ValueWalk’s Q&A session with Professor Shubha Ghosh, a professor of law and the director of the Syracuse Intellectual Property Law Institute. In this interview, Professor Ghosh discusses his background, the Human Genome Project, the current state of gene editing, 3D printing for organ operations, and gene editing regulation.
Can you tell us about your background as it relates to intellectual property?
I earned my law degree at Stanford Law School and took numerous courses in intellectual property and business law (as well constitutional law and international law). I did my third year paper on parallel importation of products protected intellectual property, and this work has been the basis for numerous publications, including a 2018 book from Cambridge University Press. I have taught intellectual property law courses at numerous law schools for nearly 25 years and am the author of several law school casebooks in the field of intellectual property law. In addition to my scholarly work, I have served as a consultant in several cases involving intellectual property.
When I was growing up, I remember learning about the genome being mapped – can you explain what that means and how much we have progressed since then?
The Human Genome Project was a multi-country, multi-university project funded by the National Institute of Health, launched in 1990 and declared complete in 2003. The goal of the project was to identify the nucleotides, or chemical codes, for all the genes in the human body, over 3 billion base pairs. After 13 years, the mapping was considered completed, but do keep in mind that the mapping is based on a composite across all samples that the many researchers were studying. So there is much more to learn about the specific genes in any given individual and how they work.”
In addition to the NIH sponsored project, there was private sector initiative as well, and many companies are working to further understand the chemical structure and function of genes.
Can you help folks without medical or legal backgrounds understand the current state of gene editing?
It is perhaps best to think of two ways genes are manipulated. One is recombinant technology that allows for inserting new genes in existing organisms in order to create an enhanced organism. You can think about recombinant technology as doing in a lab what happens in nature whenever two individuals reproduce. Recombinant DNA technology has been with us for over three decades and is responsible for genetically modified crops as well as modified animals.
A relatively new technology called CRISP-R allows for gene editing in the body of a living organism, much like surgery allows for removal or implantation of tissue or mechanical/electronic devices. This current technology is what the press refers to as gene editing. It is controversial because of the ethical implications and the still developing science of how such editing would work. There are legal debates ongoing over the patents, and much of the application is still in the preliminary phases.
My brother in law who is in residency says they use 3D printing for organ operations is that related to gene editing or growth of stem cells? Will printers soon be able to print actual organ cells instead of plastic for medical procedures?
3D printing allows for the printing of materials beyond the traditional paper and ink; it can permit printing of almost any type of material, including organic matter like tissue. But 3D printing of full organs is still a ways away. Right now single cell organisms have been successfully printed. 3D printing can be used in operations to make certain implants or sutures in some cases. Gene editing and stem cells are separate from 3 D printing, but as the technologies develop, there will be overlap.
What are the current rules on gene editing in the U.S.? What about Europe? What about China?
The rules are still in flux but there are ethical prohibitions against the use of gene editing on humans and for therapeutic uses.
Is this for research purposes, cosmetic or medical – and how do they differ in these places?
Research is regulated through restrictions on human subject experimentation. Cosmetic and medical applications are still a way off for ordinary use and except for unsubstantiated reports from some country like China have not occurred.
What fields are gene editing used for? Can regular people get gene editing and why would they want to?
The applications of gene editing could be broad, including perhaps removing genes associated with proclivities for cancer. The applications will depend in part on improved understanding of the functions of identified genes.
Can you give your predictions for gene editing regulation, and how it may evolve over the next 5 to 10 years?
Regulations will catch up with applications. My sense is that there will be concerns over use of gene editing in a selective way that reinforce social stereotypes based on gender, ethnicity, and disability. There will be serious issues about cost and access to technologies, especially if researchers discover uses of the technology that can extend the duration and quality of life.