How to approach patenting innovation around digital biomarkers

Analysis of health-related data collected and measured by digital devices is becoming increasingly prevalent and desirable in preventative medicine. The ubiquity of smartphones and wearable devices has spurred the generation of large volumes of health-related data on a continuous basis from across large populations.

This has consequently led to an explosion in analysis of health-related data in hitherto unexplored ways to enhance the diagnosis, treatment and prevention of diseases and other medical conditions, with innovation in this area taking place on an unprecedented scale.

One key objective is to identify so-called digital biomarkers in the health-related data. These are flags in a data set for a given individual correlating to particular health conditions. Digital biomarkers can thus serve as digital fingerprints for possible diseases and other conditions, which might have previously gone undetected. Once identified for an individual, these can be analysed to allow earlier or more accurate diagnosis. Digital biomarkers can also be used to determine or enhance the form of medical treatment given.

With the large number of available data sources, tech and healthcare companies have been turning to AI and machine-learning technologies to identify and analyse digital biomarkers from the vast pools of available data.

The attractions of obtaining patent protection in this fledgling but fast-growing field are self-evident. If a previously unknown digital biomarker for a known disease can be protected, then exclusivity conferred via patent protection can be invaluable. Often, however, the correlation of a particular biomarker to a given disease or medical condition may already be known and therefore the biomarker per se cannot be protected directly. However, valuable patent protection can often still be obtained for the innovation relating to the identification of digital biomarkers from the large volumes of health-related data acquired.

Accordingly, there are three main areas of focus for patent protection:

• protection for digital biomarker(s) per se and their identified novel correlation(s) to a given medical condition;
• protection for novel techniques and data processing used to identify digital biomarker(s) and their correlation(s) to particular medical conditions from a large volume of health-related data obtained from across a population; and
• protection for the techniques and data processing used to identify particular digital biomarker(s) and associated medical conditions for a given individual, based on their own health-related data sets.

It can be difficult to protect digital biomarker(s) if their correlation to particular diseases is already known, even at a high level of generality based on existing medical knowledge. If this is the case, focusing on the second and third areas above can still provide valuable patent protection. It is in these two areas where AI and machine learning are now frequently deployed.

When focusing on these areas, it is worth noting that medical diagnostic methods practised on the human body are excluded from patent protection in Europe. However, this exclusion has been interpreted narrowly by the EPO’s Enlarged Board of Appeal to relate to diagnostic methods that expressly include in vivo diagnostic steps. Ex vivo diagnostic steps, and thus automated data processing steps based on data already acquired, are generally not excluded under Article 53(c) of the European Patent Convention.

Protecting AI inventions for digital biomarkers

New AI technology

If the technology used to identify digital biomarkers is based on new configurations of AI processes and methods (eg, when implemented in software), then these could be patentable on the basis that a technical effect of identifying the digital biomarker would provide for enhanced treatment and diagnosis of a range of medical conditions. A defined range of likely medical conditions that could be diagnosed via the new forms of AI may well have to be set out in a patent application, while data should ideally be provided to demonstrate the effectiveness of the AI in identifying the digital biomarkers. It may not be necessary to expressly claim the diagnostic steps per se to demonstrate technical contribution and avoid technical character objections, since the Enlarged Board of Appeal has confirmed that implied technical effects may suffice for technical contribution.

New application of known AI

If the AI technology being used is well known (regardless of whether it is known for identifying digital biomarkers), then it may be difficult to obtain patent protection at a general level for the use of this technology in identifying digital biomarkers. This would likely be viewed as an obvious application of known AI technology by a skilled AI programmer. However, the type of health-related data acquired and used to identify digital biomarkers with the known AI may itself not be known in the art. Thus, claims focused on particular types of health-related input data, or the specific form of training data utilised, may be permitted.

The technical use for a defined range of likely medical conditions should be set out in the patent application, but there may be no need to disclose the computational models used in detail on the basis that they would be known to a skilled AI programmer.

Products using digital biomarkers in treatment

Alongside these areas of focus, valuable patent protection may also be obtained for medicinal products using AI techniques in treating medical conditions relating to the identified biomarkers. For example, products where a particular dosing regimen can be defined by the presence (or lack) of one or more digital biomarkers identified by a given AI technique. Moreover, products themselves identified or defined by the AI technique and the corresponding digital biomarkers could be directly claimed. For claims focused on these types of medicinal product, careful consideration needs to be given to the exact form of claim language used.

Comment

The considerations highlighted above for AI inventions involving digital biomarkers represent a number of areas of focus by patent practitioners involved with digital biomarkers. The exact form of claim language deployed when drafting patent applications and addressing objections at the EPO will depend on the specifics of the technology involved and commercial objectives.