European Patent Office (EPO) - Second Medical Use Claims

Newsletters and Bulletins / February 2002 / European Patent Office

European Patent Office (EPO) - Second Medical Use Claims in Patents

Although the European Patent Convention does not permit claims to medical methods of treatment, claims are permitted to use of known compounds for the production of medicaments for treatment of specific diseases, even if the compound is known to have some other medical use. The theory is that such claims would be infringed by those who manufacture and supply such medicaments for such an intended use but not a physician or patient who actually uses the compound. (See our Guide on European Patent Practice). In recent years, much more has become known about the underlying mechanisms of disease and it has become common to try to use claims of the type described above which, instead of defining the disease that is to be treated, instead define some underlying biological function. In Serotonin receptor/Eli Lilly, the claim in question reads

The use of (a particular compound) for the preparation of a medicament for treating a mammal suffering from or susceptible to a condition which can be improved or prevented by selective occupation of the 5-Ht_ic receptor.

The examining division rejected the claim as lacking clarity. The Applicant appealed. The Appeal Board noted that, although functional language in itself was not objectionable, as long as the application contained sufficient instruction as to how to determine whether the stated functional requirement was met or this information was otherwise from common general knowledge, but went on to say that in the present case,

"selective occupation" of a receptor, although being indisputably a pharmacological effect, cannot in itself be considered a therapeutic application. The discovery on which the invention is based, even if representing an important piece of scientific knowledge, still needs to find a practical application in the form of a defined real treatment of any pathological condition in order to make a technical contribution to the art and be considered an invention eligible for patent protection. (Emphasis in the original)

The Board therefore concluded that, since a claim, in the format before it, extended, not only to treatment of specific diseases mentioned in the application, but also to other unspecified diseases having the stated mechanism, claims in this form could

only be regarded as being clear if means are available to the skilled person for assessing whether or not an additional condition, not expressly cited in the application, but nevertheless affected by administering (the specified compound) is comprised within the scope of the claim.

The Board reviewed the evidence and concluded that at the filing date of the application,

no means involving testable criteria existed to assist the skilled person in assessing whether or not a "condition" improved or prevented by (the specified compound) was comprised in the functional definition of the claimed subject matter.

The claim therefore lacked clarity and the application was remanded to the examining division to consider claims specifying that the medicaments in question were for treatment of specific diseases mentioned in the application.

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