Are 3D Printed Tissues and Organs Patentable?

It has been long established, and recently codified in the Leahy-Smith America Invents Act (AIA), that no one is able to obtain a patent on any part of the human body. Examiners are taught to issue 35 U.S.C. 101 and AIA § 33(a) rejections even if claims are directed towards devices that are “attached to” parts of the human body and recommend applicants change the language to “configured to be attached” or something similar so that there is no doubt the human body part is not part of the claim. However, various medical and technological advances have hinted at the possibility of printing human organs in the future. Would those be patentable?

As the number of people on the waiting list for transplant organs grows steadily every year, donors and actual transplants that happen have remained relatively constant.  With this growing shortage, many doctors and scientists have turned to 3D printing as a potential solution. Unlike traditional manufacturing processes which are subtractive methods, in which excess portions of metal, wood, or plastic are removed to form the final product, 3D printing technology uses an additive process, in which objects are created by laying down successive layers of the material of choice until the object is created. This allows for the rapid creation of any object you have a digital model or scan of, and in any material supported by the printer.

While 3D printing has been popular in fields such as engineering, fashion and even food, recent advances have allowed for the 3D printing of biocompatible materials, or bioprinting. Scientists have already printed numerous blood vessels and organ tissues, and even a functional ear. These developments give rise to the question whether the scientists or the companies bioprinting these objects are able to obtain patents on them even though they exist in nature.

In one of the seminal cases related to the patentability of biological matter, Diamond v. Chakrabarty, the Supreme Court addressed whether a genetically engineered bacterium that was able to break down components of crude oil was patent-eligible subject matter. The Court interpreted the statutory language of section 101 to allow the patenting of “anything under the sun that is made by man.”[1] However, excluded from this are laws of nature, products of nature, physical or natural phenomenon, abstract ideas, and unapplied mathematical formula as they are “free to all men and reserved exclusively to none.”[2] As the genetically engineered bacteria in question were unlike any found in nature, the court determined that it was “a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity.”[3]

Following the guidelines set out in Chakrabarty, the Court later held in Association for Molecular Pathology v. Myriad that an isolated DNA fragment coding for a gene was a naturally occurring composition of matter as the inventors “did not create or alter any of the genetic information encoded in… genes”[4] and that the “location and order of the nucleotides existed in nature”[5] before they were discovered by Myriad. However, the Court ruled that the complementary DNA sequences (cDNA), which were synthetically created, were not a product of nature and thus patent eligible.

From the Chakrabarty and Myriad rulings, it would seem that currently bioprinted tissues and organs would be patentable. While some of the base materials used in the printing may be naturally produced, just like how nucleotides in cDNA can be naturally produced, the final printed product is undoubtedly manmade and not a product of nature.  Furthermore, current bioprinting technology does not yet allow for the perfect reproduction of human organs; there are marked differences between real organs and bioprinted ones, making the question of patentability easier for now.

However, should the technology develop in the future to allow for the perfect replication of human organs, the line between patentable and unpatentable subject matter could blur significantly. Such perfectly replicated organs could be considered analogous to “very short series of DNA [that] have no intervening introns to remove when creating cDNA” which “may be indistinguishable from natural DNA” and thus not patent eligible under § 101. [6]

Nonetheless, as long as the bioprinted tissues or organs do not amount to an entire human person (including fetal and embryonic states) and are distinguishable in some way from their naturally occurring counterpart, they should remain patentable under current laws.

[1] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
[2] Id.
[3] Id.
[4] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2116 (2013).
[5] Id.
[6] Id. at 2119

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