Following further stakeholder feedback, the approved form “Application for an Extension of Term of a Standard Patent” has been amended to clarify requirements for the provision of a certification under the Therapeutic Goods Act 1989 consistent with Reg 6.9 of the Patents Regulations. The amended form established with effect from 22 August 2016, requires under item 8:
“*A certificate issued to the Patentee under the Therapeutic Goods Act 1989, showing the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance is attached OR
The Patentee does not have a certificate issued under the Therapeutic Goods Act 1989, but another document is attached showing the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance. ”
And a further note has been added, specifying:
“If the Patentee does not have a copy of the certificate for Item 8, a document provided for Item 7 may be sufficient if it contains the relevant commencement date.”
Examination Group Chem3
+61 2 6283 2324
To be published in the Australian Official Journal of 1 September 2016.