In an ideal world, therapeutic and non-therapeutic use claims form two sides of the same coin. Any use that is therapeutic must be protected using the medical use claim format of “X for use in therapy” or “X for use in treating disease Y”; while any use that is not therapeutic should be protected using the traditional or non-therapeutic use claim format of “The use of substance X for purpose Z (e.g. The use of substance X as an insecticide)”.

In most cases this is straightforward: a pharmaceutical composition will have a therapeutic use while a food will have a non-therapeutic use. However, in the borderline world of functional foods, it can be difficult to determine if the technical effect produced by a product is therapeutic or not. A recent Board of Appeal decision highlights the difficulties applicants can face in this area, adding to the case law relating to methods with both therapeutic and non-therapeutic indications.

T 2074/22

This case related to an agent comprising a specific amino acid profile for use in the prophylaxis or improvement of frailty in an elderly person. The application as filed listed several manifestations of frailty, such as dementia, anxiety disorder, decrease in walking speed, loss of motivation etc.

The EPO search examiner objected that some of the disclosed manifestations of frailty, e.g. decrease in walking speed and loss of motivation, did not represent a disease while others, e.g. dementia and anxiety disorder, did relate to a disease. The search examiner argued that the manifestations that did not represent a disease could not be claimed using the second medical use format of “X for use in treating disease Y”.

In response to the search examiner’s objections, the applicant split the disclosed manifestations in the following way:

• A second medical use claim: “An agent for use in the prophylaxis or improvement of frailty, […] wherein the frailty is […] selected from the group consisting of loss of muscle mass, decline in grip strength, feeling of fatigue, depression state, delirium, dementia, sleep disorder, anxiety disorder and social withdrawal, in an elderly person.”; and
• A non-therapeutic use claim: “Non-therapeutic use of an agent for the prophylaxis or improvement of frailty, […] wherein the frailty is […] selected from the group consisting of decrease in walking speed, decrease in the amount of physical activity and loss of motivation, in an elderly person.”

In the subsequent post-grant proceedings, the Board found that, contrary to the position of the search examiner, no distinction could be drawn between a therapeutic use and a non-therapeutic use of the agent. The Board held that even if certain symptoms of frailty in elderly people are not considered an illness as such, the prevention of these symptoms necessarily aims at least at maintaining health in the patient.

The Board also noted that both the medical use and the non-therapeutic use claims in the patent defined the subject as an elderly person. The Board reasoned that an elderly person is likely to be suffering from or at risk of developing symptoms of frailty and consequently the method would always be either therapeutic or prophylactic. Consequently, the non-therapeutic use claim was refused.

This case shows that it is not always possible to separate out symptoms into therapeutic and non-therapeutic indications. The fact that the same agent was being used in the same way for the same at-risk patient group meant that the treatment could not be both therapeutic and non-therapeutic. There needs to be some difference in how the agent is used to distinguish between therapeutic and non-therapeutic indications. One example we see in the case law is the separation of therapeutic and non-therapeutic effects based on differences in the consumer group for the product.

Distinguishing therapeutic and non-therapeutic indications using consumer group

The application in T 144/83 concerned an appetite suppressant which was claimed using a non-therapeutic use claim to achieve a cosmetically beneficial loss of body weight. In this case the Board was able to see a distinction between the therapeutic effect of curing obesity and the non-therapeutic effect of cosmetic weight loss.

This case differs from T 2074/22 because it is possible to identify different consumer or patient groups for the therapeutic and the non-therapeutic uses. For the therapeutic use the appetite suppressant is administered to an at-risk patient suffering from obesity, while for the non-therapeutic use the appetite suppressant is administered to a healthy consumer seeking cosmetic weight loss.

The Board made a similar finding in T 469/94. This case related to the use of choline to reduce the perception of fatigue in a person about to participate in, or having completed, major exercise. The Board again separated the therapeutic and non-therapeutic uses based on the patient or consumer. The therapeutic use was achieved when choline was administered to patients suffering from muscular disease, muscular injury or epilepsy, while the non-therapeutic use arose from administration to a healthy consumer who has, for example, just completed major exercise.

In a more recent decision, T 815/22, the Board found that the use of an infant formula to induce a growth trajectory or development similar to that of breast-fed infants was non-therapeutic. In the decision, the Board found it relevant that the patent did not refer to infants who are affected by, or at risk of, any disorder and that all infants in the studies were healthy.

These cases show when therapeutic and non-therapeutic effects can be distinguished based on the patient or consumer group. If the product is administered to a patient that is affected by, or at risk of, a disorder, the use will likely be therapeutic. In contrast, if the product is administered to healthy individuals, the use is more likely to be non-therapeutic. The difficulty with this distinction arises with prophylactic effects achieved in a consumer who is both healthy and potentially at risk of developing a disorder.

In T 1916/19, the Board addressed the question: how likely must it be that the healthy consumer will develop a disorder for the method to be acknowledged as prophylactic therapy? Although this case does not relate specifically to a functional food, the reasoning can clearly be applied to functional foods which are intended for healthy consumers and to reduce the risk of disease.

The application in this case included claims covering both a therapeutic and a non-therapeutic effect of providing an anti-microbial effect to the skin using a particular composition. The examining division refused the application under Article 53(c) EPC, reasoning that antimicrobial activity is inherently a therapeutic prophylactic treatment of several diseases and that the therapeutic and non-therapeutic effects are inextricably linked. The Board disagreed.

The Board acknowledged that some of the realisations of the method were undoubtedly therapeutic, but also noted that some realisations were clearly non-therapeutic. The Board gave examples of therapeutic uses as application of the composition to individuals suffering from a bacterial skin infection or wound. The action of applying the composition to the hands was given as an example of either a therapeutic or a non-therapeutic use depending on the circumstances while removing body odour by applying a deodorant was an example of a non-therapeutic use.

Thus, again, the Board distinguished therapeutic and non-therapeutic indications based on the condition of the consumer or patient. The use is therapeutic if the patient is unwell, i.e. with a bacterial infection or wound, while the use is non-therapeutic for a healthy consumer who is not likely to develop a pathological state only because of the presence of potentially pathogenic bacteria on the skin.

These cases all confirm that there needs to be either an unwell or at-risk patient group for a use to be considered therapeutic, with T 2074/22 confirming that the patient group of “elderly persons” was considered “at-risk enough” for the treatment to be prophylactic. On the other hand, administration to healthy individuals with a low risk of developing a pathological disorder is considered a non-therapeutic use.

Claiming functional foods in a patent application

Functional foods are foods which provide a benefit beyond adequate nutritional effects in a way that improves health or reduces the risk of disease. Following the case law above, it seems that a functional food may fall into either the therapeutic or non-therapeutic use categories depending on the definition of the patient or consumer group.

Take, for example, functional food X which has been shown to reduce blood cholesterol. If a consumer with high blood cholesterol eats functional food X, their cholesterol is reduced and so too is their risk of developing coronary heart disease. The risk of consumers with high blood cholesterol developing coronary heart disease could be significant enough for this to be a therapeutic prophylactic use. If, on the other hand, a healthy consumer with normal blood cholesterol levels eats functional food X, their cholesterol may still be reduced, but their risk of developing coronary heart disease may be so low that this use is considered non-therapeutic.

Whether a use is therapeutic or non-therapeutic may depend on the information provided in the patent application. Therefore, it is critical to consider the uses and patient or consumer groups carefully when drafting an application.

When referring to a therapeutic use, applicants should ensure that their application defines the patient group and explains which diseases they are at risk from and how the biological effect of the functional food reduces that risk. The application will also need to include at least some experimental data to support any claimed biological effect and/or treatment of specific diseases. Finally, applicants should ensure that there is basis in the application to include the specific diseases and/or the at-risk patient group in the medical use claim language.

When referring to a non-therapeutic use, applicants should avoid statements that suggest overlap with therapeutic uses, for example discussions relating to treating diseases. Consider clearly stating that the intended consumer group is healthy and has a low risk of developing a pathological disorder. Applications will still require at least some experimental data to support any claimed biological effect in the healthy population and should include clear basis for non-therapeutic use claim language.

If an applicant is unsure whether a particular use is therapeutic or non-therapeutic, or if there are likely to be both therapeutic and non-therapeutic uses, text relating to both indications can be included in an application. However, care must be taken to describe the therapeutic and non-therapeutic indications separately in the application, for example avoid combining therapeutic and non-therapeutic indications into a single list. Also consider defining the different patient or consumer groups for each indication and ensure that there is clear basis in the application for both medical use claim language and non-therapeutic use claim language.