A Pharmaceutical Patent Term Extension is an option that is available to eligible patentees in Australia and is intended to restore a portion of the patent term that is lost while the pharmaceutical product awaits regulatory approval.
Under Australian patent law, the term of a pharmaceutical patent may be extended if certain criteria are met. In this regard, a patent term extension of up to five years (beyond the standard 20-year term) may be obtained for pharmaceutical products per se. In order to be eligible, more than five years must have passed between the filing date of the patent and the date on which regulatory approval for a product covered by the patent was obtained in Australia. Furthermore, in relation to eligibility for a patent term extension, section 70(2) of the Patents Act 1990 (Cth) states:
Either or both of the following conditions must be satisfied:
a) 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;
b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA
technology, 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.
It is worth noting that deadlines are strict and the claims of the patent should be reviewed well before the relevant deadline for requesting the patent term extension. Patentees should also be aware that only one patent term extension can be granted per patent. However, multiple patents can be extended based on the registration of a single pharmaceutical product.
IP Australia has recently updated their fee structure (implemented on 1 October 2020). Of particular note is that the renewal fees have increased significantly for the possible five years available under the patent term extension. The below table summarizes the renewal fee increase:
|Renewal Year||Old Fee||New Fee|
|Pharmaceutical Patent -20th anniversary||$2,550||$4,000|
|Pharmaceutical Patent -21st anniversary||$2,550||$5,000|
|Pharmaceutical Patent -22nd anniversary||$2,550||$6,000|
|Pharmaceutical Patent -23rd anniversary||$2,550||$7,000|
|Pharmaceutical Patent -24th anniversary||$2,550||$8,000|
Please note that there have been other fee increases associated with the updated fee structure. Please do not hesitate to contact us if you have any queries regarding pharmaceutical extensions of term, the Australian renewal fees related to these extensions, or any other changes in fees.