Canada amended its Data Protection Regulations in 2006 to provide protection for innovative drugs in a second attempt to implement Canada’s 1994 NAFTA (North American Free Trade Agreement) and TRIPS (Trade-Related Aspects of Intellectual Property rights treaty obligations. These treaties require the protection of data that is originated with considerable effort and required to be submitted for government approval. The current term of protection is eight years counting from the innovative drug’s date of approval (issuance of the notice of compliance (NOC)). For the first six years, no one else may file a submission that makes a direct or indirect comparison based on the innovator’s data. In the final two years, such a submission may be filed but an NOC cannot issue until expiry of the eight year term. In addition, subject to certain conditions, a pediatric six month extension is available. If CETA (Comprehensive Economic and Trade Agreement) is concluded, among other things, the term could be extended to ten years.
The Register of innovative drugs is maintained by the Minister of Health and lists all drugs that have been found to be eligible for protection. Protection is typically requested by the innovator during the regulatory submission process. Once listed, a drug may lose protection if it is not marketed in Canada or if a person with standing is successful in a delisting application.
The Regulations survived a challenge to their validity (2010 FCA 334; leave to appeal to SCC denied July, 2011). Since the Current Issues update in 2012, appellate cases have continued to explore the criteria to qualify as innovative drugs. Three Federal Court of Appeal cases have considered the innovative drug definition. The definition is exclusionary specifying two components that exclude a drug from eligibility: if it was previously approved; or, if it is a variation of a previously medicinal ingredient such as a salt, ester, enantiomer solvate, or a polymorph. As such, if a drug is previously approved or a variation, it does not qualify for data protection.
Two appellate cases considered the first exclusion: what constitutes a “previous approval”. In Celgene (2013 FCA 43, Noel JA dissenting; reversing 2012 FC 154), the Federal Court of Appeal denied data protection for thalidomide. Although it was withdrawn from the market as unsafe and then approved decades later based on substantial research, the original approval made the drug previously approved. On the other hand, in Sanofi-Aventis Canada (2012 FCA 106; aff’g 2011 FC 507), data protection was confirmed for a drug that was previously available under the Special Access Program. SAP access was not sufficient to make a drug previously approved. There is a third case (not appellate) on the previously approved definition that was discussed in last year’s Current Issues (Epicept, 2010 FC 956). A medicinal ingredient approved by DIN (Division 1), as homeopathic/over the counter drugs was a previous approval that denied data protection for a subsequent Division 8 drug. While it was a new drug, it was not an innovative drug, having been previously approved under the less rigorous Division 1.
The final appellate decision considered the second exclusion (Takeda Canada Inc. v. Canada (Health) 2013 FCA 13, Stratas JA dissenting, affirming 2011 FC 1444). The Court interpreted the group of five examples within the phrase “not a variation of a previously medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph” as absolute bars. The Court denied protection to the enantiomer DEXILANT as a matter of law. Falling within one of the enumerated examples of variations meant no entitlement to data protection regardless of the nature and extent of the data necessary to be submitted to obtain approval. The dissent held that on a purposive construction of the “innovative drug” definition in accordance with the treaties, the five listed chemicals should not be treated as absolute. An application for leave to appeal to the Supreme Court of Canada has been filed.
The main decisions in the last year give guidance on the scope of the Regulations, eligibility criteria and what constitutes an innovative drug. One of the three Federal Court of Appeal decisions found the drug was entitled to data protection. Each of the other two decisions, denying data protection to the drugs at issue, had dissents. We expect in the next year, the precise scope will continue to be defined in the jurisprudence and, if CETA is concluded, that there will be further amendments to the Regulations to implement Canada’s treaty obligations.