Canada provides data protection for “innovative drugs” for a term of eight years. A pediatric six-month extension is also available. The eight-year term is divided into two periods: six years of “no filing” and then two years of “no approval”. In the first six years, no one may file a submission making a comparison based upon the innovator’s data. In the last two years, a submission may be filed but the approval (the Notice of Compliance) cannot issue until the expiry of the eight-year term. Drugs that qualify are listed on Health Canada’s Register of Innovative Drugs.
So what qualifies for “innovative drug” status in Canada? As reported in Current Issues, 2013, the early cases under the 2006 Data Protection Regulations settled some aspects of protection eligibility. The split appellate panels in the decisions highlight the interpretation challenges in the definition of “innovative drug.”
“Innovative drug” is defined by the two things it is not: 1) a drug that was not previously approved or 2) a variation of something previously approved. For this latter exclusion, five specific examples are listed: a salt, ester, enantiomer, solvate or polymorph.
On the first aspect, “previously approved” means never previously approved. In one of the split decisions, the court denied protection for thalidomide based on the original thalidomide approval, revoked decades earlier. It was a bar to data protection despite the considerable efforts to originate data shown in the case (Celgene 2013 FCA 43, Noel JA dissenting; reversing 2012 FC 154). However, making a drug available under the Special Access Program, even in significant quantities, does not bar data protection since it is not an approval (Sanofi-Aventis Canada 2012 FCA 106; aff’g 2011 FC 507).
On the variation aspect of the definition, a second split appellate panel found that if a drug falls within one of the five listed examples, it is an absolute bar regardless of how much effort was spent in originating the data (Takeda Canada Inc. 2013 FCA 13, Stratas JA dissenting, aff’g 2011 FC 1444, leave to appeal to SCC denied).
With some of the parameters settled, there has been minimal litigation. One case commenced in 2013 by Hospira Healthcare Corporation (“Hospira”) sought judicial review of the minister’s denial of a Notice of Compliance for the drug oxailiplatin. The minister found the data protection regulations applied. In challenging this decision in the Federal Court, Hospira attempted to exclude the innovator whose product was referenced. Hospira did not name the innovator Sanofi-Aventis Canada Inc. (“Sanofi”) as a party. The filed materials referred to “Chemical Entity A” instead of “oxailiplatin.” The court granted leave to Sanofi to be added as a party. It had the right to participate in the process (2014 FC 179).
Health Canada publishes a Therapeutics Product Directorate Statistical Report each year. The report for 2012/2013 discusses a number of items relating to data protection. The number of applications filed average at 18 per year with a peek in 2011/2012 of 29. The vast majority of the approvals are pharmaceutical, the next highest number being biological. Veterinary innovative drugs average at four per year. There are few data protection court cases referenced in the report. All of these case have been covered in previous editions of Current Issues. The single case commenced in the last reporting period of 2012/2013 was discontinued. Since then, the Hospira case was commenced.
On the trade side, the historic CETA negotiations concluded with a trade treaty. A 10-year term for data protection was among the contentious intellectual property issues being negotiated. The end result seems to be the status quo for data protection.
Canada is joining the Trans Pacific Partnership Negotiations. What may be on the table in those negotiations for IP remains to be seen.