Australia Darunavir Patent Term Extension- Denied

AU Patent number 680635 in the name of G.D.Searle LLC was sealed on 27 November 1997. The normal 20 year term of the patent will expire on 24 August 2013. On 29 August 2007, the patentee filed an application for an extension of term of the patent under section 70 of the Patents Act 1990. The extension is based on the substance darunavir. During examination of the application, a Senior Examiner reported that there was another substance (known as amprenavir) within the scope of the claims that had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG), and as a consequence the application for an extension of term was not made within six months of the commencement of the first inclusion in the ARTG of goods that contain a relevant pharmaceutical substance. The patentee requested a hearing, which was held in Canberra on 15 October 2008. The patentee was represented by Shahnaz Irani, patent attorney with Spruson & Ferguson.

Extension of the term of a patent relating to pharmaceutical substances is governed by Part 3 of Chapter 6 of the Patents Act. For present purposes, the only question relates to when an application for an extension of term must be made. This is addressed in subsection 71(2):
“An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist or, any of the pharmaceutical substances referred to in subsection 70(3);(c) the date of commencement of this section.”In the present case, the date the patent was granted is 27 November 1997, and the date of commencement of section 71 was 27 January 1999 .

The court denied the application for patent extension since the application was not made within six months of the date of the earliest first inclusion in the ARTG. Dr Barker , Delegate of the Commisioner of Patents , further stated that "In a case such as the present, the patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223. Of course, it is also open to the patentee to withdraw the application for extension of term (for instance, if the true term of the extension is zero"

"Equally, the Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made. In the present case the Commissioner has become aware of the listing of amprenavir, and has no option but to act on this information".