19/06/2025
Cervical Screening Awareness week presents us with an opportunity to reflect on just how far we’ve come in early detection and prevention – and how much further we can still go. On that front I’m particularly interested in how AI-based imaging and diagnostics is transforming the speed and accuracy of cervical screening analysis.
Such advances come with significant potential to save lives and reduce the pressure on our healthcare systems. Yet, bringing these innovations to market requires more than just cutting-edge technology. It relies upon a robust intellectual property (IP) strategy. From protecting proprietary algorithms to navigating regulatory pathways, the right IP approach ensures that innovations not only reach patients but also remain sustainable and competitive.
The State of Play
Cervical cancer remains the fourth most common cancer in women globally with around 660,000 new cases and around 350,000 deaths in 2022[1]. Rates of cervical cancer are particularly high in low- and middle-income countries, where access to preventive care is often limited.
Cervical screening, sometimes known as a “smear test”, is an effective way to prevent the development of cervical cancer by looking for early signs of cell abnormalities. However, up to 1 in 3 people who are eligible for a cervical screening in the UK choose not to book an appointment.[2] Cervical Screening Awareness Week aims to highlight the importance of regular cervical screening, address common concerns and encourage open conversations about cervical health.
The next big breakthrough?
Researchers from the Chinese Academy of Medical Sciences and Peking Union Medical College have highlighted the potential for AI not only in the image recognition and processing of cervical sample images, but also in machine learning models to predict cervical cancer risk and assist in guiding biopsy procedures[3].
One standout innovation is the miLab™ CER, developed by Korean MedTech company Noul in partnership with NVIDIA – an innovative on-device solution for cervical cancer screening, which harnesses AI to deliver test results in as little as 15 minutes. By integrating sample staining, digital imaging, and AI-based analysis into a single platform, the miLab™ CER reduces the need for multiple diagnostic tools and trained personnel—making it especially valuable in resource-limited settings.
To protect the miLab™ CER, Noul has filed several patent families relating to the diagnostic device (including US11898947B2) and patches for storing and staining test samples (including US12216033B2). Notably, Noul’s patent filing strategy predominantly targets high-income countries, including the US, South Korea, Europe, and Canada. While Noul and similar MedTech companies may develop technologies aimed at underserved or global populations, patent filing strategies must also consider manufacturing and distribution locations, as well as the presence of competitors.
Further considerations for AI-based MedTech innovation
While AI holds great promise in healthcare, its integration into clinical practice faces several challenges. These include the standardisation and improvement of datasets for training AI models, and ensuring that the use of AI meets ethical and regulatory requirements. Given the high costs and risks associated with MedTech development due to strict regulatory requirements, inter-company collaboration and resource-sharing may be particularly beneficial for scaling access to the technology and its affordability. From an IP point of view, licensing agreements including cross-licensing may therefore help companies to develop complementary technologies and share distribution channels without losing IP protection. This is because cross-licensing agreements allow two or more parties to share use of each other’s protected technology while maintaining ownership of their IP.
Other developments aimed at improving cervical screening access include a cervical screening kit with more cost effective components that also improve the visualisation and access to the cervix (US 2025090012 A1), and an at-home testing kit which allows patients to self-collect and pre-process cervical samples at home (US 20240410890 A1). Such tools may widen access to cervical screenings and encourage participation, particularly for those who face barriers to attending in-person screenings.
As we look to the future, innovations in AI and diagnostic technology offer promising solutions to improve the accessibility, accuracy, and efficiency of cervical cancer screening, particularly in underserved regions. However, realising this potential will require thoughtful collaboration, robust regulatory frameworks, and strategic IP management.
Here at Reddie & Grose, our specialist cross-disciplinary team has a wide breadth of experience in drafting and prosecuting patent applications relating to medical technology and can advise on patent filing strategies.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
[1] https://www.who.int/news-room/fact-sheets/detail/cervical-cancer#:~:text=Cervical%20cancer%20is%20the%20fourth,compared%20to%20women%20without%20HIV
[2] https://www.england.nhs.uk/2023/01/nhs-urges-women-to-book-a-cervical-screening-as-a-third-dont-take-up-vital-offer/
[3] https://www.cancerbiomed.org/content/early/2024/09/19/j.issn.2095-3941.2024.0198#sec-8
