Innovative drugs are eligible for eight years of data protection (data exclusivity) in Canada. For six of these eight years, a generic drug manufacturer may not even file an abbreviated new drug submission to get its marketing approval by relying on this protected clinical trial data. A recent case involving Celgene's THALOMID (thalidomide) looked at the controversy over whether a drug qualifies as "innovative" and is entitled to data protection (appeal pending)1. An "innovative drug" is defined in the Data Protection Regulations2 in part as "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister." This case will be of interest to companies developing old drugs for new uses. It established an exception to the clear rules stating the ineligibility of previously approved drugs (and their mere variations) for data exclusivity. The Court tried to limit the future of the applicability of the case but it remains of significant interest as a potential foot in the door to expand the definition of innovative drugs. Last Fall, Health Canada issued guidance on another expansive exception, where prior approval of a drug for veterinary use would not preclude it from being an "innovative drug" when approved for human use, and vice versa3.
Celgene argued that THALOMID was an "innovative" drug despite the fact it contained the previously approved medicinal ingredient thalidomide. The thalidomide drug was approved in Canada as early as 1960 and prescribed to treat sleeplessness and morning sickness in pregnant woman. Thalidomide was permanently taken off the market in 1962 when it was discovered that it was associated with severe birth defects, such as deformed limbs.
Celgene's research in the 1990's revealed that, despite its controversial past, 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. At the same time however, the government advised Celgene that THALOMID was not eligible for data protection because the medicinal ingredient had been previously approved. Celgene brought an application for judicial review of the government's decision.
In overturning the decision, the Federal Court noted that Celgene's innovation was to take something that was banned as dangerous and which had not been found to be safe and efficacious and to show it to be a useful, lifesaving drug. To do so, Celgene could not rely on old data, but had to produce new data.
The purpose of the data protection provisions of the Regulations is to encourage and reward innovation by protecting the innovator's data. As the previous approvals had been withdrawn, Canadians could not benefit from the re-development of thalidomide unless new information and data demonstrated its safety and efficacy.
The Court found that the prior thalidomide approval should not stand in the way of data protection of THALOMID. Drug submissions filed after the 1960's must include new and more extensive data. Further, the Court held that (1) the prior approval for thalidomide was short-lived and never should have been given at the time, (2) the drug was essentially banned until Celgene submitted its new drug submission for THALOMID, and (3) approval was granted for Celgene's product on the basis of completely new studies and data. Thus, THALOMID was an "innovative drug" and eligible for data protection.
The circumstances of the present case involving a scorned drug are unlikely to arise very often. If the decision survives on appeal, innovators will use it to try to expand availability of data exclusivity. We will then see if the Court is correct in its prediction that the decision will have only a "limited impact in the foreseeable future."
Footnotes
1 Celgene Inc. v. The Minister of Health (2012 FC 154).
2 SOR/2006-241.
3 Publication of Clarifications to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (Health Canada. October 1, 2011).
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