects. This was demonstrated in T1635/09 (above), in which the contraceptive effect was deemed to be inseparably associated with the therapeutic reduction of harmful side-effects, and the presence of a "non-therapeutic" disclaimer in the claim did not overcome the objection. Likewise in T780/89, a claim to the use of certain compounds for "non-therapeutic immunostimulation" of non-human animals could not prevail because the administration of the compounds still actually led to the health benefits of immunostimulation. It was made clear by the Board in T 1077/93 that if the therapeutic and non-therapeutic aspects are indivisible, then the exclusion cannot be avoided by a purely formal rewording of the claim.

Under EPO practice it is possible to add such a disclaimer to a claim, even if the disclaimer is not disclosed in the application as filed. However, it is important to do so cautiously and with professional advice from a European attorney, because disclaiming too much or too little subject-matter could be fatal for the validity of the claim in post-grant proceedings.

Alternative claim formats are not always available

As mentioned, if a claimed non-therapeutic method is deemed to be inseparably associated with a therapeutic effect, then the method will fall within the exclusion of Article 53(c) EPC. In that scenario, an applicant can attempt to change the claim format to rescue some patentable subject-matter. Article 53 EPC states:

Therefore, purpose limited product claims are patentable when the recited purpose is the use in a method which, if presented as a method claim, would be excluded from patentability. So, if a claim is deemed to encompass a therapeutic method, it can be re-cast in the following use-limited product claim format:

This format provides for a therapeutic use-limited claim, whereas the original intention of the method claim was to protect non-therapeutic uses. This is clearly not ideal, but at least some claim scope has been salvaged.

Unfortunately, at this point some cases fall into a trap, which arises from the EPO's established practice of requiring the "method of treating Y" in the above therapeutic use-limited product claim format to be a defined, real treatment of a pathological condition (see e.g. T 241/95). Claims intended to cover non-therapeutic methods are, quite naturally, often worded such that they do not refer to a pathological condition. As a result, when re-cast into this use-limited product claim format, the recited use is not considered to be the defined, real treatment of a pathological condition. In this event, such claims are then objected to as being improperly formatted, and so are interpreted as being directed to the substance/composition per se, often with associated prior art problems.

As an example, consider the claim:

This claim would most likely be excluded by Article 53(c) EPC for encompassing inseparable methods of treatment by therapy, e.g. prophylaxis of skin cancer. Re-casting the claim into the purpose limited product claim format above would lead a claim such as:

Reducing wrinkles on the skin of a subject is not a defined, real treatment of a pathological condition. This claim would therefore be deemed improperly formatted, and so directed to UVA-blocking agent X per se.

In this way, applicants can be trapped with neither the non-therapeutic method claim, nor the therapeutic use-limited product claim format, being achievable.

The applicant could try to present a claim in the therapeutic use-limited product format specifying the treatment as the prevention of skin cancer, UV-induced skin damage, or another pathological condition. However, given the EPO's strict requirement for all claim amendments to find basis in the application as filed (Article 123(2) EPC), this is only an option if the application was drafted to include a disclosure of such treatments.

For these reasons, particular care needs to be taken when drafting applications to non-therapeutic methods that encompass therapeutic effects. Decisions need to be taken at that stage whether or not to include disclosures of therapeutic effects/ methods. On the one hand, such disclosures could undermine arguments on the separable nature of the non-therapeutic method, but on the other they could provide basis for a fall-back therapeutic use-limited claim format. It is possible to include both non-therapeutic method claims and therapeutic use-limited product claims in the same claim set, provided that the above-discussed requirements for both claim categories are met.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.