PTE provisions relating to pharmaceutical products in Australia in comparison with European SPC and USA PTE

Pharmaceutical products in Australia can win up to five years of Patent Term Extension (PTE). This article reviews Australian PTE Law and its relationship with regulatory pathway for approving medicinal products. The article describes recent PTE cases involving pharmaceutical products and analyses how effective these PTE provisions are in Australia. Finally, it compares PTE provisions in Australia with European SPC (Supplementary Protection Certificate) and USA PTE Provisions.