Wearable tech watch iStock 000075360523 Full

Medical software applications (apps) are becoming increasingly common and useful but how do you protect the IP behind them?

From measuring how far we’ve moved with mobility trackers to monitoring diabetes or epilepsy on a smartphone, medical apps are giving us greater awareness and control of our health needs. 

But as the number of health-related apps grows, dealing with more conditions and situations, how do you protect the intellectual property behind them? Is a medical app patentable? 

Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators forum as “software intended to be used for one or more medical purposes without being part of a hardware medical device”. 

Regulation of SaMD is risk based and depends on the intended purpose of the software, namely for: diagnosis, prevention, monitoring treatment or alleviation of disease. 

While international regulatory bodies seek to develop internationally harmonised guidance for SaMD, Patent Offices don’t differentiate this software category. 

Inventions implemented using software must pass a test for patent eligibility, before even assessing novelty and inventiveness.  Patent eligibility (including for SaMD) typically has nothing to do with the purpose, efficacy or social value of the technology, and everything to do with how it works.  

Where software is merely for record keeping or manipulation of data this will typically not be considered SaMD, nor patentable.  Where software provides a diagnostic or advisory function, this qualifies as SaMD, but is not necessarily patentable. 

Regardless of where an app falls on the SaMD spectrum, if there is innovation in how the diagnostic or advisory function is implemented in the software app, it may be considered patent eligible.   

To improve the likelihood of convincing Patent Examiners to treat your SaMD as patent eligible, specifications need to be drafted carefully to accommodate the current varying global assessment regimes, and anticipate changes in the future.  

The problem for developers is lack of harmonisation and frequent change in patent eligibility tests in different jurisdictions.  For example: 

  • The US requires “something more” than generic software implementation.
  • Europe allows patents for inventions which utilise technology to solve problems and this may include software in certain circumstances.  Patent eligibility is based on the methodology utilising technology to perform diagnostic or advisory functions – so the solution that underlies the app needs to be novel and not obvious.
  • In Australia patent eligibility is based on the “substance of the invention” and under current practice requires software implementation innovation addressing a technical problem.    

Currently patent eligibility for medical apps is highly dependent on solution implementation, rather than fundamental concept or medical benefit.  But this may change.  

If you are a medical app developer it is worth seeking advice from a patent attorney, as there may be more potential for protection than you realise. 

 

This article first appeared in the April edition of Australasian BioTechnology, the journal of AusBiotech.

Our Expert Project Lead

Related Content