Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285

Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285

Pfizer failed to establish, on the material before the court, a reasonable (objectively founded) belief that it may have the right to obtain relief for patent infringement as required by FCR 7.23(1)(a); the inference that the BRENZYS process fell within the relevant patent claims did not rise above speculation, being based largely on product similarity rather than process specifics, and Pfizer's evidence, notably Dr Ibarra's, did not provide a sufficient evidentiary foundation.

Parties
First Prospective Applicant: Pfizer Ireland Pharmaceuticals; Second Prospective Applicant: Wyeth LLC; Third Prospective Applicant: Pfizer Australia Pty Ltd ACN 008 422 348; Prospective Respondent: Samsung Bioepis AU Pty Ltd ACN 611 890 094
Jurisdiction
Australia
Judgment Date
21 March 2017
Procedural Posture
Application for Preliminary Discovery / Judgment After Contested Hearing
Outcome
Application dismissed with costs
Legal Topics
Preliminary Discovery, Patent Infringement, Biosimilars, Admissibility of Expert Evidence

Case Brief

Summary, issues, holding and outcome

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Parties

Pfizer Ireland Pharmaceuticals

First Prospective Applicant

Wyeth LLC

Second Prospective Applicant

Pfizer Australia Pty Ltd ACN 008 422 348

Third Prospective Applicant

Samsung Bioepis AU Pty Ltd ACN 611 890 094

Prospective Respondent

Procedural Posture

Application for Preliminary Discovery / Judgment After Contested Hearing

  1. 1 Whether the applicant held a reasonable belief of a right to obtain relief for patent infringement within FCR 7.23(1)(a)
  2. 2 Whether the applicants made reasonable inquiries under FCR 7.23(1)(b)
  3. 3 Whether the required evidence for preliminary discovery was present

Ratio Decidendi

Pfizer failed to establish, on the material before the court, a reasonable (objectively founded) belief that it may have the right to obtain relief for patent infringement as required by FCR 7.23(1)(a); the inference that the BRENZYS process fell within the relevant patent claims did not rise above speculation, being based largely on product similarity rather than process specifics, and Pfizer's evidence, notably Dr Ibarra's, did not provide a sufficient evidentiary foundation.

Court Disposition

Application dismissed with costs

Orders

  • The application be dismissed.
  • The applicants pay the respondent's costs.