Gene Editing and the Law: Should CRISPR Be Regulated as a New Form of Intellectual Property?

Introduction

CRISPR gene editing has transformed the trajectory of medicine, holding out the possibility of cures for inherited diseases such as sickle cell disease. However, this revolutionary technology raises immediate legal and ethical issues of ownership and accessibility. Intellectual property protections have stimulated innovation, but the unique nature of CRISPR demands rethinking existing legal structures. This article argues that CRISPR should be regulated as intellectual property but with necessary protections, including compulsory licensing, state and price regulation, in order to achieve a balance between innovation and ethical considerations and access to life-saving treatments. The following sections examine CRISPR's legal classification, ethical concerns, accessibility in healthcare issues, and policy recommendations for a balanced regulatory regime. 

Background and Context: CRISPR and the Intellectual Property Debate

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a powerful gene-editing tool that can edit DNA at a specific site. Initially isolated from bacterial immune systems, CRISPR is now used for medical, agricultural, and biotech purposes varying from curing inherited diseases to growing disease-resistant plants. However, like all breakthrough technology, issues have emerged concerning ownership and control. The development of CRISPR has been overshadowed by aggressive patent wars, most significantly between the Broad Institute and the University of California, Berkeley. The U.S. Patent and Trademark Office (USPTO) plays a critical role in granting patents on gene-editing technologies, which determine who has the right to enjoy profits from CRISPR-related innovations. The legal framework of CRISPR is complicated by biotechnology patent complexities and differing national regulations. While patents stimulate scientific investment, they also potentially restrict access to lifesaving drugs. The question is whether patenting CRISPR stimulates innovation or inhibits competition and raises more universal ethical and legal questions.

Should CRISPR Gene-Editing Technologies Be Classified as Intellectual Property?

Proponents argue that patents induce innovation since they provide returns on research and development. Patent protection also prevents abuse and unauthorized use, upholding ethical standards of research. Of note, universities and biotech firms have developed significantly due to CRISPR patents, thereby securing their place in scientific development. Critics warn that over-patenting could create monopolies, making gene therapies prohibitively expensive. The controversy over Myriad Genetics' BRCA gene patent is a tale of warning in which patenting genes meant restricted access to life-saving cancer tests. In addition, the "owning" of genetic mutations raises questions about the commercialization of human genes and potential exploitation. Different countries approach patents on gene editing differently. The European Patent Office (EPO) has put restrictions on the patenting of human gene alterations, but China has emerged as a hub for gene-editing research. The infamous He Jiankui scandal, in which Chinese scientist He Jiankui created gene-edited babies, shows the possible dangers of unrestricted CRISPR application. The scandal demonstrates the necessity for tighter international regulations to prevent unethical gene editing.

Misuse of the Gene Patents

Patents may inflate the price of gene therapies, rendering them unaffordable for low income individuals. Existing policies such as compulsory licensing and government subsidies attempt to balance patent rights with affordability, but they do not succeed. As an example, Zolgensma, a gene therapy for spinal muscular atrophy, was made one of the most expensive medicines in the world due to patent-based pricing. The medical and scientific worlds also express fears that gene patents could exacerbate health inequalities. Misuse of the gene patents, for example, being used for designer babies or genetic modification, is an ethical issue. Furthermore, gene patents have had a history of being linked with discrimination against healthcare, just like how specific genetic tests ended up being out of reach for marginalized groups.

The misuse of gene patents extends beyond pricing concerns and enters a realm of profound ethical dilemmas, particularly in the context of CRISPR technology. One of the most controversial applications is the potential for "designer babies," where genetic modifications could be used to enhance physical traits, intelligence, or athletic ability rather than to treat diseases. This raises concerns about exacerbating social inequalities, as access to such enhancements may be limited to the wealthy, deepening existing class divides. Furthermore, these practices echo eugenics, a historically dangerous ideology that promotes the selective breeding of "desirable" traits while potentially discriminating against individuals with disabilities or perceived genetic disadvantages. Such applications of CRISPR risk reinforcing biases against genetic diversity, reducing the acceptance of natural human variation. Beyond social concerns, there are also significant scientific risks such as germline editing, which alters DNA in a way that is heritable across generations, could introduce unforeseen genetic complications that persist indefinitely. The lack of regulatory consensus across countries further complicates the issue, as some nations may impose strict bans while others permit experimentation, leading to ethical gray zones in global biotechnology governance.

What Should Happen Next? A Path to Justice and Reconciliation

A fair intellectual property regime should encompass alternative models such as patent pools and compulsory licensing. Patent pools, where multiple stakeholders share patent rights, could reduce monopolization without destroying innovation incentives. Compulsory licensing would also allow governments to authorize low-cost CRISPR-based treatments in cases of public health necessity. Legislators can learn from past instances where government intervention brought about a balance between innovation and public interest. The Bayh-Dole Act, wherein publicly funded research was allowed to be patented yet public access was assured, can serve as a model for CRISPR regulation. Government-led price controls and public-private partnerships can also maintain affordability while promoting continued research. International cooperation is the cornerstone of CRISPR patent law. WHO and the FDA need to come up with guidelines that allow for ethical applications of CRISPR without reducing incentives for research.

These regulations should demand accessibility by requiring businesses that benefit from public investments to follow fair pricing models. Moreover, independent regulatory bodies should manage genetic research in a manner that prevents unethical applications and discrimination. Legal regulation of CRISPR as intellectual property entails complex challenges requiring a highly balanced approach. Despite the fact that patents are vital in driving innovation, uncontrolled monopolies could deny individuals access to life-saving treatments. To mitigate these concerns, policymakers must apply flexible patent policies, government regulations, and ethical standards to prevent discrimination and exploitation. Scientists, ethicists, and policymakers should collaborate in developing fair and equitable CRISPR policies that promote innovation and public health.

Legal regulation of CRISPR as intellectual property presents complex challenges that demand immediate and decisive action. While patents drive innovation, unchecked monopolization threatens to deprive millions of life-saving treatments. Without swift policy intervention, the unchecked commercialization of CRISPR could deepen global health disparities and enable unethical genetic manipulation. To prevent this, policymakers must urgently implement flexible patent frameworks, enforce stringent government oversight, and establish ethical safeguards against discrimination and exploitation. The future of genetic medicine hangs in the balance, therefore scientists, ethicists, and lawmakers must act now to create equitable CRISPR policies that serve both innovation and humanity.

Image Source: The Varsity