By: Alex Okun

Health and wellness are a key driver of consumer spending in the United States (US). The US pharmaceutical market is expected to exceed $1 trillion by 2030, and the value of its “wellness” industry (which includes everything from fitness equipment to psychotherapy) has skyrocketed to nearly $1.8 trillion. As life expectancy in America has remained relatively low and as Americans have become increasingly reluctant to seek synthetic remedies, market leaders have seized upon the trend toward natural health treatments. However, many companies have attempted to patent traditional medicines as if they were cutting-edge drugs, usually at the expense of the indigenous peoples who discovered them.

Patents

In the US, the owner of a utility patent has the right to prohibit anyone from selling their invention for 20 years from the date the patent is filed. To obtain patent protection, the invention must be “novel” and advance beyond existing technology in a way that would not be obvious to others in the industry. Patent examiners usually check global patent databases and trade publications to determine the state of existing technology (or “prior art”), and then assess the “obviousness” of the claimed invention in context. Even if granted, however, a patent is vulnerable to legal challenge if a third party disputes either the novelty or the obviousness of the invention. If a plaintiff can establish that the patented invention was either already in use or was merely an obvious advance over existing methods, the patent will be revoked. 

Biopiracy

“Biopiracy” is defined as patenting an indigenous group’s traditional knowledge or genetic resources for commercial gain. Perhaps the most infamous case was in 1995 when two US researchers patented the use of turmeric as an antimicrobial treatment for open wounds. They were granted the patent, but a group of Indian scientists sued to have it canceled because turmeric has been used in medicine for thousands of years. The patent was successfully canceled, but international biopiracy threatens traditional knowledge in medicine, foods, and industrial materials. Attempts at fighting back have generally been successful only in the most egregious instances, or when national governments have intervened on the people’s behalf in US courts.

Soon after the revocation of the turmeric patent, the Indian government took proactive measures by assembling a database of traditional medicine texts and translating them into English. This was consequential particularly for US law because evidence proving that an invention was used before being patented (an essential step to cancel a patent) must be available in English. When an invention has already been patented abroad this process is relatively simple because the US is obligated by treaty to recognize patents issued in most other countries. The US has not, however, ratified the treaties requiring the recognition of foreign discoveries that were never patented. As a result, US law only recognizes evidence of foreign “public use” of an invention if provided in the 9 months following a patent’s issuance. This places a significant burden on remedies and inventions based on traditional knowledge, which is often codified in oral traditions or ancient texts without readily available translations.

Global Guardrails

The Convention on Biological Diversity (“CBD”), which went into effect in 1993, was the first legally binding treaty designed to “conserve biological diversity, to sustainably use its components and to share equitably the benefits arising from the use of genetic resources.” Although the treaty recognized the rights of indigenous people to their knowledge, a far more significant advance toward effective legal protections came from the Nagoya Protocol in 2014. The Nagoya Protocol was intended to “ensure that traditional knowledge associated with genetic resources” is accessed only with the informed consent of the indigenous community from which those resources originated. It also created a framework for a “benefit-sharing mechanism” that would remunerate indigenous communities for the commercial gains resulting from the use of their traditional knowledge. The Access and Benefit-Sharing Clearing House provides information on the laws, procedures, and model contracts for benefit-sharing agreements for all of the Protocol’s member states. 142 nations have now ratified the CBD and Nagoya Protocol, including most of the European Union. However, the United States has neither joined the Convention nor participated in the benefit-sharing that Nagoya was intended to facilitate.

A key gap in the Nagoya Protocol’s provisions was that it did not address the issuance of patents. As a result, patent applicants are not obligated under the treaty to disclose whether traditional knowledge went into their inventions. However, 30 countries came to a solution in May 2024 with the Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (“GRATK”). Ratifying states must require patent applicants to disclose any source(s) of traditional knowledge underlying their claimed inventions, and the countries or indigenous groups from which the knowledge originates. While it does not mandate its members to reject applications due to traditional knowledge sources, the disclosure requirement will enable greater transparency in the patent examination process. GRATK also calls for a global system of traditional knowledge databases, such that national patent offices can more readily assess whether an application truly contains a “novel” invention. This would create a more efficient, robust patent examination and allow indigenous advocates to challenge patents without expending excessive resources to collect the requisite evidence. The World Intellectual Property Organization (“WIPO”), which administers GRATK, already administers a database of global patents and now maintains an extensive list of traditional knowledge databases worldwide. Although GRATK is only binding on its 38 signatories as of December 2024, experts are hopeful that it will soon be ratified by major economies like Australia, Brazil, and India.

Conclusion

In the context of traditional medicine, there is not necessarily an inherent conflict between social justice and innovation. The discoveries of indigenous people can fill the existing gaps in modern medicine and serve the needs of patients who either do not want or cannot use existing treatments. However, three key needs must be met for the system to be just: attribution of source, informed consent, and sharing the profits from these cures with the people who created them. All three issues are addressed by GRATK (attribution) and Nagoya (consent and benefit-sharing), and the growing web of traditional knowledge databases is empowering advocates to challenge biopiracy when it occurs. Although it is unclear whether the new administration will seek US accession to either treaty, patent law in its current form has been effectively used by advocates to combat biopiracy at its source. Unless the USPTO commits to more proactively examining traditional knowledge sources, this fight will remain dependent on the availability of traditional knowledge resources and the vigilance of indigenous advocates.