Monday, February 25, 2013

Is Thalidomide an "Innovative Drug"?

Monday, February 25, 2013
Earlier this month, the Federal Court of Appeal in a two to one decision decided No, Thalidomide is not an “Innovative Drug”.

Thalidomide has had a checkered past. It was launched commercially in the late 1950s, approved in Canada in November of 1960 under the brand names Kevadon and Talimol, as a treatment for morning sickness and other pregnancy associated ailments. In April 1962, thalidomide was permanently withdrawn from the Canadian market and its approval cancelled because of its devastating terateogenic effects which resulted in thousands of children being born with deformed or missing limbs (see Paragraph 5 of the FCA decision).

Thalidomide was later shown to be effective for the treatment of various life threatening conditions including leprosy and some forms of cancer. An NOC was issued for Thalidomide in 2010. The Minister of Health at that time “advised Celgene that THALOMID would not be eligible for data protection because its medicinal ingredient, thalidomide, had been previously approved by the Minister in at least two drugs - KEVADON and TALIMOL.” (see Paragraph 18 of the FCA decision). The Minister’s decision was overturned by the Federal Court.

As noted in the FCA decision, the Federal Court decision (paragraph 31) was “based on the following combined facts:
i. The prior approval of thalidomide was short lived and should never have been given at the time;
ii. Thalidomide was effectively banned until Celgene came up with its NDS for THALOMID; and,
iii. The 2010 NOC approval was granted for Celgene’s product on the basis of completely new studies and data.” 
The Federal Court of Appeal reviewed this decision, focusing in its review on “Is thalidomide a “medicinal ingredient not previously approved in a drug by the Minister”?” paying particular attention to the meaning of “previously approved” (See paragraph 40 of the FCA decision).

The Federal Court of Appeal in its decision did not view the over 30 year ban as relevant and concluded that the phrase “previously approved” should be strictly construed to include any prior approval and therefore thalomide is not an “innovative drug” and not entitled to data protection.

By Claire Palmer