Are 3D-Printed Human Organs Patentable?
A recent post on the IPWatchdog blog raises an interesting legal question – are human organs patentable… if they’re created using a 3D printer?
According to Nature magazine, “printed body parts brought in US$537 million last year, up about 30% on the previous year.”
Most of the 3D-printed body part business focuses on titantium hip replacement joints, which can be tailored to each patient.
Other body-parts-in-development include:
- An artificial ear that includes hydrogel, cartilage cells, and “silver nanoparticles to form an antenna”
- A rudimentary kidney
- Skull implants
- An airway splint for an infant with a damaged trachea
- Blood vessels
- Patches for damaged livers
- Duck feet
Printing with Cells
Some of the 3D printing projects use non-organic materials like titanium, or blend living cells with non-organic materials. Emerging technologies allow live cells to be used as “ink” and assembled layer-by-layer into tissue.
The Verge recently reported that one challenge in printing with cells is that they tend to collapse under their own weight before they solidify. Researchers at the University of Florida in Gainesville seem to have overcome that problem by printing in gel, which acts as a “scaffold.”
Plant patents have been allowed under US law since 1930. Title 35 United States Code, Section 161 states:
Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor…
For example, Monsanto has been diligent in enforcing its patent on soybeans resistant to Roundup weed killer, as I wrote about here.
In 1980, the US Supreme Court in Diamond v. Chakrabarty ruled that an artificial micro-organism that eats oil slicks could be patented because it was “non-naturally occurring,” and a “product of human ingenuity.”
As the New York Times reported, in 1988 Harvard University received the world’s first patent for a higher form of life – a mouse genetically engineered to provide a model for cancer studies.
However, the recent America Invents Act (AIA), which overhauled US patent law, states that “no patent may issue on a claim directed to or encompassing a human organism.”
The problem is, the AIA doesn’t actually define “human organism.”
An article published in Genetic Engineering & Biotechnology News suggests that Chakrabarty provides a precedent for the patenting of printed human organs:
The first prong of the Chakrabarty test asks whether or not a bioprinted organ is a naturally occurring manufacture. The Supreme Court has defined the term “manufacture” as “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.” Based on this definition, a bioprinted organ is a “manufacture”…
The Organ Market
Since more than 120,000 people in the US alone are on waiting lists for organ transplants, the artificial organ market will likely be a lucrative one. The development of the industry will be encouraged if courts rule manufactured human organs are patentable.