Part 2: Deep dive into the EPO case law relating to claims at the interface of therapeutic and non-therapeutic uses
In the second part of our series looking at claiming new uses in Europe, we take a deep dive into the EPO case law relating to use claims at the interface between therapeutic and non-therapeutic uses to help illustrate the pitfalls applicants may face when claiming a new use.
For an introduction to pursuing protection for new uses in Europe, please see Part 1 of our series here, providing a practical guide to consider when drafting and prosecuting applications directed to new therapeutic or non-therapeutic uses.
Below we consider issues that may arise when a non-therapeutic use inevitably has a therapeutic effect, we look at cases where therapeutic uses and non-therapeutic uses were considered to be distinguishable and we highlight issues that may arise when a claimed medical use is not considered to be a therapeutic use.
Therapeutic and non-therapeutic uses are indistinguishable
In T 290/86 the EPO’s Board of Appeal considered if the use of a composition for the removal of plaque was solely cosmetic or necessarily defined a therapeutic treatment. Although the proprietor had argued that the removal of plaque from a person's teeth has a clear cosmetic aspect insofar as the resulting cleaner teeth improves the appearance of that person, the patent disclosed that plaque is a dominant etiological factor in caries and periodontal disease and that the removal of plaque was beneficial in those conditions.
The Board reasoned that cleaning plaque and/or stains from teeth will always inevitably have a therapeutic effect (at least in the prophylactic sense) as well as a cosmetic effect. As the two effects could not be separated, the claimed cosmetic use was not allowable.
Practical point – Claims to a non-therapeutic use that always inevitably encompasses a therapeutic use are not allowable at the EPO. Applicants wishing to claim only the non-therapeutic or cosmetic use of a composition should avoid any suggestion that a therapeutic effect may also be obtained.
Similarly, T 158/13 claimed a non-therapeutic use of a stimulative perfume composition for releasing persons from a physiological mental condition of sleepiness, sense of fatigue and inactivity in daily life, and for refreshing and activating their mental condition. The Board reasoned that sleepiness or inactivity in daily life may not only be a physiological condition, but may also arise from a pathological condition, such as depression, which cannot be clearly distinguished from a non-pathological condition.
Use of the term “perfume” in the claim didn’t exclude the therapeutic use because the patent demonstrated that the administration of the perfume composition led to a clearly measurable stimulative effect on the brain. So it was not possible to draw a clear distinction between therapeutic and non-therapeutic use.
Practical point – Using terminology from the art to imply a non-therapeutic use may not be enough to exclude a therapeutic use that is inevitably achieved. Be explicit that the composition is for a non-therapeutic or cosmetic use and clearly define the group of consumers that would benefit from the non-therapeutic or cosmetic use of the composition. Include data showing the non-therapeutic benefits of the composition in the relevant consumer group. When claiming only the non-therapeutic use, avoid including data that demonstrate a therapeutic effect.
Therapeutic and non-therapeutic uses are distinguishable
In T 144/83 the Board considered a claim to a method of improving the bodily appearance of a non-opiate-addicted mammal, which comprised dosing of a composition until a cosmetically beneficial loss of body weight occurred. The Board acknowledged that in some cases it may be difficult to distinguish between the cosmetic and therapeutic effect, i.e., losing weight and curing obesity. They reasoned, however, that this should not be allowed to work to the disadvantage of an applicant who, according to the wording of the claims, seeks patent protection for cosmetic treatment but not for the therapeutic treatment as such. Claims to the cosmetic use were therefore allowed.
Practical point – Careful wording of a non-therapeutic use claim may result in the claimed use being allowable even when it is, in some circumstances, difficult to distinguish between the cosmetic and therapeutic effect. When therapeutic and non-therapeutic uses will be claimed, ensure the description describes each use individually and take care to draw a distinction between the therapeutic and non-therapeutic uses to be claimed.
In T 1916/19 the Board considered a non-therapeutic method of providing an anti-microbial effect to skin. The Board acknowledged that at least some realisations of the claimed method of providing an anti-microbial effect on skin are therapeutic in nature, e.g., where the composition is applied to individuals suffering from a bacterial skin infection or a wound. However, the Board also followed the arguments of the proprietor that there are at least some realisations of the method which are clearly non-therapeutic. Removing non-pathogenic bacteria responsible for unpleasant body odour e.g., by applying a deodorant composition, is not a therapeutic/prophylactic application, but a cosmetic application. The claimed non-therapeutic use was allowed.
Practical point – It is useful to be able to point to realisations of a method which are clearly non-therapeutic, even when there are other realisations of a method which are therapeutic. Clearly define patient groups and/or consumer groups for different uses of the composition.
Claimed medical use not a therapeutic use
In T 1186/16, the Board considered a claim to a food material comprising palatinose and a foodstuff composed of certain types of carbohydrates for use in a method of reducing the blood glucose level increase caused by consuming the foodstuff. The proprietor had argued that the claims inherently excluded the treatment of healthy individuals and non-therapeutic embodiments. However, the Board did not agree. They reasoned that fluctuations of glucose blood levels are physiologic, and glycaemia typically increases after consumption of carbohydrates, such as sucrose. This natural phenomenon occurs in healthy individuals without being associated with any pathological condition. The Board also highlighted the use of palatinose in sport drinks used by athletes to supply a constant stream of energy to the muscles over a long time and, as a result, to enhance endurance performance. The Board therefore concluded that healthy individuals benefit from a prevention of increases of blood glucose levels caused by the ingestion of carbohydrates and that the achievement of this effect serves non-therapeutic purposes.
Further to this, the patent did not mention "therapy" or "therapeutic treatment" and the tests reported in the patent were carried out on healthy individuals. There was also no evidence provided that healthy individuals, such as healthy athletes practising sport, would inevitably enjoy a therapeutic benefit from the claimed method. The claims were therefore interpreted as a food material comprising palatinose and a foodstuff composed of certain types of carbohydrates (that is merely) suitable for use in a method of reducing the blood glucose level increase caused by consuming the foodstuff.
Practical point – When claiming a therapeutic use applicants should seek to provide data demonstrating the claimed therapeutic benefit derived by individuals in the intended market. Describe specific patient groups that would benefit from receiving the composition for therapeutic purposes, define the disease(s) to be treated, and include data evidencing the therapeutic effect of the composition.
More recently, in T 815/22, the Board considered a claim to a nutritional composition for use in 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 proprietor had argued that the invention was limited to the therapeutic use of the nutritional composition, specifically the use of the claimed infant formula in an "at-risk" group of formula-fed infants to promote a growth pattern or body development which prevented the occurrence of metabolic diseases such as diabetes. However, the claim did not refer to infants affected by or at risk of any disorder.
The idea underlying the claimed invention was considered by the Board to be the administration of a nutritional composition to infants which is similar to human milk, in order to promote a postnatal growth trajectory or body development which is similar to that observed in infants fed with human milk. For all infants, receiving nourishment is a prerequisite for healthy development and for preventing disorders which could arise if an infant is malnourished or fed with a food which does not promote normal growth. The Board concluded that the use of infant formulas for providing nourishment and promoting the normal growth trajectory and body development observed in breastfed infants does not qualify as a medical use.
Practical point – If a product will be marketed to a group of consumers that encompasses, but is not limited to, consumers that will obtain a therapeutic effect, consider pursuing claims to a non-therapeutic use and/or therapeutic use claims that define a patient group.
Conclusions
Before claiming a new therapeutic or non-therapeutic use in Europe, careful consideration should be given to the intended market for the composition. As set out in our practical points in Part 1 of our series of articles on this topic here, when drafting a new application we recommend defining possible patient and/or consumer groups, defining any disease to be treated and including data showing the therapeutic effect and/or non-therapeutic benefits of the composition in the defined patient and consumer groups.
If you would like to discuss claiming a new therapeutic or non-therapeutic use in Europe please do reach out to Sophie Evans or your usual Kilburn & Strode contact.