Patentability of 3D Printed Human Organs

We would have all come across the concept of organ transplants which has actually become a common phenomenon given the tremendous evolution in science and technology; hold on to that thought, and couple it with the invention of 3D printing, a booming technology that can be used to manufacture anything and everything; which brings us to the revolutionary breakthrough technology called BIO-PRINTING, that could allow 3D printers to synthetically create human organs.

The technology of 3D printing dates back to the 1980s and its protection as an Intellectual property right is an interesting thought which has been discussed in one of our earlier blogs. Of late, scientists, biotechnology companies and research centers have been competing to bring this theory of 3D printed human organs to reality. Blood vessels, organ tissues, and small organs such as a functional ear have already been synthesized using a 3D printer, similarly, creating whole organs, for the purpose of transplants, research, drug development and test does seem to be within the realm of possibilities. If achieved, Bio-printed or 3D printed organs could be created from a patients’ own cells and thus eliminating the probability of the organ being rejected by his immune system, which is the major concern in all organ transplant cases.

If scientists are able to practically bring to reality this theoretical concept, besides being one of the biggest revolutions in medical history, inevitably there will be a haste to patent this unimaginably rewarding inventive technology.

As I have already elucidated in my previous article, the interplay between biotechnology and patent law is blurry and open to interpretation by the courts and the patent office. The on-going practice in India as well as in the U.S. is almost the same and both jurisdictions very clearly do not encourage “a naturally occurring” element to be patented. Uncertainty glooms over the question as to whether a synthetically altered version of a naturally occurring specimen is patent eligible.

An exception to non-patentability of “living thing occurring in nature”

Going in line with the observations of Myriad case, which has also been applied by the Indian Patent Office in recent patent applications, the obvious argument in favour of patent-eligibility of bioprinted organs will be that it is not a product occurring nature, but rather is a product of human manufacture and innovation. Also considering the fact that the composition and manufacturing of 3D printed organs require technically sophisticated scientific methods and precise machinery might come in handy for claiming patent for it as a synthesized product not occurring in the nature.

Having said that, the Patent Office or the Courts may face a dilemma to overlook a genuine fact these organs merely replicate the design, shape and functions of a naturally occurring human organ, and moreover are created using real human cells (occurring in the nature) as the building blocks.

As of now the fate of a “lab-created” human organ can be best voiced with this quote by Margaret Drabble: “When nothing is sure, everything is possible.”

Related Posts:

• Patenting Human Genes