Under the TRIPS Agreement, you are not obliged to grant patent protection to pharmaceutical new uses of known substances. As regards process patents on new uses, the exclusion of new use patents could be justified by broadly construing the "methods for treatment" exception under Article 27.3 (a), TRIPS Agreement (see below). This argumentation cannot be advanced, however, in order to exclude product patents on new uses. Product patents on new uses can only be excluded from patentability by strictly applying the patentability criteria (see chapter 2.4).

This TRIPS provision clearly aims at avoiding the risk that patents could prevent medical doctors from administering treatments in their every day practice, for example, in prescribing the dosage of prescribed medicines for specified patients.

Due to the absence of any authoritative interpretation of Article 27.3 (a), TRIPS Agreement, you as a legislator can construe this provision narrowly (Option 1) or broadly (Option 2) and thus determine whether in your country new uses can be patented or not.

The circles below present Article 27.3 (a) of the TRIPS Agreement. If you move your mouse into the inner or outer circle, the explanation will appear.

 

The second option, which would justify the exclusion from patentability of new uses of known substances, is indirectly supported by the so-called "Swiss formula" practice of the European Patent Office (EPO). To learn more about this Swiss formula and the patentability of new uses under the European Patent Convention (EPC), please follow the link to the document below.

Patentability of new uses under the European Patent Convention and the "Swiss Formula" (.pdf, 15 kB)