Patenting cosmetic methods encompassing therapy

The European Patent Convention prohibits the grant of patents to "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body" (Article 53(c) EPC). This exclusion is seen most often for inventions in the medical sector. However, objections to non-patentable therapeutic methods may also arise in the cosmetics sector, even if this is not the intended use of the invention, and the options to overcome this require great care.

According to EPO case law, therapy relates to the treatment of a disease in general or to a curative treatment in the narrow sense, as well as the alleviation of the symptoms of pain and suffering. A prophylactic treatment, aimed at maintaining health by preventing ill effects that would otherwise arise, also amounts to a method for treatment by therapy.

The exclusion from patentability of therapeutic methods does not refer to cosmetic methods. The EPO's Enlarged Board of Appeal has explained that the express wording of the exclusion of therapeutic methods cannot be extended to treatments which are not therapeutic in character (such as cosmetic methods). Thus, while it is not possible to claim a therapeutic method at the EPO, it can be possible to claim a cosmetic method, such as for example "A method of dyeing hair using a composition comprising...". Claiming a cosmetic method in this way may be helpful where the cosmetic composition is itself known (and thus not patentable for lack of novelty) but is used in a new and inventive way.

Yet, difficulties arise where a cosmetic method encompasses both therapeutic and non-therapeutic indications. A recent decision by the EPO Board of Appeal (T1916/19 of 19 May 2020) illustrates these difficulties, where claims of the patent application were directed to "a non-therapeutic method of providing an anti-microbial effect to skin comprising the steps of applying a composition to the skin...".

The Examining Division refused the application because the antimicrobial activity of the composition would remove pathogenic microorganisms from the skin and thereby provide a prophylactic therapeutic method. Since the claim inevitably encompassed a method of therapy (despite being intended for a cosmetic use), it was prohibited from patentability under Art 53(c) EPC. This approach was supported by a long line of EPO case law confirming that a cosmetic method is excluded from patentability if it also encompasses a method of therapy.

In some cases, a disclaimer might be used to specify that the method is "non-therapeutic", with the result that the claim no longer encompasses the non-patentable therapeutic method. The disclaimer may not even need to be disclosed in the application as originally filed (an undisclosed disclaimer) on the condition that it only removes subject matter that is excluded from patentability for non-technical reasons (in this case a therapeutic method). However, this is only possible where the cosmetic and therapeutic effects are clearly distinct, which the Examining Division did not believe was the case when providing an anti-microbial effect to the skin. The Examining Division therefore refused the patent application.

The EPO's Board of Appeal disagreed and overturned the Examining Division. The Board explained that some realisations of the claimed method might be therapeutic in nature, e.g. where the individual is suffering from a bacterial skin infection or a wound. Other realisations may or may not be therapeutic depending on the specific circumstances, e.g. applying the composition to the hands. However, other realisations are clearly non-therapeutic, e.g. removing non-pathogenic bacteria responsible for body odour such as in a deodorant. Even where pathogenic bacteria may also inevitably be removed, this is not necessarily prophylactic therapy, because potentially pathogenic bacteria present on the skin of a healthy individual are not likely to develop a pathological state. For this reason, the Board concluded that the non-therapeutic indication was distinct and allowed the disclaimer to a "non-therapeutic" method.

The Board went on to summarise that there are essentially three types of method in this context: a) purely non-therapeutic; b) purely therapeutic; and c) mixed therapeutic and non-therapeutic. Where a method is purely non-therapeutic, no objection should arise because there is no therapeutic method present. Where a method is a mix of therapeutic and non-therapeutic, a disclaimer to "non-therapeutic" may be allowed provided that the non-therapeutic method is clearly identifiable and separate from the therapeutic method. However, where a method is purely therapeutic, a disclaimer to "non-therapeutic" would not be allowed, because the disclaimer would render the claim scope void and would be self-contradictory¹.

This is a welcome outcome for applicants in the cosmetics sector. Claims to cosmetic methods may be especially valuable where inventions lie in the new use of a known cosmetic ingredient or composition. It is therefore useful for applicants to consider when drafting patent applications if a cosmetic method could encompass a therapeutic method, and if the cosmetic method is clearly identifiable and separate from the therapeutic method. Many of these difficulties could be addressed by careful drafting of the patent application, specifically focussed on the European rules, making it worth seeking European input before first filing.

Alternatively, if an undisclosed disclaimer is introduced after filing, it must be used with extreme caution, since if applied incorrectly it could severely prejudice the validity of the patent after grant. For example, if an undisclosed disclaimer is found to remove more subject matter than necessary, it can be found to add subject matter. Or, if the disclaimer does not remove enough subject matter, the claim can still encompass non-patentable subject matter. In either case, it is unlikely that an erroneous disclaimer can be rectified after grant, since this could lead to unallowable claim broadening. Experienced professional representation is recommended for use of disclaimers.

In summary, cosmetic methods can receive objections to non-patentable subject matter at the EPO if they encompass therapeutic methods, even if this is not the intended use of the invention. A disclaimer to a "non-therapeutic" method may be allowable, but only in specific circumstances and with great care.

For further information, contact Frederick Nicolle, Managing Associate (Patent Attorney), Intellectual Property at Simmons & Simmons.

¹ It may also be possible to protect the therapeutic aspect in terms of a substance or composition for use in the therapeutic method (i.e. as a 2nd medical use claim), but this is outside the scope of this article.