Finding psychedelic prior art: 5 Questions for Porta Sophia’s Shahin Shams
Shams discusses her role at Porta Sophia and the data team’s recent work.
Psychedelic substances predate humans by millions of years, but it’s only in the last few decades that people have attempted to create their own — and to patent their results. U.S. patent law requires that patentable drugs be novel and inventive — and any evidence that the drug has previously been synthesized or widely used suggests that it’s not particularly novel or inventive. Members of the general public can file what’s called a “third party submission” to the U.S. Patent and Trademark Office to point patent examiners towards that kind of evidence, which people in the patent world call “prior art.” A non-profit group called Porta Sophia maintains an online psychedelic prior art library and files third party submissions to ensure that as much psychedelic information as possible remains in the public domain.
Shahin Shams is a data and patent analyst at Porta Sophia. A biomedical engineer by training, Shams’s research focused on gene therapy and gene editing systems, an at-times controversial topic. From there, Shams became interested in psychedelics: another area that had great promise in therapeutic treatments, but that faced a “similar sort of uphill battle.” Shams was one of the first people to join Porta Sophia in 2021, and is now studying law at U.C. Berkeley. The Microdose spoke with Shams about her role at Porta Sophia and the data team’s recent work.
What happens when a patent application is approved that includes things that belong in the public domain?
A patent is essentially a government sanctioned monopoly. If something is claimed in a patent and that claim is granted, then the patent owner has exclusive rights to make, sell, and distribute that product. That market exclusivity also means the patent owner can control how that therapeutic application is leveraged — and that could put a lot of other individuals who have been freely using this information in a very bad predicament. They could face infringement litigation.
To be clear, we aren't against patenting. We are always in support of good patents. But we want to ensure that the public domain stays in the public domain — that the public has rights and access to all the knowledge to which it already has rights and access.
Are there any recent applications you’ve been focused on that illustrate that risk?
There’s one case that is part of a patent family owned by Turtle Bear Holdings who have filed quite a few patent applications. Essentially what they’re claiming is microdoses of psilocybin — it covers a method of treating or reducing symptoms of a mood disorder by administering 1 to 10mg of psilocybin or psilocin 1 to 6 times per day. When you actually take a look at the substance of it, what that claim is saying is that you are treating a mood disorder using 1 to 10mg of psilocybin once a day — that's literally how microdosing works. They were granted that patent earlier this year.
It’s an unfortunately typical practice that when you receive a patent, that “parent” application can be a sort of anchor from which you can also file child applications to take up more territory in that research space. There are two child applications associated with that psilocybin microdose patent, which were filed immediately after the parent was granted. The claims of those child applications were not only highly similar to that of the parent, but also expanded upon the rights that the parent application provided, so we filed third party submissions against them. Additionally, both those applications were being evaluated by the same examiner that granted the parent.
We were able to submit a very small amount of prior art, and the examiner issued a rejection, citing the prior art we submitted. We are very hopeful; this will at least cause the applicants to restrategize.
You mentioned earlier that the same patent examiner who looked at the parent application also was presiding over the child applications. Is there variability among individual examiners in how likely they are to take into account third party submissions, and to dig into examples of prior art mentioned in those submissions?
When it comes to examiners, there's quite a bit of information regarding the record of patent examiners; there's actually an online resource for their three year grant rates. As for how our third party submissions are received, we have not traced examiners. And in any case, there are a lot of variability points that make it difficult to make a determination on whether our submissions are well-received. A lot of it also may come down to the fact that when we do a third party submission, we're not allowed to make any arguments. We're not actually allowed to explain why we're including the prior art that we are. So what we're doing is pulling direct quotations and organizing them in a way that we hope effectively conveys our argument.
What’s the most obscure source you all have included as a source for prior art in one of your third party submissions?
A lot of these forums that we source from, especially for older pieces of underground prior art, were posted between 2006 and 2012. My computer has trouble processing it sometimes; it takes me back to the MySpace era. We had one very interesting case where we made a submission regarding a patent application using MDMA and Viagra together for sexual enhancement. That's something that’s talked about online extensively; it’s a very common practice in the club drug scene, and people call it Foxy Sex-tasy. We found this one specific post on the site Erowid where someone posted about it, saying that Foxy Sex-tasy is the colloquial name for the combination of MDMA and Viagra.
In their rejection, the U.S. Patent and Trademark Office actually quoted and screenshotted that post as evidence as to why that application should not be allowed and it’s now effectively abandoned. It’s funny how this one Erowid post we found led to the complete abandonment of this patent application. Thank you to that poster; that was a very valuable experience to post about!
That was actually a great litmus test to see whether these types of obscure publications were going to be accepted by the Patent Office. We’ve always looked for signs that the examiner is actually using the prior art that you're providing, and in the past, we’ve frequently seen the prior art we point to coming up in the USPTO’s rejections, but it’s hard to know whether they found it themselves, or from us. This was the first time where we actually saw one where it was so niche and so outside of anything that an examiner would just randomly stumble upon in the USPTO’s internal database searches that we knew they’d found it from our submission, and that our method of continuing with third party submissions was actually a viable road for us to go down.
What trends are you currently seeing in the patent world?
As the field is maturing, mainstream pharmaceutical companies’ interest in the space is evident; many of the claims being drafted in applications are more reflective of pharma’s usual gimmicks. A good example of this is a patent application from Compass Pathways, focused on a polymorph of psilocybin called Hydrate A. It's one of the polymorphs they have in their pipeline, and unlike Polymorph A, which courts already decided was novel (not everyone agrees), all the elements used to define Hydrate A are identical to psilocybin trihydrate, which is well known and a very common form of psilocybin that has been thoroughly documented.
By using creative claim language, and by including fancy chemical analyses in the claim language itself, this company is effectively monopolizing compositions of a very powerful established resource. And other companies are learning from that; they might also try to include such aspects to make it seem like they’re patenting a new compound, when in actuality it could just be redefining something that's already in existence to gain control over it.
This interview has been edited and condensed for clarity and length.