Despite wariness around the steep rise in psychedelic patents over the last year, patents continue to be applied for and granted on everything from LSD for food allergies to DMT vape pens. Patents have been hotly debated in open letters and blog posts and on panels, yet there have been relatively few actual challenges to patents—in part because it’s a complex and expensive process to push back against a patent once it’s been granted.
The most high-profile challenge so far happened at the end of last year, when the non-profit Freedom to Operate filed two petitions for post-grant review (PGR) against patents for a synthetic form of psilocybin held by mental health company Compass Pathways. But these petitions took around a million dollars and months of work from a team of hired scientists and lawyers. As the psychedelic field becomes saturated with more patents, not many organizations or individuals have the resources to do the same.
The concern around psychedelic patents is more than a philosophical one about whether a corporation can own nature. Who legally owns what can impact the cost of psychedelic products and services later on, as well as drive investor decisions, determining which companies thrive and which do not. Having tools and resources to navigate the patent landscape can help create more equitable access. Recent actions taken by Freedom to Operate highlight some alternatives to filing exorbitantly expensive petitions.
This week, Motherboard has learned, Freedom to Operate sent a letter directly to George Goldsmith, the co-founder and CEO of Compass, asking him to either willingly disclaim one of Compass’ psilocybin patents or sign a document that would promise Compass would not enforce that patent. Compass did not respond to questions about how it will respond to the letter by the time of publication.
Also this week, Freedom to Operate published new research characterizing a solid form of LSD—not in response to a known patent, but as a preemptive strike to create prior art, or a published record of the existence of the research, so that no one can patent this form of LSD in the future.
What these actions represent more broadly are different strategies that can be employed in response to the rush to patent every element of the psychedelic experience. The publication of the LSD research is a form of “defensive publishing,” while the letter is reminiscent of patent pledges and patent pools that have long existed in fields that find themselves overwhelmed with intellectual property claims that can—contrary to the very purpose of IP laws—end up hindering innovation.
These lower-cost, lower-effort tactics by Freedom to Operate highlight more accessible techniques to block corporate attempts to monopolize psychedelic intellectual property; they could be used by other companies or individuals. They also represent a shift in the battle against psychedelic patents. It may be impossible at this point to eradicate them altogether. The fight at this point is more about what is done with patents—which at least in theory can be tools of inclusion, rather than exclusion.
The letter that was delivered to George Goldsmith, the CEO and cofounder of Compass, on Tuesday is a direct appeal to Goldsmith regarding Compass’ psilocybin patents.
Though Freedom to Operate filed petitions against two of Compass’ patents last year, Compass has another psilocybin patent for a different solid form, called Hydrate A, that Freedom to Operate hasn’t yet filed a petition against. Freedom to Operate believes its research showed that Hydrate A is not a new form of psilocybin—this is significant because patents are only supposed to be granted on new inventions. Research published in the peer-reviewed crystallography journal Acta Crystallographica, and funded by Freedom to Operate, claims that Hydrate A was available as early as 1963 and was used in human clinical trials as early as 2017.
The letter asks Goldsmith (and Compass) to “disclaim” the patent on Hydrate A, or sign a document saying that Compass will “not attempt to enforce any claim” of that patent. This is called a “covenant not to sue,” essentially a promise that a patent holder will never sue another person for using an invention they own. In this case, the covenant not to sue is asking Compass not to enforce its IP against the “Psilocybin Therapeutic Community” more broadly.
Freedom to Operate sent this letter in an attempt to avoid filing another petition for post-grant review, Jack Griem, a lawyer for Freedom to Operate, told Motherboard. “The fact that Hydrate A existed well before Compass filed its patent application, according to the peer-reviewed science published in Acta C, is beyond reasonable dispute,” Griem said. “The open letter asks Compass to respect that science and avoid wasting money and time on legal proceedings that could be spent on research and development for the benefit of patients.”
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If Goldsmith signs the covenant not to sue, “that will clear the way for research to proceed without fear of a meritless lawsuit threat from Compass,” Griem said.
Griem admitted it’s rare for a company to disclaim a patent or issue a covenant not to sue before a court has stepped into rule on a patent’s validity. But he asserts that this situation is “unusual in that proof of invalidity has been established in a peer reviewed publication that came out after the patent was issued.” Compass did not respond to questions about Hydrate A or Freedom to Operate’s claims that the polymorph is not novel.
Compass Pathways has had three months to file a response to Freedom to Operate’s petitions from December, and its responses were made public in the last two weeks. In those responses, Compass made claims about why the petitions are not valid, including the assertion that its solid form of psilocybin wasn’t actually depicted in Freedom to Operate’s research, but is different in shape, per Compass’ measurements. It also said that the petition didn’t include Carey Turnbull or Usona Institute’s name as petitioners—these should have been included, it argued. (The petition includes Freedom to Operate and Turnbull’s companies Ceruvia Lifesciences LLC, and B.More Inc, but doesn’t name the nonprofit Usona Institute or Turnbull explicitly.)
We will have to wait and see whether Goldsmith will sign a covenant or disclaim the company’s Hydrate A patent, but given the detailed responses to the filed petitions, it seems unlikely, said Graham Pechenik, a patent attorney at Calyx Law. Still, the practice of making promises around patent enforcement itself is not unheard of, and it’s a way of avoiding costs, whether in licensing or having to endure legal skirmishes.
Companies might acquire IP, and then promise not to enforce the rights attached to that IP in some capacity, whether against certain parties or in certain circumstances. For instance, in 2014, Elon Musk wrote that he would not be enforcing any of Tesla patents. “Too often these days [patents] serve merely to stifle progress, entrench the positions of giant corporations and enrich those in the legal profession, rather than the actual inventors,” Musk wrote.
A covenant is similar to a “patent pledge,” which involves IP holders making promises about what they will and will not do with a patent. The academic lawyer Jorge L. Contreras defined pledges as “public commitments to limit the enforcement or other exploitation of one’s patent rights.”
Microsoft and IBM have made similar pledges. Twitter’s Innovator’s Patent Agreement meant that Twitter promised to only use patents defensively—except with an inventor’s permission. Pechenik shared another example of a broad promise to not enforce patents: a defensive patent license (DPL). This is a patent license “where any party can publicly declare that all of its patents and any future patents it may acquire are freely given to all others making the same commitment. Patents are therefore freely shared within the DPL community, but can still be asserted against others outside of it (so not fully public domain),” he said.
This is similar to what’s called a “patent pool,” where members of the pool make a promise to each other to license any patents that they own on “fair, reasonable, and nondiscriminatory terms,” or FRAND licensing. “It’s essentially a promise not to sue,” said Michael Mattioli, a professor of law at Indiana University. “It’s a promise to engage in good faith licensing.” Depending on the particulars, these covenants and pledges are not always a legally enforceable contract, but it has some legal teeth to it, he added.
Why would any company sign such a pledge, or join a pool? It’s not just a selfless move. In the early days of the patent system, the relationship between patents and products was often one to one. “Let’s say you wanted to build a piece of agricultural machinery that was patented, often you just needed to get a license from one patent holder and you could build that product,” Mattioli said.
But after the industrial revolution, machines became more complex. In order to make one machine, a person often needed to get permission from many different patent holders. Today, in the world of smartphones and other complex technology, making a product can require permissions from dozens.
That creates a problem, and one that’s been well-studied in other fields outside of psychedelics. First, it’s expensive to even identify all of the patent holders, and a party would need to hire a lawyer to figure it out. After the companies who hold the patents are found, they have to negotiate with each one of them. There’s the risk that if a company finds out their cooperation is essential, they’ll set their licensing fee extremely high.
“It’s a holdout situation,” Mattioli said. “That state of affairs is bad for not only companies that want to make things, but the patent holders themselves,” because the other patent holders are also stuck in the holdout.
These are the kinds of situations where patent pools have arisen, when a group decides to share IP to facilitate the production of a product. Patent pools have thrived in settings where it’s possible to identify nearly all of the patents essential to some end product—like all the components that make up a computer.
“In the medical space, that’s sometimes more elusive or nebulous,” Mattioli said.
Since there’s been a large growth in the psychedelic industry, but very few actual products being delivered yet widely—due to legal and regulatory restrictions—we don’t know yet how patents will impact the roll out of services. What are all the necessary components of a psychedelic service, and who owns each requisite part? If a similar situation arises as did in the tech world, we may see the natural emergence of pools or pledges to avoid difficulties.
Signing a pledge or joining a pool also allows an owner to keep their patent, rather than having it invalidated. Having a patent, even if you agree to never enforce it, can still cast a big shadow.
“It can discourage other companies or researchers from even coming near the claim subject matter,” he said. “It might also help them get investments that may send signals about how innovative they are.”
The research published by Freedom to Operate takes a slightly different approach. It’s a characterization of a specific salt form of LSD called LSD D-tartrate. LSD, like psilocybin, can be made into a solid in the lab through crystallization. The shape of the solid form, made up of repeating LSD molecules, is called a polymorph.
Unlike Freedom to Operate’s petitions from last year, which argued against known patents from Compass based on the publication of psilocybin polymorphs, this research was undertaken proactively—it’s not known that anyone has filed a patent on this form of LSD yet, and by publishing its structure, it is now in the prior art and theoretically un-patentable.
Freedom to Operate used an independent chemical analysis laboratory, the same one used for the psilocybin research, and found that LSD D-tartrate has a single solid form, which they have called Form A. Freedom to Operate submitted the research to Porta Sophia, the non-profit psychedelics prior art database. This research has not been submitted for peer review by an academic journal, but will be undergoing Porta Sophia’s scientific review.
The goal “is to try and stop bad patents from issuing because the evidence regarding the existence of the LSD D-tartrate polymorph is now in the prior art,” Griem said.
David Nichols, a professor emeritus of pharmacology at Purdue University and expert in synthesizing psychedelics, said that he thinks that this polymorphic form has been made and used before, but not published on or characterized specifically. “There might be others, and this only publishes this one, so it protects this salt but not any others, leaving an open path, while at the same time not precluding others, should they exist, from possible patents,” Nichols said. (Nichols is also named as one of the co-inventors on some of Compass Pathways’ psilocybin patents.)
Publishing this LSD research is a form of defensive publishing, a strategy with a long history. It’s like salting the earth, said Mattioli. “It’s creating a place where no one can claim exclusivity,” he said.
Sometimes, it’s patents that are used defensively: Up until 2013, there was a defensive patent publication called a statutory invention registration (SIR) which could be used to make sure that an invention would enter the public domain. There was also a type of U.S. patent application called a defensive publication. “By filing a SIR or a defensive publication, the applicant waived the right to get a patent on an invention, so it was only for the purpose of creating prior art,” Pechenik said.
In the biotech space, one example of a SIR was the SNP Consortium from 1999. This created open access to a genetic map of small DNA changes so that no one could get a patent on them, since they had been previously published.
People can also defensively publish outside of the patent office, as Freedom to Operate has done. This too has precedence: From 1958 to 1998, IBM had a defensive publication called the IBM Technical Disclosure Bulletin. MIT and Cisco created a Prior Art Archive, which, like Porta Sophia, exists so that patent examiners can more easily search for prior art, and Graham said it is searched by USPTO patent examiners.
As the academic lawyer Robert Merges described in a paper, the Merck Gene Index was created in the mid-’90s to be a public database of expressed human genes. In 1998, the Index had published over eight hundred thousand gene sequences. “Their idea was to try to get out in front of the land grab to try to make it impossible for anyone to patent,” Mattioli said.
One benefit to this approach is that it can be much less expensive than applying for individual patent rights, or challenging already granted patents. That doesn’t mean it’s entirely affordable though, depending on how much defensive publishing you want to do.
According to one estimate, the Merck Gene Index cost over a million dollars—but for the same amount of money needed for one or two petitions for PGR, it protected thousands of genes. Recent evaluations found that “the Merck strategy has contributed to a significant easing” of the concern of too many patents in that area, Merges wrote.
There could be uses of defensive publishing that are helpful for the public too: people could publish on negative results, things that they’ve tried that didn’t work. Then, people wouldn’t file for patents on products or uses that may not have much usefulness, or even may be unsafe or ineffective.
But just because something is defensively published doesn’t necessarily mean that it will always be an effective patent blocker. “A patent examiner has limited time for searching, and may only search specific databases,” Pechenik said. “If prior art can’t be found by the patent examiner, it’s useless to keep over broad patent claims from being granted.”
The patent office may have examiners who lack knowledge in psychedelics. This has happened before with software patents, as I. Glenn Cohen and Mason Marks recently wrote in an essay in the Harvard Law Review. “The [patent office] was inundated with software patent applications containing unfamiliar vocabulary and ambitious claiming strategies, which led to a sudden influx of low-quality patents,” they wrote.
We’ve already seen instances already in the psychedelic space where patent examiners don’t do very much searching for prior art that might exist. For a recently granted patent on a DMT vape pen, records show that the examiner only looked for 7 minutes and only searched Chemical Abstracts Plus and the patent database for prior art.
“Though admirable, projects like Porta Sophia are more of a band-aid than a long-term solution because they burden local communities with cataloging their practices and submitting them to prior art libraries,” Cohen and Marks wrote.
Psychedelic defensive publishing will have to contend with cases like these, and ensure that any defensive publications are in fact seen in order to be successfully defensive.
Since patent applications are secret for 18 months, what if there has already been a patent applied for the same LSD polymorph? “Hopefully, the patent applicant will see the LSD polymorph publication and drop the application,” Griem said. “The applicant should realize that there can be no patent on the LSD D-tartrate polymorph because the polymorph was necessarily created when LSD D-tartrate was made over the years since it was discovered by Albert Hoffman.”
Defensive publishing, patent pools, and patent pledges can help avoid what’s called a patent thicket, Mattioli said. This is when a field has so many patents that it’s necessary for a person to gain permission from multiple patent holders in order to produce a product or engage in some avenue of scientific research. This issue has been a source of debate in genetic technologies and cancer therapies.
Patent thickets can create what Rebecca Eisenberg, an academic lawyer at University of Michigan, called an “anticommons.” “This is when there are too many permissions needed in order to go into some product space,” Mattioli said. If different parties hold the patents to crucial components of an invention, it could stifle the use of that invention.
It can also drive an increase in “patent hopping,” when to better navigate a thicket, a party decides to get a patent by making very subtle modifications to something that already exists, and claim it as novel based on those modifications.
“Though technically different from the original, the updated version often provides little or no improved function,” Cohen and Marks wrote. “Product hopping, as we use the term here, can be achieved by filing secondary patents that claim modified versions of a base compound.”
It’s usually only entities that have enough money to deal with all the legal logistics that have the ability to patent hop. Because of this, Cohen and Marks wrote that “patent exclusivity enhances existing disparities.”
For psychedelics, we still don’t know the relationship between patents and the potential products or therapies, or patents and basic scientific research. Whether it be defensive publishing or patent pledges, it’s possible we could see more of these strategies become necessary as the field matures.
“Patent pools are using the tools of the tools of the law to create something like a public land trust,” Mattioli said. “Defensive publishing has been helpful in settings where companies realize that the industry they want to operate within cannot take hold in an environment of heavy patenting.”
For now, the psychedelic community will have to continue to wait and see what actions are taken by various big players: if pledges or pools will start to form, or whether defensive publishing will take off in a larger way, outside of just Porta Sophia. Now that Compass has filed its response to Freedom to Operate’s petitions, the Patent Trial and Appeal Board will decide whether to institute a trial on the validity of its patents that have been challenged.
But all in all, it could help bring about a different way to think about how patents can be used: not only to exclude other people from an invention, but to include them. This is not how they’re often viewed, currently. In an email obtained by Motherboard from last year from psychedelic investor Christian Angermayer, he wrote, “Many psychedelic companies out there will never be able to bring a product to market, as they will hit the patents of Compass and Atai.” (Angermayer is a funder of Compass and co-founder of ATAI Life Sciences.)
Colleen Chien, a law professor at Santa Clara University School of Law, has written about what it might mean to shift our perspective of what patents are for—inclusion or exclusion— and how this could actually help drive innovation. Granting patents has long been associated with “taking away the rights of others,” according to Chien.
“We’re used to thinking that excluding rather than including rivals in the practice of one’s technology, leads to innovation,” she wrote. But what if more innovation could come from inclusionary patent practices instead? Isn’t the reason we have patents in the first place to drive innovation? The result could be “a more participatory, inclusive innovation ecosystem that does not discriminate on the basis on where an idea is born,” Chein wrote, “but enables the best ideas to find their way to the market through any variety of pathways.”
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