Canada: Federal Court Grants Data Protection To THALOMID

Last Updated: March 25 2012
Article by Julian Worsley

In Celgene Inc. v. The Minister of Health, 2012 FC 154, the Federal Court considered a judicial review application challenging the Minister of Health's refusal to list Celgene's drug THALOMID on Health Canada's Register of Innovative Drugs (the "Register"). In the result, the Federal Court granted the judicial review, and declared that THALOMID is an "innovative drug" and eligible for listing on the Register.

By way of background, with amendments to the Food and Drug Regulations ("FDR") in 2006, a generic manufacturer may not file an ANDS on the basis of a comparison to an "innovative drug" within the first six years of the eight-year period after the innovative drug has received a notice of compliance ("NOC"). In addition, the Minister of Health may not issue an NOC to the generic manufacturer before the end of the eight-year period. It is these prohibitions that result in what is known as "data protection." In short, Health Canada cannot approve generic versions of drug products that are listed on the Register until the expiry of the data protection term. An "innovative drug" is defined in C.08.004.1(1) of the FDR as "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph." The interpretation of this definition, and in particular the words "previously approved" was the focus of this judicial review.

As described by the Court, the drug thalidomide was originally approved in 1960 (KEVADON) and 1961 (TALIMOL) before being withdrawn from the market in 1962 due to its teratogenicity. Despite its tragic history, thalidomide was eventually found to be effective in the treatment of leprosy and other conditions, including cancer. As set out by the Court, Celgene was exclusively devoted to the commercialization of thalidomide to treat life-threatening diseases, including cancer and a painful condition associated with leprosy. Celgene's THALOMID brand of thalidomide was available in Canada through Health Canada's Special Access Programme starting in 1995. In 2009, Celgene filed a new drug submission ("NDS") with Health Canada, and a NOC was issued in 2010.

The Minister of Health advised Celgene, however, that THALOMID was not eligible for data protection because the medicinal ingredient, thalidomide, had been previously approved by the Minister in at least two drugs, and sought submissions from Celgene on the issue. Celgene took the position that thalidomide should not be considered as having been previously approved within the meaning of C.08.004.1 of the FDR; in addition, Celgene argued that THALOMID should be added to the Register because the NDS for THALOMID contained new, significant independent data. Ultimately, the Minister of Health determined that THALOMID was not eligible to be added to the Register, and Celgene brought this judicial review of the Minister's decision.

In the result, the Court held that the prior approvals of KEVADON and TALIMOL should not stand in the way of data protection for the later approved product. Submissions filed post-1963 necessarily include new and more extensive data, including data relating to efficacy, as compared to data filed in a pre-1963 submission.

This, combined with the fact that (1) prior approval for thalidomide was short-lived and should never have been given at the time, (2) this new drug was effectively banned until Celgene came up with its NDS for THALOMID, and (3) approval was granted for Celgene's product on the basis of completely new studies and data, militated in favour of the Court declaring that THALOMID is an "innovative drug" and eligible for listing on the Register. The Minister of Health has appealed the Federal Court's decision.

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