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Summary

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Intellectual property – Patents – Medicines – Section 8 damages action remitted to Federal Court for redetermination based on non-hearsay evidence – Does proving compensatory damages, which are based upon restoring the plaintiff to a hypothetical position in a “but for” analysis, require evidence demonstrating that “nothing made it impossible” for the plaintiff to be in that hypothetical position?

The respondent, Pfizer Canada Inc. (“Pfizer”) is the corporate successor to the original patentee and innovative manufacturer of venlafaxine hydrochloride, a drug marketed under the name Effexor XR. The Canadian Patent 1,248,540 related to it was set to expire on January 10, 2006. In 2005, Ratiopharm, the corporate predecessor to the applicant, Teva Canada Limited (“Teva”), wanted to market its generic version of venlafaxine hydrochloride and filed an abbreviated new drug submission. Health Canada informed Ratiopharm that it would not issue a notice of compliance until the requirements under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 were met. On the eve of the expiry of the ’540 Patent, Canadian Patent 2,199,778, covering the extended release formulation of venlafaxine was issued and Pfizer listed it on the Patent Register against Effexor XR. On the same day, Ratiopharm (Teva) served a notice of allegation, accepting that its notice of compliance would not issue until after the expiry of the ’540 Patent but alleging that the newly-listed ’778 Patent was invalid or would not be infringed by its generic version of venlafaxine. Pfizer applied for an order of prohibition preventing the Minister from issuing a notice of compliance to Ratiopharm (Teva), and triggering the automatic twenty-four month stay. Ratiopharm (Teva) filed a motion to dismiss Pfizer’s prohibition application, submitting that the ’778 Patent was not eligible for listing on the Patent Register. That motion was granted and Pfizer’s prohibition application was dismissed. On August 2, 2007, the Minister granted Ratiopharm (Teva) a notice of compliance for its generic version of venlafaxine. Teva then commenced an action for damages under s. 8 of the Regulations for having been improperly kept off the market during the period of the statutory stay.

Lower Court Rulings