Regulatory Norms and Intellectual Property Rights for Biomarker Research

Abstract

The healthcare industry has hugely benefited from the advent of biomarkers in diagnostics. The process of translation of a biomarker from “bench to bedside,” however, involves various key steps which are monitored by autonomous bodies to ensure that the biomarker/biosimilars under consideration are safe and meet the regulatory guidelines established by them. This chapter aims to provide an overview of global regulatory bodies and discusses the various norms required for commercialization of biomarkers, with special focus on the role of proteomic-based tools to help study the efficacy of these biomarkers. Another facet, concurrent with the post discovery-based endeavors from regulatory bodies, is the protection of intellectual property rights of a researcher’s discovery-based work. Patent claims have repeatedly been under the scrutiny of legislative bodies due to controversies on subjects like patent eligibility resulting in the impediment of scientific progress and research. This has consequently resulted in restricting the disputed product’s use in diagnoses and other applications. Additionally, this chapter overviews the nuances of patent filing to protect the intellectual property rights of researchers involved in the discovery of biomarkers prior to their commercialization.