PsyCap Special Report: The Role of Ethical IP in Psychedelic Drug Development

Want to learn more about the intriguing subject of ethical IP in psychedelic drug development? You can draw deep insights from leading experts in the space at Psychedelic Capital, the psychedelic industries premiere due-diligence conference series hosted by Microdose. 

The modern psychedelic renaissance is characterized by promising new mental health treatments, lucrative investment opportunities, and the cultivation of a healthier, happier society. However, while the developed world views this next generation of psychedelic medicines as a massive success, deciding on the best way forward is crucial for the greatest benefit. Doing this means being cautious about patentability and intellectual property, as these are tools that decide which organizations will wield the power in shaping the future of psychedelic therapy. 

Recognizing the promise that is psychedelic medicine and its therapeutic potential in revolutionizing mental healthcare is undoubtedly a priority for mankind today. However, equally important is the need to reconcile this earnest intention with the need for paying tribute to and adequately compensating the indigenous cultures these medicines hail from. How can society mindfully incorporate psychedelic medicine into modern pharmacopeia? What can be considered “novel” in this space if traditional molecules, such as psilocybin (the active ingredient in magic mushrooms) can’t be patented? Is it fair for European and American companies that are using psilocybin to disrupt the $1.5 billion dollar antidepressant market, to do so in a conscious and ethical manner? This piece will explore ethical IP in psychedelic drug development and offer insight into these important questions.

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The Role of IP & Patents In Psychedelic Drug Development 

While psychedelics have shown remarkable potential in the research arena, there’s still some distance between their current position and their ultimate reintegration into modern, mainstream society. Successfully developing new drugs takes time and is incredibly expensive. In fact, it is currently estimated to cost upwards of $1 billion dollars to successfully move a new drug all the way through the development pipeline and become accessible to the world at large. Considering the fact that 9/10 drugs fail to successfully complete that journey, it becomes evident rather quickly that intellectual protection and patenting are necessary to secure investor confidence in the current paradigm for developing pharmaceutical drugs. According to the United States Patent and Trademark Office (USPTO), “a patent for an invention, is the grant of a property right to the inventor.” In other words, a patent is a type of intellectual property right, and once it is in place, it gives the owner the right to prevent others from copying the invention for a period of 20 years from the filing date.

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Why Are Patents Important When Developing Novel Drugs?

Without patents, competitors could easily duplicate the manufacturing of a drug and there would be little incentive, within the current paradigm, for anyone to create these new treatments. To put it into layman’s terms, people with diseases like cancer, epilepsy, and arthritis would not have life-changing treatments without patents. It would be impossible to complete the long regulatory process and attract the investment of hundreds of millions of dollars needed to move a drug through the development pipeline if a product can simply be copied. Patents prevent this problem and ensure innovative therapies reach patients.

Read: The Critical Role of Patents in Novel Drug Development

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Naturally-Occurring & Traditional Psychedelic Molecules Cannot Be Patented

It is important for the reader to understand exactly what is being patented in the emerging psychedelic space. More importantly, perhaps, is understanding what cannot be patented: the naturally occurring and traditional psychedelic molecules. Drugs such as psilocybin, mescaline, DMT, ketamine, and MDMA are all in the public domain and cannot be patented. So what can be patented and protected? Current patents being filed in the psychedelic space cover things like novel formulations and delivery mechanisms of currently existing psychedelic compounds. For instance, Lobe Sciences is currently developing a nasal spray device to deliver a compound psychedelic formulation containing NAC (N-acetyl-cysteine) and a microdose of psilocybin. Additionally, some companies, like MagicMed Industries, are focused on creating new molecules based on natural psychedelics to create an improved drug. These new, altered molecules are patentable and provide the necessary framework to create new and focused treatments for different neurological and psychological health conditions from their natural predecessors.

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The “Open Science” Argument for Psychedelic Medicine

There is, of course, the argument that psychedelic drugs should not be treated the same, patents and all, like other pharmaceutical drugs. Instead, there is a good argument to be made for a more egalitarian, open science approach to psychedelic science and drug development. Essentially, the current patient-centric paradigm could lend one organization that holds a particular patent, too much control over the formulation of compounds or even the process of therapy itself. Indeed, this debate is explored and great insight shared in a brilliant piece by Vice News titled “Can a Company Patent the Basic Components of Psychedelic Therapy? From the aforementioned article: “With a monopoly comes the ability to shape the psychedelic therapy market as a whole: what it will cost, and, therefore, who will have access to it. The granting, negotiating, or rejecting of patents like this one will help define what the future of psychedelic medicine looks like.”

The “Ethical IP” panel in the upcoming March edition of Psychedelic Capital, featuring MAPS founder, Rick Doblin, will explore this debate even further. Make sure to join us for this exciting event and reserve your spot today. 

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Additional Considerations in the Establishment of Ethical IP in Psychedelics

Aside from protecting the actual molecular formulations of psychedelic drugs, companies are also filing patents on the process of therapy itself. When taking the important element of therapy into consideration, it can be seen that there are many parallels between the modern therapy setting and the ritualistic/ceremonial uses of traditional psychedelics. It is here that the concept of cultural sustainability is important to consider, as drawing on centuries-old practices of how these compounds were used can be hugely beneficial in establishing the best practices moving forward. For instance, the Bwiti tribe in Africa that utilizes the iboga plant in the ceremony, do so in the context of coming-of-age rituals, where an entire village comes together in the celebration of life for a specific community member. The element of community is particularly important to indigenous cultures and can be a valuable source of insight as we establish modern protocols for working with these substances.

In his article on the use of sustainable psychedelics, Tim Ferris poses the question, “What if we incorporated some of the best practices—the most meaning-imbued aspects—of the traditional with the reliability of synthetics?” Since synthetic psychedelics are an increasingly prominent part of the modern renaissance, this concept of incorporating those valuable aspects of traditional psychedelics into current and future practices serve an important purpose in this discussion.

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Ethical IP in Psychedelics is Being Discussed & Debated By Thought Leaders

The issue of ethical IP in psychedelic drug development has already gotten some celebrity spotlight when Christian Angermayer wrote an open letter to Tim Ferriss on LinkedIn. Things got even more interesting when Rick Doblin offered an insightful comment and asked how Angermayer can support decriminalization but not legalization. With intellectual property and patentability being so important to the psychedelic drug development space, it is encouraging to see thought leaders and industry experts discussing the topic in the public space.

Want to learn more about the importance of IP & Patents in the burgeoning psychedelic sector? Make sure to grab the Special IP & Patents Report compiled by Microdose as well as our partners and sponsors. For even deeper insights, join us at Psychedelic Capital where the topic of ethical IP in psychedelics will be explored by industry experts and thought leaders.

Gaurav Dubey

Gaurav Dubey

Gaurav Dubey is a dynamic clinical biologist, evidence-based branding professional and entrepreneur with a passion for scientific writing and traveling the world. He earned a dual bachelor’s degree in biology and philosophy from the University of Miami in 2011 and his Master’s in Biotechnology from Rush University Medical Center in 2015. Gaurav was recently published as lead author in the world's leading transplant journal, The Journal of Heart and Lung Transplantation, for a study investigating second-time lung re-transplantation. He is passionate about psychedelic medicine and recently accepted a position as content editor at Microdose, an opportunity he is very excited about. He is also the Founder & President of Karmik, LLC, an evidence-based branding firm for extraordinary life science brands.