In a very recently published decision, the European Patent Office (EPO) has clarified the distinction between standard use claims and 2nd medical use claims, i.e. the claim format allowed by the EPO in order to circumvent the European Patent Convention’s (EPC’s) prohibition regarding the patentability of methods of therapeutic treatment of the human or animal body.

In particular, in decision no. T 1635/09 the EPO Board of Appeal had to decide whether the use, as an oral contraceptive, of a composition in which the claimed concentrations of the hormone content are so low that they prevent or reduce the likely pathological side-effects of the oral contraceptive could be patented at the EPO or not.

In its decision, the Board referred to the fact that the EPO normally considers a contraceptive use as patentable. Nevertheless, in the case at hand the Board considered that the feature whereby the claimed hormone content concentrations are so low that they prevent or reduce the likely pathological side-effects of the oral contraceptive represented a therapeutic treatment method feature.

The Board further held that, in the present case, the feature relating to the hormone content concentrations was an essential feature of the invention (i.e. it could not be deleted from the claims). Thus, the therapeutic aspect of the claimed subject-matter (reduction or prevention of side-effects) could not be separated from the non-therapeutic aspect (contraception), not even by a disclaimer such as the language “non-therapeutic use”.

Of course, the above issue might have been resolved by rewording the claims n the 2nd medical use format (“Use of a product X for manufacturing a medicament for use in therapy Y”) rather than in the standard use format (“Use of a product X for exerting activity Y”). However, in the present case the patent (including standard use claims but no 2nd medical use claims) had already reached grant when the matter reached the Board. As a result, the Board had to consider whether the patent could be rescued by rewording the standard use claims as 2nd medical use claims. Now, the EPC prohibits the rewording of granted claims when such rewording causes the resulting claims to cover subject-matter not already covered by the granted claims, and thus causes a change of scope of the patent. Interestingly, the Board held that such rewording could not be allowed in the present case, as the standard use claims and 2nd medical use claims, albeit being use claims, have different scopes.

Thus, in this decision the Board has addressed the question of how the two claim formats (standard use claims and 2nd medical use claims) compare to one another in terms of scope, and has established that the scope of these two claims format is not the same.

It remains to be seen whether this decision will be followed by the EPO in the future, especially as it is quite unusual that the EPO addresses claim scope issues resembling infringement considerations.

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