Epicept Corporation v. Canada (Health) (2010 FC 956)

T-2009-09

Judicial review of Minister’s decision that CEPLENE is not an “innovative drug” for the purposes of data protection, CEPLENE, September 24, 2010

The Minister of Health refused to grant data exclusivity to data from Epicept’s phase I and phase II clinical trials because CEPLENE is not an “innovative drug”. CEPLENE includes the active ingredient histamine dihydrochloride for use in remission therapy in acute myeloid leukemia. CEPLENE was approved as a new drug and received a Notice of Compliance. The Minister refused to grant data protection because the active ingredient had been previously approved in another drug in Canada. This decision was important for Epicept as its relevant patent expires in 2010.

Epicept challenged the decision by way of judicial review. The Court upheld the Minister’s interpretation of an “innovative drug” under the data protection provisions and refused to grant data exclusivity to Epicept. The Court held that an “innovative drug” is a new drug whose active ingredient has not been previously approved.