Patents on Psychedelics: The Next Legal Battlefront of Drug Development

This essay (2021) is one of the first publications to emerge from the POPLAR initiative at Harvard Law School. The essay explores issues regarding the patenting of psychedelics given their controversial history and offers suggestions on how to reduce the risk of biopiracy and the issuance of meritless psychedelic patents.

Abstract

“In the past few decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for centuries, and researchers studied them in the 1950s and 60s. However, most psychedelics were banned in the 70s, when President Nixon launched the U.S. war on drugs. Fifty years later, rising rates of mental illness, substance use, and suicide are prompting researchers to revisit psychedelics, and some have gained permission to study them in limited quantities. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Patents on psychedelics raise unique concerns associated with their unusual qualities, history, and regulation. Because they were criminalized for decades, the Patent Office lacks personnel with expertise in the field, increasing the likelihood of granting meritless psychedelic patents. Moreover, because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, the exploitation of Indigenous knowledge without compensation. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. The Essay presents proposals to reduce the risk of biopiracy and the issuance of meritless psychedelic patents. Potential solutions include the implementation of psychedelic patent pledges, the creation of psychedelic prior art repositories, and the tightening of patentability requirements for novel drug therapies. The Essay concludes that ultimately, due to their importance to the advancement of science and public health, psychedelics are appropriately viewed as research tools, eligible only for limited patent protection.”

Authors: Mason Marks & I. Glenn Cohen

Notes

In recent years, there has been a renewed interest in psychedelics in research communities across the globe. Thanks to the efforts of these psychedelic researchers, solid clinical evidence is helping to change the narrative surrounding psychedelics. We are now beginning to realize that psychedelics are not ‘devoid of medical value’ as their classification as Schedule I substances implies.

Nonetheless, while evidence-based research is essential in proving the safety and efficacy of these compounds, it is important that we widen our lens beyond the walls of laboratories and clinics as psychedelics edge toward medicalization. Analyzing the various cultural, political and societal factors that are continuing to shape psychedelic medicine is necessary to ensure equitable access and governance of these substances.

The present essay is the first release from the POPLAR initiative at Harvard Law School. The Project on Psychedelics Law and Regulation (POPLAR) is the first academic initiative focused on promoting safety, innovation, and equity in psychedelics research, commerce, and therapeutics. Although only a draft version, the essay at hand provides food for thought to a number of issues surrounding the medicalization of psychedelic’s, primarily the ethical, legal, and social implications of patenting psychedelic substances.

Main concerns

• Awarding patents on psychedelics can be seen as contentious given their use in traditional practices for centuries and runs the risk of monopolizing a product of nature.
• The US Patent and Trademark Office lacks personnel with the necessary expertise in this field as a result of psychedelics being controlled substances for the past decades and could lead to the issuing of “meritless patents.”
• The patenting of psychedelics by Western corporations may promote biopiracy as they capitalize from the knowledge and practices of Indigenous groups who have long used psychedelics.

Proposed solutions

• The creation of prior art repositories, similar to Porta Sophia a recently released archive of psychedelic prior art, can help prevent the issuance of bad patents by ensuring that lesser-known references are not easily overlooked.
• Tightening of US requirements for novelty and non-obviousness e.g prohibiting patent claims on molecular variations of psychedelics because they lack inventiveness.
• The introduction of patent pledges meaning companies would not enforce their patent rights under certain conditions.
• The most radical proposal is to entirely forego granting patents on psychedelics.

The present essay is one of the first to take a deep dive into the implications surrounding the patenting of psychedelics. In the business of drug discovery, patents are ‘standard industry practice.’ However, given the unique relationship society has had with psychedelics, perhaps standard industry practice need not apply in order for the therapeutic potential of psychedelics to be truly widespread.

Ultimately, discussing the thoughts presented in this essay while the psychedelic industry is in its relative infancy is essential if psychedelics are going to be a solution for the global mental health crisis we are experiencing.

Summary

ABSTRACT

In the past two decades, researchers have rekindled interest in the therapeutic use of psychedelic substances, which were banned in the 70s. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics.

This Essay analyzes the ethical, legal, and social implications of patenting controversial substances. It proposes to reduce the risk of biopiracy and the issuance of meritless psychedelic patents by implementing psychedelic patent pledges, creating psychedelic prior art repositories, and tightening patentability requirements for novel drug therapies.

INTRODUCTION

In the past few decades, pioneering researchers have rekindled interest in the therapeutic use of psychedelic substances, which were banned in the 70s. However, a growing body of clinical research shows that psychedelics show promise for mitigating several public health crises.

Popular media coverage of psychedelics research has reinforced public interest in their medical and non-medical use. Two psychedelics are making their way through the FDA approval pipeline, and the market is predicted to reach $10.75 Billion by 2027.

This Essay analyzes the ethical, legal, and social concerns raised by the growing trend of patenting psychedelic therapies. It provides recommendations for meaningful reform of the patent system and discusses how patents can be abused to monopolize facets of the emerging psychedelics market.

Patents are a form of government granted monopoly that entitles their holders to exclude others from making, using, or selling their patented inventions for approximately 20 years from the date they filed a patent application.

The sudden influx of psychedelic patents has prompted criticism from stakeholders including patient advocates, scientists, journalists, lawyers, and members of Indigenous communities. They argue that patents monopolize products of nature and should remain affordable and widely available.

Many debates have been sparked by patents on genetic technologies and cancer therapies, but psychedelics have unique features that raise concerns that could exacerbate pre-existing problems with intellectual property protection related to commercializing medical products.

To obtain a patent on a psychedelic compound, applicants must convince examiners that their technologies are novel, non-obvious, useful, and within the scope of patent eligible subject matter.

A patent must be a “process, machine, manufacture, or composition of matter” and cannot include a “product of nature”, an “abstract idea”, or a “natural phenomenon”. However, patent applicants can overcome this hurdle by modifying psychedelic compounds.

Applicants have used several techniques to game the patent system, including product hopping, which involves making subtle modifications to an existing technology and claiming the result as a novel invention. This practice has been criticized for wasting scarce resources and deterring meaningful innovation.

In many cases, large, well-capitalized firms can navigate the murky regulatory waters surrounding psychedelics research and development. The PTO lacks examiners with sufficient knowledge of psychedelic compounds and their history, which could allow bad patents to breeze through the system.

The PTO has limited resources and the time it spends searching for relevant prior art may often be inadequate. Because psychedelics have been prohibited for decades, relevant knowledge may be derived from non-U.S. sources and may not have been published in English.

Lack of experience might cause examiners to miss relevant prior art, provide a lower standard of review, and issue bad psychedelic patents. This has already occurred in the software space, where examiners were inundated with patent applications containing unfamiliar vocabulary and ambitious claiming strategies.

Compass has acquired several compositions of matter patents that claim crystalline polymorphs of psilocybin. Some countries are less welcoming to polymorphic patents, however.

To receive a patent, an applicant does not need to prove that the claimed invention will work. In fact, patent doctrine considers data from fictional, purely imagined scenarios to be equivalent to data derived from real experiments.

The food allergy patent may lack novelty, as related methods had been publicly disclosed as early as the 1960s.

Patent rights are not ironclad and can be challenged in court for lack of novelty, non-obviousness, patent eligibility, or failure to satisfy other requirements.

Critics argue that many psychedelic patents would not stand up to scrutiny, but even patents that might ultimately be invalidated can be used offensively to cause significant harm.

Ketamine is a cautionary tale of chiral chemistry, where the DEA limits the number of scientists who can participate in research and the total mass of psychedelics produced each year, artificially restricting efforts to research and commercialize them.

In the past fifty years, there has been little meaningful innovation in psychopharmacology, with newer SSRIs offering only modestly improved side effect profiles.

Product hopping is a practice used by drug companies to prevent their products from becoming substitutable with generic drugs. A related practice involves making subtle modifications to substances in the public domain and patenting the results as new inventions.

Ketamine, a drug used to manage treatment resistant depression, was discovered to be able to be prescribed off-label by Janssen pharmaceuticals. Janssen isolated esketamine, the left-handed version of ketamine, and received FDA approval to market it under the trade name Sprovato.

FDA approval of esketamine has created a quandary for patients and providers who prefer using generic ketamine. Spravato, the patented ketamine variant, has failed to show a meaningful benefit over generic ketamine prescribed off label.

The Canadian Federal Court of Appeal held that Spravato is not an “innovative drug” eligible for data exclusivity, a type of monopoly right issued by drug regulatory agencies. However, U.S. patent law does not acknowledge these distinctions, which allowed Janssen to patent escitalopram and esketamine.

Without action by policymakers, companies commercializing naturally-occurring psychedelic compounds may follow a similar playbook, patenting subtle variations on widely used natural compounds, or methods of administering them, preventing competitors from entering the field.

Bioprospecting is the practice of identifying useful natural resources that can be commercialized. Some claim it can be a façade for exploiting Indigenous communities.

Many psychedelics have long been used by communities around the world. Iboga, a plant in Gabon, contains the psychedelic compound ibogaine, which is being commercialized.

Companies patenting psychedelic substances are exploiting practices that Indigenous communities have developed over centuries for use in healing and religious ceremonies. However, U.S. patent law lacks protections against biopiracy, and some aspects of international treaties may facilitate it.

The Doha Declaration on the TRIPS Agreement and Public Health, signed in 2001, addressed the commercializing of Indigenous knowledge, but provided inadequate compensation.

Some describe bioprospecting agreements produced under TRIPS as paternalistic and exploitative. Porta Sophia, a non-profit library for psychedelic prior art, could improve prior art searches and help prevent issuance of bad patents by ensuring that lesser-known references are not easily overlooked.

A better option may be to limit the enforcement of patents on psychedelics, by prohibiting patents on salts, enantiomers, and other variations on existing inventions, or by requiring companies to pledge not to enforce their patent rights under certain conditions.

In 2014, Tesla Motors announced that it would no longer enforce its patent rights against competitors who use its technology in good faith. Toyota and SpaceX have also made similar pledges.

Some call for patent pledges in the psychedelics industry. However, the law is unclear on whether informal promises not to enforce patents are legally binding.

Some have questioned whether psychedelic patents are necessary to incentivize innovation. A non-profit organization called MAPS has made MDMA a viable therapy for PTSD without patenting the fruits of its research.

Strong arguments can be made for prohibiting patents on psychedelics, because they represent the most innovative approach to mental healthcare in decades, and the most promising potential solution to the mental health crisis.

Researchers believe psychedelics could help with mental health conditions and lead to a better understanding of the human mind and brain. They believe keeping psychedelics in the public domain would be similar to prohibiting patents on abstract ideas, products of nature, and natural phenomena.

In this essay, we have put it on the table that policymakers should take seriously the idea of prohibiting patents on drugs.

CONCLUSION

Psychedelics have a complex history and regulation, and the existing patent system often rewards those who patent “me-too drugs” that are insignificant advancements over existing therapies, reducing the public benefit received per research dollar spent.

In this essay we have set out a series of possible ways to curb the downsides of patents in the psychedelics field.