Emily Xiang is an IPilogue Writer, President of the Intellectual Property Society of Osgoode, and a 2L JD candidate at Osgoode Hall Law School.
What is Bioprinting?
Bioprinting is an innovative technology that uses cells, organic materials, and biological molecules to create complex models and structures. Its major advantage is forming organic tissue constructs with a high degree of repeatability, flexibility, and accuracy. Since its first breakthrough in the health and pharmaceutical industries in the 2010s, the application of 3D bioprinting has grown to include tissue engineering, cancer research, dentistry, regenerative medicine, and skincare/cosmetics. In 2021, the global 3D bioprinting market was valued at CAD $491.34M and is expected to grow from there.
3D Bioprinting in the Cosmetics Industry
The use of bioprinted tissue by cosmetics companies has seen tremendous growth in recent years. In Europe, following the EU Regulation on cosmetic products (EU/1223/2009) which banned animal testing for cosmetic purposes, cosmetics companies have had to seek alternative methods of ethical testing on varying skin types that would also produce accurate results. Moral advantages are not the only kind of benefit that bioprinting technologies can offer. Since human skin is multilayered and comprised of various cell types, 3D bioprinting presents the unique ability to deposit cells in meticulous arrangements that closely resemble actual human skin, resulting in more accurate models and faster, cheaper, and more effective testing procedures. Since 3D bioprinting entered the marketplace, global cosmetic leaders such as L’Oréal and Proctor & Gamble have invested significantly into the R&D of bioprinting technologies, with a view to revolutionize the practice of dermatology in the future.
3D Bioprinting & Canadian Patent Law
From an intellectual property law perspective, could 3D bioprinted material be patented? While the scope of patentable subject matter in Canadian patent law is generally considered quite broad, products and techniques related to bioprinting blur the line between the living and the non-living, which could complicate matters. In Harvard College v Canada (Commissioner of Patents), the Court held that “higher life forms,” such as genetically modified plants or animals, were not patentable but affirmed the patentability of the genetically modified genes in question. Since the decision, the Canadian Patent Office has more clearly delineated the distinction between higher and lower life forms in the Manuel of Patent Office Practice (MOPOP), which defines lower life forms as unicellular and higher life forms as being multicellular. In Chapter 17.02.02 of the MOPOP, the Patent Office states that “[a]rtificial organ-like or tissue-like structures that are distinct from true tissues and organs and that have been generated by human intervention through the combination of various cellular and/or inert components may be considered, on a case-by-case basis, to be manufactures or compositions of matter with the scope of section 2 of the Patent Act.”
While some ambiguity remains regarding the patentability of bioprinted materials, there has been some success in patenting methods and techniques associated with bioprinting. Despite these patents, however, bioprinting technology can still be said to be distinct from, for example, more cutting-edge gene editing technology, for which the core of the technology can be patented and can thereby lead to intellectual property disputes. In contrast, the core elements of bioprinting derive from relatively old 3D-printing techniques that are already free from patent protection, providing innovators working with bioprinting technology some more leeway to appropriate the existing methodologies in the field.
While cosmetics companies constitute some of the more recent actors to leverage the new technology, bioprinting has gained incredible commercial momentum in the industry in recent years, with interest no longer being restricted to academic circles but also gaining traction in the marketplace. As the research and development of 3D bioprinting continues to evolve, the need for the law to take a more explicit stance on the subject matter will become increasingly apparent.