Methods of treatment: is there any protection available in europe?

Author: Colm Murphy

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are not patentable in Europe because they are not regarded as inventions which are susceptible of industrial application. This provision, which is set out in Article 52(4) of the European Patent Convention (EPC), is also embodied in the National laws of the member states of the EPC. The exclusion is included solely on the grounds of public policy to ensure that those who carry out such methods as part of their medical or veterinary duties are not inhibited by the existence of patents.

Pharmaceutical companies, however, carry out significant research to identify new therapeutic uses for known compounds. Because these compounds are already known, patent claims directed to the compounds per se are not available. In the United States developments of this type may be protected using method of treatment claims. So how then can protection be achieved for such new therapeutic applications within the legislative framework that is in place in Europe?

What is Patentable?

Firstly, Article 52(4) EPC, being an exclusionary clause, must be interpreted narrowly. It does not, of course, apply to those treatments that do not include a therapeutic element or constitute a surgical or diagnostic method. A single step in a claim that involves a therapeutic, surgical or diagnostic procedure will be sufficient to render the claim unpatentable. A considerable body of case law has developed in Europe that provides guidance on the types of methods that are considered to fall outside the exclusion.

Generally, therapy is interpreted broadly and embraces prophylactic methods as well as curative treatments, so trying to argue that a method does not result in therapy because it is merely preventative will not work. The question of whether a medical practitioner is required to carry out the method, while providing a useful indicator, is not sufficient in its own right to decide whether a particular method will be excluded. However, if a medical practitioner must carry out the procedure, it is a likely indication that a method of treatment is being performed.

Non-therapeutic treatments are patentable if the non-therapeutic effect is distinct and separate from any therapeutic effect. Thus, for example, cosmetic methods will be patentable if it can be shown that the cosmetic effect is not inextricably linked to any therapeutic effect that may also be occurring. If the effects are not separable, merely calling the method 'a cosmetic method' will be insufficient to meet the requirements of Article 52(4).

A diagnostic method must, of course, be practiced on the human or animal body for it to be excluded, in which case any diagnostic method performed on cells in culture, or a sample obtained from a patient, should fall outside the exclusion. A surgical procedure is prohibited from patentability regardless of its intended purpose, therapeutic or otherwise.

Article 52(5) EPC explicitly provides that any substance or composition for use in a method of treatment may still be patentable. Therefore, the Article 52(4) exclusion is designed to control what a doctor administers to a patient as opposed to how he administers it. This concept of novelty is not available in any other technical field. For example, in the mechanical field, a claim worded as 'apparatus for use in a field Y', will not be novel if the apparatus per se is known. The prescribed use is not considered limiting to the apparatus features. In the event that a known compound does not have any previously recognised use in any medical application, the Enlarged Board of Appeal of the European Patent Office (EPO) in the landmark decision of G5/93¹ ruled that such a new use can be claimed broadly as 'composition X for use as a medicament', and no specific indication of the therapeutic use is required for the claim to be considered allowable.