Mark Rohrbaugh & Gwen O’Loughlin: Drug Patents, March-In Rights, and NIH Technology Transfer

In this episode of the Vital Health Podcast, host Duane Schulthess examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today’s political rhetoric about “government-developed drugs” often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from:

• Mark Rohrbaugh: Former Director of Technology Transfer and Innovation Policy at the National Institutes of Health (NIH), IP Consultant at Vital Transformation

• Gwen O’Loughlin: Research Partner at Vital Transformation

They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug’s origins, why “march-in rights” were designed as a development backstop rather than a pricing tool, and how proposals to redirect royalties or restrict NIH-industry collaboration could disrupt the pipeline that turns early science into real-world therapies.

Key Topics:

• NIH’s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why “NIH developed all drugs” is a misleading simplification.

• Government Interest Statements: What the statement signals, why it is inconsistently surfaced across patents, and what large-scale reviews suggest about how often it appears in drug-related patent portfolios.

• March-In Rights and Policy Misuse: The original purpose (anti-shelving and public health needs), how petitions are evaluated in practice, and why pricing-based efforts have not succeeded.

• Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools.

• Forward Outlook: How royalty diversion or restricting partnerships could weaken incentives and capacity, and why the guests anticipate near-term disruption with longer-term consequences.

Opinions expressed are those of the speakers.

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