Patent Eligibility of 3D Printed Organs Will Soon be an Issue

June 6, 2014

Biotech companies and scientists are working on a breakthrough that could allow specialized 3D printers to create human organs, a process known as “bioprinting.” Scientists already have printed blood vessels, a variety of organ tissues, and last year Princeton University scientists printed a functional ear.

Should scientists and companies who manufacture organs be able to obtain patents on them even though they already exist in nature?

The interplay between these new technologies and patent laws are unclear and ripe for examination by the courts. The Supreme Court weighed in on the question of patent eligible subject matter last year, in Association for Molecular Pathology v. Myriad Genetics, deciding whether a naturally occurring DNA segment could be patented. In that case, the Court invalidated previously issued patents on a gene sequence, but upheld a patent on synthetically created DNA.

The Court’s reasoning in Myriad hints that the touchstone of such decisions should be whether the subject matter is an unknown but natural phenomenon, or a manufacture or composition of a matter that does not occur naturally.

Both the process of creating a bioprinted organ or tissue and the composition of such organs and tissues may form the basis for future patent applications. A patent for a human liver would be denied, but would an application for a lab-created liver which functions like a human liver be denied?

Patentability will likely rest on what the applicant seeks to patent: the method, the bioprinted substance or the organ itself.

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