Patents on Psychedelics: The Next Legal Battlefront of Drug Development

Marks and colleagues situate their essay within the recent revival of interest in psychedelic substances for therapeutic use, noting a long history of Indigenous and mid-20th century clinical use followed by decades of criminalisation under U.S. drug policy. They emphasise that contemporary clinical trials and commercial interest have produced a surge of patent filings on compounds and delivery methods such as psilocybin, DMT, ibogaine, ketamine, and MDMA, and that this trend raises distinctive ethical, legal, and social concerns because of psychedelics’ history, natural origins, and regulatory status. The paper sets out to diagnose the risks that patenting could pose to scientific progress, access, and Indigenous communities, to explain how U.S. patent law and Patent and Trademark Office (PTO) practice can facilitate the grant of weak or abusive patents in this field, and to propose regulatory and normative responses. The essay is organised in five parts: it characterises the threat posed by psychedelic patents; analyses patentability and PTO practice; uses ketamine as a case study of problematic secondary-patenting strategies; examines bioprospecting and biopiracy concerns; and offers a menu of policy responses to reduce unwarranted monopolies over psychedelics.

This work is a legal and policy analysis rather than an empirical study. The investigators draw on doctrinal review of U.S. patent law and PTO practice, analysis of selected patent filings and grants, discussion of regulatory frameworks (including the Controlled Substances Act and international agreements such as TRIPS), and illustrative case law and administrative examples to support their arguments. Analytical tools include examination of patentability criteria (novelty, non-obviousness, utility, and subject-matter eligibility), the PTO’s prior art search process and resource constraints, and the doctrine surrounding secondary patents (for example, patents on enantiomers, salts, or polymorphs). The authors supplement doctrinal analysis with case studies and concrete examples: pending and granted patents by commercial entities (e.g. Compass Pathways and others), a contentious patent claiming methods to treat food allergies, and the ketamine/esketamine commercialisation path exemplified by Janssen’s Spravato and relevant judicial treatment in Canada. To address ethical and social dimensions, the authors review the practice of bioprospecting and international intellectual property treaties, and consider stakeholder responses such as non-profit research approaches and patent-pledge models. Where available, they cite specific patent documents, regulatory declarations, and court outcomes to illustrate how legal rules operate in practice.

The essay identifies several interlocking risks posed by contemporary psychedelic patenting. First, the PTO may be prone to granting low-quality or overbroad patents in this area because decades of prohibition reduced both publication of prior art and PTO examiner expertise; many relevant uses are undocumented, unpublished, or transmitted orally, making prior art difficult to locate. The authors explain that inadequate prior art searches combined with the presumption of patent validity can allow broad claims to issue and be used strategically to deter competitors. Second, standard tactics in pharmaceutical patenting—product hopping, secondary patents on enantiomers or polymorphs, and claims framed to capture clinical context—have appeared in the psychedelics space. The paper cites Compass Pathways’ filings claiming aspects of the treatment environment ("set and setting") and patents on crystalline polymorphs of psilocybin as examples. A PTO grant to Palo Alto Investors claiming methods of using psychedelics for food allergies is presented as an instance where the patent grant outpaced scientific support for utility. Third, the ketamine/esketamine story is offered as a cautionary empirical analogue: Janssen isolated and patented esketamine, obtained regulatory approval for Spravato, and acquired market advantages despite limited evidence that the patented product offers meaningful clinical benefit over off‑label generic ketamine. The authors note that a Canadian court questioned whether such enantiomer patents constitute genuine innovation rather than mere variations. Fourth, bioprospecting and biopiracy present distinct ethical and legal concerns. Many psychedelics originate in Indigenous practices and natural resources; commercial actors filing patents risk appropriating traditional knowledge without consent, acknowledgement, or compensation. The essay references historical examples of contested botanical patents and argues that international IP regimes like TRIPS can facilitate commercialisation that sidelines Indigenous stewardship. Finally, the authors summarise a set of interventions to mitigate these harms. Shorter-term fixes include creating prior art repositories (for example, the non-profit Porta Sophia) and encouraging patent pledges not to enforce claims on certain aspects of psychedelic practice. More structural reforms they discuss are tightening novelty and non-obviousness standards (for example, limiting patents on salts, enantiomers, and polymorphs) and, more radically, excluding psychedelics from patentability entirely or encouraging non‑patent development models as pursued by MAPS and Usona. The authors acknowledge practical trade-offs, including industry resistance and the financial challenges of moving therapies through costly regulatory approval without exclusivity.

Marks and colleagues interpret their findings to mean that the current intersection of patent law, regulatory prohibition, and commercial enthusiasm creates a heightened risk of meritless or opportunistic patents in the psychedelics field. They argue that such patents can have outsized harms: they may appropriate Indigenous knowledge, erect monopolies that stifle research and competition, and redirect clinical practice and reimbursement towards patented variants that offer little incremental benefit. The essay situates these concerns within broader debates about pharmaceutical patents and innovation policy, noting that tactics like product hopping and secondary patents have long been criticised in other therapeutic areas. Because many psychedelics derive from natural products and long-standing communal practices, the authors contend the moral and practical stakes are especially high here: keeping foundational tools freely available supports scientific inquiry and equitable access. They further posit that the PTO’s limited familiarity with the field and the unique forms of prior art associated with psychedelics increase the likelihood that weak claims will issue and then be enforced in ways that deter challengers. Limitations and uncertainties the authors acknowledge include legal and political resistance to tighter patent rules, the imperfect or provisional nature of repository or pledge solutions, and the practical problem that forbidding patents entirely might reduce private investment needed to navigate the regulatory ‘‘valley of death’’ between discovery and FDA approval. They also note that informal patent pledges can be ambiguous and may preserve substantial control for pledging entities over enforcement. In terms of policy implications, the essay recommends interventions at multiple levels: civic initiatives to improve prior art discovery, judicial and legislative clarification to narrow permissible secondary patents, and promotion of non‑proprietary research models. The authors frame psychedelics as potentially foundational research tools—invoking the analogy of the microscope for biology—to justify treating them as deserving special protection from monopolisation. They stop short of prescribing a single solution, instead urging that meaningful patent reform be seriously considered alongside community‑driven and non‑profit approaches.

The issuance of low-quality patents on psychedelics reflects the substances’ distinct history, natural origins, and regulatory context, together with systemic weaknesses in patent examination. While prior art repositories and patent pledges can mitigate some risks, the authors conclude that deeper patent reform is necessary to prevent the grant and enforcement of meritless psychedelic patents and to safeguard scientific progress, equitable access, and Indigenous interests.