The Australian Patent Office makes clear that products with two physically separated parts are not eligible for pharmaceutical patent term extension.
This note provides a brief summary on the recent decision of a Delegate of the Commissioner of Patents reported as Pharma Mar S.A. [2020] APO 8. Wrays acted for the applicant.
Background
Pharmaceutical patent term extensions (PTE) are available to patentees in Australia where a patentee has been delayed in bringing a pharmaceutical substance to market. This may happen through delays caused by Australia’s rigorous clinical trial process, which must be navigated before marketing approval for a pharmaceutical substance is acquired.
Australia’s PTE patent legislation thus compensates patentee’s for marketing approval delays, providing them with an effective patent term similar to patent terms observed for other technologies outside the pharma industry. A PTE may be achieved for up to five (5) years, on top of the 20-year regular patent term.
A PTE will be granted if the following conditions, amongst others, are satisfied:
- one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification (s70(2)(a) Patents Act 1990)
- goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods (s70(3)(a) Patents Act 1990).
These conditions were considered in the recent decision of a Delegate of the Commissioner of Patents, Pharma Mar S.A. [2020] APO 8 (the Decision).
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