For decades, healthcare has largely followed a one-size-fits-all approach, with patients diagnosed with the same condition often receiving the same treatment regardless of their genetic makeup, lifestyle, or biological differences. While this model has led to significant medical advances, it does not account for the fact that individuals can respond very differently to the same therapy. As a result, treatments may be highly effective for some patients while offering limited benefit, or even causing adverse effects, for others.
Personalized medicine is changing this paradigm by tailoring healthcare to an individual’s unique genetic, molecular, environmental, and clinical profile. Advances in genomics, biomarkers, artificial intelligence (AI), and companion diagnostics are enabling clinicians to better predict disease risk, identify the most appropriate therapies, and monitor treatment responses with greater precision. Rather than treating diseases based solely on symptoms or broad patient populations, personalized medicine seeks to deliver the right treatment to the right patient at the right time.
From conventional healthcare to precision medicine
The impact of personalized medicine is already being felt across a wide range of therapeutic areas. A study estimated that nearly 80% of the variation in drug response can be attributed to differences in an individual’s DNA. This has accelerated the integration of genomic technologies into clinical practice, enabling physicians to make more informed decisions about disease diagnosis, treatment selection, and patient care.
One of the clearest examples is the use of whole genome sequencing to diagnose rare diseases. At Karolinska University Hospital, whole genome sequencing has become a standard diagnostic tool for patients with suspected rare genetic disorders. More than 15,000 patients have undergone testing, with approximately 23% receiving a genetic diagnosis, demonstrating how genomic analysis can shorten diagnostic journeys and enable earlier, more targeted interventions.
Personalized medicine has also transformed cancer care by using biomarkers to guide treatment decisions. Researchers from the University of Kansas Cancer Center, Emory University School of Medicine, and the Southwest Oncology Group (SWOG) Cancer Research Network recently identified blood-based biomarkers that can predict which women with hormone receptor-positive breast cancer are unlikely to benefit from chemotherapy. By identifying patients who are unlikely to respond, clinicians can avoid unnecessary treatment and its associated side effects while pursuing more effective therapeutic options.
Advances in cell and gene therapies are further expanding the possibilities of precision medicine by addressing disease at its genetic source. One notable example is CASGEVY, the first approved CRISPR-based gene-editing therapy for sickle cell disease and transfusion-dependent beta thalassemia. Rather than managing symptoms, CASGEVY modifies a patient’s own blood stem cells to increase fetal hemoglobin production, reducing or eliminating the need for frequent blood transfusions. Personalized medicine has advanced even further with fully individualized therapies. In 2025, a group of researchers designed and delivered a custom CRISPR treatment for an infant with CPS1 deficiency, a rare metabolic disorder, completing the entire process from diagnosis to treatment in just six months.
Artificial intelligence (AI) is also becoming an important enabler of personalized medicine. Researchers at Johns Hopkins University developed the Targeted Real-Time Early Warning System (TREWS), now commercialized by Bayesian Health, which can detect sepsis between two and 48 hours earlier than conventional methods. The system has reduced sepsis mortality by 18% across several U.S. hospitals. Similarly, Aidoc‘s FDA-cleared CARE Foundation Model uses AI to identify multiple critical conditions from medical imaging within a single workflow, helping emergency departments prioritize patients who require immediate care.
As these technologies advance, understanding the evolving patent landscape provides valuable insight into where innovation is taking place. In this article, we examine the technologies driving personalized medicine and analyze global patent activity across this rapidly evolving field.
The patent landscape for personalized medicine
The rapid development of personalized medicine is reflected in a growing body of intellectual property covering technologies used to understand, diagnose, and treat disease at an individual level. To examine this innovation landscape, the analysis focuses on four CPC subclasses that capture complementary aspects of the personalized medicine ecosystem: A61K 40, which covers cellular immunotherapy; A61K 48, which encompasses medicinal preparations containing genetic material; G16H 20, which relates to healthcare informatics, including healthcare resources and processes; and G16H 50, which covers information and communication technologies specifically adapted for healthcare applications. Together, these CPCs provide a broad view of innovation spanning therapeutic interventions, genetic medicine, healthcare management, and digital diagnostic technologies.
The graph shows a clear increase in patent activity across personalized medicine technologies from 2016 to 2025, highlighting the rapid pace of innovation in this field. Among the four CPC subclasses, G16H 50 experienced the strongest growth, rising from around 5,000 patent filings in 2016 to nearly 18,000 in 2025. This trend reflects the growing importance of digital health technologies, including artificial intelligence, clinical decision support systems, wearable devices, and healthcare data platforms that enable personalized diagnosis and treatment. Similarly, G16H 20 demonstrated steady growth until 2023, indicating sustained investment in healthcare informatics and digital resource management. A61K 40 also maintained relatively stable patent activity from 2016 to 2021 before experiencing a gradual decline, suggesting continued innovation in medicinal preparations and their therapeutic applications despite increasing emphasis on digital health technologies. A61K 48 showed moderate growth before declining after 2021, reflecting shifts in research priorities and the maturation of certain gene-based therapeutic technologies.
The patent trends are consistent with recent developments in personalized medicine, where advances in artificial intelligence, genomics, and precision diagnostics continue to reshape healthcare. AI-powered tools are increasingly being integrated into clinical workflows to analyze patient data, predict treatment responses, and support individualized care. At the same time, improvements in next-generation sequencing and gene-based therapies have accelerated research in genetic medicine, contributing to continued innovation in subclasses such as A61K 48, while ongoing research into targeted therapeutics and precision drug formulations continues to support innovation in A61K 40.
Recent investments by pharmaceutical companies and technology firms in AI-driven drug discovery, digital therapeutics, and precision oncology further reinforce the growing convergence of biotechnology and digital health. These developments suggest that personalized medicine will remain a highly active area of research and intellectual property, with future growth expected as emerging technologies mature and gain wider clinical adoption.
Major filers and key jurisdictions
Patent activity across the four selected CPCs highlights different centers of innovation within personalized medicine. In cellular immunotherapy, represented by A61K 40, the United States leads with 6,802 filings, followed by Europe with 5,925 and China with 4,668. The strong U.S. position is consistent with its concentration of cell therapy companies and research institutions, including Immatics Biotechnologies, Juno Therapeutics, the University of Texas, Kite Pharma, and Iovance Biotherapeutics. The leading assignees also demonstrate a mix of biotechnology companies and academic institutions, reflecting the collaborative nature of innovation in cellular immunotherapy.
For A61K 48, covering gene therapy, China leads with 9,381 filings, followed by the United States with 6,643 and Europe with 6,318. Japan and South Korea also show significant activity, with 4,277 and 3,548 filings, respectively. China’s strong position reflects the rapid expansion of its biotechnology sector and growing investment in biopharmaceutical innovation.
At the organizational level, however, the leading assignees shown in the figure are predominantly U.S.-based academic and biotechnology organizations. The leading assignees include the University of Pennsylvania, Regeneron Pharmaceuticals, Intellia Therapeutics, Inserm, the University of Texas, and the University of California. Notably, Regeneron Pharmaceuticals appears among the leading assignees in both cellular immunotherapy and gene therapy, highlighting its broad involvement across multiple areas of personalized medicine.
The landscape shifts toward digital health in G16H 20, which covers digital technologies for therapy and health planning. China leads with 25,192 filings, followed by the United States with 18,007 and Europe with 9,694. South Korea and Japan record 8,244 and 5,131 filings, respectively. The high volume of activity in China indicates rapid expansion in digital healthcare technologies, particularly those supporting therapy, health management, and patient monitoring. The leading assignees include Cilag AG, Philips, CareFusion, Insulet, Dexcom, and Samsung Electronics, highlighting the involvement of both established healthcare technology companies and specialized digital health and medical device firms.
G16H 50, covering digital technologies for medical diagnostics and data analysis, has the highest level of patent activity among the four categories. China leads with 57,494 filings, more than twice the 26,284 filings recorded in the United States. South Korea and Europe follow with 13,568 and 13,456 filings, while Japan records 7,835. Germany and the United Kingdom have 4,543 and 2,835 filings, respectively. The exceptionally high level of activity reflects growing investment in digital diagnostics, data analysis, and AI-enabled healthcare. Philips is the leading assignee, followed by Siemens Healthineers, Fujifilm, Hoffmann La Roche, Samsung Electronics, and Canon Medical Systems, demonstrating the strong presence of major medical technology and healthcare companies in this field. Notably, Philips and Samsung Electronics appear among the leading assignees in both G16H 20 and G16H 50, suggesting their broad involvement across digital health, therapy, and diagnostic technologies.
Overall, the patent landscape shows a progression from relatively broad international activity in cellular immunotherapy and gene therapy toward much higher levels of patenting in digital health. China is particularly prominent in digital technologies for therapy and diagnostics, while the United States maintains a strong position across all four areas. The presence of major pharmaceutical, biotechnology, medical device, and healthcare technology companies across these fields also demonstrates how personalized medicine is increasingly bringing together biological therapies and digital technologies.
Conversation with Andrew Tindall
To better understand how patenting trends in personalized medicine play out in practice, we spoke with Andrew Tindall, Patent Director at HGF Limited. In our conversation below, Andrew shares how the patent landscape for personalized medicine has evolved over the past decade, the role of emerging technologies in the field, and key considerations when navigating cross-industry collaborations in patent filings.
Q: How has the patent landscape for personalized medicine changed over the past decade?
A: We have seen significant changes over the last decade on the legal side of things. As a UK and European practitioner, I am relatively lucky that the legal framework remains applicant-friendly in my home jurisdictions (at least for now). However, in the US, the Supreme Court in Mayo (2012) and Myriad (2013) raised the bar on patenting simple genetic associations or biomarker correlations. This was initially the cause of significant uncertainty, especially given the importance of the US market. Fortunately, clarity has returned as effective approaches to pursuing these kinds of inventions have emerged over the years.
In part because of this, we have seen a shift from broad claims on genetic discoveries toward more narrowly tailored protection of technologies, diagnostics, data analytics, and therapeutic applications. This kind of shift is not that surprising as the field matures, but makes establishing freedom to operate and determining the “white space” much more challenging for precision medicine companies.
Q: Which areas of personalized medicine are seeing the most innovation today, such as genomics, AI, companion diagnostics, or gene therapies?
A: While all are growing, I’d argue that the most transformative developments are occurring at the intersection of these fields rather than within any one technology alone. When you think about it, that makes sense: whether it is AI processing genomic data in new ways, or companion diagnostics for advanced therapeutics being built on better multi-omics approaches, the pace of innovation compounds at these interfaces. Although, for me personally, the most exciting innovation is at the frontier of gene therapy – this is where we see “personalised” medicine in the most direct sense, providing entirely new, tailored cures that would have been unthinkable ten or fifteen years ago.
Q: Biomarkers have become central to precision medicine. How important are they from an intellectual property perspective, and what makes them strategically valuable?
A: From an IP perspective, biomarkers are often the key that determines which patient receives which treatment. When linked to a clinical decision or change in pathway, such as whether or when to administer a particular drug, they can control access to patients. This requires both high selectivity and specificity, but markers that achieve this create both clinical and commercial value, becoming standard procedure in the clinic, supporting the commercial success of drugs, and forming an attractive package for acquisition.
However, a major challenge with biomarker inventions is how to properly claim them in a way that secures meaningful exclusivity. Imagine you have identified a panel of 27 circulating miRNAs which, together, can be used to diagnose a disease at a very early stage, with high accuracy. A claim that specifies detecting all 27 miRNAs may be of limited value, as a competitor omitting one of these, or substituting it for a different miRNA, would circumvent the claims whilst riding the coattails of the invention. So there is an appeal to claiming methods using subsets of a panel, say 5 or more from the list of 27 miRNAs, but patent offices tend to push back on this – have you really shown that any subset of five markers can provide an accurate prediction?
Q: Why is intellectual property becoming increasingly important as personalized medicine continues to advance?
A: Well, firstly, because investment and competition in the field remains strong. This need to establish a defensible niche, safeguard invested capital, and signal that the company will be able to leverage the science into a profitable return leads innovators towards a detailed IP strategy. To this end, personalised medicine patent filings have increased significantly over the last decade and, at the same time, the focus of those filings has shifted towards stronger, more considered positions.
Beyond patents, data exclusivity is becoming increasingly important in personalised medicine. For many precision medicine companies, the real asset may not be the patented assay, but the generation of proprietary genomic and clinical outcomes datasets. We’ve already seen data exclusivity drive M&A deals, and investment decisions are becoming increasingly linked to the quality of a company’s overall exclusivity strategy, not just the number of patents it owns. Despite being such an important piece of the puzzle, capturing and protecting this exclusivity is rarely on company or patent attorney radars. A holistic approach is needed from attorneys to guide their clients here, and fortunately this can be as satisfying for us as it is rewarding for them.
Q: Personalized medicine often involves collaborations between biotech companies, pharmaceutical firms, healthcare providers, and technology companies. What IP considerations become especially important in these partnerships?
A: A big consideration with collaborations is ownership of IP. Each party typically brings a different valuable asset to the table: a pharma may contribute the therapy, the biotech company provides a biomarker or analytic platforms, and the healthcare provider brings patient data and samples. Creating an arrangement upfront where the ownership and future direction of the newly-generated IP is secured, whether this comprises patents, data sets, or knowhow, and doing so at the same time as safeguarding the background IP, is key to a successful partnership.
Another challenge is that legal developments in the future may change what is and is not patentable in this space. We saw this ten years ago in the US with Mayo and Myriad, but the law governing personalised medicine is still in flux, and it is likely to remain this way as interest in these technologies continues to increase. For collaborations this is especially important, as different stakeholders may have different priorities for the future direction of the IP, meaning that legal changes may need to be anticipated in multiple territories. This makes predicting these changes very difficult, but necessary, as patent filings need to incorporate a degree of future proofing, especially where global portfolios are concerned.
What’s ahead?
Personalized medicine is entering a new phase in which advances in genomics, artificial intelligence, diagnostics, wearables, and gene therapies are increasingly converging. As these technologies become more accessible and generate larger volumes of patient data, the opportunity to detect disease earlier, predict treatment response, and deliver more individualized care will continue to grow.
Andrew Tindall expects this convergence to be driven in part by falling costs for technologies that generate and process health data. “The quality and extensiveness of the data has always put limits on what is achievable for personalised medicine, but this is set to improve exponentially.” In the coming years, personalized medicine could combine continuous “passive” monitoring from wearables, cheaper at-home monitoring through microfluidics and devices, periodic multi-omics testing, and contextual information from personal data. As computing becomes cheaper, these different sources of information could be integrated and analyzed to identify meaningful insights at earlier stages.
“Together, this means better data will be coming into the personalised medicine pipeline, and more rigorous analysis can be performed on it,” Tindall says. “As a result, we could see more effective treatments, or even earlier, pre-emptive interventions.”
This convergence will also create a more complex intellectual property environment. Innovation is increasingly occurring at the intersection of biotechnology, healthcare, and digital technologies, making it harder to define clear boundaries around inventions and ownership. From an IP perspective, Tindall notes that “practitioners will need to step outside their comfort zones, working in teams to understand the full technology stack in order to properly protect these technologies.”
For innovators, this means IP strategy will need to evolve alongside the technology. Strong protection can help attract investment, support collaboration, and create commercial opportunities, while careful management of background and newly generated IP will become increasingly important as partnerships span pharmaceutical, biotechnology, healthcare, and technology companies.
Ultimately, the next phase of personalized medicine will depend not only on scientific and technological breakthroughs, but also on the ability to protect, manage, and commercialize those innovations. As precision healthcare moves closer to becoming a mainstream approach, a robust IP strategy will be critical to turning scientific advances into accessible and scalable solutions for patients.
OUR FEATURED GUEST
ANDREW TINDALL
Patent Director, HGF
Andrew is a patent attorney and IP strategist who works with innovators and investors developing new technologies in biotechnology, novel foods, precision medicine, and cleantech.
He helps startups, SMEs, and high-growth companies build strong IP strategies, attract investment, and protect their market position. Andrew also advises investors by conducting IP due diligence before investment decisions. His experience spans the full company journey, from early-stage development to IPO and beyond.
HGF is one of Europe’s leading intellectual property firms, bringing together patent attorneys, trademark attorneys and IP solicitors to provide a fully integrated IP service. With offices across the UK, Ireland, the Netherlands, Germany, Switzerland, France and Austria, HGF supports innovative organizations throughout the IP lifecycle, from protection and commercialization to enforcement and dispute resolution.
HGF has a particularly strong reputation in the life sciences sector, advising biotechnology, pharmaceutical, diagnostic and medical technology companies on the protection and management of complex intellectual property portfolios. Combining deep scientific expertise with commercial and legal insight, HGF helps clients navigate evolving technologies and maximise the value of their innovation in a competitive global market.