Spotlight on

Precision Medicine

We are witnessing a healthcare revolution. Thanks to advances in genetic analysis, molecular biology and cell science, we now know more about the human condition than ever before. This wealth of information opens the door for a new era of medicine, treating the patient, not just their disease.

With advances in data collection and analysis, our understanding of the physiologic and genetic basis of disease, as well as the variations between different patients, is increasing exponentially.  This is allowing us to understand why individuals respond differently to the same treatment. This emerging model of precision medicine means that medical decisions, treatments, practices and products are tailored to the individual patient.

The completion of the Human Genome Project in 2003 was an early step in our journey to understanding of the genetic basis of disease.  Developments in nucleic acid sequencing and our understanding of genomics has been critical to the emergence of precision medicine, but other technologies play a central role too, with advances in proteomics, metabolomics and cell biology, as well as informatics, biosensors and artificial intelligence all play a part in this exciting field.

This new personalised approach to healthcare has many benefits for both the individual and society which include:

  • Improving diagnosis accuracyoncology has been at the forefront of this movement. By classifying diseases into more precise subtypes, clinicians are able to more accurately diagnose and prognose disease.

  • Optimising treatments – when a genetic or molecular signature of a disease is discovered, an obvious and productive area of research involves looking for drugs that can target this specifically. This is one of the central approaches of the burgeoning field of immunotherapy.

  • Improving patient experience – clinicians can predict the treatments with the best safety or tolerability profile for a particular patient. Variations in the amount, or structure, of particular enzymes or signalling molecules in an individual may affect the way a patient responds to, or processes, a particular drug.

  • Reduced healthcare costs – in the face of an ageing world population, the cost of healthcare continues to raise dramatically. Currently there is significant waste of resources in the use of ineffective treatments. If treatment can be optimised to enhance efficacy, not to mention avoiding the costs of managing adverse reactions, significant savings could be made.

  • New drugs on the market – the identification and analysis of biomarkers is becoming an essential part of prospective drug development programmes, as well as helping to repurpose existing drugs. This has the potential to markedly increase success rates for new drug approvals, as higher response rates in specific populations can be achieved.

Read our Precision Medicine Blogs

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The Technologies Behind Precision Medicine

Precision or personalised medicine encompasses and draws on many different complex technologies. From analysis and diagnosis to treatment, prevention and even prediction, a number of fields combine in this exciting emerging field.

Biomarkers, personalised medicine and companion diagnostics

A biomarker is a measurable indicator of a biological state or condition. Traditionally, the identification of biomarkers has been an observational side product of clinical practice. However, the last few decades have seen us move into an industrialised process of biomarker discovery, capitalising on advances in areas including genomics, proteomics, and other ‘omics’ technologies, whilst aided by improvements in data analysis and bioinformatics.  These advances have resulted in an explosion in the biomarker field, with new biomarkers and new classes of biomarkers, contributing to new and more precise diagnoses of diseases and conditions.  These new biomarkers will improve our understanding of complex disorders such as cancers and immune diseases, as well as helping us to predict and monitor their progression, or provide insights into drug safety.   Ultimately, these new approaches may allow us to detect diseases before they are symptomatic, or at a stage when they are more amenable to treatment.

A key use for biomarkers is in identifying those patients that will benefit most from a particular treatment.  By matchmaking patients with the treatment that is right for them in this way, this new doctrine of personalised medicine has the potential to improve patient outcomes and experience by maximising treatment responses or by minimising adverse side effects.  A key element of personalised medicine is the development of companion diagnostics (CDx).  These are used to determine whether a patient is likely to benefit from a particular therapeutic agent.

Liquid biopsy

Liquid biopsy has emerged as a powerful diagnostic tool in recent years. The term liquid biopsy refers to the use of different body fluids such as blood, urine and saliva for analysis of the health of patient, with blood samples being most commonly used.  In recent years, components of blood including cell free DNA (such as circulating tumor DNA and circulating fetal DNA), microRNAs, extracellular vesicles, tumor educated platelets, and even circulating tumor cells, are increasingly being appreciated for their use in advance diagnostics, whilst benefiting from the minimally-invasive nature of this technique.

Bioinformatics, biological applications of big data

Precision medicine has been made possible by significant advances in our ability to detect and quantify changes in biology, such as small changes in the number of copies of a particular nucleic acid sequence, or the presence of particular point mutations. These advances are only part of the story, however, as their true potential can only be reached with accompanying (and sometimes guiding) advances in informatics.

Bioinformatics is a term which is used as an umbrella to encompass work that may also be referred to as computational biology or medical informatics. It is an interdisciplinary field of science that combines biology, computer science, mathematics, statistics and engineering and heralds a new approach to biomedical/biological sciences, with large amounts of data at its core. 

Although many companies understand the value of bioinformatics and are investing heavily in this space, many have been reluctant to seek patent protection for their inventions. There seems to be a common misconception that software isn’t patentable. Whilst this isn’t true, the complexity of these technologies requires technical and legal expertise in both life sciences and computer sciences.

Next generation sequencing 

One of the most significant technological advances in life sciences has come in the form of “next generation sequencing” (NGS).  These technologies resulted in a step change in our ability to obtain genetic information.  Whereas in the 80’s-90’s Sanger sequencing allowed the sequencing of a single short fragment of nucleic acid at a time (up to a few hundred bases), today’s high-throughput sequencing technologies allow the sequencing of an entire genome in a few hours and for an ever decreasing cost.  

Today’s high-throughput and high-content assays enable the rapid collection of data from a large number of samples and in fine detail, transforming the nature and sheer amount of genetic data available to researchers.  Technologies such as Illumina sequencing, nanopore sequencing and microfluidics are changing our understanding of the molecular basis and hallmarks of disease and fuelling the development of new diagnostics and treatments.  More recently, transformational technologies such as single molecule real time sequencing and single cell sequencing are allowing researchers to cell-population summary measures and look at variability and heterogeneity in populations of cells. This has resulted in invaluable insights into the aetiology of diseases such as cancer and will transform the way medicine is practiced in the clinic.   

Gene editing technologies

Gene editing technologies, such as CRISPR and TALENs have the potential to transform medicine, not only enabling us to treat diseases but also prevent them. Whilst research into editing genes has been going on for many years, new advanced techniques have made it much simpler and faster to modify multiple DNA sequences simultaneously and with high precision.  Nucleic acid sequences within the body that contribute to disease can be targeted specifically and accurately, to repair or replace problems in the code, treating the patient at the genetic level.

CAR-T and adoptive cell therapies

These game-changing cancer treatments are an example of truly personalised medicine. Immune cells (particularly T cells) are removed from the patient, modified in the laboratory and returned to the patient. The cells can be modified to express a chimeric antigen receptor (a CAR), a synthetic receptor that recognises a target antigen that is found on the patient’s cancer cells.

Biological applications of artificial intelligence and machine learning, such as image processing (e.g. for diagnostics)

Exciting developments are arising from the use of advanced algorithms and computing in healthcare. Artificial intelligence (AI) techniques such as neural networks, decision trees and deep learning are being used in a wide range of biological applications. In diagnosis, for example, AI has been used to identify disease in biopsy images, x-rays or other images, performing as well as (and sometimes better than) specialist doctors. Deep learning techniques are being used to process vast amounts of genomic and physiologic data to identify new correlations that offer new diagnostics, as well as to design new therapeutic tools. These are just a few of the ways in which AI is changing modern medicine.

Pink Blood Cells

Liquid Biopsies

Supporting Precision Medicine

Whilst tissue biopsies have been the gold standard for genetic testing in cancer over the past decades, liquid biopsies hold great promise in the field of precision medicine and are emerging as a convenient and accurate alternative to conventional tissue biopsies. Our precision medicine team are experts in this area and work with companies at the cutting edge of this technology. Explore more about liquid biopsies in our dedicated blog series.

Liquid biopsy blog series

Forward-looking for Precision Medicine Technology

This is a complex and diverse area of domestic and international law, with different countries holding differing perspectives on patenting precision medicine technologies.

We understand the challenges in this area, and can advise you on how to adapt your IP strategy to deal with these. For example, while the EPO is a very favourable jurisdiction for protecting inventions in the precision medicine space, over the last few years the USPTO has become a much more difficult forum (following the US Supreme Court’s 2013 Prometheus and Myriad decisions). We can advise on the international landscape and we work with trusted international partners to shape strategies with the best chance of success.

We also recognise that methods of diagnosis are increasingly performed across international borders, with samples sent internationally to centralised processing facilities and data flowing between jurisdictions.  This can cause difficulties in enforcing patents and should therefore be considered carefully at the early stages of the patent process.  We recognise the importance of understanding how the technology will be implemented and can work with you to design a patent strategy which will reflect and protect the situation in the real world.

Talk to our Specialists

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Mewburn Ellis


Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.