Navigating the patent landscape for LDTs and IVD tests

For international readers outside of the U.S., this paper can be used as a case study resource.

Patent law directly pertains to the development and commercialization of all diagnostic tests, including laboratory-developed tests (LDTs) and in-vitro diagnostic (IVD) tests. Specifically, patent law is a key consideration during the test lifecycle, and the United States Supreme Court caused a seismic shift in the patenting process for diagnostic tests over the last decade. Although LDTs and IVD tests differ in some respects, the same IP laws and regulations apply equally to both types of in-vitro diagnostics.

In this paper authored by the Arizona State University’s College of Health Solutions, "Intellectual property associated with LDTs and IVD tests", learn about:

  • The options for protecting intellectual property for IVDs and LDTs, including those that rely on existing technology or known biomarkers
  • Potential avenues for biomarker and platform patent protection under current patent law
  • The steps that an organization can take to understand the patent landscape for a particular test

About the Arizona State University College of Health Solutions

Recognized by U.S. News & World Report as the country’s most innovative school, Arizona State University (ASU) is where students and faculty work together to advance research, strategic partnerships, entrepreneurship, and economic development.

The ASU College of Health Solutions is dedicated to translating scientific health research and discovery into practical intervention. Their Master’s Degree in Biomedical Diagnostics is designed to address the role of diagnostics in clinical and research decision-making. With the only program of its kind in the world, ASU is dedicated to being the academic and intellectual center of the diagnostics industry.

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