Patents for medical technology inventions – how are they faring…

Patents for medical technology inventions – how are they faring…

We analyse three recent Patent Office decisions for guidance on medical technology patents following the High Court’s judgment in Aristocrat. 

In brief

Whether computer-implemented inventions are patentable subject matter (a “manner of manufacture”) remains a highly contentious issue under Australian law. While many computer programs, at least at face value, could arguably satisfy the fundamental requirement of resulting in an “artificially created state of affairs” of economic utility,[1]
computer-implemented inventions are at risk of being classed as mere schemes or ideas.

It was hoped that the recent High Court decision in Aristocrat v Commissioner of Patents [2022] HCA 29 (Aristocrat) would deliver some much-awaited clarity on this issue. However, the judgment was split 3:3, resulting in no binding precedent.

In the wake of this judgment, we consider three recent decisions of the Australian Patent Office that have considered the ground of manner of manufacture in the context of the rapidly-developing field of medical technology.

The Regents of The University of California [2022] APO 77

What was the invention?The patent application relates to a method of reducing cognitive decline through the use of a computer-implemented training system. The user is presented with a cognitive task with and without distractions and the system records any differences in performance.

An example given in the specification is a simulated driving experience where the user is presented with irrelevant visual signs. The difficulty of the task is adjusted according to how well the user responds to the signs.

The claimed method is intended to treat a range of cognitive disorders, including those generally associated with aging, as well as ADHD.

Was it a manner of manufacture?The patent applicant argued that the invention was patentable by virtue of the computer operation of the method, and also as a method of treatment or therapy.

In summarising the relevant principles, the Delegate of the Commissioner of Patents noted the split decision in Aristocrat but highlighted that the High Court affirmed the correctness of earlier Full Court decisions.[2]
The Delegate also observed that the High Court appeared to confirm that an ‘advance’ in computer technology is not a useful test for patentability (as opposed to, for example, an ‘improvement’ or ‘adaption’).[3]

The Delegate observed in relation to the computer-implemented aspects of the claims that the present invention is performed using standard or generic computer technology. In light of this, he found that there was no claimed improvement or adaptation to a computer to perform the invention, or solving of a technical problem in computer technology. There could therefore be no patentability via the computer-related aspects of the claimed invention.

He then turned to the applicant’s submission that the invention was a method of treatment. In light of the broad descriptions in the specification, the delegate found that there was no particular medical or physical condition targeted by the invention, and that the invention merely seeks to improve cognitive ability in a general sense. It was held that there was therefore no material advantage provided by the method and that it did not address any identifiable technical problem. The invention was found to be a mere scheme for enhancing cognition and not a patentable invention.

Alistair Mann v Electronic Pain Assessment Technologies (epat) Pty Ltd
[2023] APO 1

What was the invention?The patent application is directed to a method and system for determining the effect of pain medication on a patient using automated, objective criteria, particularly in patients with reduced capacity to explain their condition to a healthcare professional.

The invention seeks to address the need for improvements to the existing system based on the American Geriatric Society (AGS) guidelines, which the patent application describes as subjective and prone to inconsistencies.

The claimed invention involves determining a pain “score” for a patient using visible or audible indicators of pain, such as particular facial features as captured by a camera. This data is analysed by software, which can learn from a database of images expressing the presence or absence of pain.

Was it a manner of manufacture?Instead of characterising the invention as a patentable computer-implemented invention, the patent applicant argued that the application was essentially a diagnostic method. The applicant drew an analogy with the invention the subject of the Ariosa decision,[5]
which relates to the detection of foetal DNA in a maternal plasma or serum sample. The images of a patient in pain were argued to be akin to taking a physical sample.

The delegate disagreed, noting that in the Ariosa
case, the invention involved detecting an analyte that had not previously been discovered. Here, however, there was no suggestion that the inventors discovered a new way of detecting pain.

The opponent argued that the claims were overly general, related to methods merely requiring generic computer implementation, and related to components of a system that were well-known. The Delegate sided with the opponent, concluding that the invention was a mere scheme for automation of existing multi-factorial techniques, in particular the AGS. In summarising the relevant principles, the Delegate referred to the Aristocrat decision in essentially the same way as in the University of California decision referred to above.

The Delegate pointed to the fact that the application describes the invention only in very general terms, with no implementation examples and no indication of how the algorithm identifies facial features or carries out comparison steps. There was therefore found to be no technical benefit demonstrated by the application. Also of relevance was the fact that the opponent’s expert conceived of the exact subject matter of the patent when presented with a relevant hypothetical problem.

CareFusion 303, Inc. [2023] APO 17

What was the invention?The invention generally relates to a system for managing the preparation and distribution of medications from a pharmacy. The system includes a display screen, a memory that stores instructions, and a processor that executes instructions.

More specifically, the invention manages queues of orders for medication based on a variety of factors and determines the appropriate means of filling the orders, including whether returned medication can be used. According to the specification, this allows a healthcare professional to select medications in a way that minimises waste.

Was it a manner of manufacture?The patent applicant argued that the claims were directed to a new system providing a unique technical solution to the technical problem of remotely verifying prescription fulfilment. The applicant further submitted that the batching and aggregation of orders in a virtual queue has a practical and useful effect, including providing optimised directions to the healthcare professional.

The Delegate noted that the applicant argued during examination that in light of Aristocrat there was no need to establish an advance (or improvement) in computer technology. Instead the invention needed only involve some “adaptation or alteration of, or addition to, technology otherwise well-known[6]
in the relevant common general knowledge. The examiner disagreed, stating that the High Court decision does not provide binding precedent. The Delegate summarised the relevant principles from Aristocrat in much the same way as in the other Patent Office decisions described above.

In his analysis, the Delegate observed at the outset that the invention in question involves the processing and presentation of administrative or business information. Citing RPL Central, the Delegate stated that where a claimed invention is a computerised administrative process, it may be a manner of manufacture if the invention lies in the computerisation. However, he concluded that the method in question used nothing more than the standard operation of generic computers with generic software to implement a scheme.

Key takeaways

Perhaps unsurprisingly, the impact of Aristocrat on the Patent Office appears to have been fairly minimal so far. In particular, these three decisions did not engage in any detailed consideration of the split judgments, though each decision noted that the earlier Full Court decisions have been affirmed and that Aristocrat appears to have confirmed that an advance in computer technology is not a useful test for patentability. This is in line with recent changes to the Patent Manual, which have replaced references to “an advance” with an “adaptation to” in computer technology.

As these decisions highlight, inventions in the medical technology space can give rise to complex questions of patentable subject matter. Such technologies tend to be largely comprised of software, which can render patents vulnerable in light of the present uncertainty surrounding computer-implemented inventions. Perhaps intending to avoid this hurdle, patentees have sought to classify them as diagnostic methods or methods of treatment. While the ambiguity regarding computer-implemented inventions will persist for the time being, it remains clear that the relevant enquiry is always as to the substance of the claimed invention, not its form.

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