Broadly speaking, the issue in this case was whether an
amendment to a drug submission could trigger the data protection
provisions if the initial filing of the submission had not done so.
Justice Gagné agreed with the Minister that it could and, in
this case, did.
The circumstances of this case were somewhat unique in that
Hospira filed its drug submission before Sanofi-Aventis'
submission for ELOXATIN® was filed. Typically, approval of a
generic version of a drug is obtained by way of an Abbreviated New
Drug Submission (ANDS), in which the generic relies on information
in the innovator's submission concerning safety and
effectiveness. This allows the generic company to avoid having to
complete time-consuming and expensive clinical trials. Since
Hospira wished to obtain a NOC for its oxaliplatin product before
Sanofi-Aventis had received its NOC for ELOXATIN®, Hospira had
to file a New Drug Submission (NDS). Hospira did so on Oct. 27,
Shortly thereafter, Sanofi-Aventis filed its NDS for
ELOXATIN® and received a NOC on June 15, 2007. ELOXATIN®
was subject to data protection under the Food and Drug
Meanwhile, Hospira faced obstacles in respect of its submission,
as it did not have clinical trial data for its product. Ultimately,
Hospira received a Notice of Noncompliance (NON) on March 28, 2012,
due in part to Hospira's failure to establish clinical safety
On July 24, 2012, Hospira responded to the NON by relying on
ELOXATIN®'s approval. On Oct. 31, 2013, the Minister
advised Hospira that it would not receive its NOC until after
expiry of the data exclusivity period for ELOXATIN®.
Before the Court, Hospira argued that the Minister had
misinterpreted section C.08.004.1(3) of the data protection
provisions. This provision provides that, if a manufacturer
directly or indirectly compares its drug with an innovative drug
covered by data protection:
the generic manufacturer cannot file
its submission until 6 years after the issuance of the
innovator's NOC; and
the Minister cannot approve the
generic's submission until 8 years after the issuance of the
Hospira argued that, in order for the data protection provisions
to be triggered, it had to run afoul of both (a) and (b). Since the
2006 filing of Hospira's NDS had not triggered the application
of the data protection provision under (a), Hospira argued that the
Minister could not apply paragraph (b) to prevent Hospira from
receiving its NOC.
The Court disagreed with Hospira's interpretation of
C.08.004.1(3). In deciding that the Minister's interpretation
was correct, the Court relied in part on the data protection
provisions' purpose of protecting innovators from unfair
commercial use of undisclosed data. Further, the Court held that
Hospira's interpretation would be contrary to Canada's
obligations under NAFTA and TRIPS.
In a related case, Hospira Healthcare Corporation v Canada
(Minister of Health) (2015 FC 1206), Hospira had
challenged the Minister's decision that it must address a
patent on the Patented Medicines (Notice of Compliance) Regulations
Patent Register in respect of ELOXATIN®. Hospira's NDS was
filed prior to the listing of the patent on the Patent Register,
but Hospira had filed a SNDS after the patent had been listed.
Justice Gagné dismissed the application as moot, since the
patent had expired and, in any event, the Minister could not issue
Hospira its NOC due to the data protection provisions.
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.
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