Beyond the Psychedelic Competitive Moat: Chasing the Patent Dragon

by HealthMatters February 16, 2024, 5:49 pm 1.8k Views

By Amanda Rose Pratt and Shahin Shams

In the last five years, the granting of overly broad psychedelic patents led to the creation of the nonprofit online psychedelic prior art library Porta Sophia. As Porta Sophia-affiliated researchers with expertise in psychedelic science, patent law, archival history, and rhetoric, we have come face to face with the way psychedelic hype manifests within the world of psychedelic patent documents.

Here, we examine hype in the context of a perennial tension at the heart of patenting communication: between advertising innovation and keeping it secret. Given the fact that innovators cannot disclose their technological innovations if they hope to gain patent rights over them, and that they simultaneously need to attract investors—often on the merits of their intellectual property portfolios—what public communication strategies emerge? We look closely at the patenting strategies of the psychedelic biotech company MindMed here because their case reveals important insights about the rhetorical dynamics related to tensions around public psychedelic patent communication.

First, not unlike psychedelic patent applications more broadly, a large percentage of MindMed’s claims to innovation are overly broad. MindMed is currently listed as the assignee of 33 U.S. patent documents – 31 of which focus on psychedelic technology and the application thereof: 29 applications are active, one is abandoned, and one issued as a patent. Porta Sophia identifies ~90% (26) of these active applications as highly threatening “Tier 1” status, meaning the claims would do significant damage to the psychedelic field if granted by locking historically utilized therapies behind high paywalls and limiting future research.

Second, the case of MindMed sheds light on the role of patents within the growing phenomenon of industry-university partnerships in psychedelics. Indeed, it’s not just big corporations that are in the patenting game. A range of entities are filing psychedelic patent applications – from publicly traded corporations to universities and government bodies. As of mid-September 2023, Porta Sophia has filed 60 third-party interventions on patent applications that we evaluate as especially egregious. Of those, eight were filed in response to patent applications submitted by Mind Medicine, Inc. (MindMed). An additional four Porta Sophia interventions responded to one of MindMed’s University partners, Universitätsspital Basel (University Hospital Basel, or UHB). Thus, filings related to these patents represent a combined total of twelve, or 20%, of our total interventions.

Third, and perhaps most pressingly, the heart of this MindMed case study offers unique insight on the impact of Porta Sophia’s intervention strategy itself. As we will discuss below, MindMed recently submitted two related patent applications—one was expedited to preclude the possibility of intervention and thereafter was granted; one was not expedited, Porta Sophia filed an intervention on it, and was rejected.

Holding IP Cards Close

Just over a month from their genesis, on April 1, 2020, MindMed announced their collaborative partnership with UHB – they acquired an exclusive license to eight LSD clinical trials and more than ten years of data via an agreement with Matthias Emmanel Leichti’s lab in Switzerland. An immediate priority seemed to be securing intellectual property, and MindMed has certainly been active in the world of psychedelic patenting since.

The collaboration with Leichti plays a key role in MindMed’s psychedelic intellectual property landgrab. Eight of MindMed’s U.S. applications list Leichti as an inventor; beyond these applications, MindMed will have rights to psychedelic patents generated through Leichti’s lab at UHB.

While the uninitiated might think that an obvious strategy for generating interest from psychedelic investors in the publicly traded MindMed would involve amplifying all prospective patent activity via public communications, only four of MindMed’s nearly 200 press releases include reference to patenting or IP in their title.

In an August 3, 2021 Fireside Chat, newly-minted MindMed interim (now official) CEO Robert Barrow addressed this dearth of public communications on patenting, saying:

for those of you who perhaps see at times we are less vocal about every new patent filing we have: some organizations like to say every time they file a provisional patent application. That’s fine, that’s good for them. There’s actually an enormous commercial value to holding your cards close to your chest and not going out every time you’re filing something and saying “hey this is what I have.” As soon as you disclose what you’ve been working on and what your technology you believe is, it gives everyone else an opportunity to work around it.

So MindMed reaches the catch-22 of patenting communication. Innovation is at the root of a promise to shareholders, but as part of a calculated long-term strategy to secure IP, MindMed is clearly not in the business of broadcasting every provisional patent application.

The 18-month “dark period” before patent applications are made public works with this “cards to the chest” approach to make an already opaque patent strategy less transparent. And to even further preclude the possibility of making patent strategies transparent to the public, applicants with ample financial means can fast-track applications by requesting prioritized examination through “Track One” or petitioning for 12-month accelerated examination so that their applications are examined before the dark period expires.

Candy-Flipping

So let’s examine an instance where MindMed/UHB did just that. UHB’s patent application U.S 17/549,807 (hereafter referred to as “‘807”), titled “MDMA Treatment to Enhance Acute Emotional Effects Profile of LSD, Psilocybin, or other Psychedelics,” was granted as of June 21, 2022, resulting in U.S. patent 11,364,221. The patent generally claims the use of an empathogen to enhance a positive response to a psychedelic. More specifically, the patent describes the coadministration of MDMA to enhance a positive emotional response to LSD – a common combination widely known as “candy-flipping.”

The granting of this patent has drawn attention from mainstream news outlets and outrage from the psychedelic community. Though a large body of prior art exists to establish that this technology was known, the improper granting of this patent was likely driven by either lack of access to and/or lack of familiarity with “often-illegal” sources of prior art.

The ‘807 application was granted an accelerated examination process, meaning that the inventors paid to have its examination expedited. As a result, when the ‘807 application became publicly available on March 31, 2022, examination had already commenced during the 18 month “dark period,” thus precluding third parties from intervening through submissions of prior art to the USPTO.

However, the story doesn’t end there. A very similar parent application to ‘807, U.S. 17/238,088 (hereafter referred to as “‘088”) did not have an expedited examination. This case is an important one to follow because Porta Sophia filed a third-party submission of prior art to the USPTO for ‘088 on April 14, 2022 (while the ‘807 application was still being examined), demonstrating that the claims of the application lacked novelty and were obvious. The USPTO eventually utilized the art submitted against ‘088 to reject the vast majority of the application’s original and amended claims on the basis that the prior art showed that the claims failed to meet the U.S. patentability standards of novelty and nonobviousness on Februrary 23, 2023.

This prior art being utilized to reject the ‘088 application’s claims adds an important point of concern surrounding the ‘807 child patent being granted. When filing an application with the USPTO, all applicants have a duty to disclose any and all prior art relevant to the examination of that application that they are aware of (37 CFR § 1.56). UHB did not meet this standard by failing to disclose to the patent office the prior art Porta Sophia submitted related to ‘088. Since our third-party intervention for ‘088 was filed on April 14, 2022, and the ‘807 parent patent wasn’t granted until June, the question remains as to why this prior art was not disclosed. Indeed, the claims of the ‘807 application were highly similar to ‘088, so much so that in both the non-final and final rejections the USPTO issued to the claims of the ‘088 application, the examiner stated that the claims of the two applications were “not patentably distinct” from one another even after UHB amended ‘088’s claims (USPTO). Indeed, the claims of the ‘807 application were highly similar to ‘088, so much so that in both the non-final and final rejections the USPTO issued to the claims of the ‘088 application, the examiner stated that the claims of the two applications were “not patentably distinct” from one another even after UHB amended ‘088’s claims (USPTO).

04/22/21 – ‘088 application filed

11/12/21 – ‘088 application publicly available

12/13/21 – ‘807 application filed (along with a Petition for 12-month Accelerated Examination)

03/11/22 – ‘807 receives first office action, commencing examination and eliminating the possibility of third-party interventions

03/31/22 – ‘807 application publicly available

04/14/22 – Porta Sophia files third-party submission on ‘088

04/20/22 – ‘807 application’s claims allowed by the USPTO

06/21/22 – ‘807 application’s patent officially issued (US11364221)

02/23/23 – ‘088 first rejected – rejection cited prior art provided in PS 3PX

Examination of this application continues, and to date, the UHB has amended the ’088 application’s claims four times in repeated attempts to gain patenting rights. Though the USPTO has granted UHB’s requests for continued examination even after final rejection, they have stated that UHB’s amended set of claims “does NOT place the application in condition for allowance.” Essentially, even with the claim amendments UHB has made, the patentability concerns the USPTO had for this application had not been effectively addressed—concerns that included the claims not being patentably distinct from claims in ‘807. The USPTO has issued another action rejecting all amended claims on the grounds that the prior art Porta Sophia provided established obviousness to one skilled in the art. UHB is currently awaiting further evaluation from the application’s examiner on the most recent set of amended claims.