3.12 Extension of Term of Standard Patents Relating to Pharmaceutical Substances

Date Published

Relevant Legislation

The Act

Section 70

Applications for extension of patent

Section 71

Form and timing of an application

Section 74

Acceptance or refusal of application

Section 75

Opposition to grant of extension

Section 76

Grant of extension

Section 77

Calculation of term of extension

Schedule 1


The Regulations

Regulation 6.8

Information to accompany application


The Intellectual Property Laws Amendment Act 1998 amended the Patents Act 1990 to provide for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance.

Requirements for Obtaining an Extension of Term

In order to obtain an extension of term for a patent, the following requirements must be met:

  • the patent must, in substance, disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
  • goods containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and

  • the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent.

Provided the requirements of the Act are satisfied, the term of the patent (in its entirety) may be extended.

Rights of Patentee During the Extended Term

The rights of a patentee during the extended term of a patent are however limited over the normal rights in a patent. Although the term of the patent as a whole is extended, exploitation of any form of the invention that is not a pharmaceutical substance and exploitation of pharmaceutical substances for non­therapeutic uses do not constitute infringement of the patent during the extended term (sec 78).