I. Introduction

            The current decline in biodiversity is faster than any other point in human history.[1] Overexploitation is the leading driver of biodiversity loss; species are harvested at unreplenishable rates. Government, non-government, and industry representatives are searching for direction in addressing this rapid species loss. In particular, the World Intellectual Property Organization (“WIPO”) is looking to channel biodiversity conservation through patent systems by instituting an origin disclosure requirement within the patent application process. This paper explores the intersection of biodiversity and innovation, contending the origin disclosure requirement is an unjustified, ineffective mechanism to effectuate biodiversity conservation.

Part II describes the biodiversity crisis as it relates to innovation and consequentially, intellectual property (“IP”). This includes an overview of the functioning international conservation laws and patent systems- the legal environment influencing innovation and the context in which an origin disclosure requirement operates. Part III delves into the origin disclosure requirement itself, the logic behind it, and a critique of its operation and compatibility with the legal environment explored in Part II. Finally, accounting for the shortfalls of an origin disclosure requirement described in Part III, Part IV further addresses the barriers to effectuating biodiversity conservation through IP law and explores alternative mechanisms.

II: The Intersection of Biodiversity and Intellectual Property

The provided background reveals the relationship between biodiversity and patent law. 

Conceptualizing how biodiversity operates as a resource is necessary to understand how an origin disclosure requirement operates in the larger scheme of patent procurement. This context includes an emphasis on genetic resources and the current legal frameworks shaping biodiversity conservation and patent systems. 

A. The Value of Biodiversity

            Biological diversity (or “biodiversity”) is a panoramic term that encompasses the entire variety of life present on Earth.[2] The Convention on Biological Diversity defines it as “the variability among living organisms from all sources, including inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species, and of ecosystems.”[3] The value of biodiversity is best represented through the benefits that humans derive from life on Earth (i.e., Earth’s plants, animals, fungi, microorganisms, etc.). Biodiversity is fundamental for the ecosystems that all living organisms depend upon for food, air, water security, and numerous other benefits.[4] Accordingly, a decline in biodiversity represents a diminution of ecological complexity.[5] FEspecially for the purposes of this paper, the implications of biodiversity loss can be appreciated as a vague, but realistic, threat of option foreclosure.[6]  This is the probability of loss of potential benefits derived from species richness.[7] Essentially, the threat of extinction to both known and unknown biological resources necessarily threatens the ability to derive benefits from them. 

Many human activities harm biodiversity[8], and effective conservation requires an understanding of the relationship between biodiversity and ecosystem function.[9] In all, the fate of Earth’s biodiversity “depends upon how humanity interacts with natural systems, where human society can act as both custodian and consumer of natural systems.”[10] Conceptualizing biodiversity as measurable elements of diversity—genetic, organismal, or ecological—allows for tailored quantification in this complicated field of over one million species (and counting).[11]

1. Genetic Resources

Genetic diversity is focused upon here because of the often-unregarded role it plays in sustaining innovation. Genetic diversity refers broadly to genetic variability- a property that describes the innumerable variations in the genetic code that allows for species’ characteristic adaptability to life on Earth.[12] The unique genetic codes and characteristics of living organisms—biological or genetic resources[13]—and the habitats that sustain them may be appreciated as important economic and political assets, essential to modern industrialized society.[14]

Although unseen, genetic material has commercial value. The information encoded in DNA translates to an organism’s distinct properties.[15] Properties that create value when characterized and applied. In this sense, the loss of biological resources (and thus genetic diversity) is the diminishment of a wellspring for “future development of new combinations, new genomes, species, and ecosystems, be it through natural evolution or technological combination [in a lab].”[16] If genetic diversity falls below critical thresholds, the biodiversity at higher levels (species and ecosystems) cannot be sustained.[17]

Adducing material applications founded in genetic resource technology effectively demonstrates the value of biological and genetic resources. To illustrate, animal peptides, like venom compounds, have been utilized to produce a wealth of pharmaceuticals. In fact, society owes one of the greatest advances in cardiovascular medicine, the advent of ACE inhibitor captopril (Capoten), to the Brazilian pit viper (Bothrops jaraca). Studying the viper venom’s unique property for lowering blood pressure led to Squibb’s breakthrough drug Capoten; their first one-billion-dollar drug designed from the template of viper venom.[18]

The pharmaceutical industry has a long-standing practice of sourcing from biodiversity by using a  practice termed “bioprospecting.”[19]Natural products (like the pit viper’s venom) and their genetic precursors are structurally optimized by evolution to serve medicinally relevant functions, making them invaluable resources to the advancement of human health.[20] Where high-tech combinatorial chemistry methods are limited (in synthesizing new compounds), Mother Nature provides diverse and continuously evolving structures in natural products.[21] Combining drug design chemistry with the wide structural diversity and biological activity of genetic resources is a no-brainer for industry giants; evidenced by the industries’ large-scale utilization of ethnobotanical diversity in drug exploration.[22] Over 50% of currently available FDA-approved drugs are derived from natural products.[23]

Similarly, genetic resources for food and agriculture have proven pivotal to food security and productivity.[24]A well-known representative would be genetically modified organisms (“GMOs”), direct derivatives of genetic resources. Many widely planted crops are genetically vulnerable to certain pests, pathogens, or environmental conditions.[25] Genetic resources like crop wild relatives encode beneficial traits that agricultural geneticists use to modify domesticated crop plants.[26] For example, wild sunflowers have been used to enhance seed production with disease resistance, herbicide resistance, and salt tolerance.[27] USDA reports indicate that 87-96% of corn, 92-99% of cotton, and 91-99% of soybeans planted in the United States are genetically engineered varieties.[28] Similarly, livestock breeds are routinely enhanced through gene selection and breeding programs. This is illustrated regularly in selecting for heat tolerance in dairy cows; different breeds and populations are analyzed and chosen based on better productivity and/or physiological durability under heat stress.[29]

2. Industry Dependence on Biodiversity

 The potential for scientific breakthrough and economic development fuels multi-industry engagement in bioprospecting.[30] Indeed, bioprospecting advances humankind; the progression of science and corresponding industrial, economic, and societal growth cannot be understated. However, there is a less savory practice that mirrors bioprospecting- biopiracy. The concept of biopiracy arose from the illegal exploitation and monopolization of native resources, physically and intellectually.[31] Contemporarily, corporate powers use IP systems to legitimize the taking (i.e., the harvest and potential exploitation) and ownership of biological resources from less developed countries.[32]

The implications of such activity are never solely economic. There are instruments, like IP rights, operating at different levels of the natural world to result in biodiversity degradation and other related environmental harms.[33] To understand how IP rights may be an instrument used to harm biodiversity, one should properly appreciate genetic resources as a refined product.[34] The distillation of “crude” biodiversity (e.g., plants, animals, etc.) is necessary to extract value: genetic resources. This value (monetized) is shared primarily, if not solely, with non-native corporations holding IP rights rather than the entire worth of these species and their ecosystem/community.[35] In this sense, patents can hamper the degree to which native or local industries can add value to their products.[36] Developing nations, particularly indigenous communities, are less incentivized to preserve native biodiversity when they do not profit or benefit from their own environment/natural resources.[37]

3. Illustrations 

a. The African cherry tree (Pygeum africanum)

            The African cherry tree, native to the Afromontane regions of Africa, has long been used for its medicinal properties in traditional indigenous medicine systems.[38] In the 1970s, the Western world became aware of these properties when African cherry bark extract was discovered to have pharmacologic benefit in managing benign prostate hyperplasia.[39] A slew of patents and trademarks were filed based on these therapeutic properties and the tree was quickly commercialized as an effective treatment option.[40]

            By the turn of the century, the tree became Africa’s most valuable medicinal export plant with over 3,300 tons of bark exported annually, worth over $200 million.[41] However, foreign buyers’ exploitative tactics resulted in uncontrolled and destructive harvest.[42] Mass bark exploitation has caused remarkable damage to the African cherry population, leading to worries about long-term species conservation and the sustainability of harvesting.[43] Concerns of genetic erosion surfaced as conservationists noticed the destructive exploitation had also affected endemic wildlife.[44] Poverty, corruption, and poor regulation from importing countries all contributed to overharvest.[45]

            African countries would surely benefit from national legislation to conserve the biodiversity of medicinal resources. Despite potential domestic policy or management efforts, the risk of overexploitation in poor countries like Cameroon, the Democratic Republic of Congo, Kenya, Uganda, etc. is still high. This fact has not given pause to Western industry members, as IP trends indicate the bark extract formulations/uses are still being protected and a quick internet search will reveal hundreds of “Pygeum [Africanum]” extract-based supplements. 

 b. American horseshoe crab (Limulus polyphemus)

Horseshoe crabs (those of the Limulidae family), are widely used in the biomedical sector after the unique properties of their milky-blue blood were discovered in the 1950s.[46] Special immune cells in the crabs’ blood are used to detect bacterial endotoxins, a property that translated to an important commercial biomedical product: Limulus amebocyte lysate. This lysate has become a ubiquitous biomedical product; pharmaceutical/biomedical industry members cannot opt out of consumership because any drug, vaccine, device, etc. that may contact blood or cerebrospinal fluid must be tested for the presence of endotoxins before approval.[47]

The raw material, crab blood, is required to create this product. Regulation of crab harvest is lenient because the animals are captured, bled, and returned alive to the ocean.[48] However, the established mortality associated with this practice is at least 15-30%, and spawning surveys indicate even greater morbidity in female crabs.[49] The decline in spawning females has resulted in the near-elimination of entire horseshoe crab populations along the Massachusetts and Delaware coastline, and lower numbers affect the entire ecosystem surrounding horseshoe crabs.[50] The fear is that American horseshoe crabs, a vulnerable species, could meet the same fate as Asian horseshoe crabs- a spot on the International Union for Conservation of Nature’s endangered list.[51]

Furthermore, a synthetic alternative to the horseshoe crab-derived lysate (recombinant factor C, “rFC”) was developed twenty years ago. The original rFC patent, owned by Lonza, has also expired now (as of 2024), meaning other suppliers can produce rFC at a much lower cost, an event that would theoretically funnel the alternative into mainstream use. Studies show rFC is just as efficacious and conversion to rFC would result in a 90% reduction in the demand for LAL, equal to 100,000 less horseshoe crab bleedings per year.[52]

So what is preventing widespread adoption of rFC or alternatives? The three major market players, Lonza, Charles River, and Associates of Cape Cod, still have major investments in IP for crab blood testing-related consumables (e.g., testing kits, instruments, services, reagents, assays, etc.)[53] These derivative products and their associated IP instruments may not directly implicate horseshoe crab-derived genetic resources, but their commercial success depends upon the continuing use of crab blood.

B. Intellectual Property and Biodiversity: The Legal Landscape  

1. Patenting Genetic Resources

            Inventions that incorporate biological/genetic resources present a unique type of subject matter for IP protection.[54] Genetic resources themselves are not subject to protection because they are a product of nature- unpatentable subject matter.[55] The logic behind this distinction is that naturally occurring sequences of DNA are like stars—discoverable and naturally occurring—thus they belong to the public domain.[56] However, inventions that are based upon or developed using genetic resources are eligible for patent protection.[57]

For example, U.S. Patent No. 7,906,146, Lyophilized formulations of exendins and exendin agonist analogs, claims different weight/volume formulations of exendin-4.[58] Briefly mentioned in the patent’s background section, “exendins are peptides found in salivary secretions of the Gila Monster and Mexican Bearded Lizard, reptiles endogenous to Arizona and Northern Mexico.”[59] The use of Gila Monster peptides is rooted in the reptile’s ability to slow its metabolism and maintain constant blood sugar- a trait that was appealing to scientists looking to mitigate diabetes.[60] Note, the inventors and assignee (Amylin Pharmaceuticals L.L.C.) could not patent the Gila Monster’s venom, the exendin peptide itself, or even the genetic code of the exendin peptide- those are all products of nature that constitute unpatentable subject matter. However, they were able to patent compositions that included those genetic resources. 

2.  Commodifying Biodiversity: The Scope and Value of Genetic Patents

Restrictions in patenting genetic material have not lessened their utilization. Industries have simply shifted towards patenting applied genetics that still utilize and enhance the value of such biological resources- colloquially termed biotechnology (“biotech”). The scope of biotech patents, what they include and protect, commonly incorporates genetic material falling into three broad categories: (1) DNA, RNA, amino acid sequences, and metabolic pathways with specific functions or products, (2) chemical compounds (compound structure both characterized and uncharacterized), and (3) raw extracts or byproducts.[61] These categories are helpful in understanding the connection between a given genetic resource and how it may be patented for purposes of commercialization. Resources from the first category are the paradigmatic genetic resources, including biotechnologies such as industrial enzymes and research, diagnostic, or therapeutic tools expressed in sequence data.[62] Resources from the second category are commonly associated with quintessential biotech—pharmaceuticals and medical technologies—where compound functionality may be emphasized over the particular genetic structure.[63] The last category is associated with commercial harvesting, typical for nutraceuticals and cosmetics.[64] 

Corporations worldwide invest heavily in research and development (“R&D”) to create biotechnology. This is particularly true for “northern” countries (i.e., “western nations” like the United States, Canada, Japan, Australia, and European countries) as they represent the chief users of genetic material, the basis for biotechnology development.[65] This contrasts the areas where biodiversity is greatest, many developing “southern” nations like Brazil, Colombia, Indonesia, and India. The overlapping result is non-native biotech developers targeting tropical developing countries, often with poor and rapidly growing populations, that are increasingly dependent upon external assistance to address food and economic development needs, much less biodiversity conservation.[66] Socioeconomic dynamics aside, the natural relationship between genetic resources and scientific/technological advancement suggests patent rights are inextricable from society’s use and development of biological resources.

3. International Patent Governance 

A patent grants the owner exclusive rights for a period of time. This means that the owner (whether it be the inventor(s) or an assignee) can stop anyone from using, making, or selling their invention without permission.[67] In granting these rights, the patent system aims to promote innovation and progress by rewarding inventors. At the same time, obtaining a patent requires disclosure of the invention- publication of the data and specifics regarding that invention, meant to enable further research and awareness regarding the body of knowledge.[68] Countries vary in the legal requirements for patent obtainment, but an applicant is generally required to describe the invention clearly and with sufficient detail to allow the average person in that technical field to use or reproduce it.[69] Additionally, all countries require the invention to be useful and novel (although nations differ on what those terms mean). The United States, for example, has both codified and established judicial precedents that outline what subject matter is patentable, and what it means for an invention to be novel and non-obvious.[70]

            Patent law is jurisdictional, meaning protections are territorially limited to the country that issues the patent. Consequently, an inventor or business has to file applications in multiple, individual jurisdictions to obtain broad-scale protection. To address this arduous and expensive process, various treaties have been employed to facilitate more efficient means of obtaining multi-national IP rights. The two main routes for achieving multi-national patent rights are facilitated under the Paris Convention and the Patent Cooperation Treaty.

The Paris Convention is effectuated through the United Nations and WIPO.[71] For contracting nations, it provides national treatment-member states afford international patent applicants the same rights as a national patent holder.[72] This prevents different countries from treating foreign applicants unfavorably. Under the “Paris [Convention] route” (for obtaining protection in several countries), an applicant can file an initial application in any member country and receive twelve months priority. This means the applicant has one year to subsequently file any other individual applications to protect that same invention in another member country without forfeiting the novelty of the invention.[73]

A sort of “extension” of the Paris Convention, also administered by WIPO, is the Patent Cooperation Treaty (“PCT”). To become a contracting state of the PCT, one must first join the Paris Convention. The 1883 Paris Convention is one of the most widely adopted treaties worldwide, with 180 contracting member countries[74], the PCT is a similarly wide-scale union including the major industrialized nations.[75] The alternative “PCT route” for filing allows the applicant to simultaneously seek protection from any of 155 contracting nations with just one, single application.[76] While a PCT application doesn’t give rise to a single “international patent” it provides an applicant international priority for all member nations designated in the initial application and eighteen additional months of priority (on top of the twelve months, for thirty months total). This extra time to file means applicants have more time to collect the funds for multi-national filing- an unavoidably expensive process. Both routes have advantages for different types of applicants with different goals or budgets.[77]

4. International Law affecting Biological Resources: TRIPS and the CBD

If one visualizes the PCT as a “world patent office” processing “world patent applications”, the Agreement on Trade-Related Aspects of Intellectual Property (“TRIPS”) would be the overarching instrument establishing “global patent law” (more like an extension of the Paris Convention).[78] Naturally, TRIPS guides technology flow by regulating multilateral trade as well. This is where it overlaps with the Convention on Biological Diversity (“CBD”)- another agreement touching international technology flow, although motivated by different objectives. Hence, both agreements—TRIPS and the CBD—are relevant to patent rights and the use of biological resources.

World Trade Organization members concluded the TRIPS agreement in 1994- an effort to unify trade regulation through the establishment of minimum IP protection standards.[79] Put simply, TRIPS creates the universal bottom floor of patent protections and allows member nations to decide the upper level.[80] In a sense, it expanded on the Paris Convention by further nationalizing patent law with the impact of creating even enforcement mechanisms and requiring a 20-year term.[81] Notably, TRIPS requires patents to be granted in all subject-matter fields, including genetic material, so member countries cannot wholly exclude patents implicating genetic resources without violating the agreement.[82]

Around the same time TRIPS was being negotiated, the United Nations Environment Program, noticing the alarming extinction rate, initiated the CBD. The CBD was an attempt to fill the gaps in global biodiversity conservation that left biological resources exposed to the whims of countries, corporations, and individuals.[83] This conservation gap could be an economic problem; some countries undervalue, and thus under-conserve, their natural resources.[84] The resulting principle, which guides the CBD, is one of “common concern for humankind” that emphasizes state sovereignty over biological resources.[85] To this end, member countries are mandated to protect their biodiversity (and cooperate if need be). Principally, this obligates the creation of national strategies to research, monitor, and protect biodiversity, restoration and maintenance of protected habitats, and governance over access and equitable benefit-sharing.[86]

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the “Nagoya Protocol”) is a supplementary agreement to the CBD. The Nagoya Protocol is aimed at effectuating one particular CBD objective: the fair and equitable sharing of benefits arising from genetic resource use. That is, the exploitation of poorer, biodiversity-rich states by developed countries. But like the CBD, the Nagoya Protocol’s success depends upon effective implementation at the domestic level. Contracting parties are further obligated to create measures for access, benefit-sharing, and compliance, but this is not without criticism of redundancy and research hampering.[87]

Notably, The U.S. is the only U.N. member state that has not ratified the CBD or the Nagoya Protocol. Despite the flexibility in their technology transfer provision, the U.S. (particularly the pharmaceutical industry) is unwilling to put IP rights on the table when it comes to promoting biodiversity sustainability.[88] The U.S. position is not necessarily unreasonable; commercially viable products won’t make it to market without effective patent protections for the investor/developer.[89] To ratify, the U.S. would prefer rigorous foreign patent protection for inventions implicating biological resources, contracting parties to voluntarily accept distribution and tech transfer conditions, and space clear of restrictions on technology development, sale, or commercialization.[90]

TRIPS’ institution of universal mandatory patent protection standards should have lessened the U.S.’ resistance to ratify the CBD, given that TRIPS “standards constitute the international law to be observed under Art. 16 of the CBD, whenever access to and transfer of a patented…technology is at hand.”[91] However, conflict between the two regulations is ever-looming as countries can choose which treaty they want to emphasize in their domestic policies.[92] The World Trade Organization is the more influential regime; membership benefits, like robust compliance and enforcement mechanisms, are economically and geopolitically valuable for any country.[93] However, members are limited in their ability to leverage IP protections for biodiversity conversation. Consequently, a developing nation that is a World Trade Organization member is bound to implement TRIPS in its legal framework, despite potential conflict with their domestic environmental interests.[94] In this sense, the CBD’s encouragement of sovereign policymaking may be pointless. If countries can’t properly enforce existing domestic regulations, or policy measures are null and inadequate in light of TRIPS requirements, there is no significant advancement towards biodiversity conservation. 

III.  Unraveling the Origin Disclosure Requirement

Reconciling the objectives of TRIPS, the CBD, and patent rights within the overarching North-South conflict is a challenge. Amongst other proposed strategies[95], the specific measure critiqued here allocates the role of resource gatekeeper to already-burdened patent offices. Decades of growing tension over the accessibility and exploitation of biological resources have prompted intergovernmental efforts to alter the conventional disclosure obligations by creating a mandatory source/country of origin disclosure requirement (the “disclosure requirement”).[96]

The disclosure requirement has been debated since 1997 and nearly thirty jurisdictions have already imposed an origin disclosure requirement in domestic legislation.[97] So why is exploration of this requirement still relevant? Those decades of negotiation have finally come to fruition in the form of a “groundbreaking” new treaty on genetic resources- WIPO’s first treaty to “address the interface between intellectual property, genetic resources, and traditional knowledge”.[98] Adopting the CBD’s definition of genetic resources, Article 3 of the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (the “GRATK Treaty”) provides the following disclosure requirement:

3.1 Where the claimed invention in a patent application is based on genetic resources, each Contracting Party shall require applicants to disclose:

1. the country of origin of the genetic resources, or
2. in cases where the information in Article 3.1(a) is not known to the applicant, or Article 3.1(a) does not apply, the source of the genetic resources.

GRATK Treaty art. 3.1, May 24, 2024, WIPO edoc GRATK/DC/7.

Although WIPO’s legal instrument is “soft law”, the new treaty obligations, operating within the inherently global context of patent protection, could result in real changes to the requirements for filing patent applications and challenging patents.[99] For example, a GRATK Treaty footnote explicitly requests the International Patent Cooperation Union (PCT application policymakers) to incorporate the origin disclosure requirement into their regulations.[100] Considering patent protections are a launch pad for prosperity and opportunity worldwide, even the slightest change in policy implicates the global innovation economy.

A. Purpose, Intent, and Operation of the Disclosure Requirement 

The disclosure requirement forces patent applicants to specify the original source of any biological/genetic material or any associated traditional knowledge[101] upon which the claimed invention was derived. This requirement is supposedly the answer to curbing biopiracy and resource misappropriation- originally posed to compliment and empower the CBD’s access and benefit-sharing requirements, thus protecting genetic resources.[102] However, the final, narrowed GRATK Treaty text merely recognizes the “potential role of the patent system in contributing to the protection of genetic resources”.[103]

The logic behind the requirement is that patent disclosures can be a tool for identifying situations where access to biological/genetic resources has been obtained without proper consent or benefit-sharing. From that point, a nation could facilitate corrective actions.[104] However, this logic requires much more than just an origin disclosure to function properly. WIPO knows this as well, but still only specifies that contracting parties may establish a genetic resource database system to accompany their mandatory disclosure requirement.[105] As such, biodiversity conservation under the GRATK Treaty relies on the assumption that a product incorporating genetic resources would be correctly indicated in the application process and the country of origin has established the necessary benefit-sharing systems to facilitate economic renumeration for conservation- a tall order for even the most developed countries.[106]

B. Ad nauseam: The Problems with Origin Disclosure Obligations

            In the wake of WIPO’s disclosure requirement revival, one should question why the origin disclosure requirement has been pursued ad nauseam. Decades of failed negotiations and inconsistent implementation raise a valid question of whether WIPO’s new treaty, and the disclosure requirement in general, is the right tool for the job. Not only does the GRATK Treaty lack the teeth to effectively protect genetic resources[107], but biodiversity depletion associated with exploitative patented technologies is arguably better served through other systems. Effective conservation is better monitored and served through a lens on commodification or commercialization (i.e., monitoring different stages of the value chain such as harvest, trade (import/export), manufacturing, and monetization) rather than patent prosecution. This contention is supported by (1) the overwhelming evidence of burden upon patent systems, (2) the serious potential to chill innovation, and (3) divergence from the foundational objectives of patent law.

1. Evidence of Burden

The burdens implicated by WIPO’s new disclosure requirement are not offset by verifiable evidence that they will ameliorate systemic inefficiencies in biodiversity conservation. Creating IP policy that responds to verifiable interests, like conserving biodiversity, should incorporate the concerns of all jurisdictions and industries, especially those that depend upon both the biosphere and patent protections to support their value chain (e.g., the pharmaceutical sector).[108] Furthermore, the far-reaching reverberations of both international and domestic IP policies demand a focus on evidence-based policymaking.[109] For the disclosure requirement, the lack of supportive evidence is an unavoidable snag WIPO policymakers failed to adequately address.

Numerous jurisdictions have already adopted a voluntary or mandatory disclosure requirement. These nations are the optimal experimental models for establishing evidence of the requirement’s effectiveness. Jurisdictions with mandatory disclosure requirements- meaning failure to comply may result in sanction, rejection, or revocation- include (but are not limited to) the Andean Community[110], Indonesia, India, China, Brazil, Costa Rica, Turkey, and Switzerland. 

Switzerland, which actively supports adding an origin disclosure requirement to the PCT, implemented a domestic disclosure requirement in 2008.[111] Article 49a of Switzerland’s Patents Act requires all patent applicants to include information regarding the source of the genetic resource and associated traditional knowledge (for inventions based upon it).[112] The invention has to make “immediate use of the genetic resource, that is, depend on the specific properties of this resource” and the inventor must have physical access to the resource before the obligation to disclose is triggered.[113] In a similar fashion to the GRATK Treaty, Switzerland’s provision purports to use patent disclosures as the starting point for corresponding authorities in the provider country. However, other industrialized nations have criticized the Swiss law’s lack of clarity, and post-disclosure control frameworks are generally absent from consideration.[114] Like the GRATK Treaty, Switzerland’s disclosure requirement functions more as a superfluous filter to patent issuance rather than means to facilitate resource tracking or conservation. 

Furthermore, European countries like Switzerland and Norway, are unconvincing proponents and poor examples of the disclosure requirement in action. For these countries, adopting the requirement is low-risk and low-impact to their patent system.[115] They can easily tout the disclosure requirement’s feasibility because it poses such minimal demands on their patent office.[116] Adopting the origin disclosure requirement is essentially a formality- nothing more than a signal of political support for the issue, rather than having any meaningful impact on actually improving access and benefit sharing.[117]

Another example of the requirement at play in a developed country, with a relatively advanced patent regime, is the Republic of Korea (South Korea). In 2012 the Korean IP Office spent six months analyzing genetic resources used in Korean patent applications before concluding that the sheer number of genetic resources implicated in patent applications demanded a systematical database.[118] The varying styles of origin disclosure (e.g., academic Latin terms, typical names, local community names, etc.) meant that Korean patent examiners had to search over 5,000 genetic resources one by one to clarify what was actually used. The resources required was far greater than expected and caused South Korea concern over the practicality of a mandatory disclosure requirement- an attention-worthy reaction considering South Korea’s IP office is one of the largest in the world with nearly one thousand examiners.[119]

Mirroring these sentiments, New Zealand, a growing innovation leader, investigated the feasibility of the disclosure requirement in three different forms.[120] The 30-year projection of administrative and compliance costs was estimated to be a minimum of $1,390,000 and up to $7,464,000 for the most resource-intensive form of the disclosure requirement (roughly $46,300 to $248,800 per year).[121] The greatest source of cost was attributed to additional application processing time- the seemingly unavoidable result of putting access and benefit-sharing compliance on the plate of patent offices. 

A candidly supportive study of Indonesia’s origin disclosure requirement further supports this dilemma, recognizing that adoption of such a requirement in patent law “can be technically complex, particularly for developing countries with inadequate human resources,” due to the lack of adequate policy/regulatory frameworks to implement the obligation.[122] This acknowledgment echoes a pattern of concern for conservation in developing countries—hollow conservation structures with missing links to facilitate law/policy like the GRATK Treaty. 

To mitigate concerns of overburdening the patent office, and likely ease the minds of potential signatories, WIPO policy drafters put “no obligations on patent offices to verify the authenticity” of an origin disclosure.[123] This addition supposedly minimizes the “transactional cost/burden on patent offices and ensur[es] [the disclosure requirement] does not create unreasonable processing delays for patent applicants.”[124] However, the treaty certainly does not prevent patent systems from conducting verification and affirmatively expects patent offices to provide guidance on meeting the disclosure requirement.[125] Even if one assumes the disclosure submission itself is all that patent offices have to ensure, who or what agency has the expertise to subsequently verify the origin? Isn’t verification necessary to monitor for fraud and any postliminary benefit sharing and conservation?  The gaps left downstream, largely unguided by the GRATK Treaty, leave patent offices with nothing more than extra paperwork to handle. 

2. Chilling Effect 

Patent applicants already wait at least 12 months (longer in most jurisdictions) for a response from the patent office- any extra hurdle only furthering the delay. Extra hurdles also equate to extra time and money spent on patent prosecution- resources many small and medium-sized enterprises don’t have. Even though applications cannot be outright rejected based on failure to adequately disclose, the potential for hiccups in a realm of brand-new law is discouraging to applicants, large and small.  

Countries with robust origin disclosure requirements, like India and Brazil, already have the longest average pendency times, reaching an average of 156 to 179 months, respectively, between filing and final decision.[126] Any extra cost and delay is notable given patent rights “more than double [a startup’s] chances of securing venture capital financing” and statistically increase a startup’s overall chance of success in the marketplace.[127]

This will inevitably chill innovation and the global innovation economy as private R&D investments, those which foster market-ready innovation, are abated.[128] The losers in this situation are not only the inventors, relying on patents to gain capital or recoup R&D and commercialization expenditures, but also a worldwide population that may have significantly benefitted from that innovation.[129] Without predictable and effective patent protections, investors would shift capital towards less risky endeavors. This possibility is especially detrimental to sectors like biotechnology or pharmaceuticals, which offer some of the greatest value to society.[130]

            One can also speculate the chilling effect may be jurisdiction-specific. Depending upon the technology, the existence of an origin disclosure requirement may be a consideration in the decision to pursue patent protection for a certain jurisdiction. Large enterprises may indicate biodiverse countries for development and/or manufacturing of their patentable products. This translates to economic flow for countries whose patents generally have limited demand in the international market. However, if the additional compliance burdens aren’t met with proportionate benefits, economic development is easily directed elsewhere. 

3. Contrary to the Fundamental Purposes of Patent Law

         Proponents of the origin disclosure requirement assert that such obligations are necessary to enforce benefit sharing and sustainable utilization in the face of biopiracy associated with exploitation from patent-holders. They argue that the transparency generated via the disclosure requirement improves the function of the patent system as well.[131] Evidence supporting this is slim and particularized.[132] Simply put, patent law is the wrong medium for effectuating biodiversity conservation.

         The growing necessity and effort to protect genetic resources have already resulted in global regulation systems (collectively referred to as “access-benefit sharing systems”). These systems, particularly the Nagoya Protocol, are meaningful regulatory mechanisms in their own right, but fundamentally incompatible with the purpose of patents. Patents and technology transfer may have overlapping subject matter (genetic and biological resources), but patents strictly encourage innovation and serve as tools for industry development.

         Patents are based upon technical information specifically provided to fulfill the objective requirements for patentability. Accordingly, all of the information provided in a patent application is generally behavior-neutral. Adding a new disclosure requirement to track and monitor the inherently non-neutral behaviors of a party pursuing access or rights to a certain biological resource is thus inappropriate.[133] While conservation is a noble pursuit, the origin disclosure requirement can easily alter and effectively undermine the neutrality of patent procurement. Moreover, adding a new requirement opens up patent law to a potentially inexhaustible demand for further information that is irrelevant to the foundationally objective application requirements- utility, novelty, and non-obviousness. 

         Any benefit from the origin disclosure requirement is negligible compared to the far-reaching effects a requirement imposes on international patent rights. The value of a steady and predictable patent system cannot be understated. IP allows for the cultivation of partnerships worldwide, complements information sharing, and ultimately serves as a pillar for innovation development. 

IV. Alternative Mechanisms to Promote Innovation and Biodiversity Conservation 

         Within the operational model of conservation, an origin disclosure requirement, necessarily simplified, serves a narrow purpose: to identify what is being commodified using genetic/biological resources. This makes sense in theory; it is logical to see how disclosure could provide an entry point to address misappropriation. Given the CBD and Nagoya Protocol’s weak compliance, it is similarly logical to try and “mainstream biodiversity”- that is, integrate biodiversity issues into all policy sectors, including IP.[134] This paper is not necessarily in opposition to integrating biodiversity and IP policy, but there are other less burdensome mechanisms to protect biological resources through patent law.[135]

         Proponents of the disclosure requirement unrealistically assume a level of simplicity and tangibility in the task of identifying a biological/genetic resource. Biological and genetic resources can be easily studied and incorporated into technology without any physical access to the resource. Unfortunately, nothing in the GRATK Treaty prevents contracting nations from applying disclosure requirements to digital sequence information (DSI).[136] Moreover, genetic resources are used, combined, and altered in increasingly complex ways that complicate the identification of a resource or allocation of rights. How “much” of a certain gene or protein is enough to warrant access and benefit sharing?[137]

         When genetic resources are functionally just bio-information, there is no physical resource to be misappropriated. A sovereign’s assertion of ownership, and demand for benefit sharing, over that information is essentially the licensing of naturally occurring DNA- clearly unpatentable subject matter. These considerations muddy and distract from the goal of protecting physical, raw biological resources. Reproducing DNA or compounds in a lab (i.e., using synthetic or abundant materials) is not threatening biodiversity. Physical changes to an ecosystem are where biological, and thus genetic, resources are being affected. Accordingly, efforts to monitor and track those resources should be focused on a phase of the value chain where overexploitation and habitat alternations (the main threats to biodiversity) occur.[138]

A. Shifting the Focus to a Different Stage in the Value Chain: Commercialization

Considering the narrow conservational purpose served by an origin disclosure requirement—to identify and trace genetic/biological resources that are commodified through innovation—the alternatives explored are specific to that goal. A de minimis standard, applicable to identification and monitoring activities at any stage, is a legal mechanism that would improve the efficiency of conservation by directing focus to higher-risk activities. More broadly, responsibility (for monitoring) could be shifted to better-suited regulatory bodies, like trade control, or even private sectors.

1. A De Minimis Requirement is Essential to Effectuating Biodiversity Conservation

A lack of clarity regarding what activities constitute access and/or use of a genetic or biological resource in the governing law (the Nagoya Protocol) is one major reason these models lack effectiveness in facilitating biodiversity conservation. Proponents of the origin disclosure requirement have oversimplified the R&D process by asking for the source of every genetic or biological influence incorporated in an invention. Theoretically, this would allow patent systems to trace each influencing resource back to its origin country/region for some other unallocated party to then facilitate sharing agreements and any conservation measures. Besides the numerous unclarities and assumptions in this theory, a major pitfall of this mechanism is that it does not address the activities that are actually threatening biodiversity- namely overexploitation. This is why a de minimis standard is necessary to narrow the scope of what resources are focused on and to ensure disclosure requirements are consistent with conservation objectives.

A 1991 patent involving a glufosinate herbicide-resistant gene is a good example of the necessity for a de minimis standard.[139] The gene was isolated from Streptomyces viridochromogenes, a bacterium native to Cameroonian soil, and then incorporated into the gene structure of plants for herbicide resistance. The question becomes does Bayer Crop Sciences, the owner of this patent, owe Cameroon for the gene derived from bacteria that inhabit soil in their country. It is arguable given the massive commercial success of this technology, but it still seems like a stretch, especially considering the technology only involves the gene sequence itself. Post-research (which itself hardly requires more than an initial sample to culture the bacteria), neither the native bacterium, the soil, nor any sort of tangible resource are being used to create this commercial product. Thus, there is virtually no effect on Cameroon’s biodiversity. In this case, requiring extra disclosures and potentially imposing further legalities (i.e., access and benefit sharing or resource monitoring) in the name of biodiversity conservation would be a waste of time and resources for all parties involved. 

Notwithstanding the fact that genetic resources greatly contribute to innovation—a principle driving biodiversity protection in and of itself—their use in R&D does not always translate to resource consumption that rises to a threat to biodiversity. In many cases, development involves numerous genes derived from any number of species, any of which are likely manipulated before derivation results in an end product. In all, a genetic resource’s overall contribution to the final innovation is usually less substantial in the grand scheme of technological development. The exclusion of minimal (de minimis) contributions from legalities surrounding genetic and biological resources would greatly increase the efficiency of systems aiming to identify and trace these resources for biodiversity conservation.[140] Shifting away from the idea of a patent disclosure-driven monitoring regime, and towards an alternative forum for monitoring and tracing resource consumption is the efficient path to allow both R&D and sustainable consumption of resources. 

2. Alternative Mechanisms for Monitoring and Traceability

Compared to patent procurement, logic favors the creation of biological resource monitorization frameworks at a different place in the value chain- where there is actually “harvest” or a revenue-generating product. Commercial consumption (use) and trade controls are essentially inseparable, so monitoring for activities that implicate biodiversity threats at these stages may be a better choice for actually identifying and facilitating conservation.[141] Furthermore, characterizing threats to biodiversity is a context-specific task, as illustrated above[142], and species are affected differently.[143]

A specific alternative would be requiring biodiversity disclosures from the private sector (e.g., businesses, companies, research institutions, etc.), similar to the demands made in the Global Biodiversity Framework’s Target 15.[144] Adopting a measure like Target 15[145] would make private parties (“businesses”) disclose their production patterns in the context of biodiversity. These disclosures or biodiversity “risk assessments” would help a business identify opportunities for generating a positive impact on biodiversity, like collaboration with source countries to promote sustainable practices, cultivation, community development, and even further R&D.[146]

Although this alternative currently relies upon voluntary participation from businesses in many countries, an obvious limitation, this type of engagement is contagious and greatly benefits companies.[147] In-house monitoring allows businesses to cater mitigation strategies without risking the loss of important proprietary rights, like a patent. They also get to use such disclosures as an opportunity for sustainable marketing.  Meanwhile, biodiversity conservation efforts benefit from the clarity in disclosing supply chain(s) and/or business portfolios- data that would indicate where (geographically) and how significantly a company is using bioresources. 

B. Pro-Biodiversity Changes within the Patent System

            There is no reason to expect any industry or area of law should be completely exempt from the efforts to mainstream biodiversity, including IP. Still, there are less contentious and less burdensome initiatives that would support biodiversity conservation through the patent system(s). One such route would employ a strategy of focusing on extinct and threatened species implicated in patent applications. Potentially working in tandem, the institution of resource databases would lessen pressure on both applicants and patent offices worldwide.

1. An Extinction Bar and Threatened Species Disclosure

            The quid pro quo of patent rights is the exchange between society, receiving an enabling disclosure of the invention, and the inventor, receiving monopoly rights.[148] Thus, if an invention’s disclosure becomes non-enabling, it follows that the inventor should lose monopoly rights. In the most extreme scenario, where a biological resource required to practice the invention becomes extinct, the invention is no longer “available to the public without undue experimentation.”[149] Although the value of a patent may vary, the loss of patent rights upon species extinction—an extinction bar—is a strong incentive for respective owners to conserve the biological resources implicated by their innovation.[150] Granted, de minimis limitations are also an important consideration for such a bar for the same reasons noted above. 

            Within the workings of an extinction bar, there are also incentives for disclosing at-risk species in a patent application. If an invention implicates a biological resource (species) that is considered at-risk (e.g., labeled as vulnerable, endangered, or critically endangered) under a uniform body like the International Union for Conservation of Nature (“IUCN”), it should be disclosed in the patent application. This disclosure would put patent offices on notice of the at-risk biological resource for any necessary further action or monitoring. For example, they may flag the application for further review by a conservation-focused administration or pass that information on to an origin-specific administrative body.

Similarly, a patent applicant could benefit from the disclosure by gaining immunity from the extinction bar when they show good faith effort to conserve the disclosed resource(s). These conservation efforts could be in the form of synthetic biology, acquiring conservation easements to resource-native lands, compensating locals to protect the species/habitat, negotiating with the local government or organizations to ensure protection—whatever strategies necessary to show a legitimate effort towards conservation.[151] For example, a patent application for a method of screening with horseshoe crab blood would require the applicant to disclose that their invention implicated a biological resource from Limulus polyphemus (American horseshoe crab), an IUCN vulnerable species, and pursue conservation efforts accordingly.[152]

An easy integration strategy could require reporting of these efforts and the resource’s conservation status with post-grant patent maintenance fees. For example, in the U.S., reporting could be required (along with the usual maintenance payments) at 3.5, 7.5, and 11.5 years after a patent is granted. Notably, to avoid an overload of future “good faith effort” confusion and litigation, patent systems would benefit from compiling a guideline of adequate conservation strategies. An advanced form of this requirement may even assess the adequacy of conservation efforts according to the patent’s economic value or the assignee’s (the entity owner’s) size.  

2. A Global Database for Biological Resources

            An organization system in which threat-focused disclosure requirements (as discussed above) could operate would further facilitate effective international conservation through the patent system. A major concern plaguing both patent offices and applicants lies in the capacity to properly disclose and assess the origins of a resource, and perhaps the most improvident policy failure of the GRATK Treaty is the absence of mandatory information system establishment. It would serve all parties, including local authorities or access and benefit sharing systems, to make a database that combines all the information an applicant needs: instructions, guidelines, identification information, resource logs, etc. Applicants would have an all-encompassing resource to help them identify at-risk resources that they should disclose or the nation-specific legalities associated with the use of a certain resource in the event of commodification. Furthermore, patent offices would be able to easily confirm required origin disclosures based on this database, and automatically connect applicants with local administrative bodies for any further compliance. 

            A working model of this database, on a national scale, is seen in Australia’s Genetic Resources Information Database (“GRID”). As the Australian government eloquently explains, “confidence by parties in the biodiversity commercialization chain is essential for investment in natural product recovery.”[153] The database provides private parties with information to help them verify the legal origins of an Australian biological resource and access associated permits or records. The ability to search a database and find legal certainty greatly uncomplicates the compliance process for companies/applicants and any necessary verification for patent offices.[154] Eliminating the risks and burdens behind disclosure requirements and compliance violations would better effectuate resource identification and monitoring on a global scale.

V. Conclusion

The relationship between biodiversity and innovation suggests patent rights are inextricable from society’s use and development of biological resources. Protecting the traditional incentives of the patent system is necessary to sustain the biotechnological advancements that are vital to mankind. Yet at the world stage, integrating biodiversity conservation into patent systems has been relatively unfruitful. The solution to mainstreaming biodiversity requires a bird’s-eye view of the entire innovation value chain. Realistic, efficient policy changes should focus on high-risk activities for overexploitation, particularly where patents are translated to products that depend upon the exploitation of biological resources. Relinquishing the contentious and burdensome origin disclosure requirement for conservation policies that employ monitorization at the commercialization stage, and focus on high-risk species implicated in patent applications, would better serve the goals of the CBD—biodiversity preservation—and allow innovation to flourish through the patent systems.