Graham Pechenik, a patent and intellectual property (IP) lawyer, recently tweeted about claims he found surprising in a pending application for psychedelic therapy using psilocybin, the hallucinogenic ingredient in magic mushrooms.
Claims are the meat and potatoes of a patent. They define the parameters and limitations of what is being claimed for an invention that an individual or organization wants to have ownership of.
That's why Pechenik felt moved to call out a patent application from Compass Pathways, a psychedelic mental health company that has previously garnered attention for both its promising results in the treatment of depression using psychedelics, as well as its transition from a charity to a for-profit company, its patent of a synthetic form of psilocybin, and having investors like Paypal founder Peter Thiel.
The patent application, filed in 2020, for “treatment of depression and other various disorders with psilocybin," includes claims involving rudimentary facets of psilocybin-assisted therapy like having "a room with a substantially non-clinical appearance.” Other claims found in the application: "the room comprises soft furniture,” “the room is decorated using muted colors,” “the room comprises a high-resolution sound system,” and “the room comprises a bed or a couch.
Some claims are about participant behaviors: “wherein the subject lies in the bed or on the couch” and “wherein the subject listens to music.” And some claims are simple actions from therapists: “the therapist provides reassuring physical contact,” “the therapist responds to the subject if the subject initiates conversation,” and “the therapist holds the hand, arm, or shoulder.”
Much of what the claims outline have been done—though not necessarily systematically or defined formally—throughout the history of psychedelic therapy in academic research centers, at retreats, and in underground settings. What does it mean for a company to try and include such claims in a patent application?
“Could these patent claims be granted?” Pechenik tweeted. “Could they be used against therapists?” Could someone treating a patient be prevented from holding people’s hands or using soft furniture—without acquiring a patent license?
Initial claims in patent applications are very rarely granted without changes being made to them; there is a yawning chasm between this Compass filing and anyone being sued for anything. But because these claims are so broad, the application raises questions about the intent behind their inclusion, Pechenik said. It also represents a growing tension in the psychedelic therapeutic space over what should and shouldn't be protected as IP.
“I think if these claims do hold up, it will change the landscape, in the sense that there will be now ownership over these therapy protocols,” Pechenik said. “Whoever does end up with these patents would be able to really dictate the use of them, either by using them to get revenue through licensing, or by using them to shape what the competition looks like by choosing to license to some and not others.”
There's no denying that there's money to be made in psychedelic mental health. But a diversity of opinion still exists as to whether psychedelic compounds should be treated like any other promising pharmaceutical drug—patents and all—or be approached with a more egalitarian "open science" attitude. With the former approach, there's been concern about any one company having too tight a grasp on different formulations of the compounds, or, now, the process of therapy itself. 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.
It’s important to note that this is a patent application, not a granted patent. As such, it can’t be used in any way to claim ownership or patent infringement.
“It’s going to be a long time before any claims coming out of this application get put in front of an examiner,” said Gretchen Temeles, a patent lawyer and special counsel at the law firm Duane Morris LLP. (In response to an emailed request for comment, Compass's Chief Communications Officer said that Compass doesn't comment on patent applications.)
Still, it can’t be ignored that it’s a boom time for psychedelic patents. Patent applications are being filed from both academic institutions and the growing number of psychedelic companies like Mind Medicine, Mydecine Innovations Group, Aion Therapeutic, Neon Mind, and Eleusis.
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“There’s not that many patents in the queue right now—there might be 100, but there’s going to be around 5000 in three years if I had to make a guess,” said David Casimir, a lawyer specializing in intellectual property who has a Ph.D. in biochemistry.
Psilocybin is a known natural compound, so it cannot be patented, but the way it’s made and used can be. The current roster of public patent applications for psychedelic therapy range from different formulations and combinations of psychedelic compounds to methods of delivery.
One patent pending is for a “method and device for creating and maintaining a personalized bubble of scent, the method including: providing a wearable device including a perfume reservoir, a perfume dispenser coupled to the perfume reservoir, and a controller to dispense a volume of perfume from the device at intervals.” Beyond just a personalized perfume scent bubble, “other liquids which may be dispensed" include, “CBD oil / cannabidiol; cognitive-enhancing drugs, nootropics and 'microdosing' psychedelic medicines (e.g. LSD, psilocybin) for therapeutic applications.”
To obtain a patent, you have to prove that an invention is novel, or new, and that it isn't “obvious” (the official term). Once an application is filed, a patent examiner at the United States Patent and Trademark Office will determine whether an application's claims are in fact new, and also non-obvious to someone “of ordinary skill in the art,” or another person who is active in the field.
The patent office can look to scientific literature and prior patents to determine if an invention deserves a patent. The amount of knowledge out there about psychedelic therapy might not be reflected in these resources because of psychedelics’ legal status. “There’s this wealth of information out there, tons of old research done in the '50s and '60s,” Casimir said. “But there's not an easy resource to find and collect this information and to put together all of the clinical information that's been gathered by anecdotal stories, case reports by individual doctors."
When that happens, it can disadvantage patent offices. Casimir has experience with this: he worked in Silicon Valley during the 1990s dotcom boom, and said he saw patents being filed for “business methods,” based on ideas around selling various products online. “All sorts of bad patents were coming out of the Patent Office at that time because the Patent Office didn't have the training, resources, or tools to find prior art in the space because people selling, for example, pet food, online wasn't necessarily published in scientific journals, and it wasn't showing up in earlier patents because it was a new field.”
Casimir said it’s a similar issue with psychedelics. To address this concern, a group of attorneys at Casimir’s law firm are now putting together a website—launching soon—that will be an resource specifically for the psychedelic drug space to assist patent offices around the world in doing a better job at reviewing these patents.
“The risk is that patent examiners just don’t have the tools and they let bad patents out the door,” Casimir said.
How all this patenting will end up influencing the distribution or accessibility of psychedelic therapy is still unclear. “Patents are good for true innovations,” Casimir said. “They let companies raise money to do their development, to sponsor their clinical trials. That's all very important. Bad patents are bad for everyone, except maybe the patent owner who owns them. They're just a drag on the system and an increase in cost. It slows down access to the market. It makes things more expensive.”
Psilocybin Alpha, a publication geared towards investors in psychedelic medicine at which Pechenik is editor at large, recently created the Psilocybin Patent Tracker so anyone can see all psilocybin-related patents and published patent applications that were filed in the U.S., starting with Albert Hofmann’s patents on LDS from 1958 and 1959. Pechenik said we’ll start to see more patent applications published soon. Applications are secret for 18 months after filing, “and a lot has happened in the last 18 months.”
Compass Pathways and Usona Institute, a nonprofit medical research organization, have both received breakthrough therapy designation from the FDA for their research on therapy for depression using synthetic psilocybin. This designation means that the preliminary clinical evidence in a study was so promising the FDA will fast-track its review process.
Usona has taken an "open science" approach to psychedelic medicine by not filing for patents and instead publishing papers sharing how to manufacture psilocybin and related compounds. Alex Sherwood, one of Usona’s medicinal chemists, explained to VICE last year that Usona makes psilocybin available to any scientist qualified to work with it, along with matching placebos, so they can do controlled experiments of their own.
Members of Usona, along with 132 individuals and organizations in all, have signed the Statement on Open Science and Open Praxis with Psilocybin, MDMA, and Similar Substances, which makes a promise to maintain “open science.” They wrote, “We will not withhold, nor will we require others to withhold, materials or knowledge (experiences, observations, discoveries, methods, best practices, or the like) for commercial advantage.”
In 2018, Compass Pathways filed a patent on its formulation of synthetic psilocybin, called polymorph A. The patent was granted in 2020. This patent was a controversial one. Critics “argue that Compass is attempting to claim ownership of prior psilocybin research and unfairly block potentially competing therapies,” as Lucid News reported in a three-part series on the development of psilocybin-based therapies for depression.
Compass's first patent application, in October 2018, had 27 claims of novelty, Jeffery M. O’Brien wrote in Fortune. These novelty claims were swiftly challenged by Carey Turnbull, a board member of Usona Institute and the nonprofit Heffter Research Institute. Compass withdrew those original 27 claims of novelty. When it resubmitted its patent claim it had 10 new claims of novelty, which Turnbull opposed again. Compass again withdrew its patent. Finally, its patent was approved on December 31, 2019, with one independent claim of novelty and 20 dependent claims.
As Russell Hausfeld reported in Psymposia, Turnbull continued to dispute the approval of this patent “through Kohn and Associates, and through Free to Operate (FTO)—a company Turnbull created to ‘further the goal of keeping psilocybin widely available for research and development’ for the treatment of conditions like depression.” That petition was denied in August 2020. Compass filed paperwork for an initial public offering (IPO) in August 2020.
Turnbull told Lucid News that he would “welcome Compass manufacturing and distributing psilocybin. I object to their preventing anyone else from doing so.”
Compass Pathways has previously been criticized for its transition from a charity into a for-profit drug company. “Compass Pathways has relied on conventional pharmaceutical-industry tactics that could help them dominate the field, including blocking potential rivals’ ability to purchase drugs, filing an application for a manufacturing patent, and requiring contracts that give Compass power over academics’ research and are restrictive even by pharmaceutical-industry standards,” Olivia Goldhill wrote in a 2018 article for Quartz.
Compass has also gotten flak for certain investors like venture capitalist Peter Thiel, the co-founder of PayPal, a vocal supporter of Donald Trump, and the bankroller behind the Hulk Hogan lawsuit that brought down Gawker Media. Because of all this history, any patent that Compass applies for will likely be met with an intense level of scrutiny—and questions about its objectives.
In May 2020, Lars Wilde, one of the three co-founders of Compass, told VICE that the polymorph patents’ purpose was to “protect our innovation,” not to prevent anyone else from making psilocybin. “The question has been raised many times, whether we would stop researchers from doing research and [the answer is] absolutely not," Wilde said.
Many of the claims in the Compass’s patent application on therapeutic methods would seem, to a layperson, to not meet the novelty requirement. Pechenik said he agreed, but that “the comparison would have to be made by the examiner. Certainly there are plenty of sort of treatment programs that have existed before relating to psilocybin and other manuals and other other ways it's been done.”
One of the challenges of psychedelic-assisted therapy is the need to standardize and generalize the kinds of therapy a person would receive, both for research purposes and to guarantee consistency for patients. But with standardization comes the ability to potentially patent any process that could be claimed as novel. If competitors are building therapy centers or clinics, it could put pressure competitively on those companies, or compel them to pay a royalty for using aspects of a company's protocol.
Casimir said that it’s not uncommon for patent applicants to file extremely broad claims, even if they know they are not patentable. “[Compass] has to know the broad claims they filed here are not patentable,” he said. “I can't imagine they believe they are. And the idea here is to let the patent office pick it up and review it, make a rejection.”
Then, once an applicant sees what the patent office responds with, they can respond with more focused or narrower claims. This process could let a broad claim that the patent office doesn’t catch slip through. “This can lead to bad patents,” Casimir said. “If the patent office doesn't do a good job, then they'll say, 'Okay, you can have this broad claim.'”
Compass's application is a PCT application, which stands for Patent Cooperation Treaty. 153 countries around the world have signed the Patent Cooperation Treaty, and filing it this way allows an applicant to file a single application in all of the countries that are signatories.
When a PCT application is filed, an international search report is issued, and a search examiner looks over the claims and identifies any references that may be relevant. Temeles said this is another benefit of filing a PCT—it can give an applicant a heads-up on what an examiner may flag, even though the international search report itself is not binding.
For this patent application, the search examiner did already identify academic papers on psilocybin-assisted psychotherapy, among them papers from Imperial College London in 2016 and 2018.
"The likelihood of claims from a PCT being granted in their original form is low,” Temeles said. “I think that it requires a pause, and a deep breath. Even with the many year drought of clinical studies in psychedelics, there's plenty of literature out there. It's a little premature, I think, to worry that they've established a monopoly over everything."
If any patent similar to this was granted, that included methods of performing therapy, the patent owner would still have to prove patent infringement, said Temeles. It’s relatively easier to prove infringement of composition, because you could get a chemical compound or synthesis process and show that they’re identical. When it comes to methods of psychotherapy, it would be more challenging.
There are other reasons to file for patents, though, besides a desire to protect your invention. A company can license an application and get a revenue stream from that. And IP is valuable for marketing purposes and soliciting investors.
“When investors invest in a company, they're generally not doing it out of the goodness of their heart, they're doing it in order to make money,” Temeles said. “And the more things a company can do to reduce the risk to the investor, the more comfortable the investor will be inputting money into the company.”
That's how Compass explains its patent decision-making process on its website: “Without IP, there would be little incentive to take the risk to fund the research and development of new products, given the large number of drug candidates that fail during the development process.”
Pechenik said that in this way, such patents, if granted, could make an impact, even if they didn't lead to the patent holder to prevent individual therapists from utilizing aspects of their claims during psychedelic-assisted therapy. “They could use that kind of as leverage to shift the competitive landscape,” he said.
It's too soon to say how it will all shake out—that's the nature of the patent process. With how high-profile psychedelic medicine has become, and all the new companies popping up trying to latch on to the trend, though, the clash between a more traditional pharmaceutical process and one based on open science and nonprofit organizations will certainly intensify, and the shape that conflict takes will largely depend on how patent applications are treated.
“There are those who want to move the industry in the direction closer to standard pharma,” Temeles said. “I think that what Compass is doing is no different than what any other pharmaceutical company would be doing.”
One of the guiding principles behind the patenting process, Temeles said, that should be held onto is that you can’t take something away from the public that is already out there.
“Psilocybin is in the public domain, which is why no one can go out and claim psilocybin,” she said. “We own it. So whatever anyone files on, it's got to be beyond that. It's got to stay out of the public domain, and that's the kind of scrutiny a patent examiner will give these claims.”
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