Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58

Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58

An application for PBS listing accompanied by a supply assurance is not an offer to the Minister to sell or otherwise dispose of the respondents' products to wholesalers, pharmacists or other third parties. It is only an assurance that sufficient stock will be available to meet demand if the products are listed, and the statutory guaranteed supply obligations arise only when the PBS determination comes into force after the patent term. Therefore the primary judge was correct that the proposed PBS listing steps would not infringe the patent.

Jurisdiction
Australia
Judgment Date
13 April 2017
Procedural Posture
Patent Appeal / Appeals From Apotex Pty Ltd V Warner Lambert LLC (no 3) [2017] FCA 94, Determined Separately From Cross Appeals
Outcome
Appeals dismissed.
Legal Topics
['pharmaceutical Benefits Scheme Listing' 'patent Infringement' 'offer to Supply' 'exploitation of Invention' 'swiss Claims' 'generic Pregabalin Products']
['intellectual Property' 'patents'] ['pharmaceutical Benefits Scheme Listing' 'patent Infringement' 'offer to Supply' 'exploitation of Invention' 'swiss Claims' 'generic Pregabalin Products']

Case Brief

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Procedural Posture

Patent Appeal / Appeals From Apotex Pty Ltd V Warner Lambert LLC (no 3) [2017] FCA 94, Determined Separately From Cross Appeals

Legal Issues

  1. 1 ['Whether an application by the respondents for listing of their products on the Pharmaceutical Benefits Scheme would infringe a patent by constituting an offer to supply and an exploitation of the claimed invention.']

Ratio Decidendi

An application for PBS listing accompanied by a supply assurance is not an offer to the Minister to sell or otherwise dispose of the respondents' products to wholesalers, pharmacists or other third parties. It is only an assurance that sufficient stock will be available to meet demand if the products are listed, and the statutory guaranteed supply obligations arise only when the PBS determination comes into force after the patent term. Therefore the primary judge was correct that the proposed PBS listing steps would not infringe the patent.

Court Disposition

Appeals dismissed.

Orders

  • ['In NSD 239 of 2017, the appeal be dismissed.' "In NSD 239 of 2017, the appellants pay the respondent's costs of the appeal as agreed or taxed." "In NSD 239 of 2017, the parties confer and file agreed proposed orders in respect of the cross appeal and notice of contention, including counsel's details, the estimated...