Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC

The Court held that Claims 10 (dependent on 9, 3–6) and Claims 13–16 of Canadian Patent No. 2,371,684 are invalid because the prior 784 Application disclosed and enabled the essential claim elements (unit oral tadalafil dosages within the claimed ranges for treatment of sexual dysfunction/ED) and, alternatively, the claimed lower/narrower dose ranges would have been obvious to a skilled drug‑development team by routine dose‑ranging work informed by the prior art (sildenafil, 377 and 784 materials); the patent is not a valid selection and no daily‑dose limitation is read into the claims.

Citation
2020 FC 816
Parties
Plaintiff/defendant by Counterclaim: Eli Lilly Canada Inc.; Plaintiff/defendant by Counterclaim: Eli Lilly and Company; Plaintiff/defendant by Counterclaim: Lilly Del Caribe, Inc.; Plaintiff/defendant by Counterclaim: Lilly, S.A.; Plaintiff/defendant by Counterclaim: ICOS Corporation Inc.; Defendant/plaintiff by Counterclaim: Mylan Pharmaceuticals ULC; Defendant/plaintiff by Counterclaim: Apotex Inc.; 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
10 September 2020
Procedural Posture
Patent Infringement and Invalidity (tadalafil Dosage Patent) / Liability Phase — Trial Judgment (federal Court)
Outcome
Claim dismissed; Claim 10 (as dependent on Claims 9, 3–6) and Claims 13–16 of Canadian Patent No. 2,371,684 declared invalid for anticipation and obviousness; costs awarded to Defendants.
Legal Topics
Anticipation, Obviousness, Claim Construction, Selection Patent, Issue Estoppel, Judicial Comity, Utility, Inducement, Damages Vs Accounting of Profits, Sealing Order
Source Language
English
Patent Law Intellectual Property Pharmaceutical Regulation Civil Procedure Anticipation Obviousness Claim Construction Selection Patent +6 more

Case Brief

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Parties

Eli Lilly Canada Inc.

Plaintiff/defendant by Counterclaim

Eli Lilly and Company

Plaintiff/defendant by Counterclaim

Lilly Del Caribe, Inc.

Plaintiff/defendant by Counterclaim

Lilly, S.A.

Plaintiff/defendant by Counterclaim

ICOS Corporation Inc.

Plaintiff/defendant by Counterclaim

Mylan Pharmaceuticals ULC

Defendant/plaintiff by Counterclaim

Apotex Inc.

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 and Invalidity (tadalafil Dosage Patent) / Liability Phase — Trial Judgment (federal Court)

Legal Issues

  1. 1 Whether asserted claims of Canadian Patent No. 2,371,684 are valid
  2. 2 Whether claims are anticipated by prior art (Canadian application/PCT WO 97/03675 - the 784 Application)
  3. 3 Whether claims are obvious in view of sildenafil, the 377 Patent and the 784 Application

Ratio Decidendi

The Court held that Claims 10 (dependent on 9, 3–6) and Claims 13–16 of Canadian Patent No. 2,371,684 are invalid because the prior 784 Application disclosed and enabled the essential claim elements (unit oral tadalafil dosages within the claimed ranges for treatment of sexual dysfunction/ED) and, alternatively, the claimed lower/narrower dose ranges would have been obvious to a skilled drug‑development team by routine dose‑ranging work informed by the prior art (sildenafil, 377 and 784 materials); the patent is not a valid selection and no daily‑dose limitation is read into the claims.

Court Disposition

Claim dismissed; Claim 10 (as dependent on Claims 9, 3–6) and Claims 13–16 of Canadian Patent No. 2,371,684 declared invalid for anticipation and obviousness; costs awarded to Defendants.

Orders

  • Claim 10 (as it depends on Claim 9, as it in turn depends on Claims 3–6), and Claims 13–16 of Canadian Patent No. 2,371,684 declared invalid for anticipation and obviousness
  • The infringement action relating to Canadian Patent No. 2,371,684 is dismissed