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Protecting the Science and Innovation of Psychedelics

The article Protecting the Science and Innovation of Psychedelics was originally published on Microdose.

A Look at Novel Intellectual Property Issues…

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The article Protecting the Science and Innovation of Psychedelics was originally published on Microdose.

A Look at Novel Intellectual Property Issues

By Kimberly I. Chew, Edward P Gamson, Ph.D., and Matthew M. Kamps

 

Psychedelic compounds (e.g., LSD) are experiencing a resurgence in popularity, this time in the realm of powerful treatments and therapies for psychiatric conditions, including anxiety, depression, addiction, and post-traumatic stress disorder (“PTSD”). We are watching the emergence of a new industry, one that could potentially address the needs of the enormous underserved mental health market, but because of the historical and sensitive nature surrounding the use of psychedelic compounds, there are new and interesting legal issues that could impact protecting and commercializing intellectual property in the area of psychedelics.  

“Psychedelic drugs” is a loose term for substances that have psychoactive properties and are active ingredients intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body.[1] Psychedelic drugs have been traditionally sourced from plants. Knowledge and use of these substances, in its broadest sense, is not new. Indigenous use of plant medicines, such as psilocybin, has been practiced for thousands of years. Recreational use in the 1960’s and 1970’s counterculture caused psychedelics to become stigmatized, and research on potential medicinal and therapeutic uses were, and continue to be, delayed as a result.  All psychedelic drugs are considered Schedule I drugs under the federal Controlled Substances Act.[2] 

An increased focus on wellbeing and therapy in recent years, along with recognition that many forms of trauma and depression are resistant to conventional treatments and medications, has led to a renaissance of science and commercial interest in psychedelic-related therapies. Studies have found many psychedelics to be effective at treating PTSD, depression, anxiety, and substance abuse disorders. In fact, some have been considered “breakthrough” therapies for difficult conditions such as PTSD, achieving results that other therapies have not.[3] With the recognition that the mental health market is underserved, the psychedelic drug market is projected to grow to $10.75 billion by 2027.[4] 

This is a nascent area for psychedelics, and there is much controversy around psychedelic-related intellectual property issues because many of the psychedelics are plant-based and associated with indigenous cultures and knowledge.  Thus, questions about whether psychedelic-related patents should be granted persist. Many believe that patents that attempt to protect, e.g., psilocybin directly should not exist and are engaging attorneys to challenge them on the basis that new patents in this area do not represent anything patentable, with the goal of developing these medicines for public rather than private benefit. For instance, the organization Freedom to Operate intends to challenge a patent granted in 2019, regarding the manufacturing process for psilocybin.[5] Other organizations have taken an “open science” approach by not filing for patents. On the other hand, laws to protect intellectual property are used to create incentives, marketplace infrastructure and further innovation. It is also important to understand that intellectual property laws differ from country-to-country.  As such, it is important to have counsel available in countries in which one desires to enter a market.

What is patentable?

Controversy notwithstanding, the amount of investor interest in this area of psychedelic discovery is astounding.[6] Many want such investments to be protected which in turn leads to intellectual property questions unique to this burgeoning industry. For instance, much study and effort have been made toward determining which of a patient’s cellular receptors should be specifically targeted or avoided for a psychedelic-based molecule to have desired therapeutic effect. In fact, some organizations have been developing whole libraries of molecules they hope to commercialize as compounds that target specific regions of the serotonin receptor. In this context, open questions abound, including the patentability of whole libraries of molecules based on psychedelics. For instance, MagicMed’s PsybraryTM [7] includes twelve (12) filed patent applications related to nine different drug categories covering 125 million individual molecules.”[8] These molecules were designed using artificial intelligence technology (which is itself a controversial and emerging issue in intellectual property) that predicts the molecules to have some binding affinity for certain parts of the serotonin receptor. This approach promises to cut down the time it takes to turn a molecule into a medicine.

However, although it seems advantageous to generate multitudes of molecules, until each is fully characterized for activity, efficacy, safety and all the other aspects necessary for a useful medication, a library of millions of molecules may not be practical. Such inventions might be at risk of being invalidated for lack of enablement, written description, or both.[9] Under 35 U.S.C. § 112, a patent must describe an invention in clear terms and specify how to make and use the invention such that one skilled in the art is enabled to make and use the invention after the patent expires without having to resort to undue experimentation. This is to ensure that the invention is communicated to the public in a meaningful way. A patent claim is invalid if it is not supported by an enabling disclosure with sufficient written description. There is risk involved with attempting to patent libraries of psychedelic molecules without sufficient evidence that the candidate compounds are functional. Courts have invalidated patent claims because of the need for testing.[10] Needless to say, recent precedent indicates the drafting of patents that claim a large genus of molecules may invite unpatentability or invalidity determinations under 35 U.S.C. § 112.

patent law

Therapeutic methodologies

Research groups and organizations are developing different therapeutic methodologies drawn to the dosing and administration of particular psychedelic-therapeutics to optimize protocols for specific conditions and treatment regimens. Different methods for producing and/or sourcing psychedelic medicines are also under investigation, such as determining whether direct ingestion of the plant-derived psychedelic, extraction from natural sources, manufacturing from recombinant DNA technology, or chemical synthesis work best for providing the medicine for use in a therapeutic setting. An open question for those working with psychedelic-based therapies is to consider is whether to attempt to patent different therapeutic methodologies, such as changes in treatment session length, modulating doses of the psychedelic during the session, or both.

Perhaps certain methods might be better protected as a trade secret, but may be difficult to scale up and protect. 35 USC  § 273 allows safe harbor for patent infringement purposes if an entity is practicing a trade secret prior to a third-party patent filing, subject to meeting several requirements.[11] That is to say, in defense to patent infringement, a prior commercial use defense (i.e., a trade secret) is available when claims of infringement are based upon patents issued on or after the date of first use .[12] Unlike patents, there is no time limit regarding how long a trade secret is protected. However, the trade secret holder has no recourse if another entity fairly discovers and begins practicing the trade secret. In sum, there are advantages and disadvantages associated with keeping certain methodologies protected as trade secrets. Notably any psychedelic treatment method that is FDA-approved  must be described in detail on the package insert of the approved product, and thus patent protection for innovative methods of treatment should be considered strongly.

Prior Art and FDA Approval Process

Another area to be wary of is the interplay between prior art and the Food & Drug Administration (FDA) approval process. For example, if an inventor waits for the rescheduling—i.e., moving a Schedule I controlled substance to, e.g., the less restrictive Schedule III—of the psychedelic-related compound before filing a patent application in the United States, they run the risk of facing intervening prior art when they eventually file their patent application, which could arise from research and clinical testing related to that compound in other countries or jurisdictions that do not have the same constraints associated with the compound. The flip side is that so long as the psychedelic-related compound remains a Schedule I substance, a patent with claims directed at that subject matter may not be easily enforced in Federal Court because it could require the patent owner to admit or disclose information confirming its sale, use, distribution, or offer to sell a Schedule I controlled substance. The foregoing dilemma poses the following question to innovators in the psychedelic space: wait to file a patent application to maximize the time one can effectively enforce their patent (and this risk additional prior art appearing), or file as soon as possible with the hope that the controlled substance will be re-scheduled during the patent term?

Furthermore, psychedelic drugs’ Schedule I status likely means their technical intricacies, the body of relevant prior art, and the breadth of claims drawn to the same are somewhat novel for patent examiners. These knowledge gaps could result in the issuance of patents undeservedly narrow or overly broad, depending on the examiner.  While the foregoing is a potential issue at the patent office regardless of the technology being prosecuted, emerging technologies like psychedelics might be more susceptible.

Beyond writing the patent application itself, a patent applicant must consider how to defend its intellectual property and identify patents improvidently issued to third parties that could impede their freedom to operate in the space. That said, challenging patents in the psychedelic space in an inter partes review (“IPR”) proceeding may be problematic because an IPR petitioner is limited to asserting grounds based on lack of novelty or non-obviousness based on patents and printed publications. As a newly emerging area, such prior art might be relatively rare, although there is a great deal written about plant extracts. Similarly, many patent owners have raised a “commercial success” defense at IPRs, arguing that product sales demonstrate that the invention was non-obvious. However, mere sales numbers may not be enough, and an inventor may need to show market share.[13] In the case of this emerging area, how would this market share be determined? Is the market considered to be only psychedelic-therapeutics or all treatments available for PTSD or major depression?  Other things to keep in mind with regard to this defense is that for these new therapies there is often more than one patent protecting a new invention, and the patent holder must clearly show the commercial success was derived from the claims of the specific patent being challenged.

Another consideration in defending patents in this context is arguing that unexpected results support the non-obviousness of a claimed  psychedelic medicine or use thereof. Here, there has been much fanfare in the news espousing psychedelics as potential breakthrough therapies, but one must still consider, in comparison to what? The Patent Trial and Appeal Board usually mandates a comparison of the claimed invention with the closest prior art.[14] In an area as new as this one, the closest prior art may not be clearly defined (if it exists at all) and should be carefully considered. There may be no other FDA-approved treatment, in which case the patentee may have “long felt need” as a further defense.

Another issue unique to a Schedule I drug that is likely to affect psychedelic-therapeutics, surrounds the approval of generic drugs and establishing bioequivalence.[15]

Digital Therapeutics

Unique to the psychedelic-mediated therapeutic space (as opposed to traditional drug treatment) are the therapists, guides, coaches, clinicians and professionals, who are guiding and advising the patient throughout the treatment and then through integration sessions associated with the patient’s mental health condition, such as PTSD or major depression. Digital therapeutics are being developed to support these treatments to assist the patient and medical professionals with this form of therapy that is anticipated to last weeks or months. These are technologies that assess, monitor, and guide patient experiences and mental wellness before, during, and after the administration of the psychedelic medicine which bring issues of copyright, trademark, privacy and data security to the fore.

A big part of the cost of this emerging area of psychiatric treatment is the hours of integration and coaching that are needed to work through traumatic experiences. One way of addressing this cost is the development of software applications to coach the patient remotely as well as apps[16] that monitor biomarkers such as heart rate, blood pressure, breathing rate, etc.  NUE Life Health Inc. recently announced raising $3.3 million in order to develop at-home ketamine therapy with music and data capture during the therapy as well as other measurements of improvements over time.[17] Mind Cure Health Inc. announced the release of iSTRYM, a mental health digital platform that will provide data on patient, psychedelic protocols and procedures to health professionals.[18] 

Other groups are seeking to provide an immersive experience with virtual reality that would also monitor biomarkers during the session. Such innovations bring up questions of cybersecurity to ensure proper transfer protocols of data, to ensure protection of Protected Health Information (PHI) and Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR) and/or applicable state privacy law compliance[19], and even ownership of any data being generated. Other questions to consider are whether the data being collected are coming through accurately and whether the right tools to secure the data, including any notes, are in place and conform to HIPAA, GDPR and/or state privacy law compliance.  Having proper security and encryption protocols in place is also of import.

Another area of concern is accreditation and licensure of the therapist/guide/coach. The presence or absence of local and state-wide patient-guide/coach privilege that is akin to a patient—doctor or attorney—client privilege also needs to be considered.[20]

Failure to meet these challenges have already exposed the data stored by a mental health startup. Vastaamo, a private company running therapy centers in Finland was breached in 2018 but was not informed of this hack until late 2020. The company was attempting to do something tailored to its needs and cited the lack of good software available, so it developed its own. The sensitive data were exploited by hackers who demanded ransom and the company then notified various government authorities of the breach. The hacker then began releasing individual patient records belonging to public figures. Lawsuits ensued whereby the private equity firm, which bought the majority of the company, sued one of the co-founders for $11.7 million. The legal woes may not be over as the stolen patient database has appeared multiple times on anonymous file-sharing services.[21] Innovative companies seeking to utilize digital therapeutics or databases, should be mindful that the data on the device itself need to be secured, as well as where that PHI information and any notes and reports on the data are stored and secured after it is transferred off the device. Such attention to detail will limit liability under HIPAA, GDPR and/or applicable state privacy law compliance as well as tort liability in the event of a breach.

Also under development are custom psychedelic music and virtual reality experiences to guide patients through their therapy sessions. One should consider copyright and design patent protections for such innovations.[22] The virtual reality space is still maturing and protecting this technology may be thorny as in the case of ZeniMax Media, Inc. et al. v. Oculus VR, LLC et al., No. 3:14-CV-1849-K (BF) whereby disputes over copyright infringement and trade secret misappropriation in virtual reality technology resulted in years of litigation and a $50 million award for copyright infringement.[23]

 

 

Trademark issues

As these medicines are being developed and commercialized, trademark issues will need to be considered. Trademarks identify the product source to consumers. Thus, we see and hear ads about Sanka® brand instant coffee and Kleenex® brand facial tissues. Trademarks that become synonymous with all products of a certain type (e.g., all brands and types of “facial tissue”)  risk losing trademark protection because the trademark has been rendered generic, as in thermos, escalator, and aspirin. Similarly, “psilocybin” is the generic name of a chemical and therefore cannot be used as a trademark. Companies developing products in this emerging area will need to consider how to protect their marks and guard against their trademark from being too descriptive.

Pharmaceutical products typically have three types of names: chemical names, the most important of which for small molecules is the International Union of Pure and Applied Chemistry (IUPAC) name; generic or nonproprietary names, the most important of which are the International Nonproprietary Names (INNs); and tradenames, which are brand names, that can be trademarked. For example, 2-(4-isobutylphenyl)propionic acid is the chemical name for the compound generically known as ibuprofen and known by particular trademarked names such as Motrin® or Advil® that are owned by their purveyors. Generic names are assigned by an official body in each country or jurisdiction. In the U.S., that body is the United States Adopted Names (USAN) Council. The trademarked name is developed by the company seeking approval for the drug. Naming of biologic pharmaceutical products is undergoing rapid change and is presently not settled.

Another consideration is where to register a trademark. Because psychedelics are still Schedule I substances under the Controlled Substance Act, and trademark registration requires use in commerce, the psychedelic-related compound cannot be registered at the federal level. Purveyors may need to pursue trademarks on a state-by-state level, in those states where psychedelics have been decriminalized, similar to cannabis-related marks.

Some interim protection may be afforded by the filing of an intent to use trademark application that does not require a statement of use in commerce. A statement of use in commerce must be filed within 6-months of the mailing of a Notice of Allowance from the USPTO. Extensions of time of up to a total of 36 months can be obtained in 6-month intervals, with a verified statement of the applicant that the applicant has a bona fide intention to use the mark in commerce and a showing of good cause for the second and later requests for extension, and a fee for each.

Conclusion

It will be interesting to see how psychedelic-mediated therapeutics will be developed and introduced to the world at large. Recent Phase 3 clinical trials of methylenedioxymethamphetamine-(MDMA-) -mediated therapy for the treatment of PTSD in early-May 2021 point to the eventual FDA approval of psychedelic medicines, and rescheduling of some form of MDMA by the Drug Enforcement Agency (DEA). This area is rapidly evolving and companies are making moves to meet the needs of developing therapeutics in this space. Mid- May of this year saw the first fully legal, DEA-approved importation of psilocybin into the U.S.,[24] and other companies are modifying their DEA Schedule I licenses to allow for further development and use of psychedelics.[25] How these issues play out will have a significant impact on investors and companies facing intellectual property issues unique to this emerging area.

Kimberly Chew, Edward Gamson and Matthew Kamps are attorneys with the law firm Husch Blackwell. The authors would like to thank Natasha Sumner, Karen Luong and Nicole Bashor for their contributions.

[1] 21 CFR § 314.3.

[2] Psilocybin designated Schedule I in 1968; LSD 1968 Schedule I; Ketamine 1999 Schedule 3; MDMA 1985 Schedule I.

[3] Stage 3 clinical trial success with MDMA-mediated therapy for PTSD. https://maps.org/news/media/9122-maps-phase-3-trial-of-mdma-assisted-therapy-for-ptsd-achieves-successful-results-for-patients-with-severe-chronic-ptsd

[4] Research & Markets Report https://www.researchandmarkets.com/reports/5240207/psychedelic-drugs-market-by-drugs-lsd-ecstasy?utm_source=GNOM&utm_medium=PressRelease&utm_code=894w6r&utm_campaign=1513085+-+Global+Psychedelic+Drugs+Market+Report+2020%3a+Market+Size+is+Projected+to+Reach+%2410.75+Billion+by+2027&utm_exec=chdo54prd

[5] See https://freedomtooperate.org/ and https://northstar.guide/ 

[6] atai Life Sciences AG has raised more than $362 million from private investors; Compass Pathways has raised roughly $117 million since its launch in 2016; MindMed’s total assets as of March 31, 2021 were $201 million, including $160 million in cash

[7] MagicMed announced in late December 22, 2020 that they have filed 12 patent applications directed to 9 different chemical compound categories covering over 125 million individual molecules.

[8] The Psybrary is MagicMed’s library of novel psychedelic derivatives developed through the combination of synthetic biology and traditional chemistry techniques. MagicMed has 13 patent applications filed for derivatives of psilocybin and DMT, 2 patent applications filed for derivatives of mescaline and MDMA with further intellectual property protection for mescaline, MDMA, ibogaine and LSD in process. 

[9] The enablement requirement of 35 U.S.C. 112(a)  is separate and distinct from the written description requirement. Vas-Cath,Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991) (“the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’”).

[10] See Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1161 (Fed. Cir. 2019) (candidate compounds “would need to be tested”; it also failed description); Enzo Life Scis., Inc. v. Roche Molecular Sys., Inc., 928 F.3d 1340, 1349 (Fed. Cir. 2019) (“undue experimentation would still be required with regard to the many other embodiments of the claims based on the number of possible embodiments and the unpredictability in the art.”); Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1385 (Fed. Cir. 2013) (patentee’s witness conceding that “until you test [compounds], you really can’t tell whether they work or not”); MorphoSys AG v. Janssen Biotech, Inc., 358 F. Supp. 3d 354, 373 (D. Del. 2019) (finding functional genus claims to antibodies non-enabled after comparing to Idenix, Enzo, and Wyeth).

[11] The standard requires (1) commercial use of the subject matter of the invention in the United States, which extends to internal commercial use, such as manufacturing processes; and (2) that such commercial use occur at least 1 year before the effective filing date of the invention or the date the claimed invention was disclosed to the public.

[12] The commercial use must occur at least one year prior before the effective filing date of the claimed invention.

[13] See Mylan Pharms, Inc. v. Astrazeneca AB, IPR2015-01340, paper 79 at 53).

[14] See Eli Lilly and Co. v. Teva Pharms. Int’l, GmbH, IPR2018-01422, IPR2018-01423, IPR2018-01425, 2020 WL 806932 (PTAB Feb. 18, 2020) at 57; Dr. Reddy’s Labs. V. Horizon Pharma USA, Inc. IPR2018-00272, 2019 WL 4239613 (PTAB Sept. 6, 2019) at 16.

[15] See John Doe v. DEA (2017) 484 F.3d 561 concerning the marketing and approval process of a generic drug for Marinol.

[16] An app is a type of software that can be installed and run on a computer, tablet, smartphone or other electronic device.

[17] https://techcrunch.com/2021/06/03/nue-life-health-raises-3-3m-for-its-psychedelics-meets-tech-mental-wellness-platform/

[18] https://www.prnewswire.com/news-releases/mindcure-partners-its-istrym-technology-with-lucid-to-discover-and-create-proprietary-music-experiences-for-use-during-psychedelic-assisted-therapy-sessions-301273772.html

[19] A resource for following the changing landscape of U.S. state privacy laws. https://www.huschblackwell.com/2021-state-privacy-law-tracker

[20] Therapist-patient privilege is beyond the scope of this article and will be covered in a future article.

[21] https://www.wired.com/story/vastaamo-psychotherapy-patients-hack-data-breach/

[22] See Kamar Intern., Inc. v. Russ Berrie and Co., 657 F.2d 1059, 1061 (9th Cir. 1981) [“Originality is the indispensable prerequisite for copyrightability.”];  Atari, Inc. v. North American, 672 F.2d 607, 615, 617-18 (7th Cir. 1982);  Midway Mfg. Co. v. Bandai-Am, Inc., 546 F. Supp. 125 (D.N.J. 1982) [court held video games, including virtual reality content, are entitled to copyright protection].

[23] https://www.polygon.com/2017/2/1/14474198/oculus-lawsuit-verdict

[24] https://www.lucid.news/wake-network-successfully-completes-first-legal-importation-of-psilocybin-mushrooms-into-the-u-s/

[25] https://www.businesswire.com/news/home/20210323005442/en/CURE-Pharmaceutical-Augments-Its-Existing-U.S.-DEA-License-in-Order-to-Initiate-Development-of-Its-Psychedelics-Based-Pharmaceutical-Clinical-Pipeline

Editor’s Note

This piece is part of a series produced by guest contributors to expand the voices on our site and in the greater conversation. While Microdose supports the education and exploration of these topics, the facts and opinions presented in this work are the author’s alone.

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