Psychedelic Therapy Meets Patent Law

Today’s episode focuses on a fascinating intersection of science, law, and economics: the rise of psychedelic therapy and the legal frameworks shaping its future. 

In this era of industrialized capitalism, there are strong incentives to promote products in emerging industries. Intellectual property law has always played a key role in fueling innovation and now, it’s poised to do the same for psychedelic therapies. 

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• Actualizing Therapy from Psychedelic Compounds Requires Acknowledging the Past Pioneers as well as Encouraging Cooperation from Current Market Players

About the author

• Ben Bourke
  
  

Transcript

Welcome to Womble Perspectives, where we explore a wide range of topics, from the latest legal updates to industry trends to the business of law. Our team of lawyers, professionals and occasional outside guests will take you through the most pressing issues facing businesses today and provide practical and actionable advice to help you navigate the ever changing legal landscape.

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Host 1 

Welcome to Womble Perspectives! Today’s episode focuses on a fascinating intersection of science, law, and economics: the rise of psychedelic therapy and the legal frameworks shaping its future. 

Host 2 

That’s right. In this era of industrialized capitalism, there are strong incentives to promote products in emerging industries. Intellectual property law has always played a key role in fueling innovation and now, it’s poised to do the same for psychedelic therapies. 

Host 1 

Let’s start with the science. Compounds like LSD, ketamine, and psilocybin, traditionally associated with hallucinogenic effects, are being chemically modified to remove those properties. Researchers are adjusting functional groups on carbon rings to change receptor binding behavior, opening the door to therapeutic applications. 

Host 2 

And this research is landing at the perfect time. Mental health issues are on the rise globally, and these compounds could offer new hope for treatment-resistant conditions like major depressive disorder and PTSD. But to make that happen, we need a regulatory and legal framework that ensures safety while still incentivizing innovation. 

Host 1 

Enter the ReSPCT guidelines, published by Nature Medicine. These guidelines propose a standardized protocol for psychedelic clinical trials, covering everything from dosing and practitioner training to patient experience and safety measures. The FDA currently requires rigorous data for NDAs and BLAs, and these guidelines could help bridge the gap. 

Host 2 

Meanwhile, the intellectual property landscape is heating up. Patents for psychedelic therapies are skyrocketing, but that raises questions about prior art and fairness. Porta Sophia, a nonprofit, is tackling this by creating a database of traditional knowledge and prior art. This helps inventors build on existing science, protects Indigenous practices, and prevents wasted investment. 

Host 1 

Speaking of Indigenous practices, there’s a proposal for a “ceremonial use” defense to patent infringement. This would protect religious or traditional uses of psychedelic compounds, similar to prior user rights and the Hatch-Waxman safe harbor. Current law doesn’t cover this, so new legislation may be needed. 

Host 2 

And if the industry moves from nascent to profitable, cooperation could be key. During COVID-19, we saw patent pledges where companies voluntarily limited enforcement to spur innovation and access. Could psychedelic therapy follow that model? Possibly, but voluntary pledges have enforcement challenges, so lawmakers may need to step in. 

Host 1 

The political momentum is undeniable. In June 2025, HHS announced plans to roll out psychedelic drugs to clinical settings within a year. Texas invested $50 million in clinical trials. And bipartisan support is growing, with lawmakers from both sides backing psychedelic research in the National Defense Authorization Act. 

Host 2 

Bottom line? Psychedelic therapy is entering the era of industrialized capitalism. To ensure safety, reward pioneers, and promote innovation, we need robust legal and regulatory structures, just as we’ve seen in biotech and pharmaceuticals. 

Host 1 

That’s all for today’s episode of Womble Perspectives. If you found this episode useful, be sure to subscribe and share. 

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