In light of the growing realism of 3D bioprinted organs, legal issues arising from these concerns can easily bleed into our society. This bleeding demands exploration. Should 3D bioprinted organs be regulated as natural organs or as medical devices? Are 3D bioprinted organs patentable? What happens if a 3D bioprinted organ is subject to a successful patent infringement suit? Does the recipient face a Repo Men fate?
The beginning of this note dissects the scientific underpinnings of 3D bioprinted organs. Part II explores statutory authority and controlling, or otherwise persuasive, case law that pertains to subject-matter patentability. Current rights associated with medical devices and one’s own natural organs are also identified in Part II. Part III analyzes how 3D bioprinted organs should be regulated and how the patentability of 3D bioprinted organs squares with potential regulatory frameworks. Ultimately, this note reaches the conclusion that 3D bioprinted organs are patentable subject matter and that, in general, 3D bioprinted organs should be regulated as medical devices. In the patentability wrinkle, this note also observes how the anti-commodification of patented 3D bioprinted organs would be a legal contradiction under current federal law.
Anna M. Whitacre,
Don't Go Breakin' My (3D Bioprinted) Heart: Dissecting Patentability and Regulation of 3D Bioprinted Organs,
J. Intell. Prop. L.
Available at: https://digitalcommons.law.uga.edu/jipl/vol27/iss2/8