Broadly deemed patentable subject matter

Patents are available for a wide range of medical research studies in Australia such as for new active ingredients, novel formulations, isolated forms of (therapeutically useful) natural products and new methods of treatment.

Patent term extensions

In compliance with Article 33, World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, Australia grants (standard) patent owners 20 years of protection.

Since 1999, Australia also grants owners of patents covering pharmaceutical substances the right to seek patent term restoration, called an “extension of term”. You can apply for up to five years of patent term extension to compensate for the process of obtaining regulatory approval. This achieves an effective patent life of up to 15 years from the date of first entry of a new pharmaceutical substance on the Australian Register of Therapeutic Goods.

Data exclusivity

Australia provides five years data exclusivity from the date the new medicine is first included on the Australian Register of Therapeutic Goods to new pharmaceutical products. It is designed to prevent market authorisation of generic forms of an assessed listed medicine by relying on clinical trials generated by the sponsor of the originator medicine.

Innovation patents

In Australia, an innovation patent lasts up to eight years – compared to 20 years for standard patents – and is designed to protect inventions that do not meet the inventive threshold required for standard patents. An innovation patent is a relatively quick and inexpensive way to obtain intellectual property protection for a new medical device or pharmaceutical substance, method or process.

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