What is a patent?

Guide to Australian patent law for life science companies.

A patent is a monopoly over an invention, granted by the Commissioner of Patents under the Patents Act 1990 (Cth). For the life of the patent, the patent owner holds the exclusive right to exploit the invention and to authorise others to do so (s 13). Exploitation is defined widely, and extends to making, selling, using and importing a patented product, as well as using a patented method or process (sch 1). The practical effect is that until the patent expires, the owner alone decides who may commercialise the invention in Australia and on what terms.

What can be patented in Australia?

An invention must satisfy four requirements (s 18(1)):

• New: not publicly disclosed anywhere in the world before the filing date (s 7)

• Inventive: not obvious to a person skilled in the relevant field (s 7)

• Useful: the application must disclose a specific, substantial and credible use (s 7A)

• Patentable subject matter: broadly, a product or process created by human intervention, rather than something that simply exists in nature.

In the life sciences, new compounds, formulations, medical devices, diagnostics and manufacturing processes all routinely qualify. New ways of treating patients can also be patented in Australia.

How do you get a patent?

Patents are granted through IP Australia, and the path usually runs:

1. Provisional application: establishes a priority date and buys twelve months to refine the invention

2. Complete application: filed within twelve months, in Australia alone or internationally through the Patent Cooperation Treaty

3. Examination: IP Australia tests the application against the requirements above

4. Acceptance and opposition: once accepted, third parties have three months to oppose the grant

5. Grant

Filing to grant commonly takes between two and five years. Official fees are modest, roughly $1,100 in total at current rates; the real investment lies in professional drafting and international filings.

How long does a patent last?

A standard patent lasts twenty years from the filing date of the complete application, provided annual renewal fees are paid from the fourth anniversary onwards (ss 65, 67).

Patents covering pharmaceutical substances can be extended by up to five years, in recognition of the time regulatory approval takes out of the patent term (ss 70–79A). When the term ends, the invention passes into the public domain.

Patents and TGA approval are two seperate hurdles

A patent is not permission to sell. Before a medicine or medical device can be supplied in Australia, it must be entered on the Australian Register of Therapeutic Goods under the Therapeutic Goods Act 1989 (Cth), and the two rights operate independently. Holding a patent will not hasten TGA approval, and holding TGA approval is no defence to infringing somebody else's patent. A protected product needs both, so patent strategy and regulatory strategy must be planned together.

What is my patent is infringed?

Exploiting a patented invention without the owner's authority is infringement, whether or not the infringer knew of the patent. The owner may sue in the Federal Court of Australia within six years of the infringing act (s 120), and the remedies are an injunction together with, at the owner's election, damages or an account of the infringer's profits (s 122).

Seeking further advice

For more on the topics raised in this guide, please review our further guides on the boundaries of patentable subject matter, extensions of term for pharmaceutical patents, and patent litigation in Australia as they are published.

If you need specific advice, please contact Wayne Condon at Biopharmalex. Wayne is one of Australia's most experienced life sciences and intellectual property lawyers, and has acted in many of the leading pharmaceutical patent cases of the past three decades.

This guide states the law at July 2026 and is general information only, not legal advice.