In 2001, alternative medicine proponent and doctor Andrew Weil told a CBS journalist that taking LSD cured his lifelong cat allergy. “I was in a wonderful outdoor setting," Weil said. "I felt terrific and, in the midst of this, a cat came up to me and crawled into my lap. I did not have an allergic reaction to it and I never did since.”
In the 20 years since, there have been no research studies in humans showing that LSD can treat allergies of any kind, and yet a patent application for using LSD to treat food allergies has just been granted, as first reported on Twitter by patent lawyer Graham Pechenik. A granted patent gives the applicant ownership of the claims stated in it. In this case, the first claim is for "A method of treating a food allergy condition in a subject in need thereof, the method comprising administering to the subject an amount of a lysergamide psychedelic agent effective to treat the subject for the food allergy condition."
Motherboard wrote about this patent application in March, noting that the application included a "prophetic example," meaning that while the claims described using LSD to treat food allergies, the applicants—the investment firm Palo Alto Investors—hadn’t actually conducted any experiments to see if LSD can be used to treat food allergies, or devised any processes by which to do so. The firm is essentially saying that if this is possible, it owns the idea. (Motherboard reached out to Palo Alto Investors for comment; we'll update the story if they respond.)
“Basically it’s a prophecy, quite literally, where you just lay out what a research program may look like, and then just prophesize what the results you hope to achieve are,” Pechenik told Motherboard at the time.
Can you own an invention that hasn’t been invented yet? You can, according to patent law. The bar for demonstrating that something actually works before filing for a patent is pretty low, said Mason Marks, the Project Lead at the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. There’s a huge difference between the requirements to get a patent and the requirements to get FDA approval, for example.
It may be surprising to people new to the world of patents that an invention doesn’t have to be proven to work in order to be patented. If something is clearly impossible, that’s another story, Marks said—as in the case of a time machine or teleportation device. But in this instance, using LSD for food allergies isn't precluded by the laws of physics, and doesn’t have to be validated through research in order to be granted a patent on it. “People can just dream up things in their mind and say, ‘Let's patent that quickly before any prior art emerges,’” Marks said. “That’s common practice.”
The question of whether such broad patent applications will be granted has been an open question in the psychedelic field, and this patent in particular shows how much the result falls on the decision-making of individual patent examiners. Flooding the patent office with broad, hypothetical applications of psychedelics and prophetic examples could be a way for companies with a lot of money to get ownership over the greater psychedelic market—even before the boundaries of what that is are defined.
An invention does however, have to be both novel and non-obvious. So while a valuable lesson about patents can be learned from this granted application—that lesson being that applicants don't necessarily have to prove something works—Marks said he’s not sure that this patent qualifies on the grounds of novelty and obviousness. After a quick Google search, Marks found a paper published originally in 1965 that described the potential use of LSD for allergies, which proposed that “the antiserotonin action of these compounds makes them of special value in the study of allergic mechanisms.”
Marks said that even Weil saying on television—and, later, on Joe Rogan’s podcast—that LSD cured his cat allergy, whether true or not, might count as prior art, or at least as an argument that using psychedelics for food allergies is obvious. Marks also found Reddit posts in his search in which people talked about how psychedelics improved their pollen allergies. “You have all these different people talking about different allergies that LSD has been useful for,” Marks said.
David Casimir, an intellectual property lawyer who helped create Porta Sofia, a psychedelic prior art repository, said that if you type in “allergies” into the Porta Sofia database, it pulls up a book from 2002 called Remembrance of LSD Therapy Past by psychologist Betty Eisner. The book recounts older stories of psychedelic experiences people had—and there are two allergy anecdotes in the book. In one, a person from 1959 reports that their milk allergy improved after using LSD.
There are a few more research references in the patent itself, like a study from 2015 that found in mice that activating certain serotonin receptors could prevent allergic asthma, or airway inflammation. This is promising, early, work—in an animal model—but not yet a smoking gun for using LSD in humans for food allergies.
This smattering of suggestive but inconclusive research means two things: that the evidence on psychedelics for treating food allergies is perhaps intriguing, but still far from conclusive, and that the idea to do so may not be novel, and therefore not eligible for patenting.
There are other problems with this patent besides prior art. One is called the "enablement requirement" of patent law, which poses a basic question: Did the patent applicants describe the invention well enough that anyone proficient in this field could make and use the invention? In their prophetic example, the applicants described the kind of experiment one could do, but didn't provide doses, what food to use, or any further detail on what would be a very complicated and sensitive study on people with food allergies.
As Casimir previously told Motherboard, another issue is called “anticipation by inherency,” which means that someone can’t patent something that was done before, even if no one recognized it. Now that this patent has been granted, Casimir took the time to crunch some numbers on LSD and food allergies, “just to get a feel for what are the odds that someone in the past with a food allergy took LSD and would have inherently gotten the benefit.”
Using numbers provided by the National Institute on Drug Abuse, which does an annual survey on drug use by high school seniors, Casimir pulled the lowest LSD usage number, from 1986, when 7.2% of high school seniors had reported using LSD. In 1986, there were roughly 2.6 million high school seniors, so 187,000 high school seniors took LSD. He then looked at the food allergy rate among 18-year-olds, which was roughly 6.5%.
“So, statistically speaking, 12,000 people who took LSD in 1986 as high school seniors had food allergies, and would have received a benefit,” Casimir said. “They would have practiced Claim 1 of that issued patent. What are the odds that none of the 187,000 people who took LSD had a food allergy? It's mathematically zero—would be the equivalent of flipping a coin and getting heads 25,000 times in a row.”
So why did this patent get granted, if there was prior art floating around, or if there were enablement requirement issues? Why didn’t the patent examiner do the math on anticipation by inherency? It really comes down to the individual patent examiner. “We've got thousands of patent examiners in the patent office and they vary in terms of how permissive they are to grant patents or how restrictive they are,” Casimir said.
There are services that track statistics on this. If you put in the patent examiner’s name for this patent into one of them, called Patent Bots, you can see that the examiner who reviewed this patent granted 83% of their cases, and is considered in the top quartile for being the "easiest" to get patents granted. (Motherboard reached out to the examiner, and will update the story if they respond.)
“It's based on luck,” Casimir said. “And there's some fairly extreme numbers; some patent examiners grant less than 1% of the applications they receive.”
Based on luck as it may be, let’s say Palo Alto Investors wanted to file more patents on other psychedelic compounds for food allergies, since this patent only makes claims on LSD. If they did that, Casimir said, it would be very likely that any related patent applications would go to the same examiner.
The prior searches a given examiner did are also part of the public record. This examiner did what Casimir called a “traditional patent search”—they looked at older patents and peer-reviewed literature, and didn’t find anything. “The prior art here you’d only get through Google or by Porta Sofia, some of the nontraditional ways to look for things,” Casimir said. “And the patent applicants themselves provided very little prior art in their information disclosure statement.”
Since this patent was granted, someone who objects to it will either have to file what’s called a third-party submission or file for reexamination in the patent office. For a patent that’s recently been granted, the route would be called a PGR, or Post-Grant Review, which allows anyone who's willing to participate to challenge a patent, but only nine months after the patent is issued. This highlights the risk when patents that have potentially serious issues around eligibility slip by examiners—it takes a proactive effort to challenge them, and if the PGR period is missed, it costs a lot of money to do so.
One concern is that these patents can impact the ability or choice of others to do research on this area. Say a small company wants to actually do the experiments this patent prophesized: they could either be sued for patent infringement, or be deterred from pursuing that line of research in the first place if another group already holds a patent on it.
That's the worry with other broad patent applications, as Motherboard has reported on before, and as Russell Hausfeld and David Nickles reported on in Psymposia. They wrote about how mental health company Compass Pathways has three international Patent Cooperation Treaty (PCT) applications which are “attempting to patent psilocybin treatment for almost every mental health condition you might think of,” including conditions they haven’t conducted research on. Filing broad patents can serve to block competition even before any research on a topic has been done.
“That’s particularly maddening because you can think of all the people with food allergies who could actually really use something like that,” Marks said.
Cathryn Nagler, a scientist and professor at the University of Chicago, told me that she, and others, think the rise in allergies is explained by environmental factors changing our microbiome—the bacteria that live in our bodies—due in large part to the misuse of antibiotics and the loss of dietary fiber from our diets. Nagler is part of a team working on isolating molecules produced by gut microbes as a treatment for food allergies. Another approach is the use of oral immunotherapy, or the exposure to tiny amounts of the food a person is allergic to in order to become desensitized to it.
An unwitting side effect of this granted patent is that it could make LSD seem like another well-researched treatment for food allergy sufferers, even though there is no evidence to back that up. “This could be quite dangerous because a person reading could say, ‘OK, I’m going to try this: take some LSD and then try some of that peanut butter or that shellfish,’” Marks said. “This has not been established at all. That person could die. So even though you could get a patent on something that has not really been established, you might question whether it's good public policy to do so. And is this the kind of invention that we really want to be rewarded with patent protection?”
It’s worth stating plainly: Don’t try to treat an allergy—especially a life threatening one—with LSD, just because an investment firm now owns the ability to do so.
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