Can You Patent Digital Biomarkers? Key Considerations and Strategies for Protecting AI-Driven Diagnostics

As smartphones and wearables become ever-present, the data they generate has transformed healthcare, particularly in preventative and personalized medicine. These digital devices continuously collect vast amounts of health data from large populations, providing valuable insights for early diagnosis and treatment. One crucial innovation emerging from this data revolution is the digital biomarker—a digital indicator correlating with specific health conditions, often identified through advanced analysis techniques like artificial intelligence (AI). However, the patentability of digital biomarkers is complex, especially when it comes to navigating existing regulations and evolving technologies. Here, we are going to explore the possibilities and challenges of patenting digital biomarkers and highlights strategies for obtaining meaningful IP protection.

What Are Digital Biomarkers?

Digital biomarkers are data-derived indicators that act as “fingerprints” for certain health conditions, signaling the potential presence or progression of diseases. For example, fluctuations in heart rate variability from wearable devices or gait patterns from smartphones can act as digital biomarkers for specific conditions. These biomarkers allow earlier and potentially more accurate diagnoses, aiding in timely medical intervention and optimized treatment.

Given the potential of digital biomarkers to enhance healthcare, companies in the technology and healthcare sectors are leveraging AI to analyze vast data sets and extract these valuable indicators. However, patenting these innovations can be challenging, especially when the correlation between a biomarker and a disease is already known.

Why Seek Patent Protection for Digital Biomarkers?

Securing patent protection for digital biomarkers offers clear advantages:

• Competitive Edge: A patent can provide exclusive rights to use, license, or commercialize a unique digital biomarker, enhancing market position.

• Market Impact: Digital biomarkers are crucial for diagnosing and treating widespread health conditions, increasing their commercial value.

• Attracting Investors: Patent protection adds credibility, making your technology more appealing to investors by safeguarding against competition in this fast-growing field.

However, many digital biomarkers correlate with known health conditions, which can make patenting challenging. In such cases, focusing on innovative methods or technologies for identifying or analyzing these biomarkers can still provide valuable IP protection.

Key Areas for Patenting Digital Biomarkers

There are three primary avenues for patent protection in this field:

1. Novel Digital Biomarkers and Correlations: If the digital biomarker itself is newly discovered and correlates to a specific health condition in a previously unknown way, it may be possible to secure a patent (or at least in some ex-US jurisdictions - see my post on patenting biomarkers here). However, this can be challenging if the association is already known in the art.

2. Innovative Data Processing Techniques: Patenting the methods used to prepare and/or analyze large volumes of health data to identify biomarkers is a strong alternative, especially if AI models are applied in novel ways.

3. Personalized Diagnostic Methods: Techniques that analyze a person’s unique health data to detect or monitor biomarkers can also be patentable, especially when combined with AI algorithms to provide personalized health insights.

Even if the biomarker itself cannot be patented due to prior knowledge or legal restrictions, focusing on the second and third areas can still yield valuable IP protection for the associated technology.

Challenges and Opportunities for Digital Biomarkers in Europe

In Europe, the European Patent Office (EPO) places specific restrictions on patenting diagnostic methods, particularly those involving direct in vivo (within the body) steps. According to Article 53(c) of the European Patent Convention (EPC), diagnostic methods practiced on the human body are excluded from patent protection. However, the EPO’s Enlarged Board of Appeal has interpreted this narrowly, meaning that ex vivo methods (those performed outside the body), such as automated data processing on pre-collected data, can still be patentable.

This interpretation provides an opportunity to patent data analysis methods involving digital biomarkers, as long as they are based on health data collected through digital devices rather than in vivo testing.

Protecting AI Innovations in Digital Biomarkers

As mentioned earlier, it is important to remember to protect the AI innovation used in the digital biomarkers. Here are strategic approaches to protect AI innovations in digital biomarker applications.

1. New AI Technology

   If your AI technology for identifying digital biomarkers is novel—such as new algorithms, configurations, or models—these can be patentable if they produce a measurable technical effect, like enhanced diagnostic accuracy. In your patent application, include a defined range of medical conditions that can be diagnosed using the AI, along with supporting data showing the AI’s effectiveness in detecting these biomarkers. This can strengthen the technical contribution, as required by the EPO, without necessarily claiming diagnostic steps directly. In the U.S., patenting the AI technology per se may be difficult due to the 101 hurdle against abstract idea after the Alice decision.

2. Novel Applications of Known AI

   If using existing AI technology in a new application, like analyzing previously unused health data to identify biomarkers, the invention may still be patentable. Focus on the specific types of health-related input data or the unique configuration of training data sets that enable the biomarker identification. While the AI model itself may not need to be disclosed in detail, claims should emphasize the innovative data application and define a specific set of health conditions that the technology addresses.

3. Medicinal Products Using Digital Biomarkers in Treatment

   In addition to securing patents for specific AI-based methods, it may be valuable to patent products that use digital biomarkers in therapeutic applications. For example, a patent application can be filed to cover methods for determining dosing or regimen of a medicinal product that relies on the presence or absence of certain digital biomarkers. For such inventions, ensure that the claim language clearly reflects the medical use and impact of the biomarker, rather than the biomarker itself, for a better chance of obtaining protection.

The patenting landscape for digital biomarkers is evolving quickly, with AI becoming essential tools in healthcare innovation. Although direct patenting of known biomarkers may be difficult, focusing on novel data analysis methods, personalized diagnostic techniques, and AI-enabled treatment products provides valuable paths for IP protection.