Federal Court of Appeal Strikes Claim for ''permanent loss of market share'' in a Section 8 Damages Action [ALTACE® (ramipril)]

CASE:

Teva Canada Limited v. sanofi-aventis Canada Inc. and sanofi-aventis Deutschland GmbH

DRUG:

Ramipril (Altace®)

NATURE OF CASE:

Section 8 Damages - Motion to strike - Failure to disclose a reasonable cause of action

SUCCESSFUL PARTY:

sanofi-aventis Canada Inc. and sanofi-aventis Deutschland GmbH

DATE OF DECISION:

May 2, 2011

Summary:

On May 2, 2011, a majority of the Federal Court of Appeal (Dawson JA; Noël JA concurring) relied on the prior decision in Fosamax® (argued by Ogilvy Renault) and struck a claim for "permanent loss of market share" under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"). Justice Sharlow dissented and held that this type of claim is arguably within the scope of section 8, is consistent with the object and purpose of the Regulations, and should not be struck from the pleadings.

On June 22, 2007, sanofi-aventis and sanofi-aventis Deutschland et al. (collectively "sanofi") commenced an action against Teva Canada Limited ("Teva") for infringing the Canadian patent for ramipril. On September 17, 2007, Teva defended the infringement action and counterclaimed against sanofi under s. 8 for damages allegedly caused by reason of a prior application under s. 6 of the Regulations. Teva's counterclaim was stayed pending a trial of the infringement action. On June 29, 2009, the Federal Court dismissed sanofi's infringement action and vacated the stay of the counterclaim.

In its Counterclaim, Teva sought damages pursuant to s. 8 of the Regulations. This section states that if a "first person" applies for a prohibition order and the application is withdrawn, discontinued or dismissed, the "first person" is liable to the "second person" for "any loss suffered" during a prescribed period. The period of liability under the Regulations begins on the date when the "second person" would have received a notice of compliance "but for" the prohibition application, and ends on the date when the application is terminated.

Sanofi-aventis brought a motion to strike Teva's claim for "permanent loss of market share" on the basis that this remedy is not within the scope of section 8. Sanofi-aventis' motion was granted by the Prothonotary and affirmed by the Federal Court judge (2010 FC 1210). Both Courts held that a "first person" is only liable for damages "suffered" during the period defined in the Regulations and not for losses "suffered" after that date.

Teva appealed to the Federal Court of...