On April 10, 2012, the Federal Court of Appeal issued its decision in Teva Canada Limited v. Canada (Health), confirming that drugs made available in Canada pursuant to the Special Access Programme (SAP) are not considered to be "previously approved" under subsection C.08.004.1(1) of the Food and Drug Regulations and therefore remain eligible for data protection. This decision provides further clarity on the circumstances under which drugs may qualify for data exclusivity in Canada.
Background
In 2007, the Minister of Health placed Sanofi-Aventis Canada Inc.'s anti-cancer drug, Eloxatin, on the register of "innovative drugs". The Minister's decision has allowed Eloxatin to benefit from the data protection provisions under the Regulations by preventing other manufacturers, like Teva, from marketing generic versions of the drug. In 2010, Teva requested that the Minister remove Eloxatin from the register on the basis that it did not meet the definition of innovative drug as Eloxatin had been available under the SAP since 1999.1 Teva's request was rejected by the Minister on the basis that authorizations under the SAP do not constitute a previous approval for the purposes of the definition of "innovative drug" under the Regulations. On judicial review, the Minister's decision was affirmed by the Federal Court.
Federal Court of Appeal Decision
In denying Teva's appeal of the lower court decision, the Court considered the issue of whether authorizations under the SAP could make a drug "previously approved" for the purposes of the data protection provisions under the Regulations. The Court provided three main reasons to support its decision on this issue.
First, having regard to the wording, architecture and purpose of the Regulations, the Court found the safety and efficacy of drugs to be of primary concern. Under the Regulations, before marketing authorization is granted in the form of a Notice of Compliance (NOC) and a Drug Identification Number (DIN), manufacturers must demonstrate the safety and effectiveness of their drugs using data and studies. The Court stated that the routes to obtain an NOC and a DIN are well-defined in the Regulations and that they do not include the SAP.2
Second, the Court stated that the Regulations have been carefully drafted to provide clarity and certainty in the drug approval process, such that the issuance of an NOC and DIN may be relied upon as an indication of regulatory approval. The adoption of an interpretation that an SAP authorization could constitute "previously approved" would lead to complicated factual inquiries and difficult questions that run counter to the theme of clarity and certainty in the area of approvals under the Regulations.
Lastly, the Court held that subsection C.08.004.1(1) of the Regulations is designed to implement certain specific treaty obligations that aim to protect an innovator who submits undisclosed data in support of an application for approval to market a drug containing a new chemical entity. The Court noted that the treaty provisions repeatedly refer to the concept of marketing approval and that in Canada, marketing approval under the Regulations requires the issuance of an NOC and a DIN.
Based on the foregoing reasons, the Court concluded that drugs for which previous authorizations under the SAP have been granted are not considered "previously approved" within the meaning of subsection C.08.004.1 of the Regulations.
Footnotes
1. Subsection C.08.004.1(1) of the Regulations states that for a drug to qualify for data protection in Canada, it must (among other requirements) be "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister [...]". [emphasis added]
2. Notably, the Court of Appeal stated that the SAP allows for the use of certain drugs despite the absence of data and studies showing the safety and efficacy of the drug and that authorizations under the SAP are best seen as compassionate permissions and not approvals.
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