23 October 2026

Breast Cancer Awareness Month: How IP Drives Innovation in Diagnostics and Treatment

Breast Cancer Awareness Month takes place every year in October. At Mathys & Squire, we stand in solidarity with the many people who have been affected by the disease and would like to call attention to the work which still needs to be done to combat it, whilst highlighting the incredible progress which has already been made.

Breast cancer accounts for the highest number of cancer cases among women worldwide, and is the second most common cancer overall, with an estimated 2.4 million new incidents in 2024 (11.8% of all diagnosed cancers), according to GLOBOCAN data. 1 in 8 women develops breast cancer in her lifetime.

Scientific advancements in the past few decades have played an indispensable role in reducing the impact of breast cancer. Supporting innovation in cancer treatment and diagnostics and making innovative approaches accessible saves lives. According to Cancer Research UK, the number of deaths due to breast cancer has almost halved in the UK since the early 1970s and decreased by 16% in the last decade alone.

Although mortality rates have improved, current predictions point towards a rise in the number of cases occurring, and the annual number of new cases is expected to reach over 3.5 million in 2050. Tackling breast cancer is, therefore, still as pressing an issue as ever and the UK needs to continue facilitating successful and scalable innovation to accelerate the discovery and implementation of new technologies.

The patent landscape in breast cancer management

Intellectual property (IP) serves a critical function in incentivising innovation. In fields like life sciences, where high-cost and lengthy research, and strict regulatory standards are necessary before a consumer-ready product is achieved, patents provide an exclusionary right which acts as compensation for inventors. An effective patent system enables technology transfer and ensures the publication of scientific breakthroughs, encouraging collaboration and the open exchange of ideas.

In addition, patent activity is a direct reflection of the extent of innovation. According to a 2025 EPO report on ‘Patents and innovation against cancer,’ more than 140,000 inventions related to cancer have been disclosed to the public in the last 50 years. The number of international patent families (IPFs) published in cancer treatment saw a sharp increase in the nineties and early twentieth century, although this slowed down between 2005 and 2015.

Nevertheless, in the last decade, there has been a second period of rapid growth, driven by emerging technologies beyond traditional cancer treatments such as chemotherapy and radiotherapy. The growth in patents related to cancer diagnostics also accelerated between 2015 and 2021.

Some of the fastest-growing, new technologies which account for the noticeable increase in IPFs related to cancer are healthcare informatics, image analysis, liquid biopsies, cellular immunotherapy, immunotherapy with antibodies or small molecule immunomodulators, non-coding nucleic acids and gene therapy. In this article, Associate Lindsay Pike takes a closer look at some of these innovation hotspots and the recent developments shaping the space.

Diagnostics in breast cancer

Detecting breast cancer early is vital to ensure that patients have the highest chance of survival possible. Improvements in diagnostics technology will reduce the mortality rate, help patients recover faster and lower treatment costs. This relies on screening tools which can distinguish a tumour from healthy tissue before it has reached an advanced stage of growth.

Phase-contrast X-ray imaging

Mammograms are currently the most common and effective screening method for breast cancer, involving an X-ray machine which is designed specifically for breast tissue.

However, mammograms are not always 100% accurate. Conventional X-rays move easily through soft tissue which makes it challenging to differentiate between breast tissue and tumours, especially for women with denser breast tissue. Mammograms miss about 6% to 8% of cancers and about 1 in 10 mammograms yield a false positive result, leading to unnecessary follow-up procedures such as biopsies.

Phase-contrast x-ray imaging is an alternative to conventional x-ray imaging, measuring changes in the phase of an X-ray sample as it passes through tissue, rather than just differences in absorption. This produces a higher-contrast scan for soft tissues, allowing the identification of smaller and younger tumours.

Scientists Marco Stampanon and Zhentian Wang have developed a phase-contrast X-ray imaging system, which they have commercialised through their spinout GratXray. Their imaging system harnesses grating interferometry (GI), which uses diffraction gratings to produce an interference pattern, allowing tumours to be detected as they disrupt the pattern. Their imaging device also operates without the need to compress the breast, which in traditional mammograms can be uncomfortable or painful. At the start of this year, the company opened a new development laboratory in Zurich to advance their mission to make reliable breast cancer screening accessible to everyone.

Liquid biopsies

Biopsies are used to test a sample of tissue or cells extracted from the body for indicators of cancer. Traditional biopsies, known as tissue biopsies, are invasive procedures in which tissue is extracted using methods such as a needle, endoscopy or surgery. Their ability to fully encompass the genetic diversity of the cancer can also be limited.

Liquid biopsies are a less invasive alternative, testing blood for valuable information about a tumour, such as genetic changes in tumour DNA that circulates in the bloodstream (circulating tumour DNA, ctDNA). Although only a few liquid biopsy tests to date have been integrated into standard care, innovation in this area is accelerating at a notable pace.

Before 2013, more IPFs related to tissue biopsies than to liquid biopsies were published every year, but in the last decade, the number of IPFs for liquid biopsies jumped from just over 500 in 2012 to 2,300 in 2021. In comparison, the annual number of IPFs published in tissue biopsies has stayed around 600-800.

Current research is looking at whether repeat or ‘serial’ ctDNA testing during treatment could help detect the genetic mutations that cause resistance or that indicate the return of a cancer before a recognisable tumour is present. For example, AstraZeneca is conducting clinical trials where eligible breast cancer patients receiving treatment with aromatase inhibitor with continued cyclin-dependent kinase (CDK) 4/6 inhibitor had their ctDNA tested for a particular genetic mutation known to be associated with acquired resistance to the aromatase and CDK4/7 inhibitors. If the resistance mutation was detected, the patient was switched to an alternative treatment (camizestrant), which significantly improved cancer-progression-free survival (see Turner et al 2026 here).

The integration of AI

AI is increasingly being harnessed to enhance the accuracy and efficiency of breast cancer screening.

The results of a research project published earlier this year involving Google, Imperial College London and the NHS studied the impact of Google’s experimental research AI system on screening accuracy and radiologists’ workload. After using AI to assess the mammograms of 125,000 women, they found that the AI-based screening identified a quarter of the total interval cancers which were not initially spotted.

Furthermore, as breast cancer incidences rise, there will be an increasing strain on specialists, of which there is already a shortage worldwide. In the UK, each radiologist only has four hours dedicated to analysing scans each week, in which they receive around 5,000 scans, and each scan must be ‘double read’ (looked at separately by two different radiologists). AI could help make the process more efficient when implemented as the “second reader”.

Treatment for breast cancer

Surgery, chemotherapy and radiotherapy act to remove, destroy or harm cells which are dividing quickly to prevent or decelerate their growth. However, these traditional treatment approaches come with significant side effects, greatly impacting patients’ quality of life, as they may also damage healthy cells.

The development of emerging approaches, such as immunotherapy, targeted therapy and gene therapy, is giving hope for a future of breast cancer treatment which is more effective and more manageable for those undergoing them. The evolution of these therapies is driving progress in personalised medicine: when medical treatment is tailored to a tumour’s specific molecular and genetic profile to optimise efficacy and minimise side effects.

Delivery systems in nucleic acid-based therapeutics

Nucleic acids, such as DNA and RNA, are chemical compounds which carry genetic information and direct protein synthesis. Nucleic acids are proving to be highly versatile tools in the fight against breast cancer with the ability to correct mutated genes, suppress diseased genes and restore immunity pathways. They can be precisely engineered to achieve the desired result with minimal off-target effects depending on the individual patient.

The effective delivery of nucleic acid-based drugs to target sites is crucial and researchers are exploring advanced delivery systems which optimise the drugs’ potency and safety. An area which has gained traction is the use of nanoparticles as vehicles, because their small size and modifiable surface properties mean they can enter tumour tissue and selectively accumulate in cancer cells.

According to a 2026 study, the growth in the number of published patent applications related to delivery systems used in genetic therapies for breast cancer treatment has surged significantly since 2020. This is likely related, at least in part, to the COVID-19 pandemic, when regulatory bodies approved the first mRNA vaccines using lipid nanoparticles. Now, nanoparticles are entering a new era: their application is extending to non-infectious diseases and a pronounced effort to transform innovation into real-world impact is observable.

Medicines targeting hormone-resistant cancer

Hormone or endocrine therapy is a form of treatment for breast cancers which are hormone receptor positive. In such cancers, hormones promote growth of breast cancer cells; hormone therapy disrupts this process by limiting the production of hormones in the body. Sometimes, tumours continue to grow despite these treatments, known as endocrine resistance, making hormone therapies ineffective.

In February 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a drug designed to control cancers which have developed resistance. Inluriyo (imlunestrant) is a daily tablet for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with ESR1 mutations which can allow cancer cells to continue signalling through the oestrogen receptor despite hormone therapy.

The role of IP in innovation for combatting breast cancer

As mentioned, IP plays an important role in driving innovation, including in the fight against breast cancer, by helping to protect new inventions and encouraging investment in time-consuming and expensive research. IP helps attract private investment and creates avenues for financial returns, for example, directly exploiting the protected innovation, technology transfers, and granting licenses. Patents in particular offer innovators – be they large pharmaceutical companies, universities or spinouts and start-ups – opportunities to recoup their investment. Patents can be utilised by companies to help secure funding and establish commercial partnerships, and therefore play a key role in translating scientific discoveries into practical advances that benefit patients.

Evidence suggests that universities and research/higher education institutes are playing an increasing role in cancer-related innovation: they accounted for almost one in three IPFs at a global level between 2002 and 2021. In contrast, there was a marked decrease in the annual number of IPFs in cancer treatment from corporate applicants after 2007, with clear stagnation over the last decade. Pharmaceutical companies are increasingly relying on science-based clinical research originating from universities, higher education institutes and public research organisations (PROs). Having an IP strategy in place at these entities is therefore critical to assist with commercialisation, spin-out formation, or developing corporate collaborations or partnerships.

In practical terms, those seeking to develop new breast cancer diagnostics and treatments should consider patent protection early in the innovation process, particularly before making their research or discoveries public. This includes before publishing research findings in scientific journal articles, or before presenting at a conference, or any other type of public disclosure which may jeopardise patent protection. Seeking advice from a specialist patent attorney, such as one of our experts at Mathys & Squire, at an early stage is therefore highly recommended.

In Europe, at the European Patent Office, a wide range of inventions relating to breast cancer may be eligible for patent protection, provided they meet the European Patent Convention requirements (e.g., they must be new, inventive, have industrial applicability, and be sufficiently disclosed in the patent application). For example, new or improved pharmaceutical compounds or formulations for treating breast cancer, diagnostic devices, laboratory testing technologies, and technical methods for identifying or screening potential cancer treatments could all be patentable. Medical products, diagnostic instruments and qualifying new medical uses may also be patentable, although methods of treatment of the human body by surgery or therapy, and diagnostic methods practised on the human body, are excluded from patent protection in Europe.

It is important to note that patentability is assessed on a claim-by-claim basis, and a research project may generate multiple potentially patentable inventions. A robust strategy to protect all the IP generated by, for example, a research project seeking to develop new breast cancer diagnostics or treatments will therefore involve: early identification of potentially valuable ideas and innovation, prompt application for suitable IP rights such as patents, plus well-thought-through confidentiality agreements, clear ownership arrangements and plans for commercialisation.

If you need help with your IP strategy, please reach out to our team of dedicated experts here.

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