HEARTLESS PATENTING: HOW THE ADVENT OF 3D PRINTED HUMAN ORGANS WILL RESHAPE OUR THINKING OF PATENT LAW.

• Author: Hernandez, Dario A.

1. Introduction

   What once was purely imaginative, is now entirely possible, because within the next decade, humanity will have the ability to print replacement organs. 3D printed organs could someday be the solution for those anxiously waiting for an organ from the donor list--a lengthy process that does not guarantee a positive result. (1) With over 113,000 women, men, and children on the national transplant waiting list there is a real need for organ transplants that can very well save the lives of thousands. (2) The story of a young girl named Alexa is a powerful reminder of this urgency--if she had a transplant she likely would have lived a long and happy life--unfortunately she never got the chance as she died waiting for a lung transplant that never came. (3) Fortunately, there is the potential to prevent what happened to Alexa as technology has evolved from simply printing a word document to potentially printing a life-saving human lung. (4)

   This Note will discuss the need to keep 3D printed human organs patent ineligible to ensure that human life is not commercialized. However, should they be deemed patent eligible, there must be legislation that guarantees affordable generic alternatives for all of those who need lifesaving transplants. Part II of this Note explains the process of 3D printing and the methods being tested to eventually successfully print human tissue and organs. Also, Part II of this note details the abuses that have taken place as the pharmaceutical drug industry has used their patent monopolies to raise drug prices on life saving drugs. Additionally, Part II further details how patent law has gradually developed to consider the possibility of patenting nature, such as human organisms and naturally occurring material.

   Furthermore, Part III sets forth current attempts by Congress to improve access to generic drugs, which could very well be applied to 3D-printed human organs. Ultimately, Part IV urges the reconsideration of the patenting of 3D-printed organs given the possibility that such patenting may be abused, much like how previous life-saving prescriptions were patented and then exploited. However, if bioprinted organs are granted patent eligibility, the legislative framework for generic drugs should serve as a blueprint for future legislation so that generic manufacturers can produce affordable organs that can save the life of a child who should not suffer the same fate as Alexa.

2. History

   1. The 3D Printing of Human Organs

      1. How Can 3D Printing Produce an Everyday Object?

         The Xerox printer walked so that the 3D printer could soar. (5) To understand how the printer has grown from printing documents to printing a kidney, one has to first unpack how exactly a 3D printer works. (6) At its core, 3D printing is a means of manufacturing by stacking layers of one or more materials to create a three-dimensional object. (7) While the sculptors of the classical times worked with a slab of marble to chisel their way towards a masterpiece, the 3D printer works in reverse as it adds thin layers on top of thin layers until it finally reaches the last layer of the finalized product. (8) Much like a 2D printer, an inkjet nozzle releases the material but, unlike a 2D printer, rather than just releasing one layer, the 3D printer proceeds to add layer after layer to the base. (9)

         The 3D printer receives its instructions from one of two sources. (10) The first option is to use a Computer Aided Design ("CAD"), which is a design file created using computer software, that is then downloaded into the 3D printer so that it can use the CAD design as a blueprint. (11) Alternatively, the 3D printer itself can scan an object to build a 3D model representation of it and then use this model to guide the printing process. (12) Think of the CAD file as the document or picture one sends to a 2D printer from one's computer whereas the 3D scanning process would be akin to how one uses a scanner to create a file and then print said file.

         Once the preferred blueprint has been chosen and the printing process has begun, the printer takes the raw material, ranging from metal powders to chocolate, and heats the material, much like a glue gun melts glue, in order to begin adding each layer on top of the other. (13) The heating process, also known as material extrusion, happens simultaneously with the layering to produce a finalized product. (14) However, depending on the final product, the printed object may need to be cleaned off to remove excess material or processed further. (15) It is at this point that the 3D printer takes a bow and humanity flexes its innovative muscles. (16)

      2. How Can a 3D Printer Create a Human Organ?

         As if printing a fork or a cup from scratch were not impressive enough, 3D printing technology is developing to the point where it can print human tissue and, one day, maybe even vital human organs. (17) Although development has not reached the stage of printing vital organs such as a human heart, there is already an individual with a 3D bioprinted bladder walking among us. (18) Because the possibility of printing a complex human organ is such an incredible and rewarding feat, researchers have developed multiple methods to reach this final prize. (19)

         The 3D printing of human organs, better known as bioprinting, will drastically differ from ordinary 3D printing as it will require the use of human material to build complex structures like a human heart. Instead of using raw materials like metal, powder, and plastic, the 3D printing of human organs uses living cells. (20) This new form of 3D printing follows a process similar to regular 3D printing but requires additional steps to ensure the final product is a living organ. (21) First, either a magnetic resonance imaging ("MRI") or computed tomography ("CT") neuroimage is uploaded to CAD software to build a digital 3D model known as a Bio-Computer Aided Design ("BioCAD"). (22) A Bio-CAD file is then downloaded to the 3D printer for use as the blueprint to guide the printing process. (23) Next, using a downloaded Bio-CAD file, the 3D printer dispenses living cells and layers them on top of each other much like the regular 3D printing process. (24) Finally, the post-processing step takes place where the 3D printed tissue begins to fuse and assemble into a living organ. (25) Usually, this process requires the premature organ to be placed in an incubator where its growth and maturation can be monitored. (26)

         Scientists have yet to perfect this process and currently are unable to create vital organs like human hearts or lungs. (27) Still, they have employed three distinct bio-printing methods that seek to explore the possibility of printing an organ. (28) The first method, inkjet bio-printing, consists of layering droplets of biomaterial on top of each other, much like ordinary 3D printing. (29) Although the aforementioned is the most commonly researched and used method, it is limited in its ability to achieve the proper biological cell density required to create live organs. (30) Still, this method has been used to bioprint functional skin and cartilage. (31)

         In a temperature-controlled environment so that the beads of material blend with one another, the microextrusion method deposits beads of biomaterial onto a 2D surface as each layer is added on top of the next. (32) While this process produces cells with higher densities than the Inkjet process, the cell viability of this process is lower than the other methods because the cells can die under high pressures. (33) Finally, Laster-Assisted bioprinting uses laser beams to guide the biomaterial, either living cells or stem cells, onto the printing surface. (34) Laser-Assisted bioprinting can deposit cells at incredibly accurate density levels due to the laser's heat, yet because of such high densities, it can be a long process that can also be expensive. (35) Ultimately, each method has its own way of moving humanity one step closer to reproducing the very organs that can save lives and revolutionize modern medicine.

   2. How Patent Law Has Evolved with Technological Advances

      1. The U.S. Patent Act

         Rooted in the Constitution, 35 U.S.C.S. [section] 101 ("Patent Act") sets forth the requirements necessary for an inventor to secure intellectual property rights. (36) The Patent Act states that, "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvements thereof, may obtain a patent, subject to the conditions and requirements of this title." (37) The invention must fit within one of these categories: process, machine, manufacture, or composition of matter in order to be recognized under the Patent Act. (38) Once an invention is deemed to fall within one of these categories, it may be granted subject matter eligibility, a requirement for patent protection. (39)

         While subject matter eligibility is the primary requirement, inventions must also be "novel" and "nonobvious" for absolute patent protection. (40) A "novel" invention is one that is not already known to the public and is determined through a comparison of current inventions to the one in question. (41) The "nonobvious" requirement expands on novelty by requiring that an invention neither be easily invented nor obvious to a knowledgeable person in the relevant field. (42) To obtain subject matter eligibility, an invention must fall within one of the following four categories: processes, machines, articles of manufacture, and compositions of matter. (43) A "process" patent protects methods that consist of multiple steps or an arrangement that produces a finalized product. (44) A "machine" patent is for physical structures that consist of parts or devices whereas "articles of manufacture" are products that are made from raw material. (45) Finally, "compositions of matter" are chemical compounds or physical mixtures, whether it be through a chemical union or a...