Mike - End of the Road - Navigating Psychedelics and Patent Law

Download In this episode, Joe Moore interviews Mike from the podcast "End of the Road". Its a great podcast covering psychedelic and spiritual topics that are probably of interest to you. Mike is an attorney and he joins us to share some insights around patent law in the psychedelic space. Kyle and Joe were even feature on the show a few months back. Disclaimer - This interview is for informational purposes only, not for obtaining legal advice. "Opinions expressed by me, at my own only, and not my firms." 3 Key Points:

1. Patent law is worth understanding and shouldn't be ignored in our current psychedelic era.
2. It can be used to help protect inventions and innovations that took time and money to develop.
3. Patents aren't all bad. They can help protect the small guy as well and large corporations.

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Navigating Psychedelics Show Notes Patent on Ayahuasca

• 1986 Boston College Law review article (source) Warren Miller, scientist and entrepreneur obtained a patent on a strain of ayahuasca vine.
• 400 indigenous tribes challenged the validity of the patent. Controversy over the patent created hostility between Ecuador and US.
• Patent criteria
• A patent must be a process, machine, or manufacture or composition of matter. A patent does not depend on whether a composition of matter is living or non-living, but rather that it is altered and is not a naturally occurring substance.
• Taking a plant from South America, and not altering it should not receive a patent.
• Organizations owning a genome?
• Transgenic modification – able to be patented
• Plant patent – specific category

Psilocybin

• Compass pathways – applied for a patent for growing psilocybin – "good manufacturing practice" global standard for manufacturing pharmaceuticals, know your dose each time, etc
• Compass Pathways applied for a British patent called the "Preparation for Psilocybin"
  • FDA requires that you meet certain standards when you test a product for purity.
  • Trying to patent a pure form of psilocybin. "Non naturally occurring"
  • Using the patent as justification to cover the cost for FDA trials.

• Group of scientists who created a statement on open practice – 4 point manifesto. (Ram Dass supports it) Trying to make it non-capitalistic – so no one can create a monopoly on it.
• Full rights can bring the risk of unfair pricing moves
  • Martin Shkreli – marked up a life-saving drug by 3000x
  • Previous groups have decades of open sharing. Compass does not have the same origins
  • Scare – Compass marks up psilocybin. Could be unethical things happening within Compass, but not much journalism done here yet.
• Once a patent is made, harder to make a similar patent.
  • Broad-based patents make it harder to create further patents down the line since they have to be novel or significantly different and precisely new
  • The process Compass is trying to patent is not the only way to produce GMP psilocybin, there are many other ways.
  • May pull a move that gives them special access to administer

• Paul Stamets – psilocybin patent application
  • Using psilocybin and niacin for neural regeneration – a neural regenerated composition based upon constituents isolated from or contained within mushroom fruit bodies or psilocybin or the corresponding synthetic molecules combined with niacin
  • Google patents – US PTO 154914503 filing date April 23, 2017, another in 2018
    • Claims - Mushrooms have improved memory, cognition, motor skills, complex computer coding challenges, hearing, sensory, vision, learning, promote neurogenesis. Therapeutic applications of psilocybin.
    • A broad patent that covers a large variety of application for using psilocybin therapeutically, not approved yet.
    • Probably would capitalize on the patent. Keen for data sharing and being public with his work.
    • Previous patent: Pesticide replacement – fungi that infects ants and brings them back to their homes. More effective than pesticide.
    • Good he applied for a patent – it would mean that it wouldn't block people from accessing it or developing their own
• Andrew Chadeayne – inventor and patent attorney
  • Has psilocybin patent update blog
  • Applied for patents in the psilocybin space

• Monopoly law
  • If there is a popular drug used in the market, a drug company wanting to capitalize – it will cover all their bases with a patent
  • Daniel Pinchbeck – theories that could work (Marxist society)
  • Cuba – healthcare model – government funds certain health care practices for the public good/applications that the US would not.
  • A model that Marxists could use to get these products on the market vs capitalist model
  • The basic idea of patents: Inventor – creates a patent to protect the invention, not to dominate the market.

• International Administration of Ketamine to treat Depression – Yale
  • Method for treating depression

• University of California – scientists using "compounds for increasing neural plasticity"non-hallucinogenic catalog of psychedelic compounds
• Novel devices for administration
  • Intranasal or inhalant administration method for THC, ketamine, etc.
• SYQE – developed method of a delivery subject for Patent Protection
  • Full spectrum whole plant extract – different from a vaporizer
  • Pctil 2015 050676
  • Syqemedical.com
  • Smoking – route of administration dosing precision standard is 30%, their dose delivery is at 70%
• Tel Aviv Israel – producing the lowest price per gram in the world of cannabis
  • All cannabis being researched in the country must come from one specific facility – set the US back
• German patent – synthetic ayahuasca DE201610014603
• Open source model
  • Common law copyright and trademark protection
  • Laws changed in 2013 – first to file the patent first, gets the invention
    • Important to get patent protection early in the process
    • Provisional, and non-provisional patent. Provisional gives a year grace period to file non-provisional without all of the details of the full application.
  • Infusion pump technology – method of delivery (ex. DMT) controls the level of a substance in the blood for an undefined, extended period of time.
    • Insulin pumps – monitor and deliver
    • Raspberry pie devices – can buy a computer and program it to do specific functions. Ex. automated brewing system with temp controls.
    • DMTx – same computer could be programmed and applied to control the levels of DMT in the bloodstream

• Joe Rogan and Elon Musk on a podcast – space travel and psychedelics talk
• Peter Theil - Hyper capitalist. Super rich.
  • Book: Zero to One. Make a product 10,000 times better than the competition, so that they will buy it. (Soft monopoly)
• Tim Ferris – most billionaires he interviewed claim they have had substantial psychedelic experiences.
• Patent activity
  • Adding cannabinoids to beer, etc.
  • Huge market opportunity for cannabis.

Links

• End of the Road Podcast - iTunes
• End of the Road Podcast - LibSyn
• Skqe Medical
• Paul Stamets Patent - Compositions and methods for enhancing neuroregeneration and cognition by combining mushroom extracts containing active ingredients psilocin or psilocybin with erinacines or hericenones enhanced with niacin

Check out this FREE online course, "Introduction to Psychedelics"

About Mike Exploring the Horizons we never touch, because we are already there....with Michael. Mike is a patent lawyer with a long history in trial law. He has a great podcast that you should check out - End of the Road