THALOMID Is Not An Innovative Drug Eligible For Canadian Data Protection

In Canada, drugs that are classified as “Innovative drugs” are eligible for eight years of data protection (data exclusivity). In April 2012, the Federal Court (Trial Division) held that Celgene’s new use of THALOMID for treating multiple myeloma was an “innovative drug” despite the previous approval of the medicinal ingredient thalidomide.¹ (For further information please see Scorned Drug Makes Unexpected Comeback that is “Innovative” Enough to Qualify for Canadian Data Exclusivity.) The Minister of Health appealed the Federal Court’s decision, and in a decision released February 15, 2013, the Federal Court of Appeal held that THALOMID is not an innovative drug and overturned the lower Court.²