Advances in health: implications and challenges of intellectual property in the era of precision medicine

This study explores the role of intellectual property (IP) in developing and commercializing melanoma biomarkers within the pharmaceutical market, focusing on precision medicine (PM). It investigates five key areas: (i) inventiveness dynamics, (ii) commercial and epidemiological motivations for patent registrations, (iii) the impact of patented technologies, (iv) the classification of technological innovations, and (v) patterns of knowledge sharing and collaboration. This study analyzes 244 Patent families (FamPat) records from Questel's Orbit database, selected without temporal restrictions up to 2023, ensuring a comprehensive longitudinal perspective. Employing a mixed-methods approach, the study combines quantitative trend analysis with qualitative content examination to classify innovations in melanoma biomarkers and assess intellectual property dynamics. Additionally, network analysis maps knowledge flows and collaboration patterns among patent assignees, offering an in-depth view of innovation trajectories and collaborative behaviors in this technological domain. The findings highlight two primary categories of melanoma biomarkers: those for predicting and monitoring disease progression and those that support therapeutic decision-making. Despite the U.S. leading patent filings since 1993, China, Europe, Canada, and Japan demonstrate more impactful innovations in this domain. Limited knowledge-sharing and collaboration between entities were observed, which may restrict further technological advancements in the market. This study offers novel insights into the convergence of IP and precision medicine in melanoma treatment. It reveals a paradigm shift towards bioinformatics-driven biomarkers and underscores the strategic importance of intellectual property for competitive positioning within the global pharmaceutical market. Findings support strategic decision-making for pharmaceutical firms involved in melanoma treatment, particularly concerning market expansion and intellectual property management.