Patent Term Extensions in Australia

Marketing of pharmaceuticals in Australia requires approval by the Therapeutic Goods Administration (TGA) and inclusion on the Australian Register of Therapeutic Goods (ARTG). Considerable research and testing are required before regulatory approval is obtained and a product can enter the market. As patent applications are typically filed during early phase research or preclinical testing, regulatory approval for a pharmaceutical substance covered by a patent is often not obtained until many years into the 20-team term of the patent. To compensate for this loss of protection, Australian patentees may request an extension of their patent for up to 5 years beyond the standard term. The goal is to provide an effective patent term of 15 years.

In order to qualify for a patent term extension (PTE):

• the patent must, in substance, disclose and claim a pharmaceutical substance per se or a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology;
• the pharmaceutical substance covered by the claims must be included in the ARTG before the 20-year term of the patent expires;
• the ARTG entry must be current at the time the application for PTE is lodged at the Patent Office;
• at least 5 years must have elapsed between the date of the patent and the date of first inclusion of a relevant pharmaceutical substance in the ARTG; and
• the term of the patent must not have been previously extended.

Unlike other jurisdictions, the rights conferred by the PTE in Australia are not confined to the pharmaceutical substance included in the ARTG. If a PTE is granted, all pharmaceutical substances covered by all claims of the patent are protected during the period of the extension – irrespective of whether they are included in the ARTG and irrespective of the number of pharmaceutical substances claimed. However, the patent is not extended insofar as it relates to substances that are not pharmaceutical substances or use of pharmaceutical substances for non-therapeutic uses e.g., veterinary products.

The length of the PTE is dependent on the date of inclusion in the ARTG of any pharmaceutical substance covered by the claims of the patent. If the pharmaceutical substance was included in the ARTG:

• less than 5 years after the effective filing date of the patent - no extension is available;
• 5 - 10 years after the date of the patent - the term of the patent will be extended to 15 years from the date of inclusion of the pharmaceutical substance in the ARTG; or
• more than 10 years after the date of the patent – a full 5-year extension is available.

Inclusion in the ARTG may be for any purpose e.g., receipt of marketing approval for the pharmaceutical substance or listing of the pharmaceutical substance for export.

An application for a PTE must be lodged within 6 months from the later of the following dates:

• the date the patent was granted; or
• the date of first inclusion in the ARTG of a pharmaceutical substance covered by the patent.

An application for a PTE cannot be made before a patent is granted or before a pharmaceutical substance covered by the claims is included in the ARTG.

Extensions of time in which to file an application for a PTE may be possible if it can be shown that the failure to lodge the PTE request in time was due to:

• an error or omission by the person concerned or by his or her agent or attorney; or
• circumstances beyond the control of the person concerned.

An application for a PTE must:

• provide the applicant (patentee) and patent details;
• identify goods containing (or consisting of) the pharmaceutical substance currently included in the ARTG and indicate how the pharmaceutical substance is in substance disclosed in the specification and falls within the scope of the claims;
• provide the date of first inclusion of the pharmaceutical substance on the ARTG;
• be accompanied by a printout from the ARTG confirming that the pharmaceutical substance is currently registered on the ARTG.

If a patent claims more than one pharmaceutical substance for which ARTG listings may be obtained at different times, dividing the pharmaceutical substances into one or more divisional applications may allow for longer PTEs to be obtained for subsequent ARTG listings.

Once an application for an extension of term is advertised accepted, third parties have 3 months from the date of publication of the notice of acceptance in the Official Journal to file a notice of opposition to the extension of term.

If you have any questions regarding the above, or any other aspect of Australian patent law, please do not hesitate to contact me by email at [email protected]