A use of a substance or composition for the treatment of humans by therapy is excluded from patentability according to the EPC Article 53(c). However, claiming a non-therapeutic use of a substance or composition may still fall under this same exclusion if the non-therapeutic use is inseparably associated with a therapeutic use.
This was confirmed by the Technical Board of Appeal in a case against a decision from the Opposition Division (T1635/09). The case in suit related to the use of a contraceptive composition with reduced concentrations of the active substances, wherein the use had the further effect of preventing or reducing pathological side-effects (i.e. a therapeutic effect).
In the Board’s assessment of the subject-matter of the patent as a whole it was found that the reduced concentrations served solely to prevent or reduce the side-effects. Thus, the contraceptive effect was inseparably associated with the therapeutic effect.
Provisions in the EPC exist for claiming the substance or composition for use in the treatment; previously in the form of Swiss-type claims, i.e. a claim directed at the use of a substance or composition for the manufacture of a product for the treatment in question. However, the Board finds that the wording “manufacture of a product” according to the Swiss-type claim inherently provides an additional protection of the product per se. Hence, in T1635/09 it was further confirmed that a use claim (as excluded under EPC) cannot readily be converted into a corresponding Swiss-type claim (or the equivalent new format) without also extending the protection of the patent.
Consequently, owing to the facts of this case, applicants (in particular from the U.S., where the similar use claims are not excluded from patentability) should carefully consider the form and wording of use claims directed at protecting treatments by therapy as well as claims related to non-therapeutic uses, wherein the use may be associated with a therapeutic effect.
Jakob Leffland Reimers, Associate