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

Summary

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 (Apo-telmisartan).

Background

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 screening process.

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.

Link to decision:

Apotex Inc. v. Minister of Health and AG of Canada, 2013 FC 1217

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