Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176

Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176

Where goods containing the pharmaceutical substances were first included in the ARTG as listed goods for export only, and no pre-TGA marketing approval was given, that earlier listing was the "first inclusion in the ARTG" and the "first regulatory approval date" for Patents Act 1990 (Cth) ss 70 and 77. The statutory language was clear, the structure of the ARTG included listed and registered goods, export-only listing permitted exploitation of the invention, and the extrinsic materials were equivocal and did not justify limiting "first inclusion" to registration for marketing in Australia. The appeal was therefore dismissed.

Jurisdiction
Australia
Judgment Date
11 September 2006
Procedural Posture
Appeal From the Commissioner of Patents / Reasons for Judgment and Orders Dismissing the Appeal
Outcome
The appeal from the Commissioner of Patents was dismissed.
Legal Topics
['extension of Term of Patents Relating to Pharmaceutical Substances' 'first Inclusion in the Australian Register of Therapeutic Goods' 'validity of Patents Regulations 1991 (cth) Reg 10.7(7)' 'use of Extrinsic Materials in Statutory Construction' 'pre TGA Marketing Approval']
['patents' 'statutory Construction' 'therapeutic Goods Regulation'] ['extension of Term of Patents Relating to Pharmaceutical Substances' 'first Inclusion in the Australian Register of Therapeutic Goods' 'validity of Patents Regulations 1991 (cth) Reg 10.7(7)' 'use of Extrinsic Materials in Statutory Construction' 'pre TGA Marketing Approval']

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Procedural Posture

Appeal From the Commissioner of Patents / Reasons for Judgment and Orders Dismissing the Appeal

Legal Issues

  1. 1 ['Whether Patents Regulations 1991 (Cth) reg 10.7(7), requiring amendment of the Patents Register in certain circumstances, is valid.' 'Whether the date for calculating the extension of term under Patents Act 1990 (Cth) ss 70 and 77 is the first listing in the Australian Register of Therapeutic Goods for export only or the later registration permitting marketing in Australia.' 'Whether extrinsic materials show that "first inclusion in the Australian Register of Therapeutic Goods" means only approval enabling marketing in Australia.']

Ratio Decidendi

Where goods containing the pharmaceutical substances were first included in the ARTG as listed goods for export only, and no pre-TGA marketing approval was given, that earlier listing was the "first inclusion in the ARTG" and the "first regulatory approval date" for Patents Act 1990 (Cth) ss 70 and 77. The statutory language was clear, the structure of the ARTG included listed and registered goods, export-only listing permitted exploitation of the invention, and the extrinsic materials were equivocal and did not justify limiting "first inclusion" to registration for marketing in Australia. The appeal was therefore dismissed.

Court Disposition

The appeal from the Commissioner of Patents was dismissed.

Orders

  • ['The application, being an appeal from the Commissioner of Patents, is dismissed.' "The applicants pay the first respondent's costs."]