Sanofi-Aventis Canada Inc. v. Teva Canada Limited

Sanofi-Aventis Canada Inc. v. Teva Canada Limited

Section 8 of the PM(NOC) Regulations is validly enacted under s.55.2(4) of the Patent Act and Sanofi’s ultra vires/constitutional challenges to s.8 fail; the Court interpreted s.8 as not permitting recovery prior to the statutory stay on the facts before it, recognized that end-date issues did not require extending liability beyond issuance of an NOC on these facts, and confirmed that damages assessments must apply ordinary causation and competition principles; TRIPS and NAFTA do not render s.8 invalid or require importing an "abuse" limitation into s.8.

Citation
2012 FC 551
Parties
Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim: Sanofi-Aventis Canada Inc.; Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim: Schering Corporation; Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim: Sanofi-Aventis Deutschland GmbH; Defendant (t 1161 07); Plaintiff by Counterclaim: Teva Canada Limited; Plaintiff (t 1357 09): Apotex Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
23 May 2012
Procedural Posture
Patent NOC Proceedings — Validity Challenge to PM (noc) Regulations S.8 / Judgment on Validity Issues (post Trial)
Outcome
Sanofi's validity challenges to s.8 of the PM(NOC) Regulations dismissed; s.8 upheld as intra vires; issues Sanofi raised did not succeed on the facts of these cases.
Legal Topics
Validity of S.8 Pm(noc) Regulations, Scope of Regulatory Power Under Patent Act S.55.2(4), Damages and Causation in NOC Context, Start and End Dates of Liability Under S.8, Interaction With TRIPS and NAFTA, Early Working Exception
Source Language
English
Patent Law Administrative Law Constitutional/ultra Vires Review International Trade Law Validity of S.8 Pm(noc) Regulations Scope of Regulatory Power Under Patent Act S.55.2(4) Damages and Causation in NOC Context Start and End Dates of Liability Under S.8 +2 more

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Legal principles 3 Authorities cited 17 Party arguments 2
Sign in to unlock

Parties

Sanofi-Aventis Canada Inc.

Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim

Schering Corporation

Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim

Sanofi-Aventis Deutschland GmbH

Plaintiff (t 1161 07); Defendant (t 1357 09); Defendant by Counterclaim

Teva Canada Limited

Defendant (t 1161 07); Plaintiff by Counterclaim

Apotex Inc.

Plaintiff (t 1357 09)

Procedural Posture

Patent NOC Proceedings — Validity Challenge to PM (noc) Regulations S.8 / Judgment on Validity Issues (post Trial)

Legal Issues

  1. 1 Whether s.8 of the PM(NOC) Regulations is ultra vires s.55.2 of the Patent Act
  2. 2 Whether s.8 permits liability to commence prior to the statutory 24-month stay
  3. 3 Whether s.8 permits liability to extend beyond issuance of a Notice of Compliance

Ratio Decidendi

Section 8 of the PM(NOC) Regulations is validly enacted under s.55.2(4) of the Patent Act and Sanofi’s ultra vires/constitutional challenges to s.8 fail; the Court interpreted s.8 as not permitting recovery prior to the statutory stay on the facts before it, recognized that end-date issues did not require extending liability beyond issuance of an NOC on these facts, and confirmed that damages assessments must apply ordinary causation and competition principles; TRIPS and NAFTA do not render s.8 invalid or require importing an "abuse" limitation into s.8.

Court Disposition

Sanofi's validity challenges to s.8 of the PM(NOC) Regulations dismissed; s.8 upheld as intra vires; issues Sanofi raised did not succeed on the facts of these cases.

Orders

  • Validity challenges to section 8 dismissed
  • Costs of the validity portion awarded to Teva Canada Limited and Apotex Inc.; if parties cannot agree costs to be dealt with as set out in the Teva Reasons and the Apotex Reasons