Sanofi-Aventis, et al. v. Apotex Inc., et al.

(Federal) (Civil) (By Leave)

(Sealing order) (Certain information not available to the public)




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Intellectual property - Patents - Medicines - Generic manufacturer seeking damages under s. 8 of Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 after delayed market entry due to statutory stay occasioned by failed prohibition proceedings - Whether lower courts erred in interpreting s. 8 of the NOC Regulations as providing a damages framework that overcompensates claimants and leads to judicial inconsistencies; in selecting April 26, 2004 as the commencement date for the period of loss; and in awarding Apotex compensation for hypothetically losing unapproved HOPE sales

The Applicants (collectively, “Sanofi”) are the patentees and have the rights to a series of Canadian patents for the drug, ramipril, used in the treatment of hypertension. The original ‘087 patent issued in 1985 and was set to expire in 2002. In an effort to extend that patent protection, Sanofi obtained a further series of patents for different indications for ramipril and listed them on the Patent Register. Between 2003 and 2008, these “new” ramipril patents were challenged by Apotex Inc. and other generic manufacturers under the PM(NOC) Regulations. Sanofi applied for prohibition orders in each case, triggering the 24-month statutory stay that kept the generic competitors off the ramipril market during that period of time. Only one prohibition application was successful. Apotex received its NOC to market Apo-ramipril in December, 2006. Sanofi commenced separate unsuccessful infringement actions against both Apotex and the other generic manufacturers. Apotex then brought an action under s. 8 of the PM(NOC) Regulations, to claim damages for its net lost profits during the period of the statutory stay.

Lower Court Rulings

May 23, 2012
Federal Court

2012 FC 553, T-1357-09
Trial judge making key findings on evidence to allow parties to calculate damages suffered by Apotex pursuant to s. 8 of the PM(NOC) Regulations by reason of delayed market entry
June 22, 2012
Federal Court

Apotex’s motion for reconsideration allowed; Liability judgment amended.
November 2, 2012
Federal Court

Precise amount of s. 8 damages and post-judgment interest to be paid to Apotex determined after calculations by parties
March 14, 2014
Federal Court of Appeal

2014 FCA 68, A-191-12, A-193-12, A-397-12, A-474-12
Apotex’s appeal in A-191-12 allowed. Sanofi’s appeals in A-193-12 and A-397-12 dismissed. Sanofi’s appeal in A-474-12 allowed solely to facilitate redetermination of quantum of damages.