Intellectual property

Patentability and inventorship

What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?

Patentees of digital health-related inventions, which often require computer implementation in one form or another, need to navigate the patentability requirement in Australia. While abstract ideas and computer-implemented inventions are not regarded as patentable subject matter in Australia, patents directed to other aspects of digital health-related inventions such as hardware, telemetry and diagnostic tools may be patent-eligible.

Recently, the Full Federal Court of Australia found that an artificial intelligence system could not be named as an inventor on a patent application (Commissioner of Patents v Thaler [2022] FCAFC 62). The High Court of Australia (Australia’s apex court) declined to hear an appeal of this decision (Thaler v Commissioner of Patents [2022] HCATrans 199).

Patent prosecution

What is the patent application and registration procedure for digital health technologies in your jurisdiction?

The Australian patent system provides the same application process across all technologies, including digital health. There are no specific provisions for digital health technologies. IP Australia (incorporating the Australian Patent Office) is responsible for pre-grant examinations, pre-grant oppositions, re-examinations and amendments to patents and patent applications. As in other jurisdictions, the process of filing to grant can take more than 18 months.

Other IP rights

Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?

Registrable IP rights are available in the form of design rights that safeguard the visual appearance of new and distinctive products, such as wearable devices that incorporate digital health offerings. Design rights are secured through an application process administered by IP Australia and last for five years initially (renewable for another five years).

Additionally, unregistrable forms of IP including copyright, know-how, trade secrets and confidential information may arise in the context of digital health technologies and offerings. Contractual measures (such as non-disclosure agreements) may help to protect the know-how, trade secrets and confidential information, such as secret algorithms in a digital health app, often in conjunction with physical and technological security measures. Copyright arises automatically in some subject matter likely to be integral to digital health offerings, such as in computer code in a digital health app.

Licensing

What practical considerations are relevant when licensing IP rights in digital health technologies?

Arrangements involving the licensing or assignment of patents are subject to Australian competition laws. In September 2019, the Competition and Consumer Act 2010 (Cth) (the CCA) was amended to repeal a section that previously exempted certain IP assignments and licensing arrangements from the full operation of the CCA. Since the repeal of this IP exemption, the Australian Competition and Consumer Commission appears to be taking an increasing interest in restrictions in IP arrangements.

Compliance with the Therapeutic Goods Act 1989 (Cth) of any relevant IP assets claimed is also likely to be an important practical consideration.

Enforcement

What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?

In Australia, there are no bespoke procedures that govern the enforcement of IP rights relating to digital health technologies.