As interest in psychedelics grows, so do efforts to legalize their use in the United States. Here’s some background on the shifting political and legal landscape.

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While plant- and fungi-based psychedelic substances have been used for millennia by cultures around the world, recent research has sparked renewed interest in using psychedelic substances in Western therapy and healing. This model has attracted nonprofits and businesses that aim to produce, gain U.S. Food and Drug Administration approval for, and supply these drugs for use under medical supervision. Many companies are seeking to patent variants of known psychedelics or create new ones.

Patent law prohibits patents on naturally occurring substances, including plants or fungi. That means certain forms of psychedelics, like unprocessed psilocybin mushrooms or Tabernanthe iboga shrubs containing ibogaine, are not patentable. But derivatives and composite versions of psychedelic molecules might be eligible if a patent applicant shows that their version is novel, non-obvious, and inventive. In other words, it can’t have appeared anywhere else, and the process to create the substance must have been innovative. Patents can also cover other aspects related to drugs, like the dosage and how the substance is administered and manufactured.

In this burgeoning field, patents are often associated with power and money. “Even having applications filed can potentially dissuade people from doing work within the space defined by some of those potential patents,” patent attorney Graham Pechenik told The Microdose. Patent portfolios can have a wide-ranging influence on other companies’ research and development, scientists’ research, and future drug prices.

Complicating matters further, the patent process can be opaque. Patent applications are sealed for eighteen months after submission. Though some companies issue press releases about their new applications, specifics are usually not revealed until after the eighteen-month period, when the patent is published. Psychedelic Alpha, a psychedelic-analysis company, maintains a collection of trackers that monitor psilocybin-, LSD-, MDMA-, and DMT-related patents granted by the U.S. Patent and Trademark Office, as well as psilocybin-related patent applications. According to its records, the USPTO granted nine psilocybin patents in 2021; additionally, another two dozen psilocybin-related patents were filed and published in 2021, as well as nine LSD-related and eleven DMT-related patents.

Psychedelic patents tend to be controversial. Some believe that patents have been granted for claims that do not meet the USPTO’s standards for being novel, non-obvious, and inventive. To assess an application’s novelty and inventiveness, patent examiners review what they call “prior art,” which usually consists of peer-reviewed research, previous patents, and other publicly available information. But psychedelic patents present a unique challenge: prior art is often hard to find. In the 1960s and 1970s, a federal prohibition on most psychedelics and stricter regulation of pharmaceutical companies pushed the few remaining studies on their use—and their findings—underground. The lack of easily found prior art can lead to incorrect assessments of whether the claims in new psychedelics patent applications are actually novel and inventive. Porta Sophia is a nonprofit group working to compile prior art on psychedelics, including files from little-known archives and news articles, to help patent examiners gain a fuller picture of the field.

Recently, two psilocybin-related patents from pharmaceutical company COMPASS Pathways have been challenged, opening up a conversation about the validity of patents on psychedelics. The U.S. Patent and Trademark Office can be petitioned for a post-grant review for up to nine months after a patent has been issued. If USPTO grants the request, it conducts an investigation into the validity of the patents under review. In late 2021, a non-profit called Freedom to Operate submitted post-grant review applications for two patents granted for what COMPASS claims are inventive, lab-made formulations of psilocybin. Essentially, FTO submitted archival prior art and a new crystallographic analysis of various crystalline forms of psilocybin to argue that COMPASS’s claims were actually neither novel nor inventive. (For more on this challenge, read The Microdose’s coverage of FTO’s first post-grant review application and the science behind it.)

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