Davies Collison Cave - Pharmaceutical Extensions: A listing in the ARTG is an inclusion
Pharmaceutical Extensions: A listing in the ARTG is an inclusion - Paula de Bruyn, Associate at Davies Collison Cave reports on Pfizer Corp v Commissioner of Patents [2006] FCAFC 190 and upholding by the Full Federal Court of the previous findings of the Commissioner of Patents and a single judge of the Federal Court:
- “where no pre-TGA marketing approval was given, an export listing in the Australian Register of Therapeutic Goods (ARTG), prior to registration to permit marketing in Australia, is to be considered as the first inclusion in the ARTG for the purpose of determining the first regulatory approval date in calculating a patent extension term”
- “the Court suggested that there could be circumstances under the present regime where certain exemptions or approvals, prior to actual inclusion in the ARTG, may be considered to be “pre-TGA marketing approval” and may establish the relevant date for the calculation of the patent extension term.”
Link to Davies Collison Cave article