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Monday, September 26, 2022

Are Psychedelic Patents Ethical?


 

As the revolutionary therapeutic potential of psychedelics resurfaces in popular consciousness, pharmaceutical companies are scrambling for patents over psychedelic compounds and therapies. 

The unique characteristics of psychedelics provoke a plethora of ethical implications in intellectual property law and our capitalist society more broadly; namely, that the patenting of psychedelic compounds promotes biopiracy and threatens public health by reducing accessibility to medicine and deterring meaningful innovation.

Despite being categorised in most jurisdictions as highly dangerous and addictive substances with no recognized medical use, psychedelic therapies now offer the most promising solution to mental illness in decades. 

Brought to the fore by a global pandemic, the mental health crisis has entered public awareness as an epidemic of vast proportions. Depression affects 264 million people and is considered a leading cause of disability worldwide. Every year more than 800,000 people die by suicide – one person every 40 seconds. Now the psychedelic renaissance is driving a global paradigm shift in public health. 

Researchers studied the therapeutic value of psychedelics briefly in the 50s and 60s before the creation of the War on Drugs resulted in their prohibition. This controversial party of compounds includes psilocybin, ibogaine, MDMA and DMT, among others. 

Psychedelics are powerful hallucinogenic substances known to induce profound feelings of wellbeing, oneness and connection in their users. Indigenous communities have been using psychedelic plant medicines for healing and spiritual enlightenment since time immemorial. 

As access to psychedelics becomes liberalised, an enthusiastic resurgence of research has taken place, often with extremely encouraging results. Psychedelics are now being studied for their potential to treat PTSD, substance use disorders, depression, anxiety and anorexia, to name a few. 

In 2018, the US Federal Drug Administration (FDA) designated psilocybin – the active ingredient in magic mushrooms – a breakthrough therapy for treatment-resistant depression. Phase Two clinical trials have found that a single dose of psilocybin-assisted psychotherapy demonstrated a highly significant and enduring reduction in symptoms of depression.

Though once unthinkable – like an impending sun glowing on the horizon – a legal psychedelics industry is now practically an inevitability. The US psychedelic sector alone is projected to have a value of $10.75 billion by 2027. However, as attitudes shift and the psychedelic renaissance unfolds, multitudinous ethical concerns are emerging over the aggressive patent strategies being waged by companies racing to dominate this lucrative field. 

Critics argue that the current legal framework leaves room for the granting of low-quality patents that serve only to monopolise the market. Psychedelic patents are contentious because they protect ‘inventions’ which are not actually new but have been appropriated from indigenous communities who have practised psychedelic medicine for as long as we have been human. Further, experts warn that a small number of companies obtaining large swathes of intellectual property in the industry’s nascence could suppress innovation and reduce access to these therapies, thus limiting the great impact that psychedelics have the potential to engender.

Problematic patents?

A patent is an intellectual property right. Obtaining a patent provides an inventor with exclusive rights to the patented process, invention or design for a limited period of time (20 years in the UK). Consequently, patent holders can exclude others from making, using or selling the subject of the patent without their permission. In the pharmaceutical context, patents protect the owner’s investment and the expensive process of drug development and approval. A product must be both novel and useful to satisfy patenting requirements. However, patent applications can be made in bad faith to dominate the market and block competition

On the face of it, one might think that psychedelic compounds don’t qualify for patent protection because they have been in use for centuries and are therefore not new. Regardless, a number of companies currently hold dozens of patents for psychedelic compounds and methods of producing and administering them. In fact, most jurisdictions would exclude psychedelic plants from patent eligibility because they are products of nature and therefore free for all to use. However, companies can get around this by making subtle variations to their naturally-occurring chemical structure.

In this way, patent law allows companies to commercialise plant-based psychedelic compounds. Compass Pathways, a billion-dollar psychedelic mental health company, has four US patents. Two of them – granted in 2021 – give Compass ownership of various forms of synthetic psilocybin called crystalline polymorphs. In 2015 the United Nations recommended that polymorphs be excluded from patentability because they are best characterised as variations of existing compounds, rather than novel inventions

The War on Drugs = Social Injustice

The criminalisation of psychedelics increases the likelihood that intellectual property will be wrongfully granted for inventions that are not genuinely novel because patent examiners are not aware of their history of use. Prohibition stemming from the War on Drugs pushed psychedelic research and use underground. Because psychedelics are illegal, practitioners are less likely to document their practice so as to avoid criminal repercussions. Compass Pathways has a pending patent application for ownership over basic components of psilocybin therapy administration, including muted room colours, soft furniture and holding the patient’s hand. Critics propose that these features of psychedelic therapy should not be eligible patents because indigenous therapists, clinical trials and underground practitioners have used these methods for decades. 

The War on Drugs is a colonial tool that has facilitated the systemic oppression of BIPOC (Black, Indigenous and people of colour) communities through their association with illegal substances. Aside from being denied safe access to healing psychedelic therapies, the stigma and criminality resulting from association with these compounds has contributed to intergenerational trauma. And yet, as legal frameworks shift and the psychedelic industry emerges, companies are being granted patents and profiting from the substances which indigenous communities have been criminalised and imprisoned over. These groups face more entry barriers to the psychedelics industry because of the higher risk of being associated with ventures seen as risky or taboo. Consequently, these circumstances reinforce the psychedelic patent monopoly because indigenous communities are alienated from a sector which their wisdom pioneered.

Psychedelic biopiracy as neocolonialism

Patent laws facilitate bioprospecting: the commercialisation of biological resources and associated knowledge for the production of agricultural and pharmaceutical goods. Bioprospecting is not inherently bad. It can be justified as a win-win situation when indigenous communities and biotechnology firms enter consensual agreements and the mined knowledge and bioresources benefit communities through financial reimbursement, employment opportunities and/or cultural development. However, the appropriation of bioresources originating from indigenous communities by Western corporate entities is deeply contentious because of the asymmetrical legal and economic relationship between them. 

In the psychedelic context, biopiracy is the exploitative practice of appropriating and patenting indigenous knowledge without compensating or acknowledging the communities that fostered and revered these practices for years. This can cause the communities that pioneered these therapies to be excluded from benefiting from them as commercialisation makes these treatments less affordable. Inadequate protection of indigenous rights have caused bioprospecting projects to displace communities from their own land while the access of pharmaceutical companies is prioritised under the pretext of environmental conservation.

The commercialisation of consciousness

Psychedelic patents are a paradox because of the conceptual chasm between neocolonial and indigenous conceptions of ownership. Patents are a tool used to commercialise psychedelics within a Western legal framework, by laying claim to indigenous knowledge and resources as property. And yet, the collective nature of this wisdom and the accumulation of plant medicine practises over generations is epistemologically incongruous with patent law because it defies the capitalist emphasis on an individual owner. Further, when laying claims to psychedelic knowledge as property, a patent regime can alter a community’s relationship by focussing on individual members as isolated entities related through power.

In a similar vein, many believe that the implications of psychedelics for public health and human consciousness are of such monumental significance to humankind, that no person or legal entity should be allowed to monopolise them. Psychedelics offer an unprecedented opportunity to research one of the world’s greatest mysteries: the human psyche. A small number of companies obtaining extensive IP over psychedelic medicine could limit the benefits on mental health globally by stifling research and limiting accessibility to these therapies. 

While patent law advocates cite the incentive to innovate as a central tenet of patent law, evidence suggests that the opposite may be true and patents actually suppress innovation. Patenting was available for previous mental health treatments like SSRIs – a standardised treatment for depression and anxiety. However, psychopharmacology has seen little advancement in the last 50 years. In fact, more than 70% of medicines brought to market in the last two decades provided no new therapeutic benefit over products already available. Instead, low quality patents saturated the market with treatments that are not greatly distinguished from one another. SSRIs lack of effectiveness – evidenced by soaring suicide rates and the consequences of a catastrophic mental health crisis – is in part what led researchers to revisit psychedelics in recent years.

Where do we go from here?

Issues with the substantive structure of the patenting system are not exclusive to psychedelics and the field of medicine more broadly struggles with similar implications. Ultimately, patents are only available to powerful corporate entities with ample financial resources and are only attractive if it is perceived that the medicine will sell at a high price. Because of the relatively low cost of manufacture, the pharmaceutical industry is one of the most profitable industries in the world. Meanwhile, 10 million people each year die from lack of access to medicines. High price points reduce accessibility to medicine, having a disproportionate impact on the global south. Regulatory reform is needed to address this skewed reward system and the inequity it creates.

In the psychedelic space, legal frameworks governing patent law require reform to reflect the history of unjust appropriation of indigenous psychedelic knowledge facilitated by the ongoing War on Drugs. Tightening the requirements of what it means for a compound to be novel is crucial to prevent the issuance of low-quality patents. In order to adequately address the harm inflicted on indigenous communities during the War on Drugs, patent law should be regulated to prevent the unjust distribution in legal ownership of these powerful substances.

The ethical line distinguishing biprospection from biopiracy is barely visible. Alternative legal mechanisms are needed to protect indigenous wisdom and remedy the unjust commercialisation and disproportionate distribution of profits to Western corporate entities. A balance must be struck whereby communities’ claims over knowledge are protected while access to their wisdom can be (consensually) facilitated for the benefit of public health. A failure to establish and enforce this kind of protection perpetuates exploitative neocolonial practices that create intra-community conflict and alienate groups from their own cultural heritage.

Furthermore, it is necessary to clarify that indigenous communities are not homogenous. Social justice advocates and bioprospectors alike construct one-sided narratives of indigenous identity as vulnerable, pure, idyllic or uneducated while purporting to act in their best interests. In 1995 the Indigenous group UZACHI (representing Zapotec and Chinantec communities) signed a bioprospecting agreement whereby the community would accumulate plant genetic material – such as mushrooms – for a company in return for laboratory and technical training. For equitable exchanges of knowledge and resources to take place, indigenous communities must have unequivocal agency over their identity and actions, in order to avoid imbuing these interactions with neocolonial paternalism

The social, legal and economic minefield of patent law in the psychedelic sector embodies the sordid space where consciousness, spirituality and capitalism collide. They shine an uncomfortably revealing light on a multitude of daunting failures in our neocolonial, profit-driven systems. It is our responsibility not to avert our gaze. Psychedelics offer a multidimensional opportunity for collective healing through rediscovery of the inherent connectivity between all living beings. Hopefully we can use this profound wisdom as a torch to reignite our courage and compassion to tackle the dark shadows of the systemic wrongs which shape our world.

Alice Swift is a freelance writer and artist with a focus on creating work that promotes compassion, empathy and community. Alice writes about all of her passions, which include social justice, the human condition, psychedelics, astrology, nature and drug policy reform. www.linkedin.com/in/alice-swift



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