Case: Teva Canada Limited (“Teva”) v. Canada (Health)

Drug: Oxaliplatin [Eloxatin®]

Nature of case: Judicial Review Application – Appeal

Successful party: sanofi-aventis Canada Inc. (“sanofi”) and The Minister of Health (“Minister”)

Date of decision: April 10, 2012

Summary

In 2007, the Minister placed sanofi’s drug Eloxatin® on the Register of innovative drugs (“Register”) under C.08.004.1(9) of the Food and Drug Regulations, C.R.C., c. 870 (the “Regulations”).

In 2010, Teva asked the Minister to remove Eloxatin® from the Register because Teva alleged that it did not meet the definition of an “innovative drug” under subsection C.08.004.1(1) of the Regulations.  Teva’s request was dismissed by the Minister.  The Minister interpreted the Regulations and concluded that authorizations by the Minister under the Canada Special Access Programme (“SAP”) do not constitute a previous approval for the purpose of the definition of “innovative drug”.  Teva’s application for judicial review in the Federal Court was dismissed.  Teva appealed that decision.

The Federal Court of Appeal confirmed that the Minister’s decision was correct and dismissed Teva’s appeal.  The Court held that “previously approved” for a new drug must mean a previous marketing approval, i.e. the previous issuance of a notice of compliance and a drug identification number, where the Minister is satisfied of the safety and effectiveness of the new drug.  Eloxatin® had not been previously approved by the Minister and was properly listed on the Register. Sanofi’s cross-appeal based on lack of standing was dismissed.

Norton Rose Canada LLP represented sanofi herein.

Teva’s Appeal

The central issue on appeal was the meaning of the terms “previously approved” in the definition of “innovative drug” under subsection C.08.004.1(1) of the Regulations: do prior SAP authorizations constitute previous approvals to prevent a “new drug” from obtaining data protection?

The Federal Court of Appeal held that the Minister was correct in rejecting Teva’s argument that previously granted authorizations under SAP make a drug “previously approved” under the Regulations.  The wording, architecture and purpose of the Regulations suggest that the word “approved” should be viewed in the context of the safety and efficacy of new drugs, a matter that is evidenced only by approvals based on data and studies as strictly defined under the Regulations.

The Court held that an authorization under the SAP is not an “approval”, as it allows for the use of certain drugs despite the absence of data and studies demonstrating the safety and efficacy of the drug.  Accepting Teva’s submission would lead to a lack of clarity and uncertainty, something the Regulations sought to eliminate by carefully setting out the circumstances for when a drug is approved.

The Court rejected Teva’s view that the purpose of subsection C.08.004.1(1) of the Regulations is to achieve a compromise between providing monopolies for a period of time to innovative drug manufacturers while allowing timely market access to generic drug manufacturers.  Rather, the Court held that data protection provisions under the Regulations were designed to implement specific treaty obligations undertaken by Canada pursuant to NAFTA and TRIPS, which require the protection of data necessary for approving the marketing of pharmaceutical products.  This in turn encourages the development of new drugs.

The Cross-appeal

Sanofi cross-appealed from the decision of Campbell J. that dismissed sanofi’s motion to strike, in which sanofi asserted that Teva lacked standing because Teva had not filed an ANDS when it commenced its application for judicial review. Sanofi also cross-appealed from the determination that the Minister’s decision was a “fresh” decision susceptible to judicial review.  The Federal Court of Appeal dismissed the cross-appeal, holding on the issue of standing that to accept sanofi’s submission would “do nothing to improve delivery of justice”, as Teva would simply restart its application.  On the matter of a “fresh” decision, the Court of Appeal held that the Minister is obligated to “maintain” the Register, which includes the power to add or delete information as necessary.  The refusal of Teva’s request was a decision concerning the maintenance of the Register and was therefore a fresh exercise of discretion susceptible to judicial review.

Link to decision:

Teva Canada Limited v. Canada (Health), 2012 FCA 106