Introduction

Over the next 2 months, the DLA Piper Life Sciences Blog: Cortex will feature a series of articles providing an insight into the 'Genomics Revolution'.

DLA Piper has pulled together its broad network of global expertise in the genomics space to bring you this series.

An Overview of the Genomics Revolution

One of the greatest advancements in healthcare this century is genomic medicine. Thanks to scientific and technological milestones spanning three centuries, we are rapidly advancing towards a world in which management of our health is truly individualised. 

Some of the key milestones that have brought us to where we are today are: the discovery of nuclein by Miescher in 1869; the discovery of the structure of DNA thanks to the work of Wilkins, Franklin, Watson and Crick (leading to a Nobel Prize in 1962); the development of DNA sequencing by two-time Nobel laureate Sanger in 1977, which led to the Human Genome Project sequencing the first human genome in 2003; and the advent of next-generation sequencing technology (also known as NGS) that offers ultra-high throughput, scalability and speed. The most recent advancement in the field of NGS is long-read sequencing (specifically HiFi and nanopore sequencing), which has been in active development since 2008. Nanopore sequencing has led to the world's first portable sequencer (Oxford Nanopore's MinION), a paradigm shifting device allowing rapid, real-time, point-of-care sequencing of DNA and RNA. The constantly evolving NGS space is forging a path towards ever cheaper, faster and more reliable sequencing, further enhancing our understanding of the role of genetics in disease, and facilitating the genomics – and multi-omics – revolution in healthcare.

But what is genomic medicine and why is it important? As Genomics England puts it, "genomic medicine uses insights from a human's complete set of DNA (their genome) to inform their healthcare, [and] by giving us a window into the molecular differences between people, [it] allows us to pinpoint individual risk of disease and response to treatment"[1]. It is a core component of personalised and precision medicine, allowing healthcare professionals to prevent, diagnose, treat and even cure disease in ever more individualised ways, leading to better clinical outcomes, improved population health and more efficient and sustainable care delivery. 

Almost all therapeutic areas can be impacted by genetic disease. Cell and gene therapies (CGTs) are a form of genomic and genetic medicine that are already revolutionising the way we address certain diseases. The first gene therapy (Gendicine) was approved in 2003 and by the end of 2023, over 76 CGTs had been launched globally[2], with over 4,000 CGT candidates in development as of mid-2024[3]. CGTs include technologies such as CAR-T immunotherapy, which has marked a change in the way we treat cancer, particularly haematological malignancies, and CRISPR-Cas9, a simple and very precise gene-editing technology with curative potential across therapeutic areas including cancer, and infectious, autoimmune and cardiovascular diseases. The world's first ever CRISPR-based treatment exagamglogene autotemcel, was approved in November 2023 by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of sickle cell disease and beta thalassemia[4]. 

As the genomics landscape evolves at speed, so do the legal and ethical complexities surrounding this transformative field. The potential to reshape human health is enormous, however with this promise comes the responsibility to address the legal frameworks that will govern these innovations and protect the interests of stakeholders, including patients, researchers, governments, and wider society.

A Breakdown of our Genomics Series

Our Genomics Series will explore the intersection between genomics and law, offering insights into the challenges that face businesses operating in, or interfacing with, the genomics field, as well as the challenges facing legislators, regulators, and legal practitioners as they navigate the rapid advancements in gene-editing and other genomic technologies. Our goal is to highlight not only the revolutionary scientific potential, but also the crucial commercial, legal and ethical considerations that must guide and govern the future of genomics.

In this opening article, we will introduce some of the key topics that will be covered as a part of the upcoming Genomics Series.

Patent Issues in Gene-editing Technology

The rise of gene-editing, particularly with CRISPR, has sparked significant debate over the patentability of life forms and genetic sequences. This series will analyse the existing patent landscape, focusing on pre-CRISPR technologies, the impact of artificial intelligence on genomics research, and intellectual property disputes over gene-editing technologies. The legal protection of genomic innovations is crucial for incentivising research, but it also raises questions about access, equity, and the ownership of fundamental biological materials.

Gene-editing, Gene Drives and Genetic Engineering

Gene-editing is being widely used in plants and with this comes various considerations in relation to the legal basis for gene-editing. This series will look at this topic from an EU perspective, considering the frameworks in place, recent judgements that influence the scope of permitted editing and European Commission proposals for a new regulation on plants that are produced as a result of new genomic techniques.

Gene drives are a new method of genetic engineering that generate a particular offset of genes throughout a population by altering the probability that a specific genetic element will be transmitted from a parent to its offspring. European legislation addresses the possible risks and regulation required in relation to gene drives and gene-editing more generally. One of the main regulatory challenges in this area arises as a result of 'deliberate release' and so further considerations will be needed when it comes to the future regulation of gene drives, which this Genomics Series will look to consider. 

Regulatory Challenges of Innovative Cell and Gene Therapies

Regulatory frameworks must keep pace with the rapid advancement of cell and gene therapies, which hold the potential to treat previously untreatable genetic disorders. With a focus on the European Union and United Kingdom, our Genomics Series will examine the hurdles that innovative gene therapies face in obtaining regulatory approvals, balancing the need for safety and efficacy with the urgency of bringing life-saving treatments to market.

Genomics and Data Protection

As genomic data becomes more valuable, protecting the privacy and security of individuals' genetic information is paramount. Our Genomics Series will consider the data protection issues arising from the collection, storage and sharing of genomic data. With regulations like GDPR setting a high bar for data privacy, this article will examine how genomic data fits into these frameworks and what steps organisations should be taking to ensure compliance, whilst at the same time having the ability to advance potentially transformative genomic research.

Governmental Approaches to Genomics

Governments and regulators across the globe are shaping the future of genomics and driving the shift towards personalised medicine. Local regulations, guidance and government initiatives aim to foster scientific innovation, whilst balancing ethical considerations, public interest and regulatory challenges.  In our Genomics Series we will explore the role of international bodies, such as the World Health Organization (WHO), in shaping the global standards for genomics and human genome editing, whilst also providing local snapshots with insights into how different jurisdictions are contributing to the development of frameworks governing genomic technologies.

Articles elsewhere in this Genomics Series will also provide local snap shots and focus points. For example, one article will act by way of an overview as to the use of genomics in healthcare in the UAE, looking at the current landscape, horizon scanning and potential challenges for those looking to capitalise on the UAE's commitment to encouraging the growth of genomics in healthcare. Our articles relating to gene-editing technology and patentability challenges will introduce an Australian focused perspective of genomics patent litigation, patentability of life and ethics. Similarly, one of our other articles will focus on potential UK patentability issues in the genomics field, both pre and post the development and more established use of CRISPR and AI technologies.

Next week in our DLA Piper Genomics Series 

Please tune in for next week’s feature, where Rebecca Lawrence will take a deep dive into patent protections in the genomics space, with a focus on the UK landscape.

[1] https://www.genomicsengland.co.uk/genomic-medicine

[2] Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios - IQVIA

[3] https://www.asgct.org/global/documents/asgct-citeline-q2-2024-report.aspx