In honour of Diabetes Awareness Week in the UK, which takes place from 8th to 15th June, we will be taking a closer look at the innovations which are revolutionising treatment.
This article will also discuss the role of intellectual property in the development of medicine and medical devices designed for people living with diabetes, and how companies can ensure they maintain a strong position in the market through their patent strategy.
What is diabetes?
Diabetes is a condition where the body cannot properly regulate the amount of glucose in the blood, leading to high blood glucose (hyperglycaemia) which can harm blood vessels, and limit the flow of oxygen and nutrient-rich blood to the body’s organs and nerves.
The level of glucose in the blood is regulated through the actions of two opposing hormones, glucagon and insulin, which are produced in the pancreas by alpha- and beta- cells, respectively. These cells are found in discrete clusters within the pancreas known as islets. Insulin triggers the absorption of glucose from the bloodstream into cells of many tissues throughout the body including fat, liver, and muscle cells.
Diabetes occurs when the body cannot properly make or respond to insulin. Type 1 diabetes (T1D) is a complex chronic autoimmune disease where the immune system destroys insulin-producing beta cells in the pancreas. In comparison, type 2 diabetes (T2D) is a metabolic disorder, often developing later in life, where the body becomes resistant to insulin or does not produce enough.
How do you treat diabetes?
The number of people with diabetes worldwide is rising and is expected to reach over 850 million by 2050, but tackling the disease remains a challenge.
Diabetes can be managed through insulin therapy, which involves daily insulin injections or use of insulin pumps to continuously deliver insulin to the patient. In 1922, Frederick Banting and Charles Best treated a teenager with T1D for the first time by injecting insulin isolated from dog pancreas. They famously sold the patents on insulin and the method of making it to the University of Toronto for $1 each in 1923. Since these early days of insulin therapy, scientific advances have included the creation of artificial insulin molecules such as short-acting insulin analogues (e.g. Lispro and Glulisine) and long-acting analogues (e.g. Glargine and Degludec) to more closely mimic the actions of normal insulin.
Nevertheless, insulin therapy is not curative and must be combined with the constant monitoring of blood glucose levels to avoid complications such as hypoglycaemia, (a dangerous low blood glucose episode). The need to constantly manage blood sugar can place a serious strain on a person’s daily life, as well as on their mental health.
However, in recent years, research into diabetes has reached a turning point. Scientists are exploring new treatments which tackle the root cause of type 1 and 2 diabetes and fully restore insulin production, leading to a future where people suffering with diabetes may no longer reliant on insulin therapy. Solutions are also emerging which make monitoring and management a lot easier, such as holistic approaches to overall health, and “med tech” device ecosystems integrated with digital AI tools to streamline and automate insulin delivery.
Key focus areas in innovation
The rise of medtech
Advancements in medtech and the digitalisation of healthcare has allowed for more accurate tracking of blood glucose levels in both T1D and T2D patients, as well as the possibility of automatic insulin injections.
For example, implantable continuous glucose monitors (CGMs) enable real-time tracking of glucose levels and can help patients understand how food, physical activity and daily routines affect their blood sugar levels, and make small self‑management changes. Recent innovations in the CGM field focus on sensor chemistry as well as improving sensor accuracy, lifespan and user comfort.
A particularly active area of patenting concerns the integration of CGMs with digital health platforms and automated insulin delivery systems to allow accurate 24/7 control. Entire device ecosystems, known as an “artificial pancreas” or a closed-loop system, may reduce the burden on people with diabetes. These systems combine a CGM in communication with an insulin pump, and a control algorithm to enable the devices to predict and respond to glucose fluctuations without user input. Such systems can also be integrated with machine learning and AI to facilitate the analysis of data and offer predictive insights.
The UK is a global leader in the rollout of hybrid closed-loop systems for people living with T1D. Following years of research and advocacy, the treatment has been offered on the NHS over the last few years and has contributed to the reduction of ethnic and socioeconomic inequality in access to diabetes treatment.
The intersection of integrated digital solutions with drugs has significantly influenced patent strategy, with innovators seeking protection for medical devices, software, predictive AI algorithms, methods for data sensing, calibration, integration and cloud storage, and user interfaces, for example, alongside next-generation therapeutic drugs to cure or modify diabetes.
A curative breakthrough for type 1 diabetes
There is currently no cure for diabetes, but the future may look different. We are seeing a movement beyond insulin therapy towards curative or disease-modifying therapies.
Immunotherapies are a new kind of T1D treatment. In 2025, the drug Teplizumab (also known as Tzield®), was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for people aged 8 and over. Teplizumab is a monoclonal antibody which modifies the immune system to prevent it from attacking insulin-producing beta cells, and is the world’s first immunotherapy for T1D. It delays the progression of stage 2 T1D into stage 3 T1D, when the diabetes becomes clinical and individuals require insulin therapy; however, it does not prevent its onset forever.
Immunotherapies such as these could be used alongside regenerative medicine, which, in the case of T1D, would repair or replace the beta cells which have been destroyed. This has been shown to be a highly promising pathway towards a cure, but there are still obstacles to overcome.
Islet transplants, involving the transplantation of islets from donor pancreas into the liver of someone with T1D, have been available in the UK since 2008, but are only used for a very small number of people. Donor islets are limited, their quality differs, and patients usually require more than one transplant. Protecting the transplanted cells from the body’s immune system in order to keep them alive and working is a major challenge; transplant patients must receive strong immunosuppressants which increase infection risk and put strain on the kidneys.
Scientists are now working to solve these issues. For example, a recent first in human study showed that gene-edited “hypoimmune” donor islet cells can successfully evade detection by the immune system and continue to produce insulin for over a year post-transplant.
Stem cell and biomaterials engineering approaches are also being harnessed to produce insulin-producing cells from stem cells, and to protect implanted cells from attack. An ongoing clinical trial in T1D patients is investigating the function of lab-grown, human stem-cell derived beta cells, and has shown promising results with patients restoring natural insulin production following transplantation.
The move to stem cell therapies will reduce the need for organ donors and enable treatments to be more scalable, and preliminary studies are underway to investigate the possibility of using autologous stem cells from the patient themselves to bypass the need for immunosuppressants.
Cell therapies are becoming one of the most important strategic areas in diabetes IP. Patent activity is increasing across the board, covering the engineered cells themselves, methods for genetic engineering and manufacturing of the cells, and devices or compositions for encapsulation and delivery. As the environment becomes more crowded, cell therapies for diabetes could become the next major patent battleground.
A holistic health approach for type 2 diabetes
One evolving class of drugs for T2D work by mimicking hormones that the body releases after eating. For example, GLP-1 is a gut hormone which binds to receptors on beta cells and tells them to release insulin. GLP-1 receptor agonists are a class of medications that mimic the gut hormone GLP-1, enhancing insulin secretion, suppressing glucagon, slowing digestion and reducing appetite. They can help people with T2D reduce blood sugar levels and lose weight, which enhances insulin sensitivity.
The success of GLP-1 therapies has made them a major focus of pharmaceutical innovation and commercial investment. The intellectual property landscape has become highly competitive in recent years, with protection expanding beyond the underlying core molecular chemical structures to encompass delivery devices, dosing regimens, manufacturing processes and combination therapies. Recent commercial successes have further intensified innovation and competition with companies seeking protection for specialised oral formulations and multi-target therapies.
While most GLP-1 therapies require regular and systemic administration through injections or oral dosing, emerging gene therapies aim to provide long-lasting benefits from a single treatment. In a significant milestone, the first-ever clinical trial of a gene therapy for T2D has recently received regulatory approval in Europe. The therapy uses adeno-associated virus (AAV)-based gene therapy to deliver instructions for making GLP-1 directly to beta cells in the pancreas. Unlike conventional GLP-1 therapies, patent protection in this area has focused on vector design, tissue-specific expression systems and promoter technologies, scalable manufacturing processes and methods of delivery.
The benefits of GLP-1 therapies extend beyond blood glucose management. Growing evidence supports that a more holistic treatment approach for T2D by integrating GLP-1 therapy with overall health management, rather than focusing on blood glucose control, leads to 8% fewer cardiovascular events, 7% fewer hospitalisations and 7% fewer bed days, putting less pressure on the healthcare system.
Key takeaways for patent strategy
Maintaining exclusivity and market control grows increasingly important as the diabetes treatment landscape evolves, with opportunities for innovation expanding and changing in nature as competition rises.
Pharmaceutical companies can no longer rely on “core molecule” protection and composition-of-matter patents alone.It is important to have a strong product pipeline with multidisciplinary patent portfolios in place to layer protection, as well as iterative strategies to ensure the protection lasts as long as possible. For example, protection can be extended through SPCs and secondary patents protecting devices, formulations, dosage regimes or additional medical indications. Secondary patents may be just as commercially valuable as the drug itself and secondary filing strategies should be considered early in patent strategy to maximise protection.
In addition, as innovation within diabetes becomes more collaborative, bringing together pharmaceuticals and biotech, freedom-to-operate (FTO) analyses and licensing agreements become more complex. There are many overlapping patent families to consider across a single treatment approach and it is vital to get an idea of the level of competition or any broad patents in the area. To avoid the risk of litigation, early FTO analysis at the very start of a research project and ongoing FTO surveillance is vital, and companies are increasingly leaning towards strategic licensing and acquisitions across key jurisdictions.
Whilst diabetes remains a significant health challenge, we are getting closer to a point where people living with diabetes can become independent from constant management, and from an external insulin source. Diabetes treatment is evolving from a “drug category” into a full metabolic health platform ecosystem, and patent strategy is evolving with it.
