As explored in “The Line Between Beauty and Science I: Patent Strategies for Biotherapeutic Cosmetics”, in the field of bio-cosmetics, “use” claims are a valuable tool for protecting innovations involving known biotherapeutic molecules that have been found to serve a new cosmetic purpose. However, as this article explores, patent applications for such use claims must be carefully drafted to avoid falling within the European Patent Office’s (EPO) exclusions for therapeutic methods. Below, Partner Samantha Moodie and Associate Clare Pratt examine relevant EPO case law and offer practical guidance for drafting successful patent applications in this evolving area.
Cosmetic use claims: The importance of distinguishing between therapeutic and non-therapeutic effects
Under the European Patent Convention (EPC), patents cannot be granted for methods of treating the human or animal body by surgery or therapy, or for methods of diagnosis practised on the human or animal body (Article 53(c) EPC). Nevertheless, the EPO has allowed Applicants to navigate around such exclusions and protect new and innovative medical treatments by means of purpose-limited product claims (i.e. “compound X for use in the treatment of disease Y”), wherein the use of compounds or compositions in therapeutic methods determines patentability.
Crucially, cosmetic uses or treatments are not excluded under Article 53(c) EPC.
When a known compound is identified as having a new cosmetic use, non-therapeutic method claims (rather than purpose-limited product claims) can be pursued at the EPO. For example, claims may be directed towards: “Use of compound X in the cosmetic treatment of Y,” “cosmetic use of X for purpose Y,” or “non-therapeutic use of X for purpose Y.”
The EPO has acknowledged that reciting “cosmetic use” or “non-therapeutic use” in such cosmetic use claims excludes (or disclaims) any therapeutic effects that could be considered to fall within the scope of the claim, and which would otherwise render the claim unpatentable under Article 53(c) EPC. However, as confirmed in the EPO’s Board of Appeal decision T 36/83, this disclaimer language is only allowable where products have a cosmetic effect that is clearly distinguishable from any therapeutic effect. In the case in question, a claim directed to “Use as a cosmetic product of thenoyl peroxide” was found to be allowable. The Board considered that the “cosmetic” disclaimer was allowed because the medical use of thenoyl peroxide to treat acne could be distinguished from the cosmetic use of thenoyl peroxide to cleanse healthy skin.
Drafting tip: When drafting ‘cosmetic use’ patent applications, it is advisable to include basis for disclaimer wording, such as “cosmetic use” and/or “non-therapeutic use”, to clearly exclude non-patentable therapeutic effects from falling within the scope of the claims.
Cosmetic use claims: The challenge of inextricably linked effects
Difficulties arise when a molecule exhibits both therapeutic and cosmetic effects that are inextricably linked and cannot be clearly separated. In this situation, where a cosmetic method has an underlying (even if unintended) therapeutic benefit, the exclusions under Article 53(c) EPC are often applied, even if the Applicant does not intend to cover any therapeutic application.
For example, in T 290/86, a cosmetic treatment relating to the removal of plaque from teeth was considered unpatentable as this method was held to inevitably prevent tooth decay, which has a therapeutic effect. A key factor in the Board’s decision was the discussion in the description of the beneficial effects of removing plaque. The Applicant had described 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 therefore took the view that cleaning plaque from teeth will always inevitably have a therapeutic effect which could not be separated from any cosmetic effect, and which rendered the use claims unpatentable.
Similarly, in T 780/89, claims to the use of certain compounds for non-therapeutic immunostimulation (stimulation of the body’s own defences) were not allowed. The Board of Appeal took the view that immunostimulation constituted a prophylactic treatment because infection is prevented.
In these instances, since the therapeutic use could not be separated from the non-therapeutic, cosmetic use, the inevitable therapeutic effect of the biological molecule could not be excluded by the use of the “cosmetic” or “non-therapeutic” disclaimer language.
Drafting tip: If protection is only sought for a non-therapeutic, cosmetic use, Applicants should avoid including statements in the description that relate to or describe any alleged therapeutic benefit of the cosmetic molecule. Such discussions may undermine any arguments that the claimed use is purely cosmetic.
Cosmetic use claims: When dual effects are acceptable
Despite these decisions, there are some useful examples of cases at the EPO where Applicants have successfully argued that a cosmetic use is patentable, even though the method potentially has a therapeutic effect alongside the claimed non-therapeutic effect.
In T 144/83, claims were granted to a method of weight loss using an appetite suppressant. The Board acknowledged that weight loss methods could have a therapeutic purpose for treating obesity but could also have a cosmetic purpose for enhancing appearance, and that in some cases, these therapeutic and non-therapeutic uses can be adjoined “without a sharp distinction”, meaning that it could be difficult to distinguish between them. However, in this case, the Applicant’s claim specified weight loss “until a cosmetically beneficial result is achieved,” without referring to obesity treatment. As a result of this wording, the Board held that the claim was limited to a cosmetic purpose, and the exclusion under Article 53(c) EPC should not apply.
Drafting tip: If it is difficult to distinguish between cosmetic and therapeutic effects, including carefully crafted disclaimers (“until a cosmetically beneficial result is achieved“) can be sufficient to exclude any potential overlapping therapeutic effect.
More recently, T 1916/19 provided further guidance on situations where cosmetic uses are patentable even when there is a potential overlapping therapeutic effect. The application related to a composition with antimicrobial effects. At first instance, the EPO rejected the application on the ground that the antimicrobial effect would inherently provide a prophylactic treatment for pathogenic bacteria. The Board of Appeal however reversed this decision and held that there were some realisations of the claimed method that were not therapeutic. In particular, the Board took the view that the removal of bacteria from healthy skin is not necessarily prophylactic, and that the presence of pathogenic bacteria on the skin of a healthy individual does not necessarily lead to a pathological state. Further, they also acknowledged that the removal of non-pathogenic bacteria could provide a cosmetic effect by reducing unpleasant body odour. As a result, the application proceeded to grant with both a non-therapeutic method claim, covering the cosmetic use, and a purpose-limited product claim, covering the therapeutic use.
A key persuading factor in this case was the argument that the prophylactic aspect of the claimed method would not be encompassed when the method was performed on a “healthy individual”.
Drafting tip: For those inventions involving compounds that have both a therapeutic and non-therapeutic effect, whether these are considered “inextricably linked” will depend on the information provided in the application. Where there is more than one use, these different uses should be clearly distinguished in the application. If there is a possibility of the use being considered to involve therapeutic and non-therapeutic effects that are linked, it is advisable to include separate definitions of the patient group or consumer for each use. For example, when claiming a non-therapeutic, cosmetic use, it may be useful to define the user as a “healthy individual”.
When Applicants are interested in claiming therapeutic uses alongside cosmetic uses, a clear definition of the diseases that can be treated should be included alongside data that demonstrates the intended therapeutic effect. In addition, user groups relevant for the cosmetic use and separate data demonstrating the cosmetic effect should also be included.
Conclusion
Given the blurred line between cosmetic and therapeutic effects in cosmetics containing biological molecules, precise and careful drafting is essential. Where dual effects are possible, patent applications should distinguish uses, define user groups, and support claims with appropriate data. With the right approach, both cosmetic and therapeutic claims can co-exist within the same application, offering robust and flexible IP protection.
