Harvard Law School this week announced the launch of a psychedelics-focused project. The initiative comes just months after Harvard-affiliated Mass General Hospital launched the Center for the Neuroscience of Psychedelics, and nearly 60 years since Timothy Leary’s downfall at the institution.
Elsewhere, California’s bill to decriminalize psychedelics cleared another hurdle earlier this week, passing the California Assembly Committee on Public Safety in a 5-3 vote.
First up, we take a look at the latest intriguing patent in the space…
Psychedelic Sector News
LSD for Food Allergies: A Prophecy Come to Pass?
“Companies can own potentially valuable psychedelic IP without anyone even knowing if it works,” writes Shayla Love in her latest piece for VICE. Back in March, Love covered a patent application that sought to claim the use of LSD to treat food allergies. Interestingly, the article points out that Palo Alto Investors, who submitted the application, “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.”
This week, our editor-at-large Graham Pechenik reported that the patent has now been granted. Given the lack of associated research, or even a clear methodology to conduct such research, this case serves as an important reminder that “the bar for demonstrating that something actually works before filing for a patent is pretty low.”
The type of support used is dubbed a ‘prophetic example,’ whereby an applicant describes “reasonably expected future or anticipated results” from experiments that have not been performed. This is in contrast to ‘working examples,’ which refer to experiments or work that has been conducted and which yielded results.
Patents reward innovation by granting the inventors a time-limited monopoly over their invention. In return, the inventors must describe their invention in a manner sufficient to enable a person having ordinary skill in the art (PHOSITA) to make and use it. This trade-off—a time-limited monopoly in return for a contribution to public knowledge —is at the core of the rationale behind patents.
Whether these ‘written description’ and ‘enablement’ requirements are met in a meaningful way in a patent that relies solely on a single prophetic example, such as the one under discussion here, is a matter for debate. In fact, one might argue that such a patent could act as a deterrent to innovation in the relevant fields of research, as undertaking costly R&D efforts on a topic that another party owns IP over is not attractive to most.
The debate surrounding patents rooted in prophetic examples bleeds into a broader concern around the filing of broad patents. As Shayla Love explains in her piece, “filing broad patents can serve to block competition even before any research on a topic has been done.”
Furthermore, this particular case may fall foul of ‘anticipation by inherency,’ a central tenet of patent regimes which should prevent a patent being allowed where its claims can be found to exist in the prior art. In Shayla Love’s article, a number of ways in which LSD for food allergies may have been experimented with in the past are highlighted. Notably, Andrew Weil has claimed that LSD cured his allergies to cats: a claim he has made on both CBS and the Joe Rogan Podcast.
Coincidentally, the USPTO issued a notice on the topic of prophetic examples this week, “reminding applicants that patent applications must properly present examples in a manner that clearly distinguishes between prophetic examples that describe predicted experimental results and working examples that report actual experimental results.” At the same time, however, it observed that “courts have sanctioned the use of prophetic examples to meet the written description and enablement requirements for a patent application” and a “patent application does not need to provide a guarantee that a prophetic example actually works.”
Read Shayla Love’s article on VICE for the full story, which touches many of the points above. Love has now profiled a number of individual patents as case studies, which she uses to make more generalizable points and observations about IP as it pertains to psychedelics.
- Awakn Life Sciences files patent applications covering NCEs targeting addiction indications;
- Compass Pathways completes dosing of Phase 2b study;
- Cybin announces positive preclinical results and Adelia milestone achievement;
- Lobe Sciences appoints Charles Grob to Scientific Advisory Board;
- MindMed included in FTSE Russell 3000 Index;
- Psilera raises $2.5m.
Harvard Law School Launches Psychedelics Research Project
Earlier this week, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School announced a new research initiative that will promote safety, innovation, equity and access in psychedelics research, commerce, and therapeutics.
The Project on Psychedelics Law and Regulation, or POPLAR, is the first academic initiative offering a clear focus on psychedelics law, regulation and ethics.
Beyond an obvious interest in legislative measures, the debate around intellectual property in the psychedelics space is set to be a “major focus” of POPLAR, which will “analyze the role of biopiracy in psychedelics commercialization and the ethics, validity, and social utility of patents on psychedelics related inventions,” Project Lead Mason Marks told Psilocybin Alpha.
Read the full piece, which includes comment from Mason Marks, here.
California Psychedelics Decriminalization Bill Passes Key Committee
In the latest win for Sen. Scott Wiener’s SB 519, the Bill passed the California State Assembly Committee on Public Safety by a 5-3 vote. In his statement, Wiener claimed that psychedelics are “fixing people’s brains,” and was supported by witnesses including veterans group Heroic Hearts.
The Bill has undergone a number of amendments since it was first introduced. Notably, a clause that mandated the expungement of historic convictions related to the possession of psychedelics was removed from the Bill. The latest committee also suggested the removal of ketamine from the bill, which Wiener accepted.
Now, the Bill heads to the Committee on Health where it will be heard on Tuesday, July 13th.
If the Bill continues to be passed by Committees, it will head to the Floor, and potentially Governor Newsom’s desk in September.
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