Eli Lilly Canada Inc. v. Apotex Inc.

Eli Lilly Canada Inc. v. Apotex Inc.

The Court held that Claims 1, 3–4 of Canadian Patent No. 2,492,540 are invalid for anticipation by Canadian Patent Application No. 2,412,594 (the 594 Application) and that all asserted Claims 1, 3–4, 7–10 and 12 are invalid for obviousness in light of the prior art (primarily the 594 Application and the 377 Patent) applying the Sanofi framework; accordingly the infringement action was dismissed and Apotex’s counterclaim granted. In the alternative, had the claims been valid the Court concluded the |||||||||| process would have infringed Claims 1,3–4 but other Apotex processes did not infringe or were exempt under s.55.2.

Citation
2020 FC 814
Parties
Plaintiffs/defendants by Counterclaim: Eli Lilly Canada Inc. et al.; Defendant/plaintiff by Counterclaim: Apotex Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
10 September 2020
Procedural Posture
Patent Infringement and Invalidity (tadalafil Manufacturing Process) / Liability Phase (bifurcated Trial)
Outcome
Action dismissed; counterclaim granted; asserted claims found invalid
Legal Topics
Claim Construction, Infringement, Invalidity, Anticipation, Obviousness, Burden of Proof, Statutory Presumptions, Regulatory Use Exemption (s.55.2), Overbreadth, Inutility
Source Language
English
Intellectual Property Patent Law Pharmaceutical Regulation Civil Procedure Claim Construction Infringement Invalidity Anticipation +6 more

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Parties

Eli Lilly Canada Inc. et al.

Plaintiffs/defendants by Counterclaim

Apotex Inc.

Defendant/plaintiff by Counterclaim

Procedural Posture

Patent Infringement and Invalidity (tadalafil Manufacturing Process) / Liability Phase (bifurcated Trial)

Legal Issues

  1. 1 Proper purposive construction of Claims 1,3-4,7-10,12 of Canadian Patent No. 2,492,540
  2. 2 Whether s.55.1 statutory presumption or Hoffmann common law presumption shifts burden of proof on infringement
  3. 3 Whether Apotex processes infringe asserted claims

Ratio Decidendi

The Court held that Claims 1, 3–4 of Canadian Patent No. 2,492,540 are invalid for anticipation by Canadian Patent Application No. 2,412,594 (the 594 Application) and that all asserted Claims 1, 3–4, 7–10 and 12 are invalid for obviousness in light of the prior art (primarily the 594 Application and the 377 Patent) applying the Sanofi framework; accordingly the infringement action was dismissed and Apotex’s counterclaim granted. In the alternative, had the claims been valid the Court concluded the |||||||||| process would have infringed Claims 1,3–4 but other Apotex processes did not infringe or were exempt under s.55.2.

Court Disposition

Action dismissed; counterclaim granted; asserted claims found invalid

Orders

  • Infringement action relating to Canadian Patents Nos. 2,371,684 and 2,492,540 is dismissed.
  • Claims 1, 3-4 of Canadian Patent No. 2,492,540 are invalid for anticipation.