Axcan Pharma Inc. v. Pharmascience Inc.

Axcan Pharma Inc. v. Pharmascience Inc.

Applicant failed to prove on a balance of probabilities that issuance of a NOC for Pharmascience's product would inevitably result in infringement of the '590 use patent because the evidence (product monograph, labelling, expert affidavits) showed the product was to be approved and promoted only for gallstone...

Source-derived case information.

Citation
2005 FC 1231
Parties
Applicant: AXCAN PHARMA INC.; Respondent: PHARMASCIENCE INC.; Respondent: THE MINISTER OF HEALTH
Court
Federal Court
Jurisdiction
Canada
Judgment Date
12 September 2005
Procedural Posture
Patented Medicines (notice of Compliance) Application (s.6(1)) / Application for Prohibition — Reasons for Order and Dismissal
Outcome
Application dismissed
Legal Topics
Use Patent, Notice of Compliance (noc), Abbreviated New Drug Submission (ands), Infringement Burden, Product Monograph, Off Label Use
Source Language
english
Patent Law Pharmaceutical Regulation Administrative Law Use Patent Notice of Compliance (noc) Abbreviated New Drug Submission (ands) Infringement Burden Product Monograph +1 more

Source-derived case record

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Legal principles 5 Authorities cited 9 Party arguments 2 Amounts and remedies 2
Sign in to unlock

Parties

AXCAN PHARMA INC.

Applicant

PHARMASCIENCE INC.

Respondent

THE MINISTER OF HEALTH

Respondent

Procedural Posture

Patented Medicines (notice of Compliance) Application (s.6(1)) / Application for Prohibition — Reasons for Order and Dismissal

Legal Issues

  1. 1 Whether applicant discharged burden that respondent's Notice of Allegation is not justified
  2. 2 Whether sale of generic product for a different approved indication would inevitably lead to infringement of a use patent by third parties
  3. 3 Whether reliance on originator's data in an ANDS demonstrates intention to infringe

Ratio Decidendi

Applicant failed to prove on a balance of probabilities that issuance of a NOC for Pharmascience's product would inevitably result in infringement of the '590 use patent because the evidence (product monograph, labelling, expert affidavits) showed the product was to be approved and promoted only for gallstone dissolution, off-label use for PBC was not inevitable, and reliance on originator data in an ANDS is lawful and not proof of intent to infringe.

Court Disposition

Application dismissed

Orders

  • Application dismissed; costs awarded to the respondent Pharmascience Inc.
  • No costs awarded to the Minister of Health