Protection period for a new 10 years as of July 2014 10 years 10 years. 1 Depends on what type of 8 for active ingredient / constituent under Section 34M of Agvet additional year (for exclusivity at issue. Orphan innovative and associated formulated Code already authorised drug exclusivity for 7 years, animal products not previously product to other new chemical entity drugs endorsed species, up to exclusivity for 5 years, maximum of 18 general antibiotic incentives years) now exclusivity for 5 years, new clinical investigation exclusivity for 3 years Protection period for previously 3 years as of July 2014 5 na na na endorsed or variations or new information Extensions linked to minor use None None 14 years for minor Minor species or minor uses registrations use species and 4 in a major species (MUMS) additional years for gets 7 years an extension to a minor species Total potential protection 10 years as of July 2014 10 years Maximum of 18 Depends on what type of 8 years period for major and minor exclusivity species Data compensation period 5 years exclusive use None None None – subsequent data to support / 8 years data for a – maintain registration of a new reconsideration of a active ingredient to support registration (as of July 2014) evaluation = AGVET (2016), NZ (2014), (2014/0257 (COD), FDA 2017, (2017), C.08.004.1 Given that IP Australia is efficient in processing patent applications, the only grounds for an extension for agvet chemicals in Australia would arise from regulatory delays by other agencies. However as the Productivity Commission has noted, patent extensions (whether formal or in the form of SPCs), do not appear to be an appropriate way to address slow regulatory processes. They create distortions and are costly to consumers. With respect to CCI, there is merit in clarifying what data and information is to be treated as CCI in the Australian context. Overseas models can assist with this. Differences in IP related provisions between the human and veterinary pharmaceuticals are discussed in Chapter 7.
Protection period for a new active ingredient / constituent and associated formulated products not previously endorsed 10 years as of July 2014 under Section 34M of Agvet Code 10 years 10 years. 1 additional year (for already authorised product to other species, up to maximum of 18 years) Depends on what type of exclusivity at issue. Orphan drug exclusivity for 7 years, new chemical entity exclusivity for 5 years, general antibiotic incentives now exclusivity for 5 years, new clinical investigation exclusivity for 3 years 8 for innovative animal drugs Protection period for previously endorsed or variations or new information 3 years as of July 2014 5 na na na Extensions linked to minor use registrations None None 14 years for minor use species and 4 additional years for an extension to a minor species Minor species or minor uses in a major species (MUMS) gets 7 years Total potential protection period 10 years as of July 2014 10 years Maximum of 18 for major and minor species Depends on what type of exclusivity 8 years Data compensation period – subsequent data to support / maintain registration of a new active ingredient to support 5 years exclusive use 8 years – data for a reconsideration of a registration (as of July 2014) None None None = AGVET (2016), NZ (2014), (2014/0257 (COD), FDA 2017, (2017), C.08.004.1 Given that IP Australia is efficient in processing patent applications, the only grounds for an extension for agvet chemicals in Australia would arise from regulatory delays by other agencies. However as the Productivity Commission has noted, patent extensions (whether formal or in the form of SPCs), do not appear to be an appropriate way to address slow regulatory processes. They create distortions and are costly to consumers. With respect to CCI, there is merit in clarifying what data and information is to be treated as CCI in the Australian context. Overseas models can assist with this. Differences in IP related provisions between the human and veterinary pharmaceuticals are discussed in Chapter 7. evaluation