Data exclusivity is a vexed issue: how to protect new innovations and additional clinical studies without the advantage of patent protection? Data Exclusivity in Australia is aimed at providing a 5 year window whereby a company can enjoy exclusive use of the data that they have generated without competition from generics.  The requirements are quite stringent with regard to obtaining Data exclusivity protection with the TGA – it is necessary for the molecule to be a New Chemical Entity on the Australian Register of Therapeutic Goods (ARTG). It is not sufficient to have a new formulation, new route of administration or new indication; the requirement is for the active ingredient not to have been previously included on the ARTG. If this requirement can be fulfilled, then it’s likely, that a five year period of data exclusivity will be applicable to the medicine. The one catch in Australia is that the data is required to be keep confidential.

 

Image courtesy of Frank Filippi, 2007, CSIRO, Scientist in the Laboratory at AAHL, Creative Commons 3.0, Disclaimer