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
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