Eli Lilly Canada Inc. v. Hospira Healthcare Corporation

Eli Lilly Canada Inc. v. Hospira Healthcare Corporation

The appeal is dismissed because the prothonotary did not err: she applied the correct 'train of inquiry' relevance test, reasonably found the evidence disclosed a plausible likelihood that Hansen used the SN2 process (thus making batch records and regulatory files relevant), and properly ordered production of unredacted DMF/ANDS and batch records; Hospira failed to demonstrate the exercise of discretion was based on a wrong principle or misapprehension of facts.

Citation
2009 FC 1316
Parties
Plaintiff (defendant by Counterclaim): Eli Lilly Canada Inc.; Plaintiff (defendant by Counterclaim): Eli Lilly and Company; Defendant (plaintiff by Counterclaim): Hospira Healthcare Corporation
Court
Federal Court
Jurisdiction
Canada
Judgment Date
31 December 2009
Procedural Posture
Patent Infringement Action (process Patent) / Appeal From Prothonotary Order Compelling Further and Better Affidavit of Documents and Production of Unredacted Regulatory and Batch Records
Outcome
Appeal dismissed with costs
Legal Topics
Patent Infringement, Discovery/disclosure, Relevance (train of Inquiry), Regulatory Filings (dmf/ands), Confidentiality and Redaction, Commercial Viability of Manufacturing Process, Chemical Process Dispute (sn1 Vs Sn2)
Source Language
English
Intellectual Property Civil Procedure Administrative Law Pharmaceutical Regulation Patent Infringement Discovery/disclosure Relevance (train of Inquiry) Regulatory Filings (dmf/ands) +3 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 4 Authorities cited 5 Party arguments 2 Amounts and remedies 1
Sign in to unlock

Parties

Eli Lilly Canada Inc.

Plaintiff (defendant by Counterclaim)

Eli Lilly and Company

Plaintiff (defendant by Counterclaim)

Hospira Healthcare Corporation

Defendant (plaintiff by Counterclaim)

Procedural Posture

Patent Infringement Action (process Patent) / Appeal From Prothonotary Order Compelling Further and Better Affidavit of Documents and Production of Unredacted Regulatory and Batch Records

Legal Issues

  1. 1 Whether the prothonotary erred in ordering production of further and better affidavit of documents and unredacted regulatory and batch records
  2. 2 Whether Lilly met the relevance/test of a 'train of inquiry' to justify production
  3. 3 Whether the content of Hospira's ANDS and regulatory certificates is entitled to a presumption of truth

Ratio Decidendi

The appeal is dismissed because the prothonotary did not err: she applied the correct 'train of inquiry' relevance test, reasonably found the evidence disclosed a plausible likelihood that Hansen used the SN2 process (thus making batch records and regulatory files relevant), and properly ordered production of unredacted DMF/ANDS and batch records; Hospira failed to demonstrate the exercise of discretion was based on a wrong principle or misapprehension of facts.

Court Disposition

Appeal dismissed with costs

Orders

  • Appeal dismissed with costs fixed at the upper range of the units in Column IV of the Tariff
  • Prothonotary Tabib's order is upheld: Hospira must serve a further and better affidavit of documents including the open and closed parts of its DMF, the relevant parts of its ANDS and amendments, the Batch Records relating to manufacture of gemcitabine and the related certificates of analysis, and produce unredacted...