CASE: Apotex Inc. v. Merck Frosst Canada et al (“Merck”) (Supreme Court of Canada)

DRUG: FOSAMAX (alendronate) 70 mg tablets

NATURE OF CASE: NOC Regulations: Section 8 damages

DATE OF DECISION: January 28, 2010

SUPREME COURT OF CANADA DECISION - SECTION 8:

On January 28, 2010, the Supreme Court of Canada denied Apotex’s application for leave to appeal from the first appellate decision concerning the scope of liability under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”), as they stood prior to October 5, 2006.

Ogilvy Renault attorneys Patrick Kierans, Jason Markwell, Andres Garin and Kristin Wall represented Merck at trial, on appeal, and before the Supreme Court of Canada.

As a result of this decision, section 8 liability is now limited as follows:

  1. A generic manufacturer may assert a claim for damages (“any loss suffered”) during a “defined period” beginning on the date on which it would have received a notice of compliance, and ending on the date on which the prohibition application was dismissed or discontinued.
  2. A generic manufacturer may not claim damages for permanent loss of market share, or any other loss, suffered after the defined period.
  3. A generic manufacturer cannot seek a disgorgement of the innovative manufacturer’s profits earned during or after the defined period.

This decision provides clarity in an area of law that has been uncertain since the first section 8 case was commenced under the Regulations in 2001.

LINK TO APPEAL DECISION:

http://decisions.fca-caf.gc.ca/en/2009/2009fca187/2009fca187.html

LINK TO TRIAL DECISION:

http://decisions.fct-cf.gc.ca/en/2008/2008fc1185/2008fc1185.html

LINK TO PHARMA IN BRIEF OF JUNE, 2009:  

http://www.ogilvyrenault.com/en/expertise_9350.htm