Abstract
I
The current draft of the proposed WIPO instrument relating to intellectual property (IP) and GRs (“the WIPO IP/GR instrument”) contains the texts and terms under negotiation as of October of 2017. 3 This document shows that the parties are split into two groups with unreconciled objectives. One group seeks an instrument that includes a GR-related patent disclosure requirement (“GR-related PDR”) for disclosure of origin (DOO) of GRs utilized in developing an invention. This group takes the position that patent systems should be linked with access and benefit-sharing (ABS) systems, to achieve objectives such as enhancing transparency of the patent system to facilitate ABS, and preventing misappropriation of GRs through the patent system. 4 The other group takes the position that the objective of the instrument is to prevent the grant of erroneous patents for inventions and no new disclosure requirement is necessary, although an applicant may be required to disclose where a GR can be obtained if that information is necessary to carry out the invention. 5
The renewal of the IGC mandate presents a timely opportunity to discuss GR-related PDRs as a tool, because the options and alternatives in the current draft of the WIPO IP/GR show how different stakeholders want to craft and use such a tool. This discussion is also timely because patent applicants and other stakeholders in the patent system are encountering an increasing number of national-level GR-related PDRs. Although the final scope and impact of the proposed WIPO IP/GR instrument may not be known for years, some form of GR-related PDR is already in force in the patent or ABS laws of almost 30 countries, including China, Brazil, India, France, Germany, Indonesia, South Africa, and the Philippines. 6 The legal scope and operational features of these PDRs vary widely from country to country, and the landscape will become even more fragmented as more countries enact PDRs in connection with implementation of GR-related international agreements, such as the Nagoya Protocol. 7 Irrespective of what transpires with the WIPO IP/GR instrument, the present analysis should provide a useful perspective for applicants and other stakeholders encountering national-level GR-related PDRs.
GR-related PDRs have the potential to impose significant burdens related to interpreting provisions and providing information. This article will briefly discuss the origins and features of GR-related PDRs, analyze the draft WIPO IP/GR instrument and its proposed GR-related PDR, and conclude with remarks on the effectiveness of GR-related PDRs in view of rapid technological changes in the ways GRs are used. This article will take a pragmatic, operational approach to the issue of GR-related PDRS and the draft WIPO IP/GR instrument, with the goal of providing insights that may be useful for stakeholders such as patent professionals and legal scholars who want a practical understanding of these topics.
Origins and Objectives of GR-Related PDRs
The origins of GR-related PDRs can be found in the debate about differences and possible synergies between patent systems and ABS systems. This debate recognizes that patent systems can grant exclusionary property rights for inventions that utilize GRs, while ABS systems are intended to conserve biodiversity by allowing states and other entities having legal rights over GRs 8 to regulate access to these GRs and share in benefits arising from their utilization. Although each of these systems has a different legal basis and serves a different purpose, they also have overlapping subject matter and a shared interest in conserving biodiversity as source of future GRs of potential value. However, this debate also recognizes that patent systems can grant patents for inventions based on misappropriated GRs. Concern that the patent system may allow patent applicants and owners to benefit from the misappropriation of GRs has given rise to the objective of linking patent systems with ABS systems in order to protect GRs.
GR-related PDRs have been proposed as tools that can link patent systems and ABS systems to achieve such objectives as monitoring the utilization of GRs, facilitating ABS compliance, preventing misappropriation of GRs, and enhancing transparency of the patent system. 9 The operational model for achieving these objectives relies on transferring relevant information from patent systems to ABS systems, to allow determination of whether a patent applicant's access and use of GRs for developing an invention was authorized and in compliance with ABS measures. In theory, this information could be used to identify unauthorized access and/or use of GRs, and provide a point of entry to address misappropriation and other ABS issues. This information is also intended to improve the functioning of ABS systems by providing downstream information about how the applicant used the GRs they accessed, in light of the original conditions of access and use. 10
Over the last 20 years, countries have implemented GR-related PDRs in response to suggestions such as those found in the European Union Biotechnology Directive, 11 the nonbinding Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization, 12 and the Nagoya Protocol, to adopt reporting measures for disclosure of the geographical origin, country of origin, or source of GRs in patent applications. These measures illustrate the spectrum of objectives and features that can be associated with GR-related PDRs.
Features of GR-Related PDRs
The fundamental challenge of drafting a GR-related PDR is how to require patent applicants to provide information that would be relevant and useful for ABS systems. Therefore, GR-related PDRs must be drafted with trigger provisions that define what conditions would give rise to a duty to comply, and disclosure requirements that identify what information must be provided if the duty to comply has been triggered. When the objectives include protecting GRs by monitoring behavior, the GR-related PDR may include sanctions for noncompliance, or provide opportunities to challenge the request for patent protection.
Trigger provisions must define the combination of targets, activities, and subject matter that give rise to a duty to comply
Trigger provisions define the relationship between GRs and the GR-related disclosures in a patent application that would trigger a duty to provide information about the origin and/or source of the GRs. 13 A 2004 WIPO study provided guidance for evaluating this relationship in terms of:
[W]hether the GR/TK [traditional knowledge] was incidental or fundamental to the development of the invention; whether the GR/TK contributed to one earlier step to a chain of innovations that over time culminated in the invention, or was a direct input to the claimed inventive step; whether particular qualities of a GR were essential to the invention, or the GR was in effect only a vehicle for a separate innovative concept; or whether a GR was used in a particular embodiment or one example in the description of the invention, but was not indispensable to arriving at (or replicating) the invention as claimed. 14
The present article identifies three necessary parts of the trigger provisions of a GR-related PDR, where the parts are characterized by functional relationships as follows:
1. The target, i.e., where to look in the application. The text may use a broad term to describe where to look in the application, such as “the application,” “the specification,” or “subject matter in an application.” The text may use a narrower term, such as “the invention,” “the claimed invention,” “products or process for which a patent is sought,” or “material which is the basis of the invention.” 2. Triggering activities, i.e., what activities to look for. The text may use a broad or even vague term, such as “relates to,” “discloses,” “involves,” “derived from,” “utilizes,” “uses,” or “includes utilization of.” The text may alternately use a narrower term, such as “based on,” “directly based on,” or “used directly or indirectly in the making of the claimed invention” to describe activities. 3. Covered subject matter, i.e., what material is being used in the triggering activities. The text may use broad terms such as “biological material,” “biological resources,” “elements of biodiversity,” or “genetic heritage.” The text may instead use narrower terms, such as “genetic resources” or “biological material of plant or animal origin.”
Analysis of a triggering provision must interpret one part in view of one or both of the other parts. For example, a triggering provision may recite broad triggering activities and a narrow target, e.g., “the invention relates to,” which limits the otherwise broad range of activities. In some cases, it is difficult to separate one part from another, e.g., the phrase “used directly or indirectly in the making of the claimed invention” defines the (narrow) target and the (somewhat narrow) triggering activities in a mutually referencing way.
Analysis also requires consulting definitions or clarifications in supporting materials, such as implementing regulations, to arrive at a complete analysis of the possible scope and impact of a GR-related PDR. For example, a definition may state that “use” must include direct or physical access to the covered subject matter, or must be limited to using the “genetic function” of the subject matter. Definitions of subject matter may specifically include or exclude human material. They may include only material with functional units of heredity, or also include derivatives without functional units of heredity. Subject matter definitions may explicitly recite, or conversely be silent about, information of genetic origin. The subject matter may be geographically limited, such that the triggering provision would only apply to subject matter from the country where the GR-related PDR is in force. Subject matter limited to “indigenous genetic resources” may provide a basis to distinguish between source and origin. Finally, linked definitions, where a first definition includes a term that is subject to its own (separate) definition, may change the potential scope of the subject matter of the first definition.
Disclosure requirements: Information must be relevant to legal status and/or ownership of GRs; information should not be relevant to patentability
GR-related PDRs must be drafted to require information that is relevant to the legal status of GRs identified by the trigger provisions (i.e., covered subject matter), as this information is likely to be relevant and useful for ABS purposes. Required information should indicate actual or potential ownership issues related to these GRs. 15 This information should be useful for identifying the entities that may have sovereign rights in the GRs, e.g., a country and/or indigenous communities within a country, and for determining whether those entities authorized the patent applicant's access to the GRs. Documentary evidence, such as an access agreement between the parties, or an internationally recognized certificate of compliance (IRCC) in accordance with the Nagoya Protocol, is preferable as a source of relevant information to determine whether the applicant's disclosed use of GRs was a permitted use. To the extent that the objectives include facilitating compliance with ABS measures through the patent system, the applicant may be required to provide proof of prior informed consent (PIC) and evidence of benefit-sharing agreements under mutually agreed terms (MAT) in accordance with national ABS measures.
Thus, GR-related PDRs should require patent applicants to supply information about GRs that is significantly different from the technical information that is already required by the standard disclosure requirements 16 of existing patent laws and regulations. Standard disclosure requirements focus on the issue of patentability of an invention as a whole, and demand technical information that will allow a patent office to determine what an inventor has invented and whether a skilled person is enabled to practice the invention based on the disclosure. The disclosure must allow a patent office to determine whether the claims recite an invention that meets the statutory requirements for patenting, and whether the application provides adequate support for the claims. Standard disclosure requirements serve the public interest by requiring a complete public disclosure of any patented invention, and ensuring that the claims of a granted patent are sufficiently definite to inform the public of the boundaries of the protected subject matter, i.e., the patented invention.
Standard disclosure requirements with respect to GRs would be satisfied by disclosures such as taxonomic information about GRs at the genus and species level, and other identifying information such as strain numbers, accession numbers, and names of specific breeds, varieties, or cultivars that were used. Patent laws and regulations define when an applicant must disclose nucleotide and/or amino acid sequence information about material disclosed in the application, and when an applicant must deposit biological material in a recognized repository and disclose the deposit. Depending on the invention and the GRs in question, relevant information may also include identification of the commercial or noncommercial source(s) from which GRs were obtained, and information such as catalog numbers, trade names, or common names. Patent examiners usually have discretionary power to request more information about GRs disclosed in an application, e.g., when additional technical information about GRs could help a patent examiner conduct a more complete search of the prior art during examination of the patent application, to help the examiner make a more informed decision about the patentability of the invention recited in the claims of the patent application.
If information about the origin and/or source of GRs is not strictly necessary to fully describe the invention, demonstrate that the inventor had possession of the invention, support the claims, and enable a skilled person to practice the invention, then the standard disclosure requirements do not require the disclosure of the origin and/or source of GRs utilized in the invention. In that case, issues of ownership and access to the GRs are not material to the patentability of the claimed invention of an application.
It is therefore crucial for GR-related PDRs to identify and require what information is required. This allows an applicant to make a clear distinction between technical information about GRs that is related to patentability issues, and the type of ownership-related information that might render a patent unenforceable or revocable because of the patent applicant's actions with respect to GRs, e.g., misappropriation or violation of the terms of access.
Additional features of GR-related PDRs
GR-related PDRs have additional features that will vary according to the objectives of the drafters. If mandatory, the applicant is required to indicate the origin and/or source of covered subject matter (GRs), or declare why the origin and/or source cannot be indicated, e.g., make a statement that the origin and/or source is unknown. If voluntary, an applicant should indicate the origin if it is known. GR-related PDRs may be universal in scope, requiring the applicant to disclose the origin of any covered subject matter, regardless of where it was obtained or used. In contrast, a national disclosure requirement may impose a duty to disclose information only when the subject matter was accessed in, originates from, or is indigenous to, the country where the requirement is in force; a reciprocal or “club” approach requires disclosures only when material was obtained from members of the agreement that defines the “club.” 17 GR-related PDRs may state whether or not the requirement is a formality or a ground for substantive refusal or revocation of the application. They may also assign responsibility for verifying disclosures. When the objectives include protecting GRs or preventing misappropriation, GR-related PDRs may include sanctions for noncompliance, or provide opportunities for third parties to challenge an application.
Analysis of the Current Draft of the WIPO IP/GR Instrument
The following analysis of the current draft of the WIPO IP/GR instrument takes into account the options indicated by [bracketed] text, and the alternative paragraphs and articles indicated by “ALT” preceding the alternative text, as presented in the original document.
Overview of draft WIPO IP/GR instrument
Briefly, the document begins with a List of Terms with proposed definitions, followed by a Preamble with proposed affirmations and statements of purpose. 18 The unreconciled split between the parties that want a new disclosure requirement, and the parties that do not want a new disclosure requirement, is demonstrated by separate texts for each position. The document concludes with provisions for defensive measures, relationships with international agreements, cooperation, technical assistance, and capacity-building.
Proposal for a disclosure requirement
Texts for a new disclosure requirement are set forth in Articles 1–5. 19 Objectives are set forth in Article 1 (Ch. I), as three separate statements summarized as follows: Paragraph 1 recites enhancing transparency of the IP system and facilitating mutual supportiveness with international agreements relating to GRs; ALT 1 recites enhancing transparency of the patent system “to facilitate the possibility of ABS through the disclosure of country of origin or source of genetic resources in separate systems such as the CBD [Convention on Biological Diversity]”; and ALT 2 recites promoting or ensuring effective protection GRs, and/or preventing misappropriation of GRs through the patent system, by ensuring patent offices have access to appropriate information. Article 2, Subject Matter of the Instrument, provides that the instrument applies either to GRs (and optionally, derivatives of GRs and TK associated with GRs), or according to ALT Article 2, to “patent applications for inventions directly based on genetic resources” (and optionally, TK associated with GRs). Article 3, Disclosure Requirement, sets forth the trigger provisions in Article 3.1 and required disclosures in Articles 3.1(a)–(c). Article 3.2 is directed to whether or not patent offices are obligated to verify the contents of the disclosure. Article 3.3 proposes a notification procedure by the patent office to the national ABS system. Article 3.4 provides that information should be made publicly available, except for any confidential information. Article 3.5 states that GRs as found in nature should not be considered inventions. Article 4 provides exceptions and limitations to the disclosure requirement, and Article 5 lists sanctions and remedies for noncompliance. 20
Proposal that no new disclosure requirement is necessary
The section entitled “Alternatives to Articles 1, 2, 3, 4 & 5 No New Disclosure Requirement” sets forth provisions for the other position. 21 ALT Article 1 lists a sole objective “to prevent the grant of patent rights on inventions that are not novel, non-obvious, and industrially applicable.” 22 No alternative to original Article 2 is presented. ALT Article 3 recites conditions for disclosure and goals that can be achieved without a new disclosure requirement. ALT Article 3.1 states that “applicants may only be required to state where the genetic resource can be obtained if that location is necessary for a person skilled in the art to carry out the invention” and that no disclosure requirements can be imposed “for reasons other than those related to novelty, inventive step, industrial applicability or enablement under which an applicant may be required to state where GRs may be obtained.” 23 ALT Article 3.2 recognizes that an entity having a legal right in the GRs may require the applicant to include a disclosure about the GRs, and to obtain consent for uses not within an original permit agreement or license. ALT Article 3.3 encourages making the entire disclosure publicly accessible, ALT Article 3.4 provides that an applicant may make other disclosures about the source of GRs at any time after filing, and ALT Article 3.5 provides term adjustment for any delays in examination, and an opportunity to correct incorrect or erroneous disclosures.
Defensive measures and final provisions
Chapter III, Defensive Measures, encourages due diligence (Art. 6) and voluntary codes of conduct (Art. 7) to establish systems for ascertaining that GRs have been accessed in accordance with any applicable ABS or regulatory requirements, using databases that would allow monitoring of compliance (Art. 6), and preventing the grant of erroneous patents (Art. 7). A footnote states that some negotiating parties consider these defensive measures to be a complementary option to the proposed disclosure requirements, while other negotiating parties consider them to be an alternative. 24 The document concludes with Chapter IV, Final Provisions, stating the relationship with international agreements (Art. 8), encouraging international cooperation (Art. 9), encouraging transboundary cooperation (Art. 10), and recommending that WIPO be involved in providing technical assistance, cooperation, and capacity building (Art. 11). 25
Analysis of proposed GR-related PDR in Article 3.1
If a version of the WIPO IP/GR instrument were to be ratified and implemented, then patent applicants and patent offices would need to be able to interpret and implement Article 3.1. It is helpful to understand that Article 3.1 is formatted as a conditional sentence with trigger provisions listed in a conditional clause, and the disclosure requirements that would result from meeting the conditions of the trigger provisions listed in the main clause. Thus, a duty to comply would arise if all aspects of the trigger provisions are met, and if a duty to comply is triggered, then the disclosure requirements would have to be met.
The trigger provisions for the GR-related PDR are set forth as follows, with [bracketing] as in the original text: “Where the [subject matter] [claimed invention] within a [IP Rights] [patent] application [includes utilization of] [is directly based on] [is directly based on the utilization of] genetic resources [their derivatives] and/or [traditional knowledge associated with genetic resources].” 26
The disclosure requirements are set forth in the main clause, which states “each Party shall/should require applicants to:” and lists information options, with [bracketing] as in the original text:
(a) Disclose the [providing country that is the country of origin] [country of origin [and]] [or [if unknown],] source of the genetic resources, [their derivatives] and/or [traditional knowledge associated with genetic resources.] (b) [Provide relevant information, as required by national law, regarding compliance with ABS requirements, including PIC, [in particular from indigenous [people[s]] and local communities], where appropriate.] (c) [If the source and/or [providing country that is the country of origin] [country of origin] is not known, a declaration to that effect.]
27
Analysis of trigger provisions
As discussed above, trigger provisions generally have three parts. The parts of the trigger provisions in Article 3.1 are as follows:
1. The target corresponds to “… [w]here the [subject matter] [claimed invention] within a [IP Rights] [patent] application … ” 2. Triggering activities correspond to “… [includes utilization of] [is directly based on] [is directly based on the utilization of] … ” 3. Covered subject matter corresponds to “… genetic resources [their derivatives] and/or [traditional knowledge associated with genetic resources].”
Part (1): The target
Article 3.1 lists two options for the target, viz., the “subject matter” within an application or the “claimed invention” within an application, but neither term is defined in the WIPO IP/GR instrument. If “subject matter” is chosen, then the entire phrase describing the target as “subject matter within a [IP Rights] [patent] application” should be interpreted to refer to the entire technical content of an application, including the specification (description), drawings, and claims. This suggests that any disclosure of the use of covered subject matter within a patent application might trigger a duty to comply. If “claimed invention” is chosen, then the scope of the target is much narrower because that term should refer to disclosures in the claims. 28 The term “IP Rights” appears for the first time in Article 3.1 and no definition is provided in the List of Terms, such that the intended scope is unknown. The phrase “… within a [IP Rights] [patent] application” will therefore be taken to mean a patent application, absent any other guidance.
Part (2): Triggering activities
Options for triggering activities are “includes utilization of,” “is directly based on,” or “is directly based on the utilization of” GRs and/or derivatives and/or TK. As defined in the List of Terms, the term “directly based on” “means that the [invention] [must] make [immediate] use of the genetic resource, and depend on the specific properties of the resource of which the inventor [must] have had [physical] access].” 29 The activity described as “includes utilization of” has broader scope because “utilization” is defined as meaning “to conduct research and development, [conservation, collection, characterization, among others,] [including commercialization] on the genetic and/or biochemical composition of genetic resources, [their derivatives] and [traditional knowledge associated with genetic resources] [including through the application of biotechnology] [as defined in Article 2 of the Convention on Biological Diversity].],” and an alternative definition further proposes that utilization includes activities “to make a new product, or a new method of use or manufacturing of a product.” 30 Biotechnology as defined in Article 2 of the CBD includes “any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use.” This is an example of a linked definition, where “utilization” expands the covered subject matter (discussed below) to include not only GRs but also their derivatives. The scope of “is directly based on the utilization of” is not defined in this document and will not be interpreted here, as Article 3.1 has a footnote that “[s]ome members noted a need for a definition for this formulation in the list of terms.” 31
Part (3): Covered subject matter
The passage describing covered subject matter as “… genetic resources [their derivatives] and/or [traditional knowledge associated with genetic resources]” shows that the original covered subject matter is GRs, which the List of Terms defines as follows: “‘[g]enetic resources’ are genetic material of actual or potential value,” where “‘[g]enetic material’ means any material of plant, animal, microbial or other origin containing functional units of heredity.” 32 The optional term “derivative” is defined as follows: “‘[d]erivative’ means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity.” 33 Because this article focuses on the WIPO IP/GR document as relates to GRs, 34 this analysis will not interpret the term “TK associated with GRs.”
The scope of the term “genetic resources” would appear to be limited to biological material that would include organisms, tissues, cells, viruses or any biological origin, that can carry out functions such as cell division or reproduction due to containing material such as DNA or RNA (e.g., as in RNA viruses) in a form that confers the property of being “functional units of heredity.” 35 Including the term “derivatives” would substantially broaden the scope of covered subject matter by adding “naturally occurring biochemical compound(s).” However, the scope of the term “naturally occurring biochemical compounds” is unclear: e.g., are derivatives limited to compounds that would be recovered from biological material by crushing the material or collecting secretions from the material, or would derivatives also include compounds that are “naturally occurring” but are disclosed in a patent application for an invention that generates the compounds under non-naturally-occurring conditions?
Discussion and analysis of hypothetical trigger provisions for the WIPO IP/GR instrument
Hypothetical trigger provisions can be constructed by combining options for target, triggering activity, and covered subject matter found in Article 3.1. Table 1 provides three examples of hypothetical constructs, with remarks on their potential scope and impact.
A further illogical outcome might be that information about non-human cell lines is required while information about human cell lines is excluded.
Disclosure provisions: What kinds of information are required?
Article 3.1 states that “each Party shall/should require applicants to” make disclosures listed in Article 3.1(a)–(c). This language demonstrates that no consensus has been reached as to whether the instrument would impose a mandatory disclosure requirement (“shall require”) or a voluntary disclosure requirement (“should require”). The proposed GR-related PDR has no geographical limitations, making it universal in scope.
Article 3.1(a): Disclosure of origin and/or source of covered subject matter
This paragraph suggests options for multiple types of disclosures that can be sorted into disclosures of “origin” referring to where a GR is found in in situ conditions, and disclosures of “source” referring to where, or from whom, the applicant obtained the GR and/or derivative. The term “country of origin,” defined as “the [first] country which possesses genetic resources in in-situ conditions” is not clear as to whether the country must be the country where a GR historically originated (the “first” country), or another country that possesses the GR in in situ conditions. The term “providing country that is the country of origin” is not defined as a phrase, but partial definitions suggest that it would be limited to a country that possesses the GR in in situ conditions and also provides the GR. Options for the transitional phrase “[and]] [or [if unknown]” would yield one option that requires disclosure of both the origin and the source, while the other options would allow disclosure of only the source, if the origin is unknown. Definitions of “source” recognize that a source can be a person, a community, an institution, or a multilateral distribution system for GRs in ex situ collections. One optional definition further proposes to include “scientific literature” as a source. Note that the “origin” options only recited GRs as subject matter, while the “source” option recited the possibility of both GRs and their derivatives (and TK associated with GRs).
Article 3.1(b): Disclosure of information regarding ABS compliance
This paragraph requires an applicant to provide any relevant information that is required by national law, to show compliance with national ABS measures, e.g., documentary evidence of PIC, especially if PIC was required from “indigenous [people[s]] and local communities],” in addition to PIC from a national authority. This paragraph may also apply to providing evidence of due diligence regarding authorized access and use.
Article 3.1(c): Declaration if origin and/or source unknown
This paragraph recognizes that an applicant may not know the origin and/or source of covered subject matter. By requiring the applicant to make a declaration that they do not know the source and/or origin of covered subject matter, information is collected that could be used to evaluate the applicant's intent, if a patent office or a third party were to allege that covered subject matter had been misappropriated.
Remarks
The disclosure requirements of Article 3.1(a)–(c) do not precisely identify what information would be relevant to ABS issues. Article 3.1(a) does not distinguish between the technical information about origin and/or source pursuant to the standard disclosure requirement, and additional information that would be relevant to ABS issues, e.g., regarding ownership or legal status of the GRs. Although Article 3.1(b) appears to require information that would be relevant to ABS compliance, this provision raises questions of whether: (1) national ABS laws and regulations already compel this disclosure with respect to GRs obtained in that country; and (2) the applicant has to provide proof of access to GRs in other countries, to be evaluated for compliance with “national law.” Article 3.1(c) does not adequately identify what triggers a declaration.
Concluding Remarks: Are GR-Related PDRs the Right Tool for the Job?
A fundamental challenge for linking patent systems with ABS systems arises from the fact that each system uses a different operational model to serve a different purpose. These systems have overlapping subject matter, i.e., GRs and their use, and a shared interest in conserving biodiversity as a source of future GRs of potential value. However, patent systems use a behavior-neutral model that relies on technical information to determine the patentability of a claimed invention, while ABS systems focus on the behavior of various parties with respect to GRs and to each other, in the context of exercising sovereign rights over GRs.
Rapid technological advances in the use of GRs have increased the distance between these systems. This article proposes that these advances have decreased the effectiveness of GR-related PDRs as tools for using the patent system to achieve ABS-related objectives. A proposal to strengthen ABS systems by evolving new tools is offered as an alternative to implementing new GR-related PDRs.
Technological advances and limited applicability of the ABS model
Current ABS systems are based on a model that defines GRs as “genetic material of actual or potential value” and recognizes that countries have “the sovereign right to exploit their own resources,” and “the authority to determine access to genetic resources.” 36 Under this model, concern about misappropriation of GRs through the patent system envisions the unauthorized use of GRs in a form that similar to the form over which a country has sovereign rights, e.g., GRs in the form of a plant that is endemic to a single geographical location and known to have a desirable biological property. According to this model, imposing a DOO requirement for a patent application where the applicant seeks patent rights for a method of propagating the plant material to enhance that desirable biological property might allow the origin of the GRs to be traced and sovereign rights identified. Further, if the applicant accessed and used the GRs without authorization, then the information collected pursuant to the DOO may allow misappropriation to be proven.
However, many, if not most, current inventions that involve GRs are complex. GRs are utilized in research and development as a source of the genetic diversity that allows organisms to adapt when their environments change. 37 GRs can be used in different forms for different purposes, e.g., as raw materials for developing new products, as components to be incorporated into farming or forestry systems, and as informational inputs for both tangible and virtual uses in screening, testing, designing, evaluating, modelling, and directed synthesis. Dematerialization of GRs due to recent advances in biotechnology and information processes now allows the use of information obtained from GRs without requiring access to genetic material, i.e., without the need to physically access “material of plant, animal, microbial or other origin containing functional units of heredity.” 38
A patent application may disclose complex uses of GRs in one or more forms as physical material, functions, and/or information. This complexity makes it difficult to identify what subject matter corresponds to GRs covered by sovereign rights, and what subject matter corresponds to inventor actions that are so far removed from the original GRs that sovereign rights do not apply. Furthermore, benefits that an applicant derives from patenting a complex invention developed using GRs, may be overwhelmingly due to actions by the inventor(s) and not to the original GRs.
Even the basis for asserting sovereign rights over GRs found within national borders is called into question by the present high level of interdependence between countries with respect to GRs. This interdependence has developed alongside agricultural development, economic development, and exploration, especially as globalization of food systems has rapidly increased. 39 As a result, even GRs found in in situ conditions in one country could, arguably, be subject to sovereign rights of other countries with earlier claims to be the “origin” of the GRs.
By comparison, patent systems focus on technical information about outcomes of an inventor's actions. Although patent systems struggle to determine the patentability of the new products and processes obtained through technologically advanced uses of GRs, patent systems do not focus on whether the inventor's actions were authorized by other rightsholders. In particular, patent systems forbid infringement, but do not monitor or police infringement during prosecution of the patent application. Patent systems recognize that many inventions build on previous inventions, and determine patentability based on the invention as a whole, in view of prior art that may include previously patented inventions. However, patent systems provide separate measures that allow patent owners to enforce their rights against others who have used their inventions without permission. Furthermore, patent systems have measures that define the conduct of inventors, owners, and others that might render a patent unenforceable, separate from the question of patentability.
Thus, the applicability of the current ABS model for connecting the behavior of patent applicants with the sovereign rights of countries (and some communities) over GRs is decreasing in the face of rapid technological advances in the use of GRs. These advances have increased the difficulty of defining what covered subject matter and triggering activities would trigger ABS compliance issues, and therefore have decreased the effectives of GR-related PDRs.
No new disclosure requirement is needed to prevent grant of erroneous patents
Furthermore, no new disclosure requirement is needed for information relevant to the question of patentability. Such a requirement could be seen as an admission that standard (conventional) disclosure requirements have failed and the patent system is not functioning properly. In fact, the existing disclosure requirements function very well by establishing clear standards for technical information that may be disclosed in the form of text, figures, sequence data, geographical data, or a biological deposit. Most patent systems already grant the examiner discretion to determine when additional information may be needed, to request that information, and to use it to improve examination or support the public's right to be able to obtain the materials required to practice the invention. Therefore, even the limited conditions for DOO that are proposed in ALT Article 3.1 are already within the scope of standard practice of most patent offices, and no statement of these conditions would be necessary.
Databases
The WIPO IP/GR instrument suggests defensive measures that include establishing databases that would provide access to previously known information about the existence and/or use of GRs, their derivatives, and TK associated with GRs. 40 Database design and accessibility has undergone tremendous changes since discussions of the WIPO IP/GR instrument began. WIPO has been active in improving databases and developing sophisticated new databases and tools, and also provides links to online databases and registries of GR and TK-related information. 41 In the WIPO IGC, discussions have included proposals for comprehensive databases, such as a harmonized “one click” database. 42 The Secretariat of the CBD has been actively developing resources, such as the Access and Benefit-Sharing Clearing House (ABSCH) as an online platform for exchanging information on ABS and a tool for facilitating the implementation of the Nagoya Protocol. 43 These examples indicate that high-quality accessible databases may prove extremely useful to help patent systems find prior art that may be relevant to patentability of inventions, and to help ABS systems monitor compliance with ABS measures. Developing database-oriented approaches can be seen as an affirmative choice, and not merely as defensive or complementary measures. Going forward, such databases may largely eliminate the need for new GR-related PDRs.
ABS systems should develop new tools that protect stakeholder interests in a changing technological context
The present analysis concludes that GR-related PDRs may be losing the ability to effectively collect ABS-relevant information from the patent system. Instead of trying to refine a tool that may be losing its usefulness, this article proposes that ABS systems should develop updated tools that address the wide spectrum of stakeholder interests. That is, instead of trying to use tools to “pull” information from the patent system, ABS systems should “push” new tools that offer incentives instead of penalties, and are capable of engaging with the rapidly changing legal and technological landscape for the utilization of GRs.
Advances in database design and accessibility may help ABS systems develop new tools for communication and monitoring. ABS systems could focus on enabling compliance with disclosure requirements in ABS agreements. ABS agreements could be designed to function somewhat like self-executing contracts that are linked to downstream compliance checkpoints such as patent offices or marketing approval bodies. For example, an access and use agreement could require the applicant to include a disclosure about the GRs in any patent application where the invention relies on using those GRs, and to obtain consent for uses not within an original permit agreement or license (as in ALT Art. 3.2). Possible features of such an approach are suggested by the continuous electronic process introduced in Brazil by the new “Biodiversity Law” and implementing regulations. 44 Starting with electronic registration with a government authority after identifying GRs of interest, 45 and prior to accessing and utilizing them for research and development, subsequent electronic notification is required when various downstream events occur, e.g., prior to filing a patent application or starting commercialization, at which time negotiations can be started based on what has occurred pursuant to access and use of the GRs.
Decision-making bodies of GR-related international agreements are currently addressing some of the issues raised by recent technological advances in using GRs, to develop new tools and models for balancing the interests of multiple stakeholders of the ABS system. One issue being discussed is whether the scope of an agreement does, or does not, cover digital sequence information obtained from genetic resources, i.e., whether or not these agreements only cover GRs in their physical form. 46 These efforts may give rise to model ABS agreements that reflect these technological advances.
While it is outside the scope of this article to propose new ABS tools and mechanisms, activities that are currently underway indicate that ABS systems are already engaging in finding new tools to promote conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, in the new technological context in which GRs are being used.