Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC

Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC

The Court held claims 6 and 18 valid: as of the Canadian filing date (June 21, 1988) the specification provided a factual basis (potent AChE inhibition, brain penetration, reversal of scopolamine-induced deficits in animals), an articulable and prima facie reasonable line of reasoning rooted in the cholinergic hypothesis, and adequate disclosure to support a sound prediction of therapeutic utility for senile dementia; accordingly the Minister is prohibited from issuing a Notice of Compliance to Mylan until expiry of Canadian Patent No. 1,338,808.

Citation
2011 FC 547
Parties
Applicant: Pfizer Canada Inc.; Applicant (patentee): Eisai Co., Ltd.; Respondent (second Person): Mylan Pharmaceuticals ULC; Respondent (regulatory Authority): The Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
12 May 2011
Procedural Posture
Application for Prohibition Under the Patented Medicines (notice of Compliance) Regulations / Hearing and Judgment (federal Court)
Outcome
Application allowed; Minister prohibited from issuing Notice of Compliance to Mylan until expiry of Canadian Patent No. 1,338,808
Legal Topics
Utility, Sound Prediction, Patent Validity, Notice of Compliance Proceedings, Claim Construction, Expert Evidence
Source Language
English
Patent Law Pharmaceutical Regulatory Intellectual Property Administrative Law Utility Sound Prediction Patent Validity Notice of Compliance Proceedings +2 more

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Parties

Pfizer Canada Inc.

Applicant

Eisai Co., Ltd.

Applicant (patentee)

Mylan Pharmaceuticals ULC

Respondent (second Person)

The Minister of Health

Respondent (regulatory Authority)

Procedural Posture

Application for Prohibition Under the Patented Medicines (notice of Compliance) Regulations / Hearing and Judgment (federal Court)

Legal Issues

  1. 1 Whether Canadian Patent No. 1,338,808 (claims 6 and 18) is invalid for lack of sound prediction of the promised utility
  2. 2 Construction of claims 6 and 18 (compound claim vs. therapeutic-use claim)
  3. 3 Appropriate evidential weight of animal studies and expert testimony as of the Canadian filing date (June 21, 1988)

Ratio Decidendi

The Court held claims 6 and 18 valid: as of the Canadian filing date (June 21, 1988) the specification provided a factual basis (potent AChE inhibition, brain penetration, reversal of scopolamine-induced deficits in animals), an articulable and prima facie reasonable line of reasoning rooted in the cholinergic hypothesis, and adequate disclosure to support a sound prediction of therapeutic utility for senile dementia; accordingly the Minister is prohibited from issuing a Notice of Compliance to Mylan until expiry of Canadian Patent No. 1,338,808.

Court Disposition

Application allowed; Minister prohibited from issuing Notice of Compliance to Mylan until expiry of Canadian Patent No. 1,338,808

Orders

  • Minister of Health prohibited from issuing a Notice of Compliance to Mylan Pharmaceuticals ULC until after expiry of Canadian Patent No. 1,338,808 (expiry Dec 24, 2013)
  • Applicants awarded costs against Mylan to be fixed at upper end of Column IV with allowance for two senior counsel; parties to file submissions on costs (maximum five pages) within 15 days