[2016] 4 F.C.R. D-13
Patents
Infringement
Appeal from Federal Court (F.C.) judgment dated June 30, 2014 and based on two sets of reasons (2014 FC 634 and 2014 FC 248) finding appellant liable for damages under Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (NOC Regulations), s. 8 — Respondent suing appellant under s. 8 for improperly keeping one of its corporate predecessors from selling venlafaxine hydrochloride under name Effexor XR related to Canadian Patent No. 1248540 ('540 patent) on market — Appellant corporate successor to Wyeth and Wyeth Canada (hereinafter referred to as Wyeth (appellant)), manufacturer of venlafaxine — Respondent corporate successor to ratiopharm inc. (hereinafter referred to as Ratiopharm (respondent)) — Ratiopharm (respondent) filing abbreviated new drug submission to market generic version of venlafaxine hydrochloride — On eve of expiry of '540 patent, Canadian Patent No. 2199778 ('778 patent) covering extended release formulation of venlafaxine issued, listed by Wyeth (appellant) on Patent Register against Effexor XR a few days later — Ratiopharm (respondent) serving notice of allegation alleging, inter alia, '778 patent invalid or would not be infringed by its version of venlafaxine — Wyeth (appellant) applying for prohibition preventing Minister of Health from issuing notice of compliance to Ratiopharm (respondent) — Ratiopharm (respondent) filing motion to dismiss Wyeth’s (appellant) prohibition application — Court agreeing that '778 patent not eligible for listing, granting Ratiopharm’s (respondent) motion, dismissing Wyeth’s (appellant) prohibition application — Minister then granting Ratiopharm (respondent) notice of compliance for its version of venlafaxine — Ratiopharm (respondent) starting action for damages in F.C. — In first set of reasons (2014 FC 248), F.C. finding, inter alia, Ratiopharm’s (respondent) business partner able to supply adequate quantities of venlafaxine product at relevant time; respondent established loss under s. 8 — F.C. quantifying respondent’s damages in second set of reasons — Main issues what must be proven, who bears burden of proof in s. 8 claim; whether F.C. wrongly admitting hearsay evidence — Plaintiff suing for damages under s. 8 having to show loss caused by failed proceedings under NOC Regulations — S. 8 providing that compensation available for “any loss suffered” during relevant period — There must be evidence that parties “would have”, “could have” ordered, supplied material in hypothetical world at relevant time — Plaintiffs bearing burden of proving hypothetical world on balance of probabilities as part of their damages claim — Nothing in s. 8 suggesting otherwise — F.C. alive to need for firm causal link between failed proceedings under NOC Regulations, claimed loss — However, improperly admitting hearsay evidence — Trend towards flexibility with regard to rules of evidence not undermining need for judges to take rigorous approach to admissibility — Here, F.C. explicitly relying upon inadmissible emails to support conclusions about what would have transpired in hypothetical world — Most hearsay objections made by appellant correct — Evidence should have been excluded — This error might have affected outcome of case — F.C. judgment therefore having to be set aside — Case remitted for redetermination to F.C. to decide, inter alia, whether, to what extent Ratiopharm (respondent) entitled to s. 8 damages; whether in hypothetical world Ratiopharm (respondent) would, could have had access to sufficient quantities of venlafaxine at relevant time — Not enough to establish this on balance of probabilities by pointing only to sufficient manufacturing capacity a long time before relevant time — Appeal allowed.
Pfizer Canada Inc. v. Teva Canada Limited (A-422-14, 2016 FCA 161, Stratas J.A., judgment dated May 31, 2016, 56 p.)