Pfizer Canada Inc. v. Pharmascience Inc.

Pfizer Canada Inc. v. Pharmascience Inc.

Claim 3, which asserted pregabalin and its racemate for treating a broad range of pains, is invalid because the specification and evidence only provided tests and a factual basis for pregabalin (the S‑enantiomer) in certain persistent pain models and did not disclose any factual basis or sound line of reasoning to predict efficacy of the racemate or efficacy across the full breadth of pains claimed; accordingly the claim is broader than the invention made or disclosed and lacks the requisite utility/sound prediction. The allegation of obviousness was not established.

Citation
2013 FC 120
Parties
Applicant: Pfizer Canada Inc.; Applicant: Warner‑Lambert Company LLC; Respondent: Pharmascience Inc.; Respondent: Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
4 February 2013
Procedural Posture
Patented Medicines (notice of Compliance) Regulations – NOC Application (patent NOC Proceeding) / Judgment (reasons for Judgment)
Outcome
Application dismissed; no interlocutory or final order prohibiting issuance of a Notice of Compliance to Pharmascience; costs awarded to Pharmascience
Legal Topics
Claim Construction, Sound Prediction (utility), Inutility, Obviousness, Selection Patents, Reissue Application, NOC Regulations
Source Language
English
Patent Law Pharmaceutical Regulatory Law Intellectual Property Litigation Claim Construction Sound Prediction (utility) Inutility Obviousness Selection Patents +2 more

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Parties

Pfizer Canada Inc.

Applicant

Warner‑Lambert Company LLC

Applicant

Pharmascience Inc.

Respondent

Minister of Health

Respondent

Procedural Posture

Patented Medicines (notice of Compliance) Regulations – NOC Application (patent NOC Proceeding) / Judgment (reasons for Judgment)

Legal Issues

  1. 1 Whether claim 3 is broader than the invention made or disclosed
  2. 2 Whether utility of the claimed compounds was established or soundly predicted (sound prediction)
  3. 3 Whether the claim is invalid for actual inutility

Ratio Decidendi

Claim 3, which asserted pregabalin and its racemate for treating a broad range of pains, is invalid because the specification and evidence only provided tests and a factual basis for pregabalin (the S‑enantiomer) in certain persistent pain models and did not disclose any factual basis or sound line of reasoning to predict efficacy of the racemate or efficacy across the full breadth of pains claimed; accordingly the claim is broader than the invention made or disclosed and lacks the requisite utility/sound prediction. The allegation of obviousness was not established.

Court Disposition

Application dismissed; no interlocutory or final order prohibiting issuance of a Notice of Compliance to Pharmascience; costs awarded to Pharmascience

Orders

  • The application is dismissed.
  • Pharmascience is entitled to costs, reasonable disbursements and applicable taxes to be paid by the Applicants jointly and severally; costs assessed at middle of Column IV with allowance for two counsel; experts' fees taxable up to senior counsel rates.