A Ketamine Patent for Behavioral Addictions Just Cleared. The Doctor Shield Has a Carve-Out
A London biotech said last week that the US Patent and Trademark Office has allowed one of its applications. The claims cover ketamine for behavioral addictions. The announcement from Solvonis Therapeutics describes claims reaching every behavioral addiction. They cover all three forms of ketamine, by any route.
Nothing is enforceable yet. But the claims describe something a lot of clinics already do. And the federal provision clinicians assume protects them has a carve-out that appears to fit this exactly.
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| Key Takeaway | Detail |
|---|---|
| What happened | The USPTO allowed the application. It is not a granted patent yet |
| When it grants | Solvonis expects grant in Q1 2027, subject to final formalities |
| What it covers | All behavioral addictions, racemic ketamine, esketamine and arketamine |
| The specifics | Dissociative doses of at least 50 mg, by any route, with or without psychotherapy |
| How long | Expected patent term to May 2042 |
| The legal wrinkle | 35 U.S.C. 287(c) shields practitioners, but excludes a patented use of a composition of matter |
| Stated intent | Partnerships and out-licensing. The release says nothing about enforcement |
What the claims cover
Solvonis Therapeutics is listed in London as SVNS. The application came from Awakn Life Sciences, which is now part of Solvonis, and was filed internationally in May 2022.
The allowed claims cover treating behavioral addictions with ketamine at dissociative doses of at least 50 mg. The company names binge eating, gambling, gaming and compulsive sexual behavior disorders, and says the claims span all behavioral addictions.
Three details matter more than the condition list. The application expressly includes racemic ketamine, esketamine and arketamine. It covers administration by any route. And it applies with or without psychotherapy.
Read that as an operator rather than an investor. Any route, 50 mg or more, therapy optional. That is a description of ordinary practice, not of a novel delivery system.
The expected term runs to May 2042. Binge eating and gambling are the company’s stated first commercial priorities.
This is not a shell with a filing cabinet. Solvonis has a ketamine treatment in Phase 3 for severe alcohol use disorder in the UK. The University of Exeter sponsors that trial, and two national research bodies co-fund it.
It also has an esketamine oral thin film in Phase 2b planning in the US, under an agreed 505(b)(2) pathway. NIDA funds preclinical work on cocaine and methamphetamine addiction. The company says every one of those programs is investigational.
It is an allowance, not a patent
This distinction is going to get lost in the coverage, so it is worth stating plainly. An allowance means the examiner has agreed the claims are patentable. The patent itself has not issued.
Solvonis expects grant in Q1 2027, subject to final formalities. Until then there is nothing to enforce. The release also says plainly that patent allowance does not constitute regulatory approval.
So no clinic needs to do anything this week. The reason to read it now is that the window to understand it closes when the patent issues, not before.
The shield most clinicians assume they have
Federal law does protect doctors from patent suits. The provision is 35 U.S.C. 287(c), and it is broader than most people expect.
It covers a medical practitioner performing a medical activity that infringes. In that case the sections providing for suit, injunctions, damages and attorney fees do not apply. The protection extends to a related health care entity.
The definition names the obvious candidates. A medical clinic is on the list by name. So the shield was built for exactly this kind of business.
The problem is what counts as a medical activity.
The carve-out, and what it says
The statute defines medical activity as performing a medical or surgical procedure on a body. Then it excludes three things. The second exclusion is the one that matters here.
| The statute | What it says |
|---|---|
| Who is protected | A medical practitioner, and a related health care entity including a medical clinic |
| From what | Suit, injunctions, damages and attorney fees for infringement by a medical activity |
| Exclusion (i) | Use of a patented machine, manufacture, or composition of matter |
| Exclusion (ii) | The practice of a patented use of a composition of matter |
| Exclusion (iii) | The practice of a process in violation of a biotechnology patent |
| The carve-back | That term excludes methods where the composition does not directly contribute to the objective |
Ketamine is a composition of matter. A method-of-use patent on administering ketamine to treat an addiction is a patented use of one.
The statute does narrow its own term. It excludes a claim where the composition fails to directly contribute to the objective of the method.
That carve-back is built for the opposite situation. It protects a surgical technique that happens to mention a drug along the way.
In these claims the ketamine is not incidental. The dose is specified, the enantiomers are specified, and the drug is the entire mechanism of the method. On the statute’s own wording, that reads as a patented use of a composition of matter.
We are not your lawyers and this is not legal advice. The language above is the statute’s own. We quote it so an operator can take the text to counsel rather than a summary of it.
What Solvonis says it wants
The release contains no statement about enforcement against anyone. Its stated strategy is to protect new treatment uses, build clinical evidence, and pursue partnering and out-licensing.
Chief executive Anthony Tennyson said the claims create scope for partnerships and licensing deals. He called binge eating and gambling a starting point rather than the limit.
Chief scientific officer David Nutt framed it clinically. He said addiction traps people in patterns they struggle to break. Ketamine, in his words, may open a window to change them.
That is a licensing posture, not a litigation posture. Suing clinics would be poor business and worse optics for a company whose own pipeline depends on clinical goodwill.
The realistic version of this is a licensing conversation somewhere after Q1 2027, not a lawsuit. It is still worth knowing which side of a carve-out you are standing on before that conversation starts.
One number worth not repeating
The release cites a published expert estimate of more than 48 million Americans affected by behavioral addictions. Its own footnote then calls that a historical expert estimate rather than a current national diagnostic survey.
The footnote also concedes it includes behaviors that are not all classified as standalone addictions under DSM criteria. A company undercutting its own headline number is unusual. The caveat should travel with the figure wherever it goes.
What is worth doing now
Not much, and that is the point. There is no patent to infringe until it issues.
What is worth doing is knowing whether your clinic treats any of these presentations, and at what dose. Check whether binge eating, gambling, gaming or compulsive sexual behavior appear in your intake or your marketing. If they do, this matters to you in 2027 and not before.
That is a documentation question more than a clinical one. It sits alongside the other items in our list of 8 gaps that create malpractice exposure. It also lands on the same calendar as the regulatory deadlines already set for 2026 and 2027.
The underlying clinical question is older than the patent. We looked at it in 2023, in what the odds are on psychedelics helping gambling addiction. The evidence base has not moved as fast as the intellectual property has.
Patients comparing supervised options can start with our directory of verified ketamine clinics.
This article is for informational purposes and is not legal or medical advice. Statutory language is quoted from 35 U.S.C. 287(c). Consult your own counsel about your practice.
