The characterisation and optimisation of the CRISPR (also known as CRISPR-Cas) system for gene editing and other applications, in undoubtedly one of the most powerful and ground breaking advances in the history of biotechnology.
CRISPR technology holds the potential to revolutionise the treatment of disease by enabling DNA to be cut at precise locations, allowing for its accurate and targeted renewal or replacement. In addition to biomedical applications, there is huge potential for the use of the CRISPR system in agriculture, using genetic modification to introduce positive genetic traits to crops and livestock such as disease resistance, drought tolerance or improved nutritional properties.
However, the technology is not without its controversies. At present, CRISPR technology is plagued with a raft of unresolved patent law, licensing, regulatory, policy and moral/ethical issues, which pose a real dilemma for those looking to harness the power of CRISPR and threaten to constrain the vast potential of the technology.
At Allen & Overy, we are committed to helping clients cut through these complexities and to provide insightful analysis of the issues facing current and prospective stakeholders in the CRISPR field.
The history of mankind’s endeavour to understand and interact with the natural world is often characterised by a long series of incremental advances punctuated by the occasional giant leap forward. The latter represent fundamental paradigm shifts in human capability and knowledge which have shaped human society and the world at large and CRISPR may be one such advance.
The field of molecular biology and genetics has been fertile ground for such transformative advances – the invention of the polymerase chain reaction (PCR) to amplify a single copy or a few copies of DNA to generate millions of copies, genetic recombination techniques, advances in gene sequencing and the Human Genome Project to name but a few. Each of these advances has paved the way for life-changing medicines and diagnostic techniques, and together are the pillars of knowledge and scientific technique upon which the possibilities and promises of personalised medicine are being built.
The discovery of the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) system and the possibilities it enables for gene editing (amongst many other technical applications) may well come to be regarded as the greatest of them all. Its ease of use and promise has fuelled its spread such that in only four years, use of CRISPR-based techniques has become common place in laboratories across the world.1 It is expected that a Nobel Prize for CRISPR is simply a matter of time – but to whom the prize is to be given is another question.
Two rival groups of inventors have laid claim to the invention of the essential components of the CRISPR system by way of filing competing patent families in various jurisdictions. This has spawned a host of different commercialisation arms, joint ventures and exclusive licensing arrangements with some of the biggest names in a range of industries. Battle lines have been drawn and disputes commenced in patent offices in the US and Europe which could determine the destination of not only the Nobel prize, but potentially billions of dollars in royalties and investment.
1. In 2015, over 20,000 plasmids were shipped to labs in over 50 countries by non-profit plasmid depositing institution Addgene [ref: Doudna and Barrangou (2016) Nature Biotech 34(9) 933]