Would you permit your genes to be edited if it meant curing your child of a debilitating or life-threatening hereditary disease? What if the same gene editing technology is utilised for non-therapeutic purposes, such as increasing one’s intelligence, or ‘designing’ a child of your choosing?
Regulators and scientists across the globe have been grappling with such issues since emergence of CRISPR-Cas9, a gene editing technique that has proven faster, cheaper and more accurate than the technologies preceding it. It is no surprise then that gene editing has been dubbed the ‘new technological gold rush’. Indeed, the possibility to eradicate genetic disease or enhance non-medical traits are no longer restrained to science fiction, they are quickly becoming a palpable reality.
Human Germline Genome Editing: Opportunities & Costs
Human germline genome editing (hGGE) techniques, such as CRISPR-Cas9, have the potential to instigate hereditary change in the human germline. This means that any ‘edits’ made to the human gene would be passed down from generation to generation. Since genes (a segment of DNA) are an expression of physical and psychological characteristics, their alteration can in theory be used for both therapeutic and non-therapeutic purposes. Whilst the former holds the potential for curing or preventing hereditary diseases such as Cystic Fibrosis, the latter paints a more sinister picture due to concerns of eugenics and designer babies.
Crucially, hGGE offers prospective parents the opportunity to have a healthy, genetically relatedchild where current Assisted Reproductive Technologies have failed. By utilising this technology to expand our reproductive boundaries, we are entering a ‘reproductive revolution’. However, the safe and equitable development of this transformative technology remains a highly controversial and persistent challenge for regulators.
Patents as a Form of Regulatory Control
The breathless pace at which hGGE is developing poses significant regulatory challenges.  Regulators and static regulatory regimes are struggling to institute appropriate legal and ethical safeguards to oversee the technologies safe and controlled development.
Interestingly, patents and their licensing procedures are being utilised to shape and exert control over the development of gene editing technologies. This regulatory control occurs in three main ways:
- Patents, by their nature, are protective and preventative;
- In order to obtain a patent, one must first satisfy licensing conditions; and
- The possibility of legal action after infringement of a patent.
Firstly, patents are an exclusive legal right to make or sell an invention. Thereby, an owner of a patent has the sole right to exclude or prevent others from making, selling or practicing the technology in question without prior permission. This capacity to prevent the commercial exploitation of novel technologies provides a unique opportunity; patents can be utilised to mould the use of hGGE during its experimental stages of development. Since patents are naturally restrictive, this serves to reinforce regulatory precaution typically exhibited in the regulation of novel technologies.
Secondly, the licensing procedure for patents operates as an avenue from which to integrate ethical standards into the development of the technology from its conception. Before a patent can be claimed, one must seek permission from a license holder surrounding the technology. As such, this process can be utilised to curtail any ethically questionable uses of the technology, either in research or clinical practice. This process can function to reduce wider societal harm since restrictions on the non-therapeutic uses of hGGE can be implemented. Further, by encouraging full disclosure on the use and purpose for which one wants to obtain a patent, the licensing process has the corollary effect of fostering wider public discussion surrounding hGGE.
Finally, the use of hGGE technology for purposes contrary to the terms of the patent can result in legal action being advanced based on patent infringement. The threat of punitive damages for unethical uses of the technology serves as a deterrent to irresponsible research practices.
Patents are ultimately a small part of a larger regulatory schema surrounding gene editing technology. They do, however, remain a valuable means from which to institute precautionary governance of the technology. Indeed, whilst irresponsible research practices might still occur (see He Jiankui, 2018), turning a blind eye to the clinical use of the technology must be dismissed. Regulators should proceed with caution, but proceed, nonetheless.
 US National Library of Medicine, ‘What are genome editing and CRISPR-Cas9?’ <https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting> accessed 20/11/2020
 Degan Wells, Joris Robert Vermeesch, Joe Leigh Simpson, ‘Current Controversies in Prenatal Diagnosis 3: Gene editing should replace embryo selection following PGD’ (2019) Prenatal Diagnosis, Vol. 39, 344 < https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1002/pd.5442 >
 Carroll D, Charo RA. ‘The societal opportunities and challenges of genome editing’ Genome Biology, (2015) < https://genomebiology.biomedcentral.com/articles/10.1186/s13059-015-0812-0 >
 J. Sherkow, ‘Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles’ (2019) The CRISPR Journal < https://ethics.harvard.edu/files/center-for-ethics/files/crispr.2019.0029.pdf >
 Cambridge Dictionary, https://dictionary.cambridge.org/dictionary/english/patent
 Shobita Parthasarathy, ‘Use the patent system to regulate gene editing’ (2018) Springer Nature < https://media.nature.com/original/magazine-assets/d41586-018-07108-3/d41586-018-07108-3.pdf >
 Sherkow, ‘Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles’ (2019) The CRISPR Journal < https://ethics.harvard.edu/files/center-for-ethics/files/crispr.2019.0029.pdf >