The Impact of 3D Bioprinting Innovation on IP Ecosystem and Patent Law: An Indian and US Perspective

Patenting issues related to emerging technologies has always caused turmoil in the innovation ecosystem since the past few decades. Three-dimensional (3D) bioprinting is one of the emerging technologies that challenge traditional patent systems around the globe due to the complexity of the subject matter related to bioprinting innovations. Traditional patent systems have historically been adapted to new technologies; however, the pace of technological advancement has always been faster. Given the complexity of bioprinting technology and the subject matter limitations in traditional patent systems, it is often challenging for patent applicants and inventors to obtain protection for their innovations, resulting in a detrimental affect on the IP ecosystem. This chapter addressed this issue by examining the patent provisions of India and the United States in light of subject matter related to 3D bio-printed tissues and organs. The initial sections of this chapter analyze the patentable subject matter exclusions as defined in Section 3 of the Patent Act 1970 and clarified by examination guidelines. The analysis of bioprinting innovations from a US perspective is provided in the chapter’s later sections, which analyzed the patentable subject matter provisions as defined by Section 101 of US patent law, examination guidelines, and relevant case law.