The 'first regulatory approval date' for pharmaceutical patent term extensions under s 70(5)(a) of the Patents Act 1990 (Cth) is the date of first inclusion in any part of the Therapeutic Register, including as listed goods, not only as registered goods. Patentees seeking to maximise patent term extensions should ensure goods are included as registered goods before being listed. The Commissioner has valid power under r 10.7(7) to amend the Patent Register to correct extensions that were granted beyond what the Act authorised. Leave to appeal under s 158(2) does not in all cases require demonstration of clear prima facie error.
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