Case: Apotex Inc. v. Minister of Health and AG of Canada,
2013 FC 1217
Drug: Apo-Telmisartan Nature of case: Judicial review of decision of
the Minister of Health Successful party: Apotex Inc. Date of decision: December 23, 2013
This was an application for judicial review of a decision made
by the Therapeutic Products Directorate ("TPD") at Health
Canada that addressed the meaning of the term "medicinal
ingredient" under the Food and Drug Regulations ("the
Regulations"). Health Canada interpreted this
terms as referring to the active substance in the final
tableted form of a drug product and not to the starting active
substance. The Federal Court disagreed and held that this
interpretation of the Regulations was unreasonable. TPD's
decision was set aside and Health Canada was ordered to reconsider
the screening of the particular drug product at issue
Apotex submitted an abbreviated new drug submission
("ANDS") for a product containing telmisartan on December
16, 2010. Apotex claimed that its product is the
"pharmaceutical equivalent" of MICARDIS, the Canadian
Reference Product (CRP). On April 14, 2011, the TPD sent a
Screening Deficiency Notice to Apotex requesting that it
demonstrate that the medicinal ingredient in the Apo-Telmisartan
tablets is identical to the medicinal ingredient in
MICARDIS. Apotex submitted that an acid-base chemical reaction
may take place during the production of Apo-Telmisartan whereby a
potassium hydroxide excipient in its formulation interacts with
telmisartan to form a salt.
The Apotex submission was rejected by the TPD at the screening
stage on the basis that the ingredient in the Apotex product was
not the same as the ingredient in the CRP. Specifically, the
TPD found that the finished product differed from the CRP in that
Apo-Telmisartan is in fact telmisartan potassium and not
telmisartan. Apotex's request for reconsideration was
denied and it sought judicial review.
Analysis and findings
Apotex urged that the term "medicinal ingredient"
should be interpreted as the input to the formulation. Apotex
pointed to a number of similar uses of the term "medicinal
ingredient" within the Regulations and argued that it
must be interpreted consistently throughout. In contrast, the
respondent Minister argued that while the term "medicinal
ingredient" is used in the Regulations to describe
"the thing used to make the drug (i.e., the input
ingredient)", this does not preclude the term "medicinal
ingredient" from being used elsewhere to mean what is found in
the finished product. The Court disagreed with the Minister's
interpretation and held that its position was "completely at
odds with statutory interpretation." However, the Court
held that "[n]othing precludes the Minster from inquiring into
the safety and effectiveness of the drug or the transformations
that may occur in the manufacturing process" during the
New judicial review application filed
The Court rendered its decision on December 4, 2013 and issued
public reasons on December 23, 2013. On December 31, 2013,
Apotex filed a second application for judicial review seeking an
order compelling Health Canada to issue a notices of compliance
(marketing approval) for its Apo-telmisartan and
Apo-telmisartan HCTZ products.
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