Advise on an extension of term for a pharmaceutical patent
Key facts
- Human involvement
- RedLawyer-led
- How AI is used
- From the patent and the Australian Register of Therapeutic Goods entry the lawyer supplies, list whether the manual's three conditions appear on the face of those documents: a pharmaceutical substance per se or a pharmaceutical substance produced by recombinant DNA technology, goods containing or consisting of that substance included in the Register, and first regulatory approval more than five years after the date of the patent. Note the manual's account of section 78. Do not say that an extension should be granted.
- What the lawyer must review
- The lawyer decides whether the patent meets sections 70 and following, calculates any term, and writes the application. The lawyer confirms, on the current manual, whether extension-of-term applications are being processed before one is filed.
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | Supporting preparation only. From the patent and the Australian Register of Therapeutic Goods entry the lawyer supplies, list whether the manual's three conditions appear on the face of those documents: a pharmaceutical substance per se or a pharmaceutical substance produced by recombinant DNA technology, goods containing or consisting of that substance included in the Register, and first regulatory approval more than five years after the date of the patent. Note the manual's account of section 78. Do not say that an extension should be granted. The tool writes nothing into the document. Substantive advice, judgement and any restricted content remain with the responsible human. |
| Lawyer | Perform the substantive analysis and decisions. Independently check any permitted supporting work and approve the exact output for its intended use. |
Checklist
- Check the substance, the Register entry and the approval date against the documents, not against the client's chronology.
- Confirm the date of the patent used for the five-year comparison is the date the Act uses, which the lawyer reads in the Act rather than taking from the manual's summary alone.
- Read the manual's current page, including any processing notice. Its amendment log records a suspension banner added on 8 January 2026 and later changed on 20 February 2026. Do not assume from that log that applications are, or are not, being accepted today.
- Confirm the advice states the narrower rights during the extended term, as the manual describes section 78.
Sources
- IP Australia patent manual: extension of term of standard patents relating to pharmaceutical substances · 2026-10-22
These are suggested working checks. Confirm the required checking with the responsible lawyer before work starts; the checking approach does not establish permission to use AI.
Sections 70, 71 and 78 were not opened as separate pages. The conditions above are the manual's statement of them. Read the Act before filing.