By Sadie Grunewald
Bioprinting, a subcategory of third-dimensional (3D) printing, will likely emerge within the next decade making artificial human organs and tissues publically available. Bioprinters are currently available but are still in the development phase. Already in 2017, there has been success in 3D printing of functional blood vessel networks. Constructs for heart valves, fingers, nerves, muscles, and other lower-level biological entities are currently under development and could become available within three to five years. For entire organs, some projections estimate that bioprinted kidneys and livers could be available within six years, while bioprinted hearts, with their complex internal geometrics, will take a little longer. This technological breakthrough will drastically change the fields of medical research and organ transplants.
These advancements bring their own legal concerns. At the moment, there are no bioprinting regulations in the U.S. and, concurrently, no litigation surrounding bioprinting technology. In addition to the current challenges 3D technologies present, bioprinting uniquely challenges intellectual property (IP) rights because of the complexities posed by biological material replication (i.e., bonding techniques, human cells sensitivities and construction, etc.). Innovators will undoubtedly seek IP rights because of the financial investments and time dealing with these complexities. However, in the current legal landscape, there is some uncertainty over what IP protection innovators have. The IP community should start considering the impact of bioprinting and what needs to be done now for the advent of such technologies. Within the next couple of years, more legal commentary is needed as the legal community adjusts to 3D printing itself and as bioprinting gets closer to being a public reality.
3D printing, also known as additive manufacturing, prints layer-by-layer instead of printing one layer of an overall design that conventional printers do. While the technology itself has existed since the early 1980s, it has recently become more accessible and commercially feasible to the public in a variety of forms. It provides both mass production and individual, customizable production. The 3D printers work from a computer aided design (CAD) file, which is similar to a blueprint, to print the designed end product. Examples of current 3D printed products include automotive designs and parts, prosthetics, bikes, sculptures, guns, clothing, and more. Leading commentators argue 3D printing will change the manufacturing industry in much the same way digitalization altered the music industry. Some estimate 3D printing will result in the loss of more than $100 billion per year in global IP revenue by 2018.
Bioprinting deposits cells layer-by-layer to grow organs and tissues using “bio-ink,” which is ink composed of cells and a base, usually hydrogel or collagen. The techniques used in typical 3D printing are too toxic or too extreme for live cells to be seeded during printing. It originated in the early 2000s when it was discovered that the living cells could be sprayed through the nozzles of inkjet printers without damaging them. The 3D bioprinted products are not always exact duplicates of natural organs, even though they behave like the natural organ, and may require synthetic scaffold to form proper structure. Like any other 3D printed item, bioprinted tissues may be created on-demand and onsite, which would likely occur in a hospital or doctor’s office when the technology moves past development and becomes available. While this will not likely result in printed organs and tissues never being entering an open market, the raw materials, such as bio-inks, hardware, and software, will.
The need for organ transplants is significant across the country and bioprinted organs and tissues could decrease the dependence on donors. Researchers around the world are currently working with kidney and liver tissue, skin, bones, and cartilage as well as the networks of blood vessels needed to keep body parts alive. Last year a group at Northwestern University in Chicago, even printed working prosthetic ovaries for mice and the recipients were able to conceive and give birth with the aid of these artificial organs. Within three to five years, a US biotechnology company, Organovo, intends to transplant printed human-liver tissue for chronic liver failure and for metabolism errors in young children. In the medical research field, bioprinting can help with the developing medications and treatments by replication tissue to test toxicity on or within the human body. Organovo already offers kidney and liver tissue for screening potential drugs for efficacy and safety. This has intrigued cosmetics companies, such as L’Oréal, to get explore how bioprinting could help test new cosmetics.
The legal adaptations to non-biological 3D printing technology will not be sufficient to address the concerns that bioprinting will bring. The limited legal commentary available on bioprinting has focused on its relation to regulation, existing organ donor law prohibiting the purchase of human organs, product liability, tort liability within the medical profession, and moral and ethical concerns. The Food and Drug Administration (FDA), the agency with regulatory jurisdiction over human tissue, has not issued any comment or regulation on bioprinting. Current regulations on synthetic biology are not sufficiently comprehensive to regulate bioprinting because bioprinting moves synthetic biology’s production out of the laboratory and potentially into anyone’s home. Undoubtedly, bioprinting will bring major ethical and moral debates.
The current IP legal landscape for bioprinting contains some uncertainty over what aspects can be protected and which aspects should not be protected for ethical or public policy reasons. Enforcement appears to be a daunting task because of the near impossibility to detect whether a person has an infringed printed organ or tissue. For example, if you were on a train, how would you detect if a person has an infringing 3D bioprinted liver? It is important to note that current laws do provide some protection to some aspects of bioprinting technology. The following discussion is intended to be broad and not overly inclusive of all the protection afforded.
Under copyright law, the end product, the bioprinted organs and tissues, are unlikely to be protected. Copyright law protects original “pictorial, graphic, and sculptural works.” 3D products created, however, may fall within the “useful articles” exemption. This is defined as works “having an intrinsic utilitarian function that is not merely to portray the appearance of the article or to convey information.” The blueprint creating the bioprinted organs and tissues, the CAD file, would merit some protection because computer programs are protected as “literary works.” For protection, the CAD file must meet the originality requirement by meeting the following requirements: (1) be independently created by the author (as opposed to copied from other works); and (2) possess at least some minimal degree of creativity. The Digital Millennium Copyright Act (DMCA) “safe harbor” provisions may provide an effective tool for copyright owners to combat the online sale or distribution of infringing CAD files and/or 3D printed articles. Overall, current copyright law appears inadequate to significantly protect IP rights for bioprinting technology.
Patent law, perhaps not surprisingly, provides the greatest protection to innovators of bioprinting technology. Bioprinting technology could gain protection under utility patent protection. Under this, a patent owner claiming a new and novel product or process has the right to exclude others from making, using, selling, offering for sale and/or importing into the U.S. any products and/or processes covered by the patent. Although copyright law cannot provide protection for the end product, patent law prevents an infringer from escaping liability when the end product is associated with the manufacture, use, sale, offer to sell, or importation of that product if the product and/or its methods of use are protected by the patent. Nevertheless, there are significant issues presented with bioprinting technology. These include what aspects are patentable and enforcement.
The most critical patentability issue with bioprinting is whether the end product is a naturally occurring human product or a “man-made,” manufactured, product. The human body is an important exception to patentability that falls under the broader IP limitation that one cannot hold IP rights on things found in nature. Notably, nonhuman organisms, animal tissues, and even human genes have been patented for years and are considered patentable subject matter so long as they are man-made or man-modified into something that does not occur in nature. What if the technology advances to such a level that the manufactured organ or tissue is indistinguishable from the naturally occurring human organ or tissue?
Trademark law does not on its face provide that much protection for innovators of bioprinting technology. This appears most useful for protecting the hardware or software used to design the bioprinted tissues and organs, not for the manufactured tissue and organs themselves. An interesting question worth exploring is whether trademarks of the bioprinted tissues and organs would help prevent the creation of a new black market for these manufactured organs and tissues. It is quite possible that with the arrival of 3D bioprinting, a black market for the manufactured organs will develop. In theory, anyone who could afford to purchase a printer, was appropriately trained, and had access to appropriate cells could start their own black market brigade. Yet again, it would be near impossible to spot trademark infringement without surgical invasion. Enforcement would be costly, bloody, and implicate constitutional rights.
Trade secret protection against misappropriation helps bioprinting rights but it is not as strong as patents. An innovator has a trade secret if the method is not publically known or apparent from simply observing the tissue and would be able to sue those who steal the method. However, the innovator would not be able to sue another innovator who independently came up with the same method because, unlike patent law, the infringer has the available defense of independent discovery.
The intersections of bioprinting and IP law create a substantial amount of questions that should be examined before the advent of the technology becomes available to the general public. Addressing issues that are likely to occur will be beneficial to the innovators themselves and also the public from receiving counterfeit organs or tissues. As the law adjusts to non-biological 3D printing, it will be important to watch for any changes in copyright law protection that would be applicable for the blueprints of bioprinting technology. To gain insight on how patent law will react to availability of bioprinting, the IP community should follow legal developments in patentability on biological matters, including the recent patent fights on gene editing. It will be critical to follow the FDA’s regulatory approach to bioprinting. Developing preemptive strategies should be considered now for innovators and companies paving the path to bioprinting technologies to protect their rights and financial investments before the technology explodes. Alternatives to traditional enforcement of IP rights need to be examined because of the complexity bioprinting technologies pose. There are enormous risks that the public and innovators may endure if these issues of regulation and IP protection are overlooked before bioprinted organs and tissues become vastly available with just one click.
 Liezel Labios, Nanoengineers 3D Print Blood Vessel Networks, Indus. Equip. News (March 3, 2017), www.ien.com/product-development/news/20853887/nanoengineers-3d-print-blood-vessel-networks.
 Eric Lindenfeld, 3D Printing of Med. Devices: CAD Designers As the Most Realistic Target for Strict, Product Liability Lawsuits, 85 UMKC L. Rev. 79 (2016).
 A Tissue of Truths, The Economist (Jan. 26, 2017), www.economist.com/news/science-and-technology/21715638-how-build-organs-scratch.
 Michael M. Lafeber, Hall of Mirrors 3D Printing & IP Law, 74 Bench & B. Minn. 20 (2017).
 Id. at 21.
 Alison DeNisco, How 4 universities are using 3D printing to create ears, cartilage and blood cells, TechRepublic (Aug. 12, 2017, 4:00 AM PST), www.techrepublic.com/article/how-4-universities-are-using-3d-printing-to-create-ears-cartilage-and-blood-cells/; Jeremy T. Harbaugh, Do You Own Your 3D Bioprinted Body? Analyzing Property Issues at the Intersection of Digital Info. & Biology, 41 Am. J.L. & Med. 167, 171-73 (2015) (describing in detail how hydrogel creates the 3D bioproduct); Michael H. Park, Note, For A New Heart, Just Click Print: The Effect on Med. & Prods. Liability from 3-D Printed Organs, 187 U. Ill. J.L. Tech & Pol’y 192 (2015) (describing the two techniques most commonly used by bioprinters).
 Harbaugh, supra note 6, at 171.
 A Tissue of Truths, supra note 3.
 Lijie Grace Zhang, John Fisher, Et Al., 3D Bioprinting & Nanotechnology in Tissue Engineering and Regenerative Medicine 350-363 (2015).
 Id. at 361.
 A Tissue of Truths, supra note 3.
 See generally, e.g., Robert Jacobson, 3-D Bioprinting: Not Allowed or Nota Allowed?, 91 Chi.-Kent L. Rev. 1117, 1117-18 (2016); Ariel M. Nissan, Regulating the Three-Dimensional Future: How the FDA Should Structure A Regulatory Mechanism for Additive Manufacturing (3D Printing), 22 B.U.J. Sci. & Tech. L. 267, 273 (2016).
 Jasper L. Tran, To Bioprint or Not to Bioprint, 17 N.C.J.T.L & Tech. 123 (2015).
 See generally, 17 U.S.C. § 101 (2015).
 Feist Publ’n, Inc. v. Rural Tel. Serv. Co., 499 U.S. 340 (1991); but see Meshwerks, Inc. v. Toyota Motor Sales, 528 F.3d 1258 (10th Cir. 2008) (holding that 3D scanning of older technology that exists in public domain does not pass the originality test).
 Lafeber, supra note 4, at 23.
 35 U.S.C. §§ 101, 271 (2015).
 Zhang, supra note 9, at 352.
 Id. at 362.
 Id. at 357.
 Katherine A. Smith, “Transplanting” Organ Donors with Printers: The Legal & Ethical Implications of Manufacturing Organs, 49 Akron L. Rev. 739, 768 (2016).
 Zhang, supra note 9, at 352.