Patentability of Solutions in the Field of Bioprint Technologies: A Comparative Law Aspect

Abstract

The paper is devoted to the issues of advisability of introducing amendments to the civil legislation in connection with the development of additive technologies or the possibility of effective application of the existing rules of law to the regulation of «innovative» civil relations.Digitization of objects of the material world associated with the creation of their digital prototypes constitutes a revolutionary element of 3D printing technology. A three-dimensional digital model (CAD file) can be easily modified, distributed and embodied in the form of a physical object by printing it on a 3D printer. This gives rise to new risks of infringement of exclusive rights to objects of patent law. In a foreign doctrine, a discussion has started regarding the possibility of qualifying the creation and circulation of digital models of patented products (inventions) as a direct infringement or indirect infringement of exclusive rights.The paper concluded that Russian patent law was not ready for the challenge generated by the development of 3D printing technology, since it was not aware of the concept of indirect infringement of the exclusive right. In Russian law enforcement practice, the concept of direct patent infringement is interpreted in a restrictive manner.The question of admissibility of patenting technical solutions in the field of bioprinting has been studied. It is concluded that in Russian law there are no fundamental obstacles to patenting technical solutions in the field of bioprinting technologies. Russian legislation provides for the possibility of patenting «natural products», as well as methods and means of treatment, which distinguishes the Russian approach from the American or European one. If the risk of genetic instability of pluripotent cells is leveled, the technology for creating bioprinted human organs will comply with the requirements of civil law. In particular, it will meet the requirements for the compliance of patented technical solutions with the public interest, the principles of humanity and morality.