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Australia

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Patent Term Extension Provision:

  • For an Australian patent to be eligible for patent term extension, the claims of the patent must contain either a pharmaceutical substance per-se, or the one produced by a process involving use of recombinant DNA technology. A pharmaceutical substance is defined as a compound, an active metabolite, a composition or a mixture of substances.
  • Requirements for obtaining PTE: to include pharmaceutical substance in the Australian Register of Therapeutic Goods (ARTG), at least 5 years between filing of patent application and date of first marketing approval, application to be made within 6 months of grant of patent and from first regulatory approval date. Therefore, the maximum period of the patent term extension is 5 years.

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