RN Collins has written a new series (3) of 18 articles for cannabis law report on 2026 Psychedelics & Legal Issues.
This is the 2nd in the series
Contact RN Collins: https://www.linkedin.com/in/rn-collins/
Patent Prior Art, Indigenous Knowledge, and the Nagoya Gap: Where the America Invents Act’s Prior Art Standard May Reach Traditional Knowledge in the Psychedelic Industry
AIA Section 102(a)(1), the Gordon Wasson Publication, and the Limits of US Benefit-Sharing Law
RN Collins, M.S., JD Candidate
https://www.linkedin.com/in/rn-collins/
Abstract
Psilocybin was not discovered by Compass Pathways. Ayahuasca was not invented by MAPS. Peyote’s therapeutic and spiritual significance was not first identified by researchers at Johns Hopkins. The psychedelic compounds now at the center of a rapidly expanding commercial industry have been used for centuries by indigenous communities in the Americas, Africa, and elsewhere for healing, ceremony, spiritual practice, and the transmission of cultural knowledge across generations. The commercial psychedelic industry has, to date, largely operated without a legal obligation to acknowledge the origins of this traditional knowledge, credit the communities that developed it, or share the benefits of commercialization with those communities. Whether that absence of obligation persists, and by what mechanism it might be addressed, is the question this article takes up.
This article argues that the America Invents Act’s 2011 elimination of the geographic limitation on patent prior art may have created, without apparent legislative intent to do so, one of the more significant available legal tools for indigenous communities confronting the psychedelic patent landscape, though the strength of that tool depends heavily on evidentiary questions that remain unresolved. Under 35 U.S.C. § 102(a)(1), a claimed invention is not patentable if it was “otherwise available to the public” before the effective filing date, a standard that could extend to knowledge documented in the ethnobotanical literature, in published accounts of indigenous ceremonies, and in R. Gordon Wasson’s 1957 Life magazine article that introduced psilocybin to a wide public audience. The AIA prior art argument is the article’s central claim, though it is not offered here as settled or certain doctrine. The Nagoya Protocol, RFRA, and FTC enforcement analysis are the contextual framework that gives the claim its fuller scope.
The article proceeds as follows. Section I lays out the AIA prior art argument as the article’s central claim. Section II surveys the federal Indian law framework and its limits. Section III considers the Nagoya Protocol and the practical, if not legally binding, force it may carry for US operators despite non-ratification. Sections IV and V develop the prior art analysis and the evidentiary challenges that could complicate it. Section VI addresses the Compass Pathways patent dispute as an illustration of both the promise and the limits of this approach. Sections VII and VIII address EU Regulation 511/2014 and the domestic benefit-sharing gap. Sections IX and X consider comparative frameworks and what a more complete policy response might require. The article concludes that the prior art tool and a benefit-sharing framework would likely need to operate together: one may help prevent monopolization, the other could work toward rewarding the knowledge sources themselves, though neither, on the present record, fully resolves the underlying gap.
I. The Central Claim: AIA Section 102(a)(1) and Traditional Knowledge Prior Art
Among the possible legal intersections between traditional indigenous knowledge and commercial psychedelic development, the patent prior art doctrine may be the most concrete and the most readily litigable. Under 35 U.S.C. § 102(a)(1), as amended by the Leahy-Smith America Invents Act, Pub. L. 112-29 (Sept. 16, 2011), a claimed invention is not patentable if “the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”
The “otherwise available to the public” language is the operative phrase for any traditional knowledge prior art analysis, though how far it reaches remains an open question that has not been fully tested against traditional knowledge fact patterns. The AIA expanded the prior art standard beyond the pre-AIA requirement of knowledge or use “in this country” and removed the geographic limitation that had previously excluded foreign traditional knowledge from prior art consideration. Under the AIA, a disclosure has no geographic requirement to qualify as prior art: prior public use, sale, or other disclosure anywhere in the world may qualify if it makes the claimed invention available to the public before the effective filing date. This geographic elimination could be the key doctrinal development that makes indigenous plant knowledge a legally operative challenge to psychedelic patents, though its application to specific fact patterns has not, to this author’s knowledge, been definitively tested.
The anchor document for the prior art landscape is R. Gordon Wasson’s article “Seeking the Magic Mushroom,” published in Life magazine on May 13, 1957. Wasson, a vice president at J.P. Morgan and amateur mycologist, participated in a velada ceremony with Mazatec curandera María Sabina in Oaxaca, Mexico in 1955 and published what appears to be the first detailed English-language account of the psilocybin mushroom ceremony, its setting, its effects, and its healing function within Mazatec tradition. The article reached an audience of millions and would likely constitute a “printed publication” within the AIA’s meaning, though whether a given tribunal would treat it as dispositive prior art against a specific patent claim depends on the claim’s scope and specificity. Albert Hofmann’s 1958 isolation of psilocybin and psilocin from Psilocybe mexicana, published in Experientia, would likely establish prior art for at least some subsequent patent claims to psilocybin composition and methods of extraction.
One practical implication is that a psychedelic patent strategy that proceeds without any traditional knowledge prior art search carries meaningfully elevated risk. Patent applicants who file psychedelic composition, method, or therapeutic use patents without conducting such a search could be exposing themselves to post-grant invalidity challenges based on prior art that is publicly available, documented in accessible literature, and specifically collected by organizations like Porta Sophia, which maintains searchable databases of traditional knowledge prior art intended for use in USPTO proceedings.
II. The Federal Indian Law Framework and Its Limits
A. AIRFA, the 1994 Amendments, and the Peyote Exemption
The American Indian Religious Freedom Act, Pub. L. 95-341 (Aug. 11, 1978), codified at 42 U.S.C. § 1996, established federal policy to protect and preserve for American Indians their inherent right of freedom to believe, express, and exercise traditional religions, including access to sacred sites, use and possession of sacred objects, and the freedom to worship through ceremonials and traditional rites. AIRFA’s original 1978 text was a policy declaration without an enforcement mechanism; courts have held it creates no judicially enforceable rights against federal agencies.
The 1994 Amendments, 42 U.S.C. § 1996a, added substantive legal protection for peyote, providing that use, possession, or transportation of peyote by an Indian for bona fide traditional ceremonial purposes in connection with the practice of a traditional Indian religion is lawful and shall not be prohibited by the United States or any State. The DEA regulatory exemption at 21 C.F.R. § 1307.31 operationalizes this protection: “[t]he listing of peyote as a controlled substance in Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church so using peyote are exempt from registration.”
The peyote protection illustrates the ceiling of federal Indian law protection for indigenous psychedelic use more broadly: it is species-specific (peyote only), user-specific (NAC members practicing a traditional Indian religion), and purpose-specific (bona fide traditional ceremonial purposes). Neither psilocybin, ayahuasca, nor other psychedelic plants with deep indigenous traditions receive comparable statutory protection, a gap that legislators concerned with this area may wish to examine.
B. RFRA as a Constraint on Commercial Operations
The Religious Freedom Restoration Act, 42 U.S.C. § 2000bb et seq., prohibits the federal government from substantially burdening a person’s exercise of religion unless the government can demonstrate a compelling interest through the least restrictive means. Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418 (2006) (Roberts, C.J., unanimous), established that the government cannot rely on the CSA’s general Schedule I designation as a categorical compelling interest sufficient to override a specific religious use claim.
The RFRA analysis could become relevant to commercial psychedelic operators where their sourcing practices or commercial marketing create conditions that interfere with indigenous communities’ ability to access traditional psychedelic plants for ceremonial purposes, through depletion of wild peyote populations, commodification of ayahuasca disrupting traditional vine cultivation networks, or economic displacement of indigenous traditional healers. This is a novel argument that would likely face significant causation and standing challenges, and it is not clear that any court has yet been asked to resolve it. It may not be legally frivolous, but its viability cannot be stated with confidence on the present record.
III. The Nagoya Protocol: International Norm Without US Obligation
The Convention on Biological Diversity, adopted at the 1992 Earth Summit, established the principle that biological resources are the sovereign property of nations and that traditional knowledge associated with those resources may be entitled to protection and fair benefit-sharing when used for commercial purposes. The United States signed the CBD but has never ratified it, the only UN member state that has not, and therefore is not directly bound by the Nagoya Protocol on Access and Benefit Sharing, adopted October 29, 2010, which entered into force October 12, 2014, and has been ratified by 142 parties as of August 2025.
US non-ratification does not necessarily insulate US commercial operators from Nagoya-derived obligations in practice, even though it removes any direct legal requirement. At least three categories of practical, indirect obligation may arise for US operators not directly subject to the Protocol. First, the Protocol creates binding obligations on 142 state parties, including countries where many psychedelic plants originate. A US commercial operator sourcing ayahuasca vine from Peru, a Protocol party, is interacting with a supplier that is itself bound by the Protocol’s requirements. Second, multinational investors and European pharmaceutical partners who are subject to EU Regulation 511/2014’s Nagoya compliance requirements may impose comparable requirements contractually on US partners. Third, ESG investor standards appear increasingly likely to require Nagoya-consistent benefit-sharing as a condition of investment in companies utilizing traditional biological resources, though this trend is uneven and its trajectory is not certain.
IV. The Prior Art Analysis
A. The Ethnobotanical Literature as Prior Art
The ethnobotanical and pharmacological literature on psychedelic plants is extensive, dates to the mid-twentieth century, and could constitute prior art for a substantial range of psychedelic patent claims, though the strength of any given piece of literature as prior art against a specific claim would need to be assessed case by case. Richard Evans Schultes and Albert Hofmann’s Plants of the Gods (1979) is a widely cited ethnobotanical survey of psychoactive plant use across indigenous traditions that has been publicly accessible for nearly five decades. Schultes’s fieldwork on Amazonian ayahuasca use, psilocybin mushroom ceremonies, and peyote traditions was documented in the published scientific literature beginning in the 1940s. Albert Hofmann’s isolation and characterization of psilocybin from Psilocybe mexicana in 1958, published in Experientia, would likely constitute prior art for at least some subsequent patent claims to psilocybin composition and methods of extraction.
B. The Oral and Ceremonial Tradition Problem
Perhaps the most legally complex prior art question is whether oral and ceremonially embedded indigenous knowledge, knowledge that was never published in the Western scientific literature but was demonstrably practiced within indigenous communities before a patent’s filing date, could constitute prior art under the AIA’s public accessibility standard. The question is not whether the knowledge existed or was used; it is whether it was “otherwise available to the public,” and this inference cannot be stated with the confidence that a formal statutory test would provide.
Many indigenous psychedelic ceremonies do not appear to have been secret in the relevant sense: they were reportedly conducted openly, observed by anthropologists, reported in published literature, and in some cases performed in contexts that included non-indigenous participants. The AIA’s elimination of the geographic limitation suggests that indigenous ceremonial use that was public within the indigenous community’s own territory could be prior art even where never recorded in a formal publication, though this reading has not, to this author’s knowledge, been tested before the PTAB or a federal court. The practical challenge is evidentiary: demonstrating to a PTAB examiner or federal court that a specific use was sufficiently public before the filing date would likely require documentary evidence, anthropological fieldwork reports, published ethnographies, historical photographs, colonial administrative records, that predates the patent’s effective filing date, and such evidence may simply not exist for many traditions.
C. Third-Party Prior Art Submissions: 35 U.S.C. § 122(e)
The AIA created a formal mechanism by which any member of the public may submit prior art to the USPTO for consideration in the examination of a pending patent application. Under 35 U.S.C. § 122(e), any person may submit prior art consisting of patents, published patent applications, or other printed publications for consideration and inclusion in the record before the first office action. Organizations like Porta Sophia, which compile traditional knowledge prior art databases, appear to be building the § 122(e) submission resources that indigenous communities, public interest advocates, and commercial competitors alike may need in order to challenge overclaiming patents before they issue.
The § 122(e) mechanism could also run in the opposite direction: a commercial entity aware of traditional knowledge prior art that would invalidate a competitor’s pending application may have a straightforward competitive interest in submitting that prior art before the application issues. Identification and submission of traditional knowledge prior art against competitor applications may therefore function as both a public interest measure and a legitimate competitive strategy, though which framing predominates in practice likely depends on the submitter’s motive and is not something this record can resolve.
V. The Compass Pathways Patent Dispute
The most significant psychedelic patent dispute to date appears to involve Compass Pathways’ patents on crystalline psilocybin (Polymorph A, also known as COMP360). In late 2021, the nonprofit Freedom to Operate filed petitions for post-grant review with the Patent Trial and Appeal Board challenging two Compass patents on the ground that the claimed crystalline psilocybin was not novel. The PTAB declined to institute the proceedings, finding that the cited prior art did not teach all five x-ray powder diffraction (XRPD) peaks recited in the claims.
The Compass PTAB decision illustrates both the promise and the limitations of the prior art approach. The prior art argument reached the PTAB but did not succeed on the technical merits of the specific XRPD peak claims as presented. One tentative lesson for traditional knowledge prior art is that the specificity of the claim language appears to be controlling, or at least highly influential. A patent claim covering psilocybin broadly may be more vulnerable to traditional knowledge prior art than a patent claim covering a specific crystalline polymorph defined by specific XRPD peaks. If this reading is correct, a traditional knowledge prior art argument would need to match the specificity of the traditional knowledge evidence to the breadth of the patent claim, a matching exercise that is not always straightforward given the gaps described in Section IV.B above.
VI. EU Regulation 511/2014 and the Benefit-Sharing Gap
EU Regulation 511/2014, which entered into application October 12, 2014 concurrent with the Nagoya Protocol’s entry into force, requires that any EU-based person utilizing genetic resources or traditional knowledge exercise due diligence to ascertain that resources were accessed in accordance with applicable access and benefit-sharing legislation, and transfer relevant information to subsequent users. A US psilocybin company that cannot demonstrate Nagoya-compliant sourcing may find itself unable to satisfy the contractual representations that EU pharmaceutical partners require for their own Regulation 511/2014 compliance, though the extent of this friction likely varies by partner and by transaction.
There is no US federal statute requiring commercial psychedelic operators to share benefits from the commercialization of traditional plant knowledge with the indigenous communities that developed it. The AIA’s prior art doctrine may be able to challenge overclaiming patents, but invalidating a patent places knowledge in the public domain, available for exploitation by anyone without any benefit-sharing obligation. A more complete policy response would likely require both instruments operating simultaneously: prior art challenges to help prevent monopolization, and benefit-sharing frameworks to help ensure knowledge sources share in the commercial value. Absent both, it appears likely that either one actor monopolizes the knowledge under patent or all actors exploit it without compensation. Neither outcome obviously benefits the indigenous communities that developed and transmitted the knowledge, though this article does not attempt to model the relative magnitude of each risk.
VII. Voluntary Benefit-Sharing and FTC Exposure
Some commercial psychedelic operators have developed voluntary benefit-sharing arrangements, formal or informal commitments specifying a percentage of revenues, credit to indigenous knowledge holders, or support for indigenous-led healing programs. A voluntary benefit-sharing commitment made within a commercial agreement would likely create a contractual obligation that is legally enforceable regardless of the absence of any statutory mandate. Parties negotiating such agreements may find it useful to draft them with the same specificity as any commercial joint venture: identifying the genetic resources covered, the benefit calculation mechanism, the payment schedule, the audit right, and the dispute resolution mechanism, though the record here does not evaluate any particular drafting approach as sufficient.
Voluntary benefit-sharing commitments made publicly, in investor materials, on company websites, in press releases, could create FTC-enforceable obligations not to make false or misleading statements about social practices. The FTC’s authority under 15 U.S.C. § 45 and the Green Guides framework (16 C.F.R. Part 260) applies to commercial claims about environmental and social practices generally, and there is no obvious reason it would not extend to psychedelic-industry benefit-sharing claims. A psychedelic company that publicly represents itself as indigenous-partnership-committed without concrete, documented benefit-sharing arrangements with specifically identified communities may have made an unsubstantiated social claim that could be actionable under the Green Guides or under Section 5’s general prohibition on deceptive acts or practices, though whether any enforcement action would actually follow depends on facts not addressed here.
VIII. Comparative Frameworks: Brazil and Peru
Brazil and Peru may offer the most instructive domestic ABS frameworks for thinking about the psychedelic industry, though neither was designed with psychedelics specifically in mind. Brazil’s Law No. 13,123 of 2015 (the Brazilian Biodiversity Law) requires commercial operators accessing Amazonian plant genetic resources, including ayahuasca vine and chacruna, to obtain prior authorization from the National Genetic Heritage Management Council (CGEN), register the access in the national management system (SisGen), and conclude a benefit-sharing agreement with the relevant traditional community before commercializing any product. A US ayahuasca company with Brazilian sourcing would need to navigate Brazilian domestic ABS law as a compliance obligation, independent of and in addition to any US domestic requirements.
Peru’s Law 27811 (2002) established a registry of collective knowledge and created a benefit-sharing mechanism for commercial use of knowledge accessed from Peruvian indigenous communities. Colombia ratified the Nagoya Protocol in 2020; its domestic implementing legislation requires prior informed consent and benefit-sharing for commercial access to genetic resources from Colombian indigenous territories. These framework laws may represent one plausible direction for international compliance obligations that US commercial actors will increasingly encounter through their supply chains, even absent US domestic ratification, though it is not certain how uniformly these frameworks will be enforced or how they will interact with US law over time.
IX. Recommendations for Policy and Institutional Design
The gaps identified above, the species-specific limits of federal Indian law, the non-binding status of the Nagoya Protocol in the United States, the evidentiary difficulty of proving oral tradition as prior art, and the absence of any domestic benefit-sharing statute, suggest several directions that legislators, agencies, and standard-setting bodies working in this area may wish to consider. These are offered as possible directions for institutional design, not as a claim that any one of them is required by existing law.
- Congress may wish to consider whether a domestic benefit-sharing statute modeled on Brazil’s Law No. 13,123 or Peru’s Law 27811 could close the gap left by US non-ratification of the Nagoya Protocol, at least for commercial use of traditional knowledge originating from within US territory or from federally recognized tribes.
- The USPTO could consider expanding formal support for third-party prior art submission infrastructure under 35 U.S.C. § 122(e), for instance, by facilitating clearer intake channels for traditional knowledge databases such as Porta Sophia’s, to reduce the evidentiary burden facing anyone attempting to challenge an overclaiming application before it issues.
- Agencies and standard-setting bodies overseeing ESG and social-claims disclosure may wish to consider whether more specific guidance for the psychedelic and biotech sectors, addressing what documentation would substantiate a public benefit-sharing claim under the FTC’s Green Guides, would reduce the risk of both unsubstantiated claims and unwarranted greenwashing allegations.
- State-level cannabis and psychedelic regulators designing therapeutic or decriminalization frameworks may wish to consider whether license or registration conditions could include a traditional knowledge and benefit-sharing disclosure requirement, comparable in structure to existing social equity provisions in state cannabis licensing schemes.
- International bodies and treaty secretariats may wish to consider developing model contractual clauses for benefit-sharing specific to psychedelic plant genetic resources, given that existing ABS model clauses were developed primarily with other biological resources in mind and may not map cleanly onto ceremonial or oral-tradition knowledge.
Whether any of these directions is adopted, and in what form, is a policy question this article does not purport to resolve.
X. Conclusion
The AIA’s 2011 elimination of the geographic limitation on prior art may have turned the ethnobotanical record, including R. Gordon Wasson’s 1957 Life magazine account of Mazatec psilocybin ceremonies and Albert Hofmann’s 1958 identification of psilocybin, into a source of invalidating prior art against at least some psychedelic patents. If this reading holds, it would represent one of the more significant legal tools currently available to indigenous communities in the psychedelic patent context, though the argument’s ultimate reach has not been tested to a degree that would allow confident prediction of outcomes. A psychedelic patent strategy that proceeds without a traditional knowledge prior art search would appear to carry avoidable risk. A psychedelic operator seeking European pharmaceutical partnerships that ignores EU Regulation 511/2014’s compliance requirements may find itself unable to close those partnerships. And a commercial claim that psilocybin produces therapeutically meaningful altered states, a claim whose foundations trace to the Mazatec community’s traditional knowledge, sits uneasily, at minimum, alongside the absence of any benefit-sharing framework behind it.
The prior art approach and the benefit-sharing framework appear to be complementary rather than substitute instruments. Prior art challenges may help prevent monopolization of publicly available knowledge; benefit-sharing frameworks could help ensure that the communities who developed that knowledge share in the commercial value it generates. Neither instrument alone seems likely to produce a fully just result: invalidating a patent places traditional knowledge in the public domain, available for free exploitation by all; benefit-sharing without patent accountability could allow monopolization of traditional knowledge to continue under patent protection. The legal landscape surveyed in this article suggests the tools for addressing both problems exist in at least preliminary form. Whether the commercial psychedelic industry, its regulators, and the indigenous communities affected by it converge on a workable combination of these tools remains, as of this writing, an open question.
Endnotes
- Leahy-Smith America Invents Act, Pub. L. 112-29, § 3(b)(1), 125 Stat. 284 (Sept. 16, 2011) (codified at 35 U.S.C. § 102(a)(1)) (a claimed invention is not patentable if “the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention”; AIA provisions effective March 16, 2013; eliminating pre-AIA geographic limitation requiring prior use or sale to have occurred “in this country”), https://www.uspto.gov/sites/default/files/aia_implementation/20110916-pub-l112-29.pdf.
- R. Gordon Wasson, Seeking the Magic Mushroom, Life, May 13, 1957, at 100 (first detailed English-language account of the psilocybin mushroom ceremony; describing Mazatec curandera María Sabina’s velada ceremony in Oaxaca, Mexico in 1955; constituting printed publication prior art for psilocybin therapeutic use claims); A. Hofmann, R. Heim, A. Brack & H. Kobel, Psilocybin, ein psychotroper Wirkstoff aus dem mexikanischen Rauschpilz Psilocybe mexicana Heim, 14 Experientia 107 (1958), https://doi.org/10.1007/BF02159243 (isolation and identification of psilocybin and psilocin; constituting prior art for all subsequent patent claims to psilocybin composition); MAPS, What’s Going On with Patents and Psychedelics? (Aug. 26, 2021), https://maps.org/news/bulletin/whats-going-on-with-patents-and-psychedelics/.
- American Indian Religious Freedom Act, 42 U.S.C. § 1996 (policy declaration), https://www.law.cornell.edu/uscode/text/42/1996; AIRFA Amendments of 1994, 42 U.S.C. § 1996a (peyote protection for NAC members), https://www.law.cornell.edu/uscode/text/42/1996a; 21 C.F.R. § 1307.31 (“The listing of peyote as a controlled substance in Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church so using peyote are exempt from registration. Any person who manufactures peyote for or distributes peyote to the Native American Church, however, is required to obtain registration annually and to comply with all other requirements of law.”), https://www.law.cornell.edu/cfr/text/21/1307.31; Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418, 424–32 (2006) (Roberts, C.J., unanimous), https://supreme.justia.com/cases/federal/us/546/418/.
- Convention on Biological Diversity, June 5, 1992, 1760 U.N.T.S. 79 (United States signed but has not ratified; United States is the only UN member state that has not ratified the CBD); Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, Oct. 29, 2010, U.N.T.S. No. 30619 (entered into force Oct. 12, 2014; 142 parties as of August 2025; United States has not ratified), https://www.cbd.int/abs/nagoya-protocol.shtml; EU Regulation 511/2014, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0511 (entered into application Oct. 12, 2014; due diligence requirements for EU-based users of genetic resources and traditional knowledge).
- Sterne Kessler, Navigating the Psychedelic Patent Landscape (Apr. 22, 2025), https://www.sternekessler.com/news-insights/insights/navigating-the-psychedelic-patent-landscape-trends-challenges-and-future-directions/ (reporting PTAB denial of Freedom to Operate’s post-grant review petitions against Compass Pathways’ psilocybin patents on ground that prior art did not teach all five XRPD peaks recited in claims; Compass patents US 10,947,257 and US 10,954,259); 35 U.S.C. § 122(e) (third-party prior art submissions); 15 U.S.C. § 45 (FTC authority); 16 C.F.R. Pt. 260 (Green Guides); Law No. 13,123 of 2015 (Brazil Biodiversity Law; CGEN authorization; SisGen registration; benefit-sharing agreement requirements); Law 27811 (Peru, 2002) (collective knowledge registry and benefit-sharing mechanism).
