The Patent Race: Synthetic Kratom & The Cannabis Playbook
They cannot patent the plant. So they are patenting derivatives of it, building companies to commercialize them, and waiting for the natural version to be cleared from the market. The patent trail is documented. The companies are named. The playbook has been run before.
TL;DR: What the Patent Record Shows
- You cannot patent a plant. Natural 7-hydroxymitragynine, occurring in kratom for millennia, is not patentable. What is patentable: synthetic analogs, modified derivatives, and claimed therapeutic uses.
- The patents exist and are verified. Memorial Sloan Kettering Cancer Center and Columbia University hold multiple patents on therapeutic uses of mitragynine-derived compounds. Patent numbers, inventor names, and filing dates are public record and confirmed via USPTO.
- The companies are named. Sparian Biosciences, co-founded by one of those patent inventors, is actively developing SBS-226, a kratom-based drug for opioid withdrawal. ATAI-backed Kures is developing KUR-101, a deuterated mitragynine compound for the same indication.
- The cannabis parallel is documented. Marinol (synthetic THC) costs 6-18x more than natural cannabis for the same active compound. Epidiolex costs 20-50x more than natural CBD. Same playbook. Same outcome.
- The timing is damning. Manufacturing patents for pharmaceutical-grade 7-OH issued November 2025, as the regulatory push was already underway. The companies and intellectual property were in place before the natural version was removed.
The Patent Trail
Natural kratom alkaloids cannot be patented. A plant metabolite that has existed in nature for centuries cannot be owned. What can be owned is a synthetic analog, a proprietary manufacturing process, or a claimed therapeutic use. The record shows all three are already secured.
The Academic Institutions
The patents are not held by obscure startups. They are held by two of the most prestigious medical research institutions in the United States, and they cover the therapeutic uses of mitragynine-derived compounds at the receptor level, not just manufacturing processes.
Memorial Sloan Kettering Cancer Center
US Patent 11,046,692 B2 (filed April 2016, granted June 2021)
Title: "Mitragynine Analogs and Uses Thereof"
Inventors: Gavril W. Pasternak, Susruta Majumdar, Andras Varadi, Rashad Karimov
Coverage: Methods of using modified mitragynine compounds to treat pain and modulate opioid receptor activity
View on Google Patents
WO2016176657A1 (filed April 2016)
The international PCT application that became US 11,046,692. Filed the same month, covering the same claims across international jurisdictions.
Gavril Pasternak spent his career at MSKCC and is one of the most cited opioid pharmacologists of the past half century, credited with foundational work on mu-opioid receptor subtypes. He co-founded Sparian Biosciences before his death in 2019 to commercialize this research. MSKCC has held intellectual property claims on therapeutic uses of mitragynine analogs since 2016.
Columbia University (jointly with MSKCC)
WO2020160280A1 (filed January 2020)
Title: "Deuterated Mitragynine Analogs as Safer Opioid Modulators"
Inventors: Andrew Kruegel, Dalibor Sames, Jonathan Javitch, Susruta Majumdar
View on Google Patents
Deuteration is a specific pharmaceutical strategy: replace certain hydrogen atoms in a compound with the heavier isotope deuterium, and the result behaves pharmacologically like the original while being sufficiently distinct to qualify as a new, patentable entity. The technique exists specifically to create patentable versions of compounds that would otherwise be unpatentable. The patent's own title states the goal: safer opioid modulators.
WO2017165738A1 (filed March 2017)
Title: "Mitragynine Alkaloids as Opioid Receptor Modulators"
Inventors: Andrew Kruegel, Dalibor Sames, Benjamin Gassaway, Jonathan Javitch
View on Google Patents
Manufacturing Process Patents (2025)
US Patent 12,466,830 (issued November 2025)
Coverage: Proprietary, controlled, reproducible method for converting mitragynine to pharmaceutical-grade 7-hydroxymitragynine at scale
US Patent 12,492,201 (issued November 2025)
Coverage: Same manufacturing process, second patent covering additional claims
Both issued while the regulatory push against the natural product was already underway.
The Patent Timeline
April 2016
MSKCC files WO2016176657A1 and the US application that becomes patent 11,046,692, covering therapeutic uses of mitragynine analogs. Same month: DEA announces intent to emergency-schedule kratom.
October 2016
DEA withdraws its emergency scheduling notice after public backlash. Over 23,000 public comments and more than 100,000 petition signatures had been submitted. The intellectual property filings continue regardless.
March 2017
Columbia files WO2017165738A1: "Mitragynine Alkaloids as Opioid Receptor Modulators."
January 2020
Columbia/MSKCC file WO2020160280A1: "Deuterated Mitragynine Analogs as Safer Opioid Modulators." The deuteration strategy makes these compounds patentable in a way their natural precursors are not.
June 2021
US Patent 11,046,692 granted to MSKCC. Five years of waiting for the intellectual property to become fully protected, commercially viable, and licensable.
November 2025
Manufacturing patents 12,466,830 and 12,492,201 issued, covering the process of producing pharmaceutical-grade 7-OH at scale. The regulatory push against the natural product is already underway.
July 1, 2026
DEA files notice of intent to temporarily schedule 7-OH and three synthetic derivatives. HHS opens a 30-day public comment period. The intellectual property accumulated since 2016 is fully secured and waiting.
The Pattern Is Documented
Intellectual property on therapeutic uses of kratom alkaloids was accumulated across a decade by major research institutions. Companies were built to commercialize it. The regulatory action removing the natural, unpatentable version from the market arrived with the commercial infrastructure already in place.
Whether that sequence reflects deliberate coordination or parallel self-interested action by different institutions, the outcome is identical: a prescription-grade replacement exists, is funded, and is waiting for the natural version to be cleared from the market.
The Companies Built to Commercialize This Research
Patents held by research institutions become commercially viable through licensing agreements or spinout companies. Both paths are documented here.
Sparian Biosciences
Sparian Biosciences was co-founded by Gavril Pasternak and Jeff Reich, MD. Its pipeline is described on its own website as "derived from the Pasternak Lab at Memorial Sloan Kettering Cancer Center" and the Majumdar Lab. Pasternak passed away in 2019, but the company continues operating with his patents and research as its foundation.
Lead candidate: SBS-226
Sparian's own pipeline page describes SBS-226 as "a new chemical entity, based on Kratom, which was synthesized and developed in the Majumdar Lab." It is being developed for opioid use disorder and opioid withdrawal, in collaboration with the National Institute on Drug Abuse and Memorial Sloan Kettering Cancer Center. Sparian's own description of its properties: "can ameliorate opioid withdrawal but does not demonstrate abuse potential, respiratory depression, or physical dependence."
A company co-founded by one of the MSKCC patent inventors is developing a kratom-derived compound for opioid withdrawal, at the same moment the natural plant millions of people use for the same purpose is being removed from the market.
Kures / KUR-101 (ATAI Life Sciences)
Kures is a pharmaceutical company in the portfolio of ATAI Life Sciences, a publicly traded CNS-focused pharmaceutical company. Its existence and pipeline are disclosed in ATAI's own SEC filings.
Lead candidate: KUR-101
ATAI's SEC filing (Form DRS, FY2021) describes KUR-101 as "a deuterated version of mitragynine" being developed "for the treatment of OUD." Mitragynine is the primary alkaloid of the kratom plant. A deuterated version is patentable in a way that natural mitragynine is not, by definition, because it is a novel chemical entity that did not previously exist in nature.
KUR-101 is the Columbia/MSKCC deuteration strategy applied to the primary kratom alkaloid, funded by a publicly traded pharmaceutical company, targeting the same opioid withdrawal indication as SBS-226.
As of March 2026
HHS confirmed to the DEA there were no approved drug applications or investigational new drug filings for these substances. No prescription version had yet entered formal clinical trials. What existed was the intellectual property, the research base, the manufacturing infrastructure, and the companies. The regulatory environment making a prescription version commercially necessary was being created simultaneously.
The pattern documented here does not require a conspiracy. It requires only that well-capitalized institutions recognized the commercial value of kratom-derived compounds, patented them, built companies to develop them, and waited for the regulatory environment to make that development commercially necessary. That environment is now being created. The facts are public record. The connections are documented.
The timing is damning.
The Cannabis Playbook
We do not need to predict what happens when a natural botanical is banned and replaced with a patented synthetic version. Cannabis already showed us. The pricing data is public, and the markup is exactly what you would expect.
Marinol and Epidiolex: The Documented Outcome
| Product | What It Is | FDA Approved | Monthly Cost |
|---|---|---|---|
| Marinol (Dronabinol) | Synthetic THC, patented | 1985 | $600-1,800/month |
| Natural cannabis | The plant, unpatentable | Not FDA-approved | $100-300/month |
| Epidiolex (Cannabidiol) | Pharmaceutical CBD, patented | 2018 | $2,700/month ($32,500/year) |
| Natural CBD | Hemp-derived, unpatentable | Not FDA-approved | $50-150/month |
Marinol costs 6 to 18 times more than natural cannabis for the same active compound. Epidiolex costs 20 to 50 times more than natural CBD. This is not the cost of development amortized over time. It is monopoly pricing, enabled by removing natural alternatives from the market and establishing patent-protected exclusivity over the only legal version.
The Markup Reality
Natural kratom currently costs most users $30 to $60 per month. If the cannabis pricing pattern holds, a prescription-grade kratom-derived compound for opioid withdrawal would cost $400 to $1,800 per month, plus required physician visits, plus insurance copays and deductibles.
The same people who currently pay $30 to $60 a month to manage pain or maintain sobriety would be required to engage with a system that charges 10 to 30 times more for the same outcome. The ones who cannot afford it would have no legal alternative.
The Legalization Re-Entry: Cannabis Confirms the Arc
The cannabis prohibition arc provides the complete template. Decades of criminalization. Slow state-by-state legalization, structured in ways that favor well-capitalized operators over the communities most affected by the original ban. Tax structures and licensing costs that make small-scale legal operation difficult. Pharmaceutical companies holding patents on isolated compounds that are legally distinct from the plant itself.
This administration has already signaled the re-entry is being planned. In May 2026, the Trump administration publicly floated federal approval for what it described as "natural 7-OH," pivoting from its own scheduling push. The policy contradiction is documented: the same federal government moving to schedule 7-OH was simultaneously exploring a pathway to re-approve a version of it through a controlled channel. That is not a contradiction. That is the playbook proceeding on schedule.
"If kratom prohibition were about public safety, there would be no patent race. If the FDA genuinely believed kratom was too dangerous for public use, they would not be creating a pathway to approve synthetic versions of the exact same alkaloids."
KTP Analysis, 2026
What the Alternative Looks Like
Prohibition is not the only option. A documented alternative already exists and is operating in more than a dozen states. Rhode Island tried prohibition, found that it didn't work, and chose the alternative instead.
The Kratom Consumer Protection Act
The KCPA is now the dominant regulatory model among states that haven't banned kratom outright. It requires:
- Mandatory third-party laboratory testing with adulterant screening
- Certificate of analysis requirements for all products sold
- Standardized labeling with actual alkaloid content
- Adult-only retail restrictions
- Bans on products containing undisclosed adulterants
This framework directly addresses every documented harm the scheduling action cites: contamination with tianeptine and other adulterants, inconsistent product labeling, and underage access. It does so without eliminating access for the millions of adults who use tested, labeled products responsibly.
Rhode Island: The Reversal Is Documented
Rhode Island banned kratom. Then it became the first state in the country to reverse a kratom ban and adopt a KCPA-style regulatory framework instead, effective April 2026. Rhode Island issued its first kratom manufacturer license under the new framework in June 2026.
That sequence, a state trying prohibition and choosing to reverse it, is the most direct available evidence that regulation works better than prohibition, because it comes from a state that tested both options and made a choice between them.
Schedule I prohibition does not reduce demand. It eliminates the regulated market, removes quality controls, and drives production to unregulated sources where the contamination problems the agency cites as justification become significantly worse. Banning the plant does not clean up the products that were causing harm. It removes the only products that were subject to any quality control at all.
The Patent Race Is the Record
The patents held by Memorial Sloan Kettering and Columbia University on therapeutic uses of mitragynine-derived compounds are real, verified, and searchable in the public patent database. The companies built to commercialize them, Sparian Biosciences and ATAI-backed Kures, are real, named, and documented in public filings. The cannabis pricing precedent, Marinol at 6 to 18 times the cost of natural cannabis, Epidiolex at 20 to 50 times the cost of natural CBD, is real and documented by the drugs' own manufacturers.
Every link in the chain described in this article is a named institution, a named researcher, a named company, a named drug candidate, or a named pricing figure, each verifiable from public records. No claim rests on unnamed sources or anonymous allegations.
The question this record poses is not whether pharmaceutical companies have an interest in replacing a natural, unpatentable botanical with a patented prescription alternative. That interest is obvious, structural, and inherent to how pharmaceutical markets work. The question is whether regulatory agencies are facilitating that outcome, deliberately or not, and whether the public understands what is being built on the other side of the prohibition being proposed.
What You Can Do
Verify the patents yourself: Every patent number in this article is searchable at patents.google.com and uspto.gov. The inventor names, filing dates, and claim language are all public record.
Read the Sparian and Kures pipelines: Both companies describe their kratom-derived drug candidates on their own websites and in their own SEC filings. The connection to the MSKCC patents is explicitly stated.
Support the KCPA: Regulation over prohibition. Testing, labeling, age restrictions, and adulterant bans. Rhode Island already showed this works better. Ask your state legislators to look at the Rhode Island model before considering a ban.
Continue the Investigation
How a Crisis Gets Built
The statistics behind the bans don't hold up. No single-substance deaths. A manufactured escalation. An inflated adverse-event count. The primary sources, read directly.
Does 7-OH Meet the Legal Standard?
The specific legal test the DEA must clear for emergency scheduling, read against its own record. The prior HHS finding it never addresses. The arbitrary-and-capricious problem.
Manufacturing Evidence
How polydrug deaths become single-substance deaths in the record, how adverse events get misattributed, and how the evidentiary standard shifts depending on who is asking.
Sources & Documentation
Every claim in this investigation is verifiable from public records. Check it yourself.
Patent Records (All Verified via USPTO / Google Patents)
- US Patent 11,046,692 B2, MSKCC, inventors Pasternak/Majumdar/Varadi/Karimov (filed 2016, granted 2021): Google Patents
- WO2016176657A1, MSKCC, same inventors, PCT international application (filed 2016): Google Patents
- WO2020160280A1, Columbia/MSKCC, "Deuterated Mitragynine Analogs as Safer Opioid Modulators" (filed 2020): Google Patents
- WO2017165738A1, Columbia University, "Mitragynine Alkaloids as Opioid Receptor Modulators" (filed 2017): Google Patents
- US Patent 12,466,830, manufacturing process patent (issued November 2025)
- US Patent 12,492,201, manufacturing process patent (issued November 2025)
Corporate Sources
- Sparian Biosciences: pipeline, team, and story pages: sparianbiosciences.com
- ATAI Life Sciences SEC Filing (Form DRS, FY2021), Kures / KUR-101 ("a deuterated version of mitragynine") disclosed as portfolio company developing OUD treatment
- HHS letter to DEA (March 2026), confirming no approved NDAs or INDs for 7-OH or related substances
Pricing Data
- Marinol (dronabinol) pricing: GoodRx, FDA Orange Book, pharmacy retail data
- Epidiolex pricing: Greenwich Biosciences (manufacturer) and insurance formulary data ($32,500/year average wholesale price)
- Natural cannabis pricing: state-licensed dispensary data (Colorado, California, Oregon)
Regulatory Timeline
- DEA Federal Register Notice, Kratom Emergency Scheduling (August 30, 2016)
- DEA Withdrawal Notice (October 13, 2016)
- DEA Notice of Intent FR Doc. 2026-13580 (July 1, 2026)
- Rhode Island Department of Health, first kratom manufacturer license issued under KCPA framework (June 2026)
- Trump administration statement on "natural 7-OH" approval pathway (May 2026)
Methodology Note
- All patent numbers verified directly through USPTO and Google Patents. Only confirmed patents are cited by number. Unverified patents from earlier versions of this article have been removed.
- Company information sourced from the companies' own websites and public SEC filings only. No investor presentations or corporate quotes that could not be independently verified are included.
- Price projections for hypothetical synthetic kratom pricing are presented as projections based on the cannabis analog pattern, not as established facts.
The Patent Trail Is the Proof
If kratom prohibition were about public safety, there would be no patent race. The intellectual property was secured before the scheduling action. The companies are named. The cannabis parallel is documented. The playbook is running.