AstraZeneca Canada Inc. v. Apotex inc.

AstraZeneca Canada Inc. v. Apotex inc.

AstraZeneca Canada has standing via an implied licence; the ’653 patent unambiguously promised an improved therapeutic profile (including lower interindividual variation) and stability to racemization; that promise was neither demonstrated nor soundly predicted across the promised therapeutic scope; inutility is fatal to validity; therefore the patent is invalid and plaintiffs' infringement claim is dismissed.

Citation
2014 FC 638
Parties
Plaintiffs (defendants by Counterclaim): AstraZeneca Canada Inc.; AstraZeneca Aktiebolag; AstraZeneca UK Limited; Defendants (plaintiffs by Counterclaim): Apotex Inc.; Apotex Pharmachem Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
2 July 2014
Procedural Posture
Patent Infringement Action With Counterclaim for Invalidity (pmnoc Context) / Trial Judgment (federal Court)
Outcome
Plaintiffs' action for infringement dismissed; Defendants' counterclaim for declaration that patent 2,139,653 is invalid granted
Legal Topics
Utility (promise of the Patent), Sound Prediction, Claims Construction, Novelty/anticipation, Enablement, Obviousness (obvious to Try), Standing, Issue Estoppel, Abuse of Process, PMNOC Proceedings
Source Language
English
Patent Law Intellectual Property Pharmaceutical Regulation Utility (promise of the Patent) Sound Prediction Claims Construction Novelty/anticipation Enablement +5 more

Case Brief

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Parties

AstraZeneca Canada Inc.; AstraZeneca Aktiebolag; AstraZeneca UK Limited

Plaintiffs (defendants by Counterclaim)

Apotex Inc.; Apotex Pharmachem Inc.

Defendants (plaintiffs by Counterclaim)

Procedural Posture

Patent Infringement Action With Counterclaim for Invalidity (pmnoc Context) / Trial Judgment (federal Court)

Legal Issues

  1. 1 Does AstraZeneca Canada have standing under s.55(1) Patent Act?
  2. 2 Are issues from prior NOC proceeding binding or preclusive (issue estoppel/abuse of process)?
  3. 3 Proper construction of the '653 patent claims and identification of the skilled person

Ratio Decidendi

AstraZeneca Canada has standing via an implied licence; the ’653 patent unambiguously promised an improved therapeutic profile (including lower interindividual variation) and stability to racemization; that promise was neither demonstrated nor soundly predicted across the promised therapeutic scope; inutility is fatal to validity; therefore the patent is invalid and plaintiffs' infringement claim is dismissed.

Court Disposition

Plaintiffs' action for infringement dismissed; Defendants' counterclaim for declaration that patent 2,139,653 is invalid granted

Orders

  • Action for declaration of infringement of claims 7, 8, and 25-27 dismissed
  • Counterclaim for declaration that Canadian Patent No. 2,139,653 is invalid granted with costs awarded to defendants