The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence. Health Canada also rejected Apotex’s request for reconsideration. The court found Apotex did not have legitimate expectations that the reconsideration panel would review Apotex’s questions, and the minister did not fetter her discretion in requiring bioequivalence.

Case:                                     Apotex Inc v Canada (Minister of Health), 2017 FC 857

Nature of case:                   Application for judicial review of refusal to reconsider an Abbreviated New Drug Submission (ANDS)

Successful parties:           The Minister of Health and the Attorney General of Canada

Date of decision:                September 25, 2017


Apotex was granted an NOC in 2003 for Apo-omeprazole, pending expiry of the patent covering the innovator’s product. However, Health Canada later revoked this approval as the ANDS did not include a study showing bioequivalence under specific feeding circumstances. Health Canada requested this study, but Apotex instead brought an application for judicial review on the basis that it had a vested right in the NOC.

The Federal Court dismissed Apotex’s application because it was out of time and held that there is no vested right until an NOC is issued. The Federal Court of Appeal upheld this decision.

Apotex refiled its ANDS for Apo-omeprazole in 2013 with the required study, but the minister again did not issue an NOC because of concern that the study was poorly designed. Apotex requested reconsideration of the minister’s decision on the basis of safety and efficacy. The minister’s position was that the issue for reconsideration was bioequivalence, and cancelled the reconsideration process after the parties were unable to agree. Apotex then commenced this application for judicial review.

Apotex alleged the minister fettered her discretion in requiring the reconsideration process to focus on bioequivalence, and it had a legitimate expectation to a reconsideration process dealing with the issues that Apotex put forth.

No legitimate expectation

The court found Apotex had no legitimate expectation that the minister’s discretion would be exercised in its favour. Justice Roy held that Health Canada’s reconsideration policy does not contemplate a process where the reconsideration panel will consider any issues raised by the manufacturer, and Apotex had been given a fair opportunity to draft an eligible reconsideration question.

No fettering of discretion

The court found the minister did not fetter her discretion by requiring the reconsideration panel to apply Health Canada’s bioequivalence guidelines. Justice Roy held that under the Food and Drug Regulations, the minister did not have discretion to not consider bioequivalence. Although the bioequivalence requirement is absolute, the minister did not restrict how bioequivalence should be assessed.

The court also dismissed Apotex’s argument that other products had been approved without strictly meeting the bioequivalence criteria of the guidelines. Justice Roy found that the examples put forward by Apotex showed bioequivalence remained the requirement for an ANDS, and the minister had been flexible in applying this requirement. In these prior cases, Apotex had obtained approval after supplementing deficient studies, but chose not to do so for Apo-omeprazole.

Link to decision:

Apotex Inc v Canada (Minister of Health), 2017 FC 857