Pharma In Brief - Canada: Federal Court Releases Decisions In Ramipril Section 8 Cases

Case: Apotex Inc. v. Sanofi-Aventis (T-1357-09); Sanofi-Aventis v. Teva Canada Limited (T-1161-07)

Drug: ALTACE® (ramipril)

Nature of case: Section 8 of the PM(NOC) Regulations – validity and quantification of damages

Date of decision: May 23, 2012

Summary

On May 23, 2012, the Federal Court released its public reasons in three companion decisions, all written by Madam Justice Snider, in respect of litigation brought separately by Teva Canada Limited ("Teva") and Apotex Inc. ("Apotex") against Sanofi-Aventis and related companies ("Sanofi") pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"). The claims concerned damages sustained by Teva and Apotex while they were prevented from marketing their generic ramipril products as a result of ultimately unsuccessful prohibition proceedings initiated by Sanofi.

The first decision, 2012 FC 551, concerned the validity of section 8 of the Regulations. The second two decisions, 2012 FC 552 (the "Teva Action") and 2012 FC 553 (the "Apotex Action") considered the quantification of Teva's and Apotex's damages. These are the first cases to proceed to a decision on issues of quantification under section 8.

Validity of section 8

The Court held that section 8 of the Regulations is enabled by the Patent Act and rejected each of Sanofi's invalidity arguments. The Court noted that the Alendronate1 decision, in which the Federal Court of Appeal considered the validity of section 8 of the Regulations on constitutional and jurisdictional grounds, provided strong direction to the Court in this case.

The Court held that many of Sanofi's arguments relating to the breadth of s. 8 did not arise. On this basis, the Court dismissed Sanofi's arguments that section 8 is overbroad because: (i) it imposes liability prior to the commencement of a prohibition proceeding; (ii) it imposes liability for a period after the issuance of an NOC; (iii) it does not allow a court to consider generic competition and imposes liability for sales made for unapproved indications; and (iv) it permits recovery where the marketing of the generic version would constitute patent infringement. With respect to the infringement argument, the Court also pointed out that this issue was decided by the Federal Court of Appeal in Alendronate. The Court also held that section 8 is not contrary to Canada's obligations under NAFTA or TRIPS.

The quantification decisions

The Teva and Apotex Actions both...