PATENT RIGHT CHALLENGES IN ARTIFICIAL ORGAN TRANSPLANTATION: PATENTING BIOMEDICAL DEVICES AND ORGAN PRINTING IN INDIA

AUTHOR – BOWYADARSHINI K & HEMAVARSHINI S 

STUDENTS AT SASTRA DEEMED TO BE UNIVERSITY

BEST CITATION – BOWYADARSHINI K & HEMAVARSHINI S, PATENT RIGHT CHALLENGES IN ARTIFICIAL ORGAN TRANSPLANTATION: PATENTING BIOMEDICAL DEVICES AND ORGAN PRINTING IN INDIA, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (14) OF 2025, PG. 24-31, APIS – 3920 – 0001 & ISSN – 2583-2344.

Abstract:

Through a doctrinal research methodology, the paper analyzes statutory provisions, leading judicial pronouncements, and international standards such as the TRIPS Agreement and WIPO guidelines. Comparative insights are drawn from jurisdictions like the United States and the European Union, where patent laws provide a broader scope for biotechnology and medical device innovations. The paper explores fundamental issues of novelty, inventive step, and industrial applicability in relation to artificial organs, while also addressing the challenges posed by hybrid inventions combining biological and mechanical elements.

Furthermore, the research evaluates the balance between patent protection and public health imperatives, particularly in the light of compulsory licensing provisions under Sections 84 and 92 of the Patents Act. It highlights how excessive patent monopolies could lead to affordability concerns and limited accessibility of life-saving technologies, thereby necessitating a policy framework that incentivizes innovation without compromising public health objectives. The findings suggest that while Indian patent law offers a structured mechanism for protecting biomedical inventions, the existing exclusions under Section 3 and ambiguous interpretations create uncertainty for innovators in the field of artificial organ technology. The paper concludes by recommending reforms that align Indian patent law with global best practices, ensuring clarity on patent eligibility criteria for biomedical devices and fostering an ecosystem conducive to innovation and ethical compliance.