In recent years, 3D printing has ejected itself from the realm of obscurity and became a household term. Currently, 3D printing is proving itself to be incredibly useful in a multitude of industries. Particularly, the potential uses of 3D printing in the biotechnology industry have sparked debate about new technologies and ideas will be protected. Throughout his article, 3D Printed Human Organs and the Debate on Applicable Patent Law, Andrew Armstrong explores the complex interaction between the rapidly evolving technology of 3D printing human organs, and U.S. patent law
Armstrong notes that “3D printed body parts, namely comprised of comparatively simple structures like titanium replacement hip joints, bring in an estimated $537,000,000 annually.”[1] By comparison these structures are much more simple to create than the complete functioning organs that 3D printing may soon provide a means of creation.[2] Due to the amount of money at stake in this emerging market Armstrong believes “there will be a rush to patent the technology that enables 3D printed organs, which brings the debate over applicable patent law to the forefront.”[3]
At the forefront of this debate is the America Invents Act (AIA) which provides that “no patent may issue on a claim directed to or encompassing a human organism.”[4] The AIA’s language is notably ambiguous, lacking guidance to tell those applying for patents what a “human organism” is.[5] It is because of this ambiguous language that Armstrong believes the courts might be left to interpret the law, absent any congressional clarification.[6]
He notes that there may be precedent set by the Supreme Court in Diamond v. Chakrabarty, where the court established a two prong test to determine whether “Mohan Chakrabarty’s patent application on a bacterium capable of breaking down crude oil was valid because it was “non-naturally occurring,” and because it was a “product of human ingenuity””.[7] However, after Armstrong consults with Christopher Peil, an experienced Silicon Valley patent attorney, he is reminded that the AIA must be satisfied, along with the two part test established in Chakrabarty.[8] Armstrong adds that the AIA “doesn’t provide the USPTO and/or the courts with much guidance in understanding and applying the law”.[9]
Armstrong concludes that “although the concept of 3D printed human organs would seem to meet both prongs of the Chakrabarty test,” that there is still a tremendous hurdle to overcome in the form of the “ambiguity over the intent of the American Invents Act with respect to this issue.”[10] In any case it appears that issue of patentability of human organs will prove to be a daunting problem for the courts courts to resolve if legislation remains in its current state.
[1] Andrew Armstrong, 3D Printed Human Organs and the Debate on Applicable Patent Law, ipwatchdog (Oct. 7, 2015)http://www.ipwatchdog.com/2015/10/07/3d-printed-human-organs-and-the-debate-on-applicable-patent-law/id=62307/ (citing Heidi Ledford, The Printed Organs Coming to a Body Near You, 520 Nature 273, 273 (2015).
[2] Andrew Armstrong, 3D Printed Human Organs and the Debate on Applicable Patent Law, ipwatchdog (Oct. 7, 2015)http://www.ipwatchdog.com/2015/10/07/3d-printed-human-organs-and-the-debate-on-applicable-patent-law/id=62307/.
[3] Id.
[4]Id. (quoting Gene Quinn, AIA Oddities: Tax Strategy Patents and Human Organisms, ipwatchdog (Sept. 12, 2013) http://www.ipwatchdog.com/2013/09/12/aia-oddities-tax-strategy-patents-and-human-organisms/id=45113/.
[5] Andrew Armstrong, 3D Printed Human Organs and the Debate on Applicable Patent Law, ipwatchdog (Oct. 7, 2015)http://www.ipwatchdog.com/2015/10/07/3d-printed-human-organs-and-the-debate-on-applicable-patent-law/id=62307/.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Id.