AstraZeneca Canada Inc. v. Apotex Inc.

AstraZeneca Canada Inc. v. Apotex Inc.

Apotex failed to prove on the balance of probabilities that any viable, approvable non‑infringing alternative was available during the infringing period (evidence was belated, incomplete and methodologically unreliable), therefore Apotex is not entitled to section 8 damages; AstraZeneca is entitled to Apotex’s profits including U.S. export profits (Scenario A), with profits‑on‑profits calculated at prime compounded annually and no tax deduction for that award.

Citation
2017 FC 726
Parties
Plaintiff (defendant by Counterclaim): AstraZeneca Canada Inc.; Plaintiff (defendant by Counterclaim): Aktiebolaget Hässle; Plaintiff (defendant by Counterclaim): AstraZeneca AB; Defendant (plaintiff by Counterclaim): Apotex Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
26 July 2017
Procedural Posture
Patent Infringement (accounts of Profits) and NOC Section 8 Reference / Damages/accounting Phase (remedies Determination)
Outcome
Court declared that (a) Apotex had no available NIA during the infringing period; (b) Apotex is not entitled to section 8 NOC damages; (c) AstraZeneca entitled to Apotex profits with profits‑on‑profits at prime compounded annually without tax deduction; and (d) AstraZeneca entitled to recover full claim to Apotex...
Legal Topics
Non Infringing Alternative (nia) Defence, Section 8 NOC Damages, Accounting of Profits, Profits on Profits Interest, Bioequivalence and Stability Evidence, Res Judicata and Foreign Judgment Treatment
Source Language
English
Intellectual Property Patents Regulatory Law Civil Litigation Non Infringing Alternative (nia) Defence Section 8 NOC Damages Accounting of Profits Profits on Profits Interest +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 5 Authorities cited 12 Party arguments 2 Amounts and remedies 1
Sign in to unlock

Parties

AstraZeneca Canada Inc.

Plaintiff (defendant by Counterclaim)

Aktiebolaget Hässle

Plaintiff (defendant by Counterclaim)

AstraZeneca AB

Plaintiff (defendant by Counterclaim)

Apotex Inc.

Defendant (plaintiff by Counterclaim)

Procedural Posture

Patent Infringement (accounts of Profits) and NOC Section 8 Reference / Damages/accounting Phase (remedies Determination)

Legal Issues

  1. 1 Was a non-infringing alternative available to Apotex during the infringing period?
  2. 2 Were Apotex's proposed NIAs bioequivalent and sufficiently stable to obtain regulatory approval?
  3. 3 Could human clinical trials ethically have been conducted to prove bioequivalence?

Ratio Decidendi

Apotex failed to prove on the balance of probabilities that any viable, approvable non‑infringing alternative was available during the infringing period (evidence was belated, incomplete and methodologically unreliable), therefore Apotex is not entitled to section 8 damages; AstraZeneca is entitled to Apotex’s profits including U.S. export profits (Scenario A), with profits‑on‑profits calculated at prime compounded annually and no tax deduction for that award.

Court Disposition

Court declared that (a) Apotex had no available NIA during the infringing period; (b) Apotex is not entitled to section 8 NOC damages; (c) AstraZeneca entitled to Apotex profits with profits‑on‑profits at prime compounded annually without tax deduction; and (d) AstraZeneca entitled to recover full claim to Apotex...

Orders

  • At no time during the infringing period did Apotex have an available NIA
  • Apotex is not entitled to any section 8 NOC damages recovery