"Patent Term Extension (PTE) Regime in Australia: Amendments and Analysis of Granted, Pending, and Refused PTE Applications"

"Patent Term Extension (PTE) Regime in Australia: Amendments and Analysis of Granted, Pending, and Refused PTE Applications"

"Patents are governed by the Patent Act 1990 in Australia. The adoption of Trade-Related Aspect of Intellectual Property Rights (TRIPS) agreement in 1995, raised the standard patent term from 16 to 20 years in Australia. For pharmaceutical innovators, 20-year term may found to be insufficient to recoup the investment in research and development (R&D), because a substantial time is required for regulatory review process before approval of the pharmaceutical product and thus, start of its actual marketing. To address this concern, the possibility of extension of the patent term beyond 20 years was introduced in Australia in 1998 by amending the Patent Act 1990. This patent term extension provision came into effect on 27 January 1999. No separate or sui generis right came into existence; rather, the duration of the patent was increased by a particular period of time, referred to as ‘Patent Term Extension(s)’ (PTE) in Australia and United States of America (USA), ‘Certificate of Supplementary Protection’ (CSP) in Canada, and ‘Supplementary Protection Certificate’ (SPC) in Europe. Since the implementation of PTE regime in Australia, a few changes took effect. This article provides an in-depth evaluation of PTE in Australia and other relevant changes. It also covers comparative analysis of number of PTE applications granted, pending, refused, and withdrawn in Australia. It was found that during these years, about 92% applications were awarded PTEs, 4% were refused and the remaining applications are awaiting decision. About 70% PTE applications cited product patents, while about 31% applications cited combination/composition patents and remaining 8% applications cited method of use patents. About 57% of granted PTEs received an extension of more than 4 years to 5 years. This article also provides analysis of type of patents referred in the PTE applications, the applicants and term of granted PTEs. Comprehensive summary of Federal Court of Australia and Full Federal Court of Australia cases is provided. These cases are related to challenges filed by PTE applicants over refusal of their applications, revocation of granted patents and challenges to the validity of granted PTE by the Commissioner of Patents, Intellectual Property Office, IP Australia, and these cases are providing directions to the Commissioner of Patents and has potential to act as precedence for future decisions on PTE. Basis analysis of available PTE data in Australia, this article also provides some valuable suggestions to the PTE applicants."