What rights do innovative drug manufacturers have in
situations where generics challenge certain Health Canada decisions
but do not name the innovators as parties?
On February 26, 2014, in Hospira Healthcare Corporation v.
Canada (Health), 2014 FC 179, Prothonotary Tabib held that an
"innovative drug" manufacturer has standing to appear on
a generic's application for judicial review of the Minister of
Health's decision to withhold the generic's NOC pursuant to
C.08.004.1 (the Data Protection Regulations) of the Food and Drug
Regulations, CRC 870. On March 11, 2014, Justice Mactavish
dismissed Hospira's appeal and upheld the Prothonotary's
decision, 2014 FC 235.
This case highlights an important point for innovators:
innovators should monitor the judicial review proceedings at the
Federal Court for proceedings implicating their rights. Without
quick action, innovators may miss out on opportunities to make
representations to the Court concerning their valuable
Under the Data Protection Regulations, a generic is prohibited
from filing a drug submission for a period of six years where the
generic seeks marketing approval (a Notice of Compliance or NOC)
based on a comparison with an "innovative drug". Once the
generic's submission is filed, the Minister is prohibited from
issuing a NOC for a further two years, or two years plus six months
in cases where the innovator submitted test data in paediatric
"Innovative drugs" are a special class of drugs,
defined in the Data Protection Regulations and by the case law,
which contain medicinal ingredients that have not been previously
marketed in Canada.
Sanofi manufactured and sold the drug ELOXATIN, which contained
the active ingredient oxaliplatin, a platinum-based antineoplastic
agent, indicated for the treatment of colorectal cancer. On June
15, 2007, the Minister of Health granted ELOXATIN "innovative
drug" status, protecting it against generic comparison under
the Data Protection Regulations.
On October 27, 2006, before ELOXATIN was granted
"innovative drug" status, Hospira filed a New Drug
Submission (NDS) seeking a NOC for a drug containing "Chemical
Entity A", which Hospira would neither confirm nor deny was,
in fact, oxaliplatin.
The usual course for generics is to file an Abbreviated New Drug
Submission (ANDS), which, by its nature, compares the generic drug
with the innovative drug. The ANDS represents that the generic and
innovative drugs are bioequivalent such that the Minister should
rely on the safety and efficacy data submitted in the
innovator's New Drug Submission (NDS) to approve the generic
version. In such a case, the Data Protection Regulations are
In this unusual case, it appears that Hospira's submission
was a NDS, which itself contained safety and efficacy data required
for the Minister to approve the drug. Frequently, when processing a
submission, the Minister will have questions about the drug product
and will direct those questions to the applicant. In answer to one
such question, Hospira referred to the ELOXATIN Product Monograph,
which had by then been granted "innovative drug"
The Minister considered this reference to be a comparison to
ELOXATIN and refused to issue a NOC until the end of the data
protection period. Hospira applied for judicial review of the
Minister's decision and Sanofi, aware of the application, moved
to amend the style of cause to recognize it as a proper
Section 18.1 of the Federal Courts Act states that an
application for judicial review may be made "by anyone
directly affected by the matter in respect of which relief is
sought." Prothonotary Tabib applied the test under s 18.1 as
most recently stated in Forest Ethics Advocacy Assn. v. Canada
(National Energy Board), 2013 FCA 236 at para. 20: "A party
has a 'direct interest' under subsection 18.1(1) of the
Federal Courts Act when its legal rights are affected, legal
obligations are imposed on it, or it is prejudicially affected in
some direct way."
Prothonotary Tabib found that, assuming "Chemical Entity
A" is oxaliplatin, it was "clear that an order reversing
the Minister's determination that the data protection regime
was engaged and ordering the issuance of an NOC to Hospira would
prejudicially affect Sanofi in a direct way". Accordingly, she
held that Sanofi was a proper respondent to the proceeding. Had
Sanofi not become aware of Hospira's application for judicial
review, its rights may have been prejudiced without any ability to
make representations before the Court.
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