There is a proliferation of digital health and wellness apps that can help one take care of their health. However, amongst innovators, there is a great deal of uncertainty around what IP rights might be available for such technologies.
Digital health and wellness apps include medication trackers, apps that monitor your sleep, and telehealth apps which put you in touch with a medical professional. Many of these apps emerged to help shoulder the burden on the health care system during the pandemic and provide access to healthcare digitally. From an IP perspective, the technologies involved sit at a complex nexus of IP law with consideration required to be given to therapeutic/diagnostic processes, software and hardware IP protection.
To deal with the emergence of healthcare apps during the pandemic, the Therapeutic Goods Administration (TGA) has set out rules for regulating software based medical devices.
While there is a reasonable amount of awareness around protecting innovations in the medical device space where physical medical devices are concerned, there is not as much around patenting healthcare apps.
Is it worth trying to protect a healthcare app? What is required for a healthcare app to be patentable?
Patents can be the key to securing your return on investment or at the very least can provide a sustainable competitive advantage over 20 years. As this is an emerging space with some apps already having millions of users it is important to adequately protect the IP associated with the apps. Protecting digital health care apps should be given as much consideration as protecting physical medical devices as a part of a comprehensive IP strategy.
The fundamental requirements for patenting your healthcare app are the same as those for patenting any other type of software application. That is, any claims to the app must be patentable subject matter, novel (new in the world) and inventive (non-obvious to a relevant skilled person).
To determine whether the app is patentable subject matter one must firstly determine what the “substance” of the invention is. The next step is to determine whether it is a “manner or manufacture” or is a technical innovation.
If there is an innovative hardware component, it is relatively straightforward to determine that the substance is a manner of manufacture. It is not as straightforward when it comes to software inventions because the substance of a software invention might be interpreted by the Examiner as a mental/business process, which is not considered to be a manner of manufacture under Australian patent law.
The substance of the invention is the core concept of the invention. It can be the improvement or difference over existing technologies. To determine the substance of the invention you could ask the question: what is the reason for the benefits provided by the invention?
In doing so, the invention must be considered as a whole and not by considering constituent parts of the invention in isolation.
The next step is to determine whether the substance of the invention is technical. If the “substance” lies in a pure business method or scheme or mere information presentation, then the invention is likely not patentable.
The method of the invention must not be merely automation of an existing manual process. The claims must define a “new” manner of manufacture.
For example, a digital health app which uses a computer to assign a health indicator to a patient which can be otherwise done by a human calculation is likely not to be patentable. However, if the calculations can be used to operate an external machine or to inform a type of technical decision it may be patentable.
Typically, a health care app can be patentable if it can be shown that there is a combination of features which work together in a new way to produce a technical effect.
The claims of the patent application must cover the substance of the invention and all necessary features that work together to achieve the technical effect. There must also be sufficient information in the specification describing how all features of the claim work together to produce the technical effect.
Your patent attorney is best placed to draft a suitable patent specification including claims.
If you are considering protecting your healthcare app or if you have any questions regarding patenting healthcare apps, feel free to contact one of Baxter IP’s patent attorneys. Our attorneys’ are skilled at overcoming patentable subject matter objections from patent offices and can advise you on patenting your health care app.
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