Merck & Co. v. Apotex Inc.

Merck & Co. v. Apotex Inc.

The court granted Apotex relief because Apotex demonstrated that use of the 518,336 Application in its Proposed Notice of Allegation was necessary to present a full invalidity argument, dissemination would be limited to parties already privy to the document (and the Minister), overlapping issues existed between the proceedings, and the prejudice to Apotex of denying relief outweighed any prejudice to Merck and co‑plaintiffs; paragraph 11 of the Protective Order merely restated the implied undertaking and was varied accordingly.

Citation
2004 FC 1723
Parties
Plaintiff (defendants by Counterclaim): MERCK & CO., INC.; Plaintiff (defendants by Counterclaim): MERCK FROSST CANADA & CO.; Plaintiff (defendants by Counterclaim): SYNGENTA LIMITED; Plaintiff (defendants by Counterclaim): ASTRAZENECA UK LIMITED; Plaintiff (defendants by Counterclaim): ASTRAZENECA CANADA INC.; Defendant (plaintiff by Counterclaim): APOTEX INC.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
9 December 2004
Procedural Posture
Patent Notice of Allegation Under Patented Medicines (notice of Compliance) Regulations / Interim Motion to Be Relieved From Implied Undertaking Rule and to Vary Protective Order
Outcome
Motion granted
Legal Topics
Implied Undertaking Rule, Variation of Protective Order, Patented Medicines (notice of Compliance) Regulations (noc), Use of Prosecution File History, Invalidity Challenge Via NOC Notice
Source Language
English
Patent Law Regulatory Law Civil Procedure Confidentiality/protective Orders Administrative Law Implied Undertaking Rule Variation of Protective Order Patented Medicines (notice of Compliance) Regulations (noc) +2 more

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Legal principles 3 Authorities cited 4 Party arguments 2 Amounts and remedies 1
Sign in to unlock

Parties

MERCK & CO., INC.

Plaintiff (defendants by Counterclaim)

MERCK FROSST CANADA & CO.

Plaintiff (defendants by Counterclaim)

SYNGENTA LIMITED

Plaintiff (defendants by Counterclaim)

ASTRAZENECA UK LIMITED

Plaintiff (defendants by Counterclaim)

ASTRAZENECA CANADA INC.

Plaintiff (defendants by Counterclaim)

APOTEX INC.

Defendant (plaintiff by Counterclaim)

Procedural Posture

Patent Notice of Allegation Under Patented Medicines (notice of Compliance) Regulations / Interim Motion to Be Relieved From Implied Undertaking Rule and to Vary Protective Order

Legal Issues

  1. 1 Whether Apotex may use confidential Canadian patent application 518,336 and its prosecution file history in a Proposed Notice of Allegation under the NOC Regulations
  2. 2 Whether relief from the implied undertaking rule is justified for collateral use in regulatory proceedings
  3. 3 Whether paragraph 11 of the Protective Order should be varied to permit such use

Ratio Decidendi

The court granted Apotex relief because Apotex demonstrated that use of the 518,336 Application in its Proposed Notice of Allegation was necessary to present a full invalidity argument, dissemination would be limited to parties already privy to the document (and the Minister), overlapping issues existed between the proceedings, and the prejudice to Apotex of denying relief outweighed any prejudice to Merck and co‑plaintiffs; paragraph 11 of the Protective Order merely restated the implied undertaking and was varied accordingly.

Court Disposition

Motion granted

Orders

  • Apotex is at liberty to use Canadian Patent Application Serial Number 518,336 and its Prosecution File History for the purpose of a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations in respect of Canadian Letters Patent 1,276,559 for lisinopril/hydrochlorothiazide.
  • Paragraph 11 of the Protective Order issued July 24, 2000 is varied to permit Apotex to use the 518,336 Application in its Proposed Notice of Allegation.