On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&D.

Vital Transformation released our report, March-in rights under the Bayh-Dole Act & NIH contributions to pharmaceutical patents one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements. 

On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&amp;D.
Vital Transformation released our report, <a href="https://vitaltransformation.com/2023/11/march-in-rights-under-the-bayh-dole-act-nih-contributions-to-pharmaceutical-patents/">March-in rights under the Bayh-Dole Act &amp; NIH contributions to pharmaceutical patents</a> one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

Vital Health Podcast

VT’s Grumpy Old Men – The Administration’s Threats to use March-In Rights

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Tim Scott, President & CEO of Biocom California, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California’s life sciences ecosystem became a global innovation engine, why the state’s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China.

Key Topics:


Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California.


Innovation Network: University and research density, regional clusters, talent, and collaboration effects.


Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity.


MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback.


Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness.

Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/tim-scott-501631/">Tim Scott</a>, President &amp; CEO of&nbsp;<a href="https://www.linkedin.com/company/biocom-california/">Biocom California</a>, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California&rsquo;s life sciences ecosystem became a global innovation engine, why the state&rsquo;s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China.
Key Topics:
<ul data-start="642" data-end="1173">
<li data-start="642" data-end="745">
Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California.
</li>
<li data-start="746" data-end="857">
Innovation Network: University and research density, regional clusters, talent, and collaboration effects.
</li>
<li data-start="858" data-end="956">
Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity.
</li>
<li data-start="957" data-end="1060">
MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback.
</li>
<li data-start="1061" data-end="1173">
Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness.
</li>
</ul>
Opinions expressed are those of the speakers.

Tim Scott: MFN Pricing, Venture Risk, and the Future of California Biotech

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.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today&rsquo;s political rhetoric about &ldquo;government-developed drugs&rdquo; often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from:
<ul data-start="273" data-end="455">
<li data-start="273" data-end="396">
<a href="https://www.linkedin.com/in/mark-l-rohrbaugh-9462a57/">Mark Rohrbaugh</a>: Former Director of Technology Transfer and Innovation Policy at the <a href="https://www.linkedin.com/company/national-institutes-of-health/">National Institutes of Health (NIH)</a>, IP Consultant at <a href="https://www.linkedin.com/company/vital-transformation/">Vital Transformation</a>
</li>
<li data-start="397" data-end="455">
<a href="https://www.linkedin.com/in/gwen-o-loughlin-8792003a9/">Gwen O&rsquo;Loughlin</a>: Research Partner&nbsp;at <a href="https://www.linkedin.com/company/vital-transformation/">Vital Transformation</a>
</li>
</ul>
They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug&rsquo;s origins, why &ldquo;march-in rights&rdquo; 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:
<ul data-start="872" data-end="1917">
<li data-start="872" data-end="1071">
NIH&rsquo;s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why &ldquo;NIH developed all drugs&rdquo; is a misleading simplification.
</li>
<li data-start="1072" data-end="1303">
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.
</li>
<li data-start="1304" data-end="1495">
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.
</li>
<li data-start="1496" data-end="1694">
Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools.
</li>
<li data-start="1695" data-end="1917">
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.
</li>
</ul>
Opinions expressed are those of the speakers.

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 speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:


Oriana Ciani:Associate Professor of Practice at SDA Bocconi School of Management


Denis Lacombe: Director General at EORTC

They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.

Key Topics:


Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.


Rare Trial Design: Small populations, randomization feasibility, comparator constraints.


Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.


HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.


Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:
<ul data-start="9398" data-end="9526">
<li data-start="9398" data-end="9482">
<a href="https://www.linkedin.com/in/oriana-ciani-bb029a8/?originalSubdomain=it">Oriana Ciani:</a> Associate Professor of Practice at <a href="https://www.linkedin.com/school/sda-bocconi-school-of-management/">SDA Bocconi School of Management</a>
</li>
<li data-start="9483" data-end="9526">
<a href="https://www.linkedin.com/in/denislacombe/?originalSubdomain=be">Denis Lacombe:</a> Director General at <a href="https://www.linkedin.com/company/eortc/">EORTC</a>
</li>
</ul>
They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.
Key Topics:
<ul data-start="9929" data-end="10469">
<li data-start="9929" data-end="10028">
Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.
</li>
<li data-start="10029" data-end="10123">
Rare Trial Design: Small populations, randomization feasibility, comparator constraints.
</li>
<li data-start="10124" data-end="10240">
Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.
</li>
<li data-start="10241" data-end="10343">
HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.
</li>
<li data-start="10344" data-end="10469">
Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.
</li>
</ul>
Opinions expressed are those of the speakers.&nbsp;This podcast was supported by Merck Sharp &amp; Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

VT’s Grumpy Old Men – The Administration’s Threats to use March-In Rights

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