Australia has a patent term extension regime available for certain standard patents relating to pharmaceutical substances. Eligible patents may have their term extended by up to five years. The regime was brought about following the Australian government’s recognition that the exceptionally long development time for pharmaceutical substances and the need for such substances to obtain government approval erode the effective life of pharmaceutical and biotech patents.
1. A pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology, must be in substance disclosed in the patent and must fall within the scope of a claim. What constitutes a pharmaceutical substance per se has developed through Patent Office decisions, and may be a compound, an active metabolite, a composition, or a mixture of substances.
2. The pharmaceutical substance, as mentioned above, must be included in the Australian Register of Therapeutic Goods (ARTG) which is administered by the Therapeutic Goods Administration (TGA), the Australian equivalent of the FDA (ie have regulatory approval).
3. There must be at least 5 years between the date the patent application was filed, and the date of first approval of any product containing the pharmaceutical substance.
An application for an extension of term must be made within 6 months of the grant of the patent, or 6 months from the first approval date and therefore first inclusion in the ARTG, whichever date is later.
The extension is the difference of the time period from the filing date of the patent to the first regulatory approval date less 5 years.
Third parties have 3 months from the date of the notice of acceptance in the Official Journal to oppose the grant of an extension of term.
The rights of a patentee during the extended term of the patent are limited compared with a patentee’s normal rights. In the extended term the following activities do not constitute patent infringement:
It should be noted that a patent (whether extended or otherwise) will not be infringed by a person exploiting a pharmaceutical substance solely for the purpose of having goods included in the ARTG or for gaining similar approval in a foreign country at any time during the term of the patent.
Renewal fees are payable during the extended term (the yearly renewal fee is equal to the 19th year renewal fee).