World Cancer Day, held each year on 4 February, highlights both the continuing impact of cancer and the remarkable pace of innovation in how it is treated.
Cancer is still the 2nd leading cause of death globally, with the disease causing many complications for treatment, such as its ability to spread throughout the body and the composite nature of tumours. However, there have been many recent advances which are providing hope for victims of cancer, from robotic surgery to advanced cell and gene therapies.
In honour of World Cancer Day, this article will showcase some of the cutting-edge innovations which have the potential to transform patients’ lives, improving accuracy and accessibility.
Innovation in oncology
Cell therapies
Cell therapies have fundamentally changed the cancer treatment landscape by harnessing the body’s own immune system to identify and destroy malignant cells. Among the most transformative developments is CAR-T (chimeric antigen receptor T-cell) therapy. CAR-T therapy has already proved successful in treating certain blood cancers and early clinical data suggests that CAR-T therapies could tackle solid tumours, which account for about 90% of all cancers and are notoriously difficult to treat due to their complex mix of cell types.
Next-generation cell therapies are showing a shift towards “off-the-shelf” treatments. This points towards a future where treatments can be produced and delivered at scale and to a much tighter timeframe, making them more accessible for patients. Mass-production is achieved through allogeneic (as opposed to autologous) sources, meaning the implanted and edited cells originate from a healthy donor rather than the patient.
In December, the New England Journal of Medicine released results of a trial in which patients received “universal” CAR-T cells. The cells were taken from a healthy donor and then genetically modified, generating a storable cache for cell therapy. The universal CAR-T cells showed promising results in treating an aggressive form of blood cancer, T-cell acute lymphoblastic leukaemia. As this cancer occurs because of abnormal T-cells, it is difficult to target with autologous T-cell therapy.
Scientists are also developing treatments with other types of cells, such as natural killer (NK) cells. NK cells can selectively attack abnormal cells, fighting cancer without triggering an extreme immune response. Advances in synthetic biology are making it possible to generate these cells using donated blood stem cells. Evidence suggests that one donor could potentially provide enough cells for thousands of treatments.
Antibodies and anti-drug conjugates
Antibody-based therapies remain a cornerstone of modern oncology. Monoclonal antibodies such as pembrolizumab, nivolumab, ipilimumab and trastuzumab have become standard-of-care in multiple indications, validating decades of investment in immune checkpoint inhibition and targeted therapy, and illustrating how long-term patent protection has underpinned sustained development in this area.
Recently, the innovation landscape has focused more heavily on antibody-drug conjugates, addressing targets which were previously considered undruggable. ADCs can deliver chemotherapy agents directly to cancer cells, again improving the level of precision to minimise the side effects which come with cancer treatment.
Cancer surgery
Approaches to tackle cancer are not just limited to pharmaceuticals; some tumours can be extracted from the body through surgical procedures. However, surgery is high-risk, and factors such as the position or composition of a tumour makes surgery in some cases impossible.
New technologies such as robotic systems and laser devices could make operating on tumours in places with restricted access feasible. Lasers can destroy tumours precisely without damaging healthy tissue, whilst robotic devices can reach places which traditional surgical tools cannot.
Researchers at the University of Oxford have developed another way to improve accuracy in surgery: a fluorescent dye which highlights cancerous tissue, including tissue which is not detected by standard imaging. This makes it easier for surgeons to find and remove malignant tissue, whilst minimising unwanted damage.
AI and diagnostic procedures
Diagnostics are also becoming more accurate, as well as less invasive. For example, liquid biopsies are non-invasive and can be more informative compared to the traditional method of surgically removing a piece of tissue or a sample of cells from the body for diagnostic purposes. Thanks to technological advances, tumour DNA fragments can be detected in blood samples. Last year, the NHS was the first in the world to implement a new liquid biopsy test for patients with lung and breast cancer, enabling the delivery of more personalised and streamlined care.
AI is becoming a core tool in efficient and effective healthcare, and cancer diagnosis is no different. AI can be used to interpret X-ray, CT, MRI and PET imaging to flag subtle abnormalities early and with high precision. The NHS has launched trials exploring how AI can improve the breast screening system, and it has just been announced that they will also be trialling AI in lung cancer diagnosis – the cancer responsible for the most deaths in the UK.
The combination of AI and less invasive methods of detection has the potential to transform the way we spot cancer in patients, bringing us closer to instant and autonomous screening. This could lead to earlier discovery and, ultimately, better treatment and a lower death rate.
Patent protection in oncology
Innovation in oncology can be costly and time-intensive. Taking a clinical candidate from bench to bedside can take many years and requires substantial investment in research, trials, regulatory approval and manufacturing. Therefore, patent protection is therefore both for securing early investment and for later recouping the costs of developing new treatments.
Patenting a new cancer treatment
A common starting point for patent protection in oncology innovation is a new therapeutic agent. The precise scope of protection available will depend on what new data has been generated, and what is already known about the same or similar agents. In addition, innovators typically build a portfolio of patent applications around a single agent over time. Such applications may be directed to:
- Compositions of matter protecting the therapeutic agent itself, often with broad medical use claims where available. These applications usually provide the strongest protection.
- Further medical uses of the agent. As development progresses, the innovator may discover that the agent is effective in treating a different cancer that was not previously recognised. A new patent application directed to this new therapeutic use may be filed, even if the agent is already publicly known.
- Formulations that improve stability, delivery, tolerability or targeting of the agent.
- Dosage regimens protecting specific dosing schedules or administration protocols of the agent.
Taken together, these different types of patent applications can form a layered protection strategy around the therapeutic agent.
What else can be protected?
Focusing only on new therapeutic agents can risk overlooking other forms of patentable subject matter in oncology. For example, although diagnostic methods are excluded from patentability in some jurisdictions, this does not mean useful protection is unavailable. Instead, diagnostic methods often require more careful claim drafting, for example, by directing claims to in vitro methods. Similarly, while methods of surgically removing a tumour may not be patentable, the tools that enable the procedure are frequently AI-driven technologies, for example, in imaging analysis, which can also form part of a valuable patent portfolio if framed correctly.
Opposition and validity challenges
Given the commercial importance of oncology patents, European patents in this field are frequently subject to opposition at the EPO. The opposition procedure provides a centralised mechanism for third parties to challenge the validity of a patent within nine months of grant. The outcome can often turn on the quality of the technical and legal arguments advanced, and the manner in which the patent is amended and defended. Beyond this period, validity may still be challenged through national revocation actions or centrally before the Unified Patent Court (UPC).
Whilst World Cancer Day is a time to acknowledge the serious impact which cancer still has on many people’s lives, it also reminds us of the extraordinary progress across the oncology landscape. Innovation is reshaping cancer care in ways that were unimaginable only a decade ago, gradually improving outcomes for patients.
Patent protection will continue to play a pivotal role, shaping how discoveries are protected, developed and delivered to patients. As therapies and diagnostics become more complex and interconnected, thoughtful patent strategy will be essential to ensure that innovation translates into real-world impact for patients.
