Merck & Co. Inc. v. Apotex Inc.

Merck & Co. Inc. v. Apotex Inc.

Claims 1, 2 and 5 of Canadian Patent No. 1,275,350 are valid and were infringed by Apotex subject to narrow statutory and common-law exemptions; Apotex is precluded from re-litigating validity issues that could have been raised in prior related litigation; Delmar compulsory license and s.56 do not excuse the specific Delmar batches in issue; s.55.2(1) and common-law experimental use shield Apotex's regulatory and bona fide experimental activities (limited by pleading and limitation rules); remedies: damages, injunction (deferred 30 days with accounting and trust conditions), no election of Apotex profits due to equities and conduct of parties.

Citation
2006 FC 524
Parties
Plaintiff (defendant by Counterclaim): Merck & Co., Inc.; Plaintiff (defendant by Counterclaim): Merck Frosst Canada & Co.; Plaintiff (defendant by Counterclaim): Merck Frosst Canada Ltd.; Plaintiff (defendant by Counterclaim): Syngenta Limited; Plaintiff (defendant by Counterclaim): AstraZeneca UK Limited; Plaintiff (defendant by Counterclaim): AstraZeneca Canada Inc.; Defendant (plaintiff by Counterclaim): Apotex Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
26 April 2006
Procedural Posture
Patent Infringement and Validity / Trial Reasons for Judgment
Outcome
Judgment for Plaintiffs: patent valid and infringed in part; limited exemptions upheld; injunction and damages ordered; costs reserved
Legal Topics
Infringement, Validity, Divisional Applications, Double Patenting, Compulsory License, Regulatory Exemptions (s.55.2), Remedies (damages, Injunction)
Source Language
English
Intellectual Property Patent Law Infringement Validity Divisional Applications Double Patenting Compulsory License Regulatory Exemptions (s.55.2) +1 more

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Parties

Merck & Co., Inc.

Plaintiff (defendant by Counterclaim)

Merck Frosst Canada & Co.

Plaintiff (defendant by Counterclaim)

Merck Frosst Canada Ltd.

Plaintiff (defendant by Counterclaim)

Syngenta Limited

Plaintiff (defendant by Counterclaim)

AstraZeneca UK Limited

Plaintiff (defendant by Counterclaim)

AstraZeneca Canada Inc.

Plaintiff (defendant by Counterclaim)

Apotex Inc.

Defendant (plaintiff by Counterclaim)

Procedural Posture

Patent Infringement and Validity / Trial Reasons for Judgment

Legal Issues

  1. 1 Construction of patent and claims
  2. 2 Whether Apotex infringed claims 1,2 and 5
  3. 3 Scope and applicability of exemptions: s.56, Delmar compulsory license, s.55.2(1), common law experimental use, dedication

Ratio Decidendi

Claims 1, 2 and 5 of Canadian Patent No. 1,275,350 are valid and were infringed by Apotex subject to narrow statutory and common-law exemptions; Apotex is precluded from re-litigating validity issues that could have been raised in prior related litigation; Delmar compulsory license and s.56 do not excuse the specific Delmar batches in issue; s.55.2(1) and common-law experimental use shield Apotex's regulatory and bona fide experimental activities (limited by pleading and limitation rules); remedies: damages, injunction (deferred 30 days with accounting and trust conditions), no election of Apotex profits due to equities and conduct of parties.

Court Disposition

Judgment for Plaintiffs: patent valid and infringed in part; limited exemptions upheld; injunction and damages ordered; costs reserved

Orders

  • Claims 1, 2 and 5 of Canadian Patent No. 1,275,350 declared valid and infringed by Apotex subject to exemptions under s.55.2(1) and common-law experimental use
  • Permanent injunction restraining Apotex from making, using or selling lisinopril products after injunction becomes effective (injunction effective 30 days after date of Reasons to permit appeal/stay application)