Consumer demand for food with health benefits is high and companies are working hard to respond to this. In 2021 the functional food market in Europe was estimated at €30 billion and forecast to grow at 2.9% per year. This has corresponded with an increase in patent filings related to functional foods[1]. However, recent case law has highlighted difficulties when trying to apply EPO medical use claim language to functional foods.
Use claims at the EPO
Different types of use claim are available at the EPO depending on the type of use for which protection is sought. A traditional use claim in the form of “The use of substance X as an insecticide”, can be used to protect a new non-therapeutic use of a known product. However, the Article 53(c) EPC exclusion from patentability of methods of treatment of the human or animal body by therapy means this traditional use claim language cannot be used when the new use is therapeutic.
For new therapeutic uses, the route to patent protection is provided by the legal fiction of Article 54(5) EPC. This acknowledges the notional novelty of substances or compositions, even when they are already known, provided they are claimed for a new use in a therapeutic method excluded by Article 53(c) EPC. These medical use claims usually take the form of “X for use in therapy” or “X for use in treating disease Y”.
What is therapy at the EPO?
At the EPO, therapy covers both curative and prophylactic methods of treatment, with prophylactic treatments being aimed at maintaining health by preventing ill effects that would otherwise arise.
A working definition of functional foods has been provided by the EU as a food which is beneficial beyond adequate nutritional effects in a way that improves health or reduces the risk of disease. Functional foods therefore occupy the space between foods and pharmaceuticals and are referred to as “borderline products”.
There is arguably overlap between maintaining health by preventing ill effects (the EPO’s prophylactic methods of treatment) and improving health and reducing the risk of disease (the EU’s functional food definition). The question of how the EPO deals with functional foods and their health claims and at what point these health claims become prophylactic methods of treatment was recently addressed by the Board of Appeal in T 815/22.
EPO Board of Appeal decision – T 815/22
The claim in this case related to an infant formula comprising lipid globules having a specific lipid architecture. It was undisputed by both sides that infant formula comprising these lipid globules was known in the prior art and consequently the patentee was relying on medical use claims specifying the therapeutic method as “promoting a postnatal growth trajectory or body development in an infant towards a growth trajectory or body development which is similar to the growth trajectory or body development observed in human milk fed infants”.
The patentee argued that this was a therapeutic method because infants who were formula-fed were known to be at risk of developing metabolic diseases such as obesity. It was argued that inducing a growth trajectory or development similar to that of breast-fed infants diminished the risk of disease and thus the claimed infant formula had a prophylactic therapeutic effect. The Board of Appeal disagreed.
In its decision, the Board referred to the Enlarged Board’s decision of G 2/08, in which it recognised that the provisions of Articles 53(c) and 54(5) EPC are complementary, such that if a method does not qualify as a therapeutic method under Article 53(c) EPC, a claim directed to a substance or composition for use in such a method cannot qualify as a medical use claim under Article 54(5) EPC. The Board of Appeal commented that it was important not to dilute the concept of treatment by therapy, which must be understood as the curative or prophylactic treatment of a pathological condition which is part of the core of the medical profession’s activities.
In relation to the specific facts of this case, the Board reasoned that although a malnourished subject may develop a variety of diet-related diseases, it would go against the rationale of Article 53(c) EPC to say that the ordinary provision of food to provide nourishment was a prophylactic method of treatment. The Board did not accept the patentee’s argument that the presence of the specific lipids possibly reduced the risk of metabolic disorders compared to infant formulas without those lipids, stating that what mattered was that feeding an infant with formula which promoted normal growth and development was not therapeutic.
Claiming functional foods in patent applications
In its decision, the Board cautioned applicants who try to obtain broad protection by claiming the attainment of a biological effect in a medical use claim rather than mentioning specific diseases, thereby running the risk that the intended use will not be considered therapeutic.
The Board found it relevant that claim 1 of 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. Perhaps if the infant formula had been shown to produce beneficial effects in a specific at-risk subset of infants, and the claim had been limited to that specific subset of infants, the outcome may have been different.
The Board also highlighted that infant formulas placed on the market are purchased in a non-medical, commercial environment and their use is the caregiver’s responsibility and not considered a medical intervention undertaken by members of the medical profession. This final point could be applied to any functional food and, if it were, it would seem to limit the utility of medical use claims in this area.
Given the borderline status of functional foods and the proximity of their effects to prophylactic methods of treatment, it still seems sensible to include medical use claims in applications for functional foods. However, to maximise the chances of navigating the EPO case law and emerging with robust functional food coverage, applicants should consider:
Including specific diseases in your application
Where medical use claims focus on the attainment of a biological effect, including specific diseases in the description and ensuring there is basis to amend the medical use claims, if necessary, provides a fallback position if this case law becomes problematic for your application. Your application will need to include at least some experimental data to support any claimed biological effect or treatment of specific diseases.
Including distinct patient groups in your application
Consider and discuss specific at-risk patient subsets for which the functional food is particularly relevant in the description of your application and ensure there is basis to incorporate these patient subsets into the medical use claims. As with the previous point, your application will require at least some experimental data to support the treatment of these patient groups.
Including traditional (i.e. non-medical) use claim language in your application
It is worth considering the inclusion of traditional use claim language directed to the attainment of the biological effect as well as medical use language in your application[2]. Ensuring that there is clear basis in your description for a non-medical use claim could be helpful if the intended use is deemed not to be therapeutic. However, if your application is drafted to cover both a medical use and a non-medical use, it is critical to provide individual support for each use.
The lists of medical and non-medical uses in the description should be distinct and any overlap should be avoided. For more information on distinguishing medical and non-medical uses see a previous article on therapeutic vs non-therapeutic use at the EPO.
