The innovative technological development of 3D printing functional human tissues and organs opens up new questions as to whether or not such technology is eligible to be patented. While in the past, US judicial rulings have addressed the patentability of biotechnology with respects to genetically modified organisms, the field of arranging and inducing naturally occurring human cells to form organs using 3D printing is a new frontier that requires addressing.
Currently, the USA faces a huge imbalance between supply and demand for organs. As of May 26, 2014, 122,880 people were on the waiting list of candidates for organ transplant. On any given day, 18 people will die while on that waiting list. The organs most in demand are new kidneys, hearts, livers, and lungs.
In an effort to address the world’s shortage in spare human organs, researchers have adapted 3D printing technology into what they now call “bioprinting.” Bioprinting technology has many potential applications, one of which includes printing functioning, three-dimensional human organs.
While normal 3D printing involves depositing layers of plastic to print objects, bioprinting substitutes the plastic with mixtures of adult or embryonic stem cells in what is referred to as “bio-ink.” Different research teams have already been able to print skin cells for burn wounds, ears, blood vessels, and bone. Experts speculate that it is only a matter of time before we are capable of printing even the more complex organs such as kidneys.
The advent of 3D printed organs raises a new and important question for patenting law: who actually owns these organs? Certainly a person receiving a 3D printed organ would afterwards be able to refer to their implant as “theirs,” but as far as patentability goes, are 3D printed organs subject to intellectual property law?
A key element to understanding this decision is the 1972 Supreme Court case of Diamond v. Chakrabarty. In this case, Ananda Chakrabarty, an immunologist from the University of Illinois at Chicago’s College of Medicine, was awarded a patent for a strain of genetically modified bacteria that he had engineered for the purpose of breaking down crude oil. The case, which started as a routine denial with the US Patent and Trademark Office, subsequently moved all the way up to the Supreme Court. The final ruling laid the ground rules for the patentability of many biotechnological advancements including genetically modified organisms. Chief Justice Warren Burger asserted that “a live human-made microorganism is patentable subject matter” because Chakrabarty’s bacteria were “not nature’s handiwork, but his own.”
3D printed organs are not necessarily genetically modified, but current thinking says that they can be subject to patenting. Though the cells and other materials used to print the 3D organs are naturally occurring, the technology used for the printing process and the scaffolding for the organ are all novel inventions.
However, the issue is not necessarily cut and dry. In particular some contest that stem cells have the power in nature to differentiate into different cell types and tissues. Therefore, facilitating that differentiation process may be considered an extension of a “natural” process, thus rendering such technology un-patentable.
Furthermore, a key factor that qualifies 3D printed organs for patenting is their dissimilarity to naturally occurring organs. If 3D printed organs are to be developed to more closely resemble naturally grown human organs, this similarity might also disqualify the printed organs from patenting. So far this is not a problem. For example, current 3D printed organs cannot yet be innervated like their natural counter-parts. In addition, although complex organs such as 3D printed kidneys are currently being developed, they will more than likely look like a tube rather than a real kidney. However, as the field of regenerative medicine continues to leap into futuristic technology, it is possible that the lines between patentable invention and naturally occurring phenomena will be further blurred.
By Sarah Takushi
Genetic Engineering and Biotechnology News
University of Pennsylvania
US Department of Health and Human Services
Wake Forest School of Medicine