Supreme Court of Canada renders landmark decision on patentability of methods of medical treatment

This was the first time the SCC has addressed the patentability of so-called “methods of medical treatment” in decades. This ruling clarifies some of the inconsistencies that have developed in this area since the Tennessee Eastman decision in the 1970s while, at the same time, leaves considerable room for debate and uncertainty in how this ruling should be applied moving forward.

Background

The patent at issue relates to uses of paliperidone palmitate (which Janssen sells under the brand INVEGA SUSTENNA^®) in the treatment of schizophrenia. The claims at issue were to a dosing regimen for treating schizophrenia that required patients to receive:

1. A first loading dose of 150 milligrams equivalent [mg-eq.] of paliperidone palmitate administered into the deltoid muscle on Day 1 of treatment;
2. A second loading dose of 100 mg-eq. of paliperidone palmitate administered into the deltoid on Day 8 ± 2 days; and
3. Maintenance doses of 75 mg-eq. of paliperidone palmitate administered into the deltoid or gluteal muscle monthly ± 7 days after the second injection.

The only issue on appeal was whether the claims constituted patentable subject matter.