Section 4 of the Patented Medicines (Notice of Compliance) Regulations (Re)

Section 4 of the Patented Medicines (Notice of Compliance) Regulations (Re)

The Court held that the Minister's ex parte factual underpinning for the reference was in genuine dispute and incapable of being resolved on the summary reference record without full evidence and cross-examination; under Rule 399 the prothonotary properly concluded there was a prima facie case to strike the Reference, and the Court, exercising its discretion de novo, struck the Notice of Application for a Reference without leave to amend and dismissed the appeal and cross-appeal.

Citation
2002 FCT 1000
Parties
Applicant/referring Tribunal: Minister of Health; Respondent/interested Party: Eli Lilly Canada Inc.; Respondent/intervener: Canada's Research-Based Pharmaceutical Companies (Rx & D); Respondent/intervener: Canadian Drug Manufacturers Association (CDMA); Intervener: AstraZeneca Canada Inc.; Intervener: Hoffmann-La Roche Limited; Intervener: GlaxoSmithKline Inc.; Intervener: Pfizer Canada Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
25 September 2002
Procedural Posture
Reference Under Subsection 18.3(1) of the Federal Court Act / Appeal From Prothonotary's Order Under Rule 51; Motion Under Rule 399 and Cross Motion to File Evidence
Outcome
Appeal and cross-appeal dismissed; the Notice of Application for a Reference struck without leave to amend
Legal Topics
Pm(noc) Regulations S.4, References Under Federal Court Act S.18.3, Ex Parte Directions Rule 322, Setting Aside Ex Parte Orders Rule 399, Striking Pleadings/notice of Application
Source Language
English
Administrative Law Intellectual Property Patent Law Health Regulation Civil Procedure Pm(noc) Regulations S.4 References Under Federal Court Act S.18.3 Ex Parte Directions Rule 322 +2 more

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Parties

Minister of Health

Applicant/referring Tribunal

Eli Lilly Canada Inc.

Respondent/interested Party

Canada's Research-Based Pharmaceutical Companies (Rx & D)

Respondent/intervener

Canadian Drug Manufacturers Association (CDMA)

Respondent/intervener

AstraZeneca Canada Inc.

Intervener

Hoffmann-La Roche Limited

Intervener

GlaxoSmithKline Inc.

Intervener

Pfizer Canada Inc.

Intervener

Procedural Posture

Reference Under Subsection 18.3(1) of the Federal Court Act / Appeal From Prothonotary's Order Under Rule 51; Motion Under Rule 399 and Cross Motion to File Evidence

Legal Issues

  1. 1 Whether this Court may strike a reference instituted ex parte under Rule 322 and varied under Rule 399
  2. 2 Whether the Notice of Application for a Reference was so irregular or the factual underpinning so disputed that it should be struck
  3. 3 Whether the prothonotary's discretionary order was based on an error of law and subject to de novo review

Ratio Decidendi

The Court held that the Minister's ex parte factual underpinning for the reference was in genuine dispute and incapable of being resolved on the summary reference record without full evidence and cross-examination; under Rule 399 the prothonotary properly concluded there was a prima facie case to strike the Reference, and the Court, exercising its discretion de novo, struck the Notice of Application for a Reference without leave to amend and dismissed the appeal and cross-appeal.

Court Disposition

Appeal and cross-appeal dismissed; the Notice of Application for a Reference struck without leave to amend

Orders

  • The Minister of Health's Notice of Application for a Reference is struck without leave to amend
  • Appeal and cross-appeal dismissed