Pfizer Corp v Commissioner of Patents [2006] FCAFC 190

Pfizer Corp v Commissioner of Patents [2006] FCAFC 190

The first regulatory approval date under s 70 of the Patents Act 1990 (Cth) refers to the date when the pharmaceutical substance was first included in the Therapeutic Register, whether as listed or registered goods. There was no error by the Commissioner or the primary judge in amending the register to reflect the earlier listed goods inclusion date. Further, regulation 10.7(7) is a valid exercise of the powers under s 228(2) as its purpose is to ensure the accuracy of the Patent Register, which is consistent with the statutory scheme.

Jurisdiction
Australia
Judgment Date
20 December 2006
Procedural Posture
Appeal / Full Court Appeal From Single Judge of the Federal Court
Outcome
Appeal dismissed; leave to appeal granted
Legal Topics
['patent Term Extension' 'validity of Regulations' 'statutory Construction' 'therapeutic Goods Act Interaction' 'appeals Leave Requirements']
['intellectual Property' 'practice and Procedure'] ['patent Term Extension' 'validity of Regulations' 'statutory Construction' 'therapeutic Goods Act Interaction' 'appeals Leave Requirements']

Case Brief

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Procedural Posture

Appeal / Full Court Appeal From Single Judge of the Federal Court

Legal Issues

  1. 1 ['Whether the extension of time for patent term was valid under the Patents Act 1990 (Cth)' 'Whether the Commissioner misconstrued s 70 of the Patents Act in determining the first regulatory approval date' 'Whether regulation 10.7(7) is invalid as exceeding the regulation making power under s 228 of the Patents Act' 'Whether the first regulatory approval date is the first inclusion in the Therapeutic Register as listed goods or registered goods' 'Whether clear prima facie error is required for leave to appeal under s 158(2)']

Ratio Decidendi

The first regulatory approval date under s 70 of the Patents Act 1990 (Cth) refers to the date when the pharmaceutical substance was first included in the Therapeutic Register, whether as listed or registered goods. There was no error by the Commissioner or the primary judge in amending the register to reflect the earlier listed goods inclusion date. Further, regulation 10.7(7) is a valid exercise of the powers under s 228(2) as its purpose is to ensure the accuracy of the Patent Register, which is consistent with the statutory scheme.

Court Disposition

Appeal dismissed; leave to appeal granted

Orders

  • ['Leave to appeal granted' 'Appeal dismissed' "Appellants to pay respondents' costs of the appeal, including costs of the leave application"]