THALOMID Is Not An Innovative Drug Eligible For Canadian Data Protection

Author:Ms Ainslie Parsons and Noel Courage
Profession:Bereskin & Parr LLP

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

Thalidomide has a controversial past: while it was approved in Canada as early as 1960 and prescribed to treat sleeplessness and morning sickness in pregnant woman, it was permanently taken off the market in 1962 when it was discovered that it was associated with severe birth defects.

Research by Celgene in the 1990's established that thalidomide was useful for treating conditions such as cancer and leprosy. Marketing authorization was issued to Celgene on August 4, 2010, for the use of THALOMID for treating multiple myeloma. However, the government advised Celgene that THALOMID was not eligible for data protection because the medicinal ingredient had been previously approved. Celgene applied for judicial review of the government's decision and the Federal Court sided with Celgene, holding that the prior thalidomide approval should not stand in the way of data protection of THALOMID.

The Canadian Data Protection Regulations (the Regulations) define an "innovative drug" as a "drug that contains a medicinal ingredient not previously approved by the Minister."3  Writing for the majority of the Federal Court of Appeal, Justice Gauthier rejected Celgene's argument that the word "approved" refers to the current status of the drug. Celgene submitted that reading down the definition of an innovative drug in this manner is consistent with the purpose and object of the Regulations and Canada's international treaty obligations.

The Court of Appeal held that a medicinal ingredient such as thalidomide that once received regulatory approval is "previously approved" for the purposes of the Regulations. Data protection is limited to new medicinal ingredients which means, in this context, submitted for the first time to the appropriate authority. The fact that...

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