The Federal Court of Canada has recently held that a drug previously approved in Canada, but withdrawn for safety reasons, could later qualify as an "innovative drug". In Celgene Inc. v. the Minister of Health1, the Court found that thalidomide satisfied the definition of "innovative drug" under the Food and Drug Regulations (the "Regulations") such that it would now be entitled to data protection. While it may be possible that new uses of previously approved drugs could be considered "innovative" where the supporting data was gathered at considerable cost and not otherwise publicly available, the Federal Court cautioned that in each instance the determination of "innovative" should be considered on a case-by-case basis.
In the early 1960s, after initially receiving approval in Canada for use in sleeplessness, minor ailments and morning sickness in pregnancy, thalidomide was permanently withdrawn from the Canadian market due to its association with foetal malformation.
In 1995, thalidomide was made available again through Health Canada's Special Access Programme2 in response to requests for use in leprosy, immune related conditions, and certain forms of cancer. In mid-2009, Celgene filed a New Drug Submission with the Minister of Health seeking market authorization for thalidomide in Canada for use in the treatment of a form of cancer. While market authorization was granted, Celgene was advised that the drug would not be eligible for data protection under the Regulations because thalidomide was not an innovative drug since it had been previously approved in Canada.
Under the Regulations, an "innovative drug" is provided with a data exclusivity period of eight years, commonly referred to as data protection, during which time no drug submission that makes a "direct or indirect" comparison to the innovative drug can be approved.
Celgene sought judicial review of the Minister's decision.
Thalidomide Entitled To Data Protection
According to the Federal Court, the data protection provisions of the Regulations were implemented in the Regulations to comply with Canada's international treaty obligations -- to encourage and reward innovation by protecting data that innovators generate to obtain drug approval. The provisions require that a drug not be "previously approved" in order for it to be eligible for data protection to ensure a manufacturer is not granted protection for something that has been previously used and for which no innovation was required.
The Court noted in its decision that it would be "inconsistent with these treaties to refuse data protection when a drug is put to an entirely new use, on the basis of extensive and genuinely new data ensuring its effectiveness and safety." Justice de Montigny stated that new uses of previously approved drugs must be considered on a case-by-case basis in order to determine how innovative they are and whether the data supporting them was "gathered at considerable cost which is not otherwise publicly available in that assembled form." In the Court's view, safety and effectiveness are main considerations with respect to drug approval and that when a drug's approval has been withdrawn for safety reasons, the drug should not be considered as previously approved.
The Court found 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." Celgene could not, however, rely on old data; instead it had to produce new data in order to obtain drug approval.
1 2012 FC 154.
2 The Special Access Programme provides those in Canada with exceptional access to drugs not approved for sale in Canada.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.