Bioprinting and culture of tissues and organs in the BRICS countries (on the example of Brazil, India, China, and South Africa): approaches of legislation on intellectual property

Abstract

This article examines the legal regulation of bioprinting (3D printing) and culture of tissues and organs in the BRICS countries through the prism of protection of intellectual property. The work demonstrates the means of protection of results acquired at each stage of bioprinting by the norms of copyright and patent law, as well as touches on the questions of the need (possibility) for patenting of “bioprinters”, “bioinks”, “biopapers”, etc. The goal of this research is to determine the necessary and possible boundaries for patenting (copyright law protection) of the means, products, processes and their moral-ethical acceptance in the society. The novelty of this work consists in a comprehensive analysis of the approaches of BRICS countries towards development, legal formalization and protection of bioprinting and culture of tissues and organs as medical and non-medical technologies from the perspective of intellectual property law. The author attempts to answer the question of (non)patentability of the process (means) and result (product) of bioprinting of tissues and organs, the “bioprinters” themselves, as well as the “bioinks” and “biopapers” they use. With regards to (non)patentability of tissues and organs acquired through 3D printing, a conclusion is made that there is an unfavorable environment for their patenting, though their production, in the author’s opinion, should the right to patenting providing that they meet the criteria (other conditions) set by patenting law of a particular country.