Regulatory norms and intellectual property rights for biomarker research

Tumpa Raj Das, Apoorva Venkatesh, Apurva Atak, Shabarni Gupta, Prasad B. Phapale*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


The healthcare industry has hugely benefi ted 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 effi cacy 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 fi ling to protect the intellectual property rights of researchers involved in the discovery of biomarkers prior to their commercialization.

Original languageEnglish
Title of host publicationBiomarker discovery in the developing world
Subtitle of host publicationdissecting the pipeline for meeting the challenges
EditorsSanjeeva Srivastava
Place of PublicationNew Delhi, India
PublisherSpringer, Springer Nature
Number of pages17
ISBN (Electronic)9788132228370
ISBN (Print)9788132228356
Publication statusPublished - 2016
Externally publishedYes


  • biomarker ICH guidelines
  • ICH E16
  • FDA review
  • biomarker assays
  • biomarker evaluation
  • US patent law
  • biomarker patents
  • composition of matter claims
  • method claims
  • infectious and noninfectious diseases


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