Eli Lilly Canada Inc. v. Apotex Inc.

Eli Lilly Canada Inc. v. Apotex Inc.

The motion for summary trial was appropriate; on the balance of probabilities the defendants proved that a physiologically acceptable salt of tadalafil could not be made (POSITA understanding of "physiologically acceptable" requires non-toxicity, purity and stability and "salt" required ionic proton transfer), and the specification failed to enable such salts. Therefore the Asserted Claims are invalid for overbreadth (claims broader than what was invented) and for insufficiency (lack of enablement); the defendants' motion is granted and the plaintiffs' infringement actions relating to the 784 Patent are dismissed. The court did not decide the inutility/inoperable-species issue definitively.

Citation
2022 FC 1398
Parties
Plaintiff: Eli Lilly Canada Inc.; Plaintiff: Eli Lilly and Company; Plaintiff: Lilly del Caribe, Inc.; Plaintiff: Lilly, S.A.; Plaintiff: ICOS Corporation Inc.; Defendant/plaintiff by Counterclaim: Apotex Inc.; Defendant/plaintiff by Counterclaim: Mylan Pharmaceuticals ULC; Defendant/plaintiff by Counterclaim: Teva Canada Limited; Defendant/plaintiff by Counterclaim: Pharmascience Inc.; Defendant/plaintiff by Counterclaim: Laboratoire Riva Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
17 October 2022
Procedural Posture
Patent Infringement (invalidity Motion) / Summary Trial (motion for Summary Trial)
Outcome
Defendants' motion for summary trial granted; motion to strike denied; Asserted Claims of Canadian Patent No. 2,226,784 invalid for overbreadth and insufficiency; Plaintiffs' infringement actions dismissed; costs on motion to strike awarded to Plaintiffs; general costs reserved
Legal Topics
Claim Construction, Overbreadth/overclaiming, Sufficiency/enablement, Utility/sound Prediction, Summary Trial, Hearsay/admissibility, Expert Evidence, Inoperable Species
Source Language
English
Patent Law Intellectual Property Civil Procedure Evidence Claim Construction Overbreadth/overclaiming Sufficiency/enablement Utility/sound Prediction +4 more

Case Brief

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Parties

Eli Lilly Canada Inc.

Plaintiff

Eli Lilly and Company

Plaintiff

Lilly del Caribe, Inc.

Plaintiff

Lilly, S.A.

Plaintiff

ICOS Corporation Inc.

Plaintiff

Apotex Inc.

Defendant/plaintiff by Counterclaim

Mylan Pharmaceuticals ULC

Defendant/plaintiff by Counterclaim

Teva Canada Limited

Defendant/plaintiff by Counterclaim

Pharmascience Inc.

Defendant/plaintiff by Counterclaim

Laboratoire Riva Inc.

Defendant/plaintiff by Counterclaim

Procedural Posture

Patent Infringement (invalidity Motion) / Summary Trial (motion for Summary Trial)

Legal Issues

  1. 1 Whether the term "physiologically acceptable salt" is an essential claim element and how it should be construed by the POSITA as of Feb 6, 1997
  2. 2 Whether physiologically acceptable salts of tadalafil can be made (fact)
  3. 3 Whether Asserted Claims are invalid for overbreadth (claims broader than invention made)

Ratio Decidendi

The motion for summary trial was appropriate; on the balance of probabilities the defendants proved that a physiologically acceptable salt of tadalafil could not be made (POSITA understanding of "physiologically acceptable" requires non-toxicity, purity and stability and "salt" required ionic proton transfer), and the specification failed to enable such salts. Therefore the Asserted Claims are invalid for overbreadth (claims broader than what was invented) and for insufficiency (lack of enablement); the defendants' motion is granted and the plaintiffs' infringement actions relating to the 784 Patent are dismissed. The court did not decide the inutility/inoperable-species issue definitively.

Court Disposition

Defendants' motion for summary trial granted; motion to strike denied; Asserted Claims of Canadian Patent No. 2,226,784 invalid for overbreadth and insufficiency; Plaintiffs' infringement actions dismissed; costs on motion to strike awarded to Plaintiffs; general costs reserved

Orders

  • Motion to strike hearsay evidence denied
  • Costs of motion to strike awarded to the Plaintiffs in accordance with Rule 407