1. INTRODUCTION
There is growing interest in patent disclosure requirements concerning genetic resources and traditional knowledge. The use of genetic resources and associated traditional knowledge contributes invaluably to innovation in the fields of agriculture and horticulture, in the food and beverage, cosmetic, pharmaceutical and industrial biotechnology sectors, among others.Footnote 1 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol)Footnote 2 to the Convention on Biological Diversity (CBD)Footnote 3 points towards the achievement of a globally emergent form of sustainable development practice concerning the above uses, including in its legal dimensions, and aspires to global justice through fair and equitable benefit sharing. It does so by establishing a framework that aims to mitigate and correct, at least partly, inequalities and distributive injustices that have historically characterized the traditional business models and value chains of genetic resource utilizationFootnote 4 (such as biotechnology development and biodiscovery) on the one hand, and the lack of recognition and protection of traditional knowledge on the other.Footnote 5 The latter is a symptom of the broader lack of recognition and protection of the rights of indigenous peoples, local communities, and small-scale farmers in many parts of the world.Footnote 6 Hence, the nexus between global environmental law and the global intellectual property (IP) system is the crossroads where instances of global justice,Footnote 7 trade and investment disciplines,Footnote 8 technology and development priorities, and international politics have met and created frictions around the issue of patent disclosure requirements over the last quarter of a century.
The Nagoya Protocol does not refer explicitly to patent disclosure requirements as such. However, these requirements represent one of the possible mechanisms that countries may choose to fulfil obligations concerning their duty to monitor the utilization of genetic resources within their jurisdictions. Therefore, patent disclosure requirements may help to address, at least partially, possible allegations of misappropriation and misuse of genetic resources and associated traditional knowledge. In the international policy debate, the distinct legal concepts of misappropriation and misuse have been referred to in more general terms as ‘biopiracy’.Footnote 9 An example of the legal definition of biopiracy may be found in Peruvian law, in which it is stated:
Biopiracy means unauthorized and non-remunerated access to and use of biological resources or collective knowledge of indigenous peoples by others, without the relevant authorization and in contravention of the principles established in the [CBD] and the rules in force on the matter. Such appropriation may occur by means of physical control, through ownership rights to products which incorporate such elements that were illicitly obtained or in some cases through invocation of such elements.Footnote 10
One of the key pillars of the Nagoya Protocol – its raison d’être to be precise – concerns compliance in user countries with the domestic legislation or regulatory requirements on access and benefit sharing (ABS) of the contracting party which provides access to its genetic resources and associated traditional knowledge (Articles 15 and 16).Footnote 11 Researchers, companies and public research institutions that undertake research and development (R&D) or bioprospecting in any state party to the Nagoya Protocol must respect the applicable ABS obligations of the providing state party not only at the time of access, but also when the R&D cycle continues in another state. In order to monitor user compliance, the Nagoya Protocol stipulates that each party shall establish one or more ‘checkpoints’ (Article 17).Footnote 12 One such possible checkpoint can be the patent (or IP) office, through the provision of additional disclosure requirements in patent (or other IP) applications.Footnote 13
Approximately 25 countries and two regional organizations have adopted various kinds of (in some cases legally binding) patent disclosure requirements for genetic resources and traditional knowledge.Footnote 14 The academic literature and international policy making at the Secretariats of the CBD,Footnote 15 the World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO) have focused prominently on whether a new legally binding obligation should be placed on all countries in the multilateral system to adopt or further harmonize patent disclosure requirements, as well as on the possible remedies for non-compliance.Footnote 16 However, despite the important and unsettled quest for international harmonization, there are several other practical reasons why the effective use of patent disclosure mechanisms to diffuse transparency across the IP system has been very limited.Footnote 17 These reasons include lack of knowledge and human resources, inadequate finance, and lack of capacity efficiently to coordinate government mandates and functions of different ministries (such as for the environment, industry and innovation).Footnote 18 Hence, there is still significant untapped potential for patent disclosure mechanisms to mainstream instances of global justice, fairness and equity.
This brief commentary does not aim to thoroughly review and assess the various proposals that have been tabled to promote the harmonization of patent disclosure requirements at the international level. A prolific literature has already considered this topic.Footnote 19 The aim is also not to analyze in fine detail the application of such requirements in any particular jurisdiction.Footnote 20 Instead, this commentary aims to provide further practical guidance to countries that wish to introduce new patent disclosure-related mechanisms into their national legal systems with a view to mainstreaming instances of global justice, fairness and equity, in line with the CBD and its Nagoya Protocol. While doing so, it raises awareness and pays due regard to the limitations arising from their extant IP obligations at the multilateral level by focusing on, inter alia, the effective use of available options under the WIPO Patent Cooperation Treaty (PCT).Footnote 21
The next section of this commentary briefly introduces the origins of the frictions between global environmental law and the international IP system in the field of biodiversity. It then summarizes the essential features of patent disclosure requirements for genetic resources and traditional knowledge and reviews how to further possible synergies between the two. Section 3 then considers the relationship between ABS obligations under the Nagoya Protocol and additional patent disclosure requirements, and explains how the latter differ from conventional disclosure obligations under patent law. Section 4 provides the necessary background to understanding the specific features of extant patent disclosure requirements in national law by focusing on their subject matter, scope, and the triggers of disclosure. In so doing, it also illustrates the influence of global environmental law in the development of such features. Section 5 examines these additional patent disclosure-related mechanisms (and their implementation) by assessing their compatibility – or the absence thereof – with relevant international IP law treaties from a legal technical standpoint.
In the transnational context of biodiscovery and its globalized R&D value chains, the final section (Section 6) concludes by drawing key lessons learned from the national implementation of additional patent disclosure requirements. In light of the unsettled debate on the need for mandatory disclosure requirements (and harmonized remedies) at the international level, this commentary puts into perspective the challenges and opportunities that arise from the adoption of patent disclosure measures that are immediately implementable. It finally considers their implications for the emergence and enforcement of the global environmental law exigencies and standards of transparency, fairness, equity and global justice under the CBD and its Nagoya Protocol.
2. GLOBAL ENVIRONMENTAL LAW AND THE INTERNATIONAL IP SYSTEM: FRICTIONS AND SYNERGIES AT THE BIO-BASED MARKETPLACE
Global law – and by inference, global environmental law – may be understood as a distinct and significant subset of transnational law, which ‘embraces any practical endorsement of or commitment to the universal or otherwise global-in-general warrant of some laws or some dimension of law’.Footnote 22 Hence, global law tends to look beyond state sovereignty as the exclusive meta-principle of legal authority and, in doing so, it explicitly considers some ‘general ethical principles and purposes in search of a legitimate grounding for its authority’.Footnote 23 The CBD is the first comprehensive international agreement dedicated to biological diversity, which was adopted in 1992 at the Rio Earth SummitFootnote 24 and has by now achieved almost global coverage with 196 parties, the United States (US) being the most notable non-party. Its objectives are:
[T]he 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, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.Footnote 25
It also reaffirms ‘the sovereign rights of States over their natural resources’, including genetic resources. In particular, the CBD provides that ‘the authority to determine access to genetic resources rests with the national governments and is subject to national legislation’ and that ‘access, where granted, shall be on mutually agreed terms … and subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party’.Footnote 26
Historically, there have been tensions between IP law, particularly relating to patents and plant breeders’ rights, and biodiversity-related legislation such as the CBD.Footnote 27 Where the invention disclosed in a patent application is shown to have some degree of dependence on the acquisition and use of genetic resources or associated traditional knowledge, or appears to include one or both of them in its scope, several developing countries have expressed concerns regarding their misappropriation or misuse,Footnote 28 and the possible violation of ABS legislation.
In an emblematic case, the patented product ‘Brazzein’ was derived from the Oubli berry, a West African fruit of the climbing plant Oubli (Pentadiplandra brazzeana Baillon).Footnote 29 The protein derived from the berry is between 500 to 2,000 times sweeter than sugar and is used as a natural low-calorie sweetener.Footnote 30 Brazzein is a substitute for currently available low-calorie sweeteners and is suitable for diabetics.Footnote 31 It is also thermostable, which makes it suitable for heat processes used in food processing.Footnote 32 The West African people of Gabon originally discovered and nurtured the plant, which was used to help nursing infants ‘forget’ their mother's milk.Footnote 33 A researcher from the University of Wisconsin observed people and animals eating the berries in West Africa and brought them to the attention of the university. The latter was granted three US patentsFootnote 34 and one European patentFootnote 35 for isolating and reproducing the protein in a laboratory.Footnote 36 One claim for the berry in the US patents is to ‘provide Brazzein in large quantities, at low cost, by artificial means’. The researchers have since concentrated on the reproduction of the protein in a laboratory, obviating the need to collect and cultivate the plant in Gabon.Footnote 37 The University of Wisconsin maintained that Brazzein is ‘an invention of a UW-Madison researcher’Footnote 38 and offered no recognition or benefit sharing to the people of Gabon. It was subsequently argued that the synthetic substitution has caused a significant fall in the price of natural Brazzein products, and many Gabonese women, who used to harvest the fruit, have lost their source of income.Footnote 39
Several other cases of alleged misappropriation or misuse of genetic resources and associated traditional knowledge are well documented in the literature.Footnote 40 This has led to the introduction of additional disclosure obligations for genetic resources and associated traditional knowledge in the national patent systems in both developed and developing countries.Footnote 41 Thus, several countries now require or invite patent applicants to disclose, among other things:Footnote 42
• the origin and/or source of genetic resources and/or traditional knowledge;
• evidence of prior informed consent for their use from the provider country and, where applicable, from indigenous peoples and local communities;Footnote 43 and
• evidence of having established mutually agreed terms for the fair and equitable sharing of the benefit derived from such use, if so required by the national legislation of the provider country.
Many megadiverse countriesFootnote 44 regard patent disclosure requirements as a crucial measure to encourage patent applicants to comply with requirements for prior informed consent and mutually agreed terms.Footnote 45 Such new patent disclosure requirements – especially when mandatory – may lead to changes in the attitudes and behaviour of inventors. Thus, they may reinforce the effects of an ABS system and reduce the free-riding incentives to freely obtain a benefit from someone else's genetic resources or traditional knowledge without adequate compensation or proper authorization. Ultimately, this should help in preventing their misappropriation.
Admittedly, the major limitation of such patent disclosure mechanisms is that there is no international legally binding obligation to use them.Footnote 46 Hence, in most user countries a large majority of patent applications associated with biological or genetic resources do not divulge their origin.Footnote 47 Furthermore, it would be unfair not to acknowledge that the lack of fair and equitable benefit sharing is also, at least partly, a consequence of poorly regulated access in the provider countries. Despite these various factors, there are other important limitations to the effective use of extant patent disclosure requirements, which could be more easily mitigated. At present, many patent disclosure requirements that pre-date the Nagoya Protocol apply only to genetic resources and traditional knowledge the provenance of which is the same country that has established the patent disclosure requirement. Indeed, under the Nagoya Protocol, if a party designates its patent/IP office as a compliance checkpoint under Article 17, then the (geographical) scope of the requirement should at least encompass all genetic resources originating from any other contracting parties. This relatively simple fine-tuning of existing legislation could allow the fulfilment of a core monitoring requirement of the Nagoya Protocol on ABS, while also enabling wider synergies with the IP system.
3. THE RELATIONSHIP BETWEEN ABS OBLIGATIONS AND PATENT DISCLOSURE REQUIREMENTS FOR GENETIC RESOURCES AND TRADITIONAL KNOWLEDGE
Given the concerns about illegal access to genetic resources and traditional knowledge under the CBD and its Nagoya Protocol, new patent disclosure requirements focus primarily on the legal status of genetic resources and traditional knowledge – that is, whether they have been acquired legally, subject to prior informed consent and mutually agreed terms, if that is required by the provider country. However, a conventional duty of disclosure already exists within the patent system with regard to information that is ‘material’ to the examination of each patent claim. This conventional disclosure does not normally require disclosure of the origin or source of genetic resources and traditional knowledge, because such information is often not strictly relevant to enable the invention or support the claims.Footnote 48
Thus, the distinctive feature of additional patent disclosure requirements related to genetic resources and traditional knowledge is their primary focus on information or documentation that may concern the legal status of genetic resources and traditional knowledge and the circumstances under which such resources or knowledge have been acquired by the applicant. Since this information is not typically required for the substantive examination of patentability, in most cases it is not considered requisite to satisfy the ‘sufficiency of disclosure’ requirement under conventional patent law. On the other hand, new patent disclosure requirements relating to genetic resources and traditional knowledge may enhance compliance with standard requirements for patent protection, in particular, the requirement of ‘novelty’. A proper scope of disclosure of information related to genetic resources and traditional knowledge may help to ensure that relevant ‘prior art’ is considered in the examination of the patent application, so reducing the risk that patents are erroneously awarded for inventions that lack novelty.
A core issue to be considered when introducing new patent disclosure requirements is how to frame an appropriate interface between ABS legislation and the patent system. How might disclosure requirements be designed to promote mutual supportiveness, synergies and complementarity between the implementation of ABS mechanisms and obligations, on the one hand, and the innovation incentives of the patent system, on the other? Countries vary in terms of their biodiversity endowment, research and biotechnology capacity, level of public and private R&D spending and biocultural sensitivities, as well as their national IP examination capacities. While there is clearly no one-size-fits-all approach, a growing number of countries have been demanding some degree of harmonization through a new legally binding international IP instrument or instruments, which have been under discussion since 2000 at the WIPO Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.Footnote 49
In the context of global biodiversity law, as anticipated in the previous section, patent disclosure requirements can be used principally as a tool to monitor the utilization of genetic resources and associated traditional knowledge, namely as a compliance checkpoint under Article 17 of the Nagoya Protocol. They can help in promoting user compliance with ABS obligations. In doing so, they may facilitate the diffusion of a quasi-extraterritorial application of the ABS standards adopted by the provider countries in the user countries,Footnote 50 as an emerging global environmental law practice that aspires to achieve a higher standard of global fairness and justice between countries, and with indigenous peoples and local communities alike.
4. THE ABC OF PATENT DISCLOSURE REQUIREMENTS: SUBJECT MATTER, SCOPE, AND TRIGGERS
In national patent or IP legislation, various concepts are used to define the subject matter of disclosure. Diverse terms are used, such as genetic resources, biological resources, traditional knowledge, traditional knowledge associated with genetic resources, indigenous knowledge, as well as processes or products derived from or developed with them. The use of such terms and their definitions parallels or is directly derived from national biodiversity legislation on ABS, which, in turn, implements global environmental law standards. Hence, biodiversity law exerts an important influence on the development of IP legislation in this area,Footnote 51 despite the fact that the communities of practitioners operating in the technical legal fields of IP and ABS are quite far apart.
At the international level, genetic resources are defined in the CBD as ‘genetic material of actual or potential value’, and ‘genetic material’ as ‘any material of plant, animal, microbial or other origin containing functional units of heredity’.Footnote 52 The latter expression is commonly understood to require the presence of coding DNA in the genetic material,Footnote 53 so may exclude many gene products at the sub-organism level, non-DNA molecules as well as proteins, which do not contain ‘functional units of heredity’.Footnote 54
On the other hand, the term ‘traditional knowledge’ may refer generally to knowledge resulting from intellectual activity in a traditional context and include know-how, practices, skills, and innovations. It is not limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources.Footnote 55 For example, South Africa defines traditional knowledge as ‘the knowledge that an indigenous community has regarding the use of an indigenous biological resource or a genetic resource’.Footnote 56
The Nagoya Protocol also defines the term ‘derivative’ as ‘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.Footnote 57 Thus, some countries would rely on the above definition of ‘derivative’ to expand the range of biochemicals that are covered by ABS provisions beyond those that are genetic resources in a strict sense (such as a naturally occurring protein).Footnote 58 Similarly, user countries may decide to monitor also the utilization of derivatives through a patent disclosure requirement.
With regard to the scope of a patent disclosure requirement, many countries require only the disclosure of genetic resources and traditional knowledge that originate within their own territoryFootnote 59 or region.Footnote 60 The impact of such patent disclosure requirements may be rather limited, since a patent applicant who files an application for an invention that is based on a genetic resource or traditional knowledge originating from a another country (or region, as applicable)Footnote 61 will not be subject to checks. A majority of compulsory patent disclosure requirements of a substantive nature enacted prior to the entry into effect of the Nagoya Protocol belong to this category.Footnote 62
In countries that are party to the Nagoya Protocol the introduction of new patent disclosure requirements as a checkpoint mechanism is only one of several possible options to enable fulfilment of their monitoring obligations. However, if such requirements are introduced, then their scope must at least encompass genetic resources that originate from any other contracting party. Thus, the designation of a country's patent/IP office as a compliance checkpoint under Article 17 of the Nagoya Protocol is an example of a situation where the geographical scope of a patent disclosure requirement must be defined based on reciprocity.Footnote 63
Finally, it is important to consider the possible trigger of a disclosure obligation. The function of the trigger is to identify markers of ‘proximity’ that create a boundary within which benefit-sharing requirements and any related compliance-monitoring obligations will apply. Under what circumstances should a patent examiner or other receiving office demand additional disclosure related to genetic resources or traditional knowledge from the applicant? Three possible triggers can be identified in national laws: when the patent application or claimed invention (i) includes the utilization of genetic resources and/or traditional knowledge; or (ii) is derived from genetic resources and/or traditional knowledge; or (iii) is based on genetic resources and/or traditional knowledge or directly based on them.Footnote 64
5. IMPLEMENTING GLOBAL BIODIVERSITY LAW EXIGENCIES AND STANDARDS: MONITORING ABS COMPLIANCE VIA THE INTERNATIONAL IP SYSTEM
The above sections have succinctly examined the key policy objectives and the principal features of new patent disclosure requirements for genetic resources and associated traditional knowledge, and their relation to global biodiversity law. The remainder of this commentary considers the question of their compatibility with two of the most important international intellectual property law treaties, which have contributed to globalizing substantive and procedural patent standards, respectively: the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)Footnote 65 and the WIPO PCT.Footnote 66
5.1. The WTO TRIPS Agreement
In 1994, a critical milestone for the development of the international IP system as we know it today was the adoption of the WTO TRIPS Agreement.Footnote 67 This Agreement required, for the first time, members of the multilateral trade system to introduce harmonized intellectual property rules within their domestic law. In particular, it required, inter alia:
• the application of the general provisions and basic principles of the multilateral trading system to international IP, such as national treatment and most-favoured-nation treatment principles;
• the application of minimum standards of protection for IP rights; and
• the introduction of enforcement-related provisions, while also affording the possibility of resolving IP-related disputes between member states through the WTO dispute settlement mechanism.
Under the TRIPS Agreement, patent protection must be available for eligible inventions that are new, involve an inventive step, and can have an industrial application. Article 27 of the TRIPS Agreement calls on WTO members to provide patent protection for both products and processes, and forbids discrimination among different fields of technology. Patent protection must be provided for at least 20 years. WTO members have also agreed that plants, animals and all essentially biological processes for their production may be excluded from patentability. However, if members do so, they are required to provide for the protection of plant varieties either by patents or by an effective sui generis system. Therefore, countries are free to choose either to provide patent protection for new plant varieties or to adopt a sui generis system, for which the most successful and widely disseminated model is the Convention of the International Union for the Protection of New Plant Varieties (UPOV Convention).Footnote 68 Furthermore, the mainstream interpretation of Article 27 of the TRIPS Agreement is that governments would generally be required to issue patents for microbiological inventions and for microbiological processes for the production of plants and animals.Footnote 69
Interestingly, Article 27.3(b) of the TRIPS Agreement also presents a built-in review mechanism, which was triggered in 1998. In 2001, paragraph 19 of the Doha Ministerial Declaration instructed the WTO TRIPS Council ‘to examine, inter alia, the relationship between the TRIPS Agreement and the [CBD], the protection of traditional knowledge and folklore, and other relevant new developments raised by members’.Footnote 70 Under this negotiating mandate, most developing countries supported the proposal to amend the TRIPS Agreement to include a mandatory obligation in patent applications to disclose the origin of genetic resources and traditional knowledge. The most recent proposals and discussions of the WTO TRIPS Council have focused on amending Article 29 of the TRIPS Agreement – instead of Article 27.3(b) – with the view to including a requirement that the applicant submit evidence of compliance with the prior informed consent and benefit-sharing provisions of the CBD.Footnote 71 The Council has also recently considered the possibility of pursuing plurilateral initiatives to overcome almost two decades of standstill on this issue at the multilateral level.Footnote 72
In the absence of an amendment to the TRIPS Agreement that would expressly regulate how to introduce new patent disclosure obligations related to genetic resources and associated traditional knowledge, if any, in the multilateral trading system, the question of their current compatibility with the TRIPS Agreement is a critical issue. In general, patent disclosure requirements can be provided either as substantive or procedural requirements.Footnote 73 Substantive requirements broadly relate to the actual nature of the invention, including considerations for assessing compliance with the standards set for patentability. As we have seen earlier, there are three patentability requirements under TRIPS: novelty, inventive step, and industrial application. Therefore, it is unlikely that a new patent disclosure requirement on genetic resources and traditional knowledge, added as a ‘fourth’ substantive standard for the patentability of gene-based inventions, could be compatible with the TRIPS Agreement as such. However, not all ‘substantive’ requirements have strictly to do with the qualities of the invention. Some deal with such issues as inventorship, entitlement to apply for or be granted a patent and other interests in a patent right. Hence, if it were crafted within the latter category, even a substantive patent disclosure requirement on genetic resources and associated traditional knowledge (that is, not concerned directly with the examination of the qualities of the invention as such) could be permissible under the TRIPS Agreement. Similarly, patent disclosure requirements regarding genetic resources and associated traditional knowledge that are framed as formality requirements are also generally acceptable – and accepted – under the TRIPS Agreement.Footnote 74
5.2. The WIPO PCT
New patent disclosure requirements on genetic resources and associated traditional knowledge should also be considered in light of their possible compatibility with the PCT.Footnote 75 As we will see, an analysis of relevant PCT provisions leads to altogether different – even rather spectacularly contrary – conclusions regarding the compatibility of patent disclosure requirements with international IP law from those resulting from scrutiny under the TRIPS Agreement.
According to WIPO, the PCT ‘assists applicants in seeking patent protection internationally for their inventions, helps Patent Offices with their patent granting decisions, and facilitates public access to a wealth of technical information relating to those inventions. By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in [152] countries’.Footnote 76 The PCT is very widely used by international patent applicants and the fees generated by the PCT system amounted to nearly 300 million Swiss francs in 2016 and 2017.Footnote 77
As regards the possibility of introducing additional patent disclosure requirements in conformity with relevant PCT provisions, due regard must be given to Article 27 PCT, which stipulates the conditions under which ‘special’ national requirements can be introduced. The above article states:
(1) No national law shall require compliance with requirements relating to the form or contents of the international application different from or additional to those which are provided for in this Treaty and the Regulations.
(5) Nothing in this Treaty and the Regulations is intended to be construed as prescribing anything that would limit the freedom of each Contracting State to prescribe such substantive conditions of patentability as it desires . . . . any Contracting State is free to apply, when determining the patentability of an invention claimed in an international application, the criteria of its national law in respect of prior art and other conditions of patentability not constituting requirements as to the form and contents of applications.
(6) The national law may require that the applicant furnish evidence in respect of any substantive condition of patentability prescribed by such law.
The face value of the above provisions is that under the PCT additional substantive patent disclosure requirements related to genetic resources and associated traditional knowledge are generally allowed. For example, India has included special requirements in its national ‘chapter’ to be complied with during the national phase.Footnote 78 In particular, the applicant shall declare if ‘[t]he invention as disclosed in the specification uses the biological material from India’ and must confirm that ‘the necessary permission from the competent authority shall be submitted … before the grant of the patent’.Footnote 79
In contrast, in accordance with Rule 51bis of the PCT Regulations,Footnote 80 only a closed list of additional national requirements would be allowed, which leaves a relatively narrow margin for manoeuvre to argue that an additional procedural or formality patent disclosure requirement would be compatible with the PCT. In particular, Rule 51bis of the PCT Regulations states that ‘the national law applicable by the designated office may, in accordance with Article 27 [of the PCT] require the applicant to furnish [inter alia, …] (ii) any document relating to the applicant's entitlement to apply for or be granted a patent’.
Arguably, legal access – or the absence thereof – to a genetic resource or associated traditional knowledge, which underpins or is used in the claimed invention, can have implications for the applicant's entitlement to apply for or be granted a patent. However, despite the above argument – and the possibility of requiring additional documentation or evidence only if the receiving office reasonably doubts the veracity of the indications or declaration concerned – Article 27(4) PCT further provides:
Where the national law provides, in respect of the form or contents of national applications, for requirements which, from the viewpoint of applicants, are more favorable than the requirements provided for by this Treaty and the Regulations in respect of international applications, the national Office, the courts and any other competent organs of or acting for the designated State may apply the former requirements, instead of the latter requirements, to international applications, except where the applicant insists that the requirements provided for by this Treaty and the Regulations be applied to his international application.
In sum, even if a new formality requirement related to patent disclosure of genetic resources and associated traditional knowledge is allowable under the PCT,Footnote 81 an international applicant may always refuse, at least in principle, to be subject to such less favourable requirement, including in the context of post-grant opposition or invalidation proceedings, where applicable.Footnote 82
6. CONCLUSIONS: IMPLICATIONS FOR GLOBAL ENVIRONMENTAL LAW
This commentary concludes that a balanced and proactive use of current mechanisms and flexibilities that are available within the international IP system can further its synergetic implementation with key biodiversity-related instruments such as the CBD and its Nagoya Protocol. However, it also argues that several ‘systemic’ limitations will persist. These include the elusive multilateral consensus on priorities for the unaccomplished reform of the multilateral trading system and, via the mandate of the WTO TRIPS Council, the review of provisions concerning the patentability of plant and animal inventions, the protection of new plant varieties, and the relationship between the TRIPS Agreement and the CBD.Footnote 83
Similarly, there are no compromises within easy reach at the WIPO IGC on IP and genetic resources, traditional knowledge and folklore, including on the subject of its normative work on IP and genetic resources. In an attempt to consider some form of global minimum standards for harmonized patent disclosure requirements, protracted IGC negotiations have now stretched over almost two decades.Footnote 84 No significant concessions are in sight, particularly from entrenched corporate interests and opponents in a few developed countries.Footnote 85 Hence, the current top-down approach for such harmonization has not yet fully proven its worth, at least for those countries and stakeholders waiting to achieve, within a reasonable time, a multilateral outcome of a legally binding nature.
However, new global standards of transparency, fairness, equity and justice may already be construed through a bottom-up approach at the national and regional levels. The adoption and diffusion of implementable common standards and ‘best practices’ concerning the disclosure of genetic resources and associated traditional knowledge in patent applications are crucially important elements in this endeavour. The globalization of such standards and ‘best practices’ can immediately be brought to fruition by the countries that have already adopted some form of patent disclosure through relatively minor fine tuning of their national disclosure measures.
At present, many pre-Nagoya patent disclosure requirements apply only to genetic resources and traditional knowledge the provenance of which is the same country that established the patent disclosure requirement. Indeed, under the Nagoya Protocol, if a contracting party designates its patent or IP office as a compliance checkpoint under Article 17, then the geographical scope of the requirement should at least encompass all genetic resources originating from any other parties. This relatively simple fine tuning of existing legislation could allow the fulfilling of a core monitoring requirement of the Nagoya Protocol, while also enabling wider synergies with the IP system. The pervasive effects of such bottom-up harmonizationFootnote 86 and an improved interface with the ABS system, in turn, can ease an effective user-compliance monitoring system for ABS checkpoints and Competent National Authorities in user and provider countries alike.
Efforts to support the implementation of the Nagoya Protocol and related regulatory instruments are well under way at the national level.Footnote 87 National and regional level initiatives can provide a powerful impulse for the development of a new generation of patent disclosure requirements that are directly connected to ABS legislation, such as in FranceFootnote 88 and Ethiopia,Footnote 89 among others. Likewise, the progressive development and reform of domestic IP systems that have introduced additional disclosure requirements, coupled with duly designed interfaces with international IP treaties, particularly the WIPO PCT system, hold potential for diffusing the effects of any single national disclosure on a much wider scale across multiple jurisdictions. This is because inventions that belong to the same patent family,Footnote 90 for which an initial single disclosure of origin is triggered, can technically be traced in all countries where a subsequent filing is made. This potentially pervasive effect of disclosure not only supports efforts to monitor user compliance under the Nagoya Protocol, but also enables defensive protection strategies of other provider countries.Footnote 91 Such strategies can effectively be used against the misappropriation of genetic resources and traditional knowledge that occurs in any other country – regardless of whether or not such country is a party to the Nagoya Protocol.
A global environmental law practice that aspires to achieve a higher standard of global fairness and justice between countries and with indigenous peoples and local communities is developing progressively. The global environmental law standards of transparency, fairness, equity and global justice, which have emerged in the field of biodiversity law, have exercised an undeniable influence and attraction on the international political discourse in international IP policy making at WIPO and the WTO. However, their impetus has still to travel a long way towards global justice and the realization of more inclusive development pathways for indigenous peoples and local communities (IPLCs) who help us to conserve 80% of biodiversity on our planet.Footnote 92 By examining the key challenges and opportunities arising from the implementation of additional patent disclosure requirements, this commentary reaches the conclusion that, in the long run, they are an important technical stepping-stone in helping IPLCs and biodiversity-rich developing countries to benefit from the dividends arising from the commercial use of biodiversity.
1. INTRODUCTION
There is growing interest in patent disclosure requirements concerning genetic resources and traditional knowledge. The use of genetic resources and associated traditional knowledge contributes invaluably to innovation in the fields of agriculture and horticulture, in the food and beverage, cosmetic, pharmaceutical and industrial biotechnology sectors, among others.Footnote 1 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol)Footnote 2 to the Convention on Biological Diversity (CBD)Footnote 3 points towards the achievement of a globally emergent form of sustainable development practice concerning the above uses, including in its legal dimensions, and aspires to global justice through fair and equitable benefit sharing. It does so by establishing a framework that aims to mitigate and correct, at least partly, inequalities and distributive injustices that have historically characterized the traditional business models and value chains of genetic resource utilizationFootnote 4 (such as biotechnology development and biodiscovery) on the one hand, and the lack of recognition and protection of traditional knowledge on the other.Footnote 5 The latter is a symptom of the broader lack of recognition and protection of the rights of indigenous peoples, local communities, and small-scale farmers in many parts of the world.Footnote 6 Hence, the nexus between global environmental law and the global intellectual property (IP) system is the crossroads where instances of global justice,Footnote 7 trade and investment disciplines,Footnote 8 technology and development priorities, and international politics have met and created frictions around the issue of patent disclosure requirements over the last quarter of a century.
The Nagoya Protocol does not refer explicitly to patent disclosure requirements as such. However, these requirements represent one of the possible mechanisms that countries may choose to fulfil obligations concerning their duty to monitor the utilization of genetic resources within their jurisdictions. Therefore, patent disclosure requirements may help to address, at least partially, possible allegations of misappropriation and misuse of genetic resources and associated traditional knowledge. In the international policy debate, the distinct legal concepts of misappropriation and misuse have been referred to in more general terms as ‘biopiracy’.Footnote 9 An example of the legal definition of biopiracy may be found in Peruvian law, in which it is stated:
Biopiracy means unauthorized and non-remunerated access to and use of biological resources or collective knowledge of indigenous peoples by others, without the relevant authorization and in contravention of the principles established in the [CBD] and the rules in force on the matter. Such appropriation may occur by means of physical control, through ownership rights to products which incorporate such elements that were illicitly obtained or in some cases through invocation of such elements.Footnote 10
One of the key pillars of the Nagoya Protocol – its raison d’être to be precise – concerns compliance in user countries with the domestic legislation or regulatory requirements on access and benefit sharing (ABS) of the contracting party which provides access to its genetic resources and associated traditional knowledge (Articles 15 and 16).Footnote 11 Researchers, companies and public research institutions that undertake research and development (R&D) or bioprospecting in any state party to the Nagoya Protocol must respect the applicable ABS obligations of the providing state party not only at the time of access, but also when the R&D cycle continues in another state. In order to monitor user compliance, the Nagoya Protocol stipulates that each party shall establish one or more ‘checkpoints’ (Article 17).Footnote 12 One such possible checkpoint can be the patent (or IP) office, through the provision of additional disclosure requirements in patent (or other IP) applications.Footnote 13
Approximately 25 countries and two regional organizations have adopted various kinds of (in some cases legally binding) patent disclosure requirements for genetic resources and traditional knowledge.Footnote 14 The academic literature and international policy making at the Secretariats of the CBD,Footnote 15 the World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO) have focused prominently on whether a new legally binding obligation should be placed on all countries in the multilateral system to adopt or further harmonize patent disclosure requirements, as well as on the possible remedies for non-compliance.Footnote 16 However, despite the important and unsettled quest for international harmonization, there are several other practical reasons why the effective use of patent disclosure mechanisms to diffuse transparency across the IP system has been very limited.Footnote 17 These reasons include lack of knowledge and human resources, inadequate finance, and lack of capacity efficiently to coordinate government mandates and functions of different ministries (such as for the environment, industry and innovation).Footnote 18 Hence, there is still significant untapped potential for patent disclosure mechanisms to mainstream instances of global justice, fairness and equity.
This brief commentary does not aim to thoroughly review and assess the various proposals that have been tabled to promote the harmonization of patent disclosure requirements at the international level. A prolific literature has already considered this topic.Footnote 19 The aim is also not to analyze in fine detail the application of such requirements in any particular jurisdiction.Footnote 20 Instead, this commentary aims to provide further practical guidance to countries that wish to introduce new patent disclosure-related mechanisms into their national legal systems with a view to mainstreaming instances of global justice, fairness and equity, in line with the CBD and its Nagoya Protocol. While doing so, it raises awareness and pays due regard to the limitations arising from their extant IP obligations at the multilateral level by focusing on, inter alia, the effective use of available options under the WIPO Patent Cooperation Treaty (PCT).Footnote 21
The next section of this commentary briefly introduces the origins of the frictions between global environmental law and the international IP system in the field of biodiversity. It then summarizes the essential features of patent disclosure requirements for genetic resources and traditional knowledge and reviews how to further possible synergies between the two. Section 3 then considers the relationship between ABS obligations under the Nagoya Protocol and additional patent disclosure requirements, and explains how the latter differ from conventional disclosure obligations under patent law. Section 4 provides the necessary background to understanding the specific features of extant patent disclosure requirements in national law by focusing on their subject matter, scope, and the triggers of disclosure. In so doing, it also illustrates the influence of global environmental law in the development of such features. Section 5 examines these additional patent disclosure-related mechanisms (and their implementation) by assessing their compatibility – or the absence thereof – with relevant international IP law treaties from a legal technical standpoint.
In the transnational context of biodiscovery and its globalized R&D value chains, the final section (Section 6) concludes by drawing key lessons learned from the national implementation of additional patent disclosure requirements. In light of the unsettled debate on the need for mandatory disclosure requirements (and harmonized remedies) at the international level, this commentary puts into perspective the challenges and opportunities that arise from the adoption of patent disclosure measures that are immediately implementable. It finally considers their implications for the emergence and enforcement of the global environmental law exigencies and standards of transparency, fairness, equity and global justice under the CBD and its Nagoya Protocol.
2. GLOBAL ENVIRONMENTAL LAW AND THE INTERNATIONAL IP SYSTEM: FRICTIONS AND SYNERGIES AT THE BIO-BASED MARKETPLACE
Global law – and by inference, global environmental law – may be understood as a distinct and significant subset of transnational law, which ‘embraces any practical endorsement of or commitment to the universal or otherwise global-in-general warrant of some laws or some dimension of law’.Footnote 22 Hence, global law tends to look beyond state sovereignty as the exclusive meta-principle of legal authority and, in doing so, it explicitly considers some ‘general ethical principles and purposes in search of a legitimate grounding for its authority’.Footnote 23 The CBD is the first comprehensive international agreement dedicated to biological diversity, which was adopted in 1992 at the Rio Earth SummitFootnote 24 and has by now achieved almost global coverage with 196 parties, the United States (US) being the most notable non-party. Its objectives are:
[T]he 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, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.Footnote 25
It also reaffirms ‘the sovereign rights of States over their natural resources’, including genetic resources. In particular, the CBD provides that ‘the authority to determine access to genetic resources rests with the national governments and is subject to national legislation’ and that ‘access, where granted, shall be on mutually agreed terms … and subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party’.Footnote 26
Historically, there have been tensions between IP law, particularly relating to patents and plant breeders’ rights, and biodiversity-related legislation such as the CBD.Footnote 27 Where the invention disclosed in a patent application is shown to have some degree of dependence on the acquisition and use of genetic resources or associated traditional knowledge, or appears to include one or both of them in its scope, several developing countries have expressed concerns regarding their misappropriation or misuse,Footnote 28 and the possible violation of ABS legislation.
In an emblematic case, the patented product ‘Brazzein’ was derived from the Oubli berry, a West African fruit of the climbing plant Oubli (Pentadiplandra brazzeana Baillon).Footnote 29 The protein derived from the berry is between 500 to 2,000 times sweeter than sugar and is used as a natural low-calorie sweetener.Footnote 30 Brazzein is a substitute for currently available low-calorie sweeteners and is suitable for diabetics.Footnote 31 It is also thermostable, which makes it suitable for heat processes used in food processing.Footnote 32 The West African people of Gabon originally discovered and nurtured the plant, which was used to help nursing infants ‘forget’ their mother's milk.Footnote 33 A researcher from the University of Wisconsin observed people and animals eating the berries in West Africa and brought them to the attention of the university. The latter was granted three US patentsFootnote 34 and one European patentFootnote 35 for isolating and reproducing the protein in a laboratory.Footnote 36 One claim for the berry in the US patents is to ‘provide Brazzein in large quantities, at low cost, by artificial means’. The researchers have since concentrated on the reproduction of the protein in a laboratory, obviating the need to collect and cultivate the plant in Gabon.Footnote 37 The University of Wisconsin maintained that Brazzein is ‘an invention of a UW-Madison researcher’Footnote 38 and offered no recognition or benefit sharing to the people of Gabon. It was subsequently argued that the synthetic substitution has caused a significant fall in the price of natural Brazzein products, and many Gabonese women, who used to harvest the fruit, have lost their source of income.Footnote 39
Several other cases of alleged misappropriation or misuse of genetic resources and associated traditional knowledge are well documented in the literature.Footnote 40 This has led to the introduction of additional disclosure obligations for genetic resources and associated traditional knowledge in the national patent systems in both developed and developing countries.Footnote 41 Thus, several countries now require or invite patent applicants to disclose, among other things:Footnote 42
• the origin and/or source of genetic resources and/or traditional knowledge;
• evidence of prior informed consent for their use from the provider country and, where applicable, from indigenous peoples and local communities;Footnote 43 and
• evidence of having established mutually agreed terms for the fair and equitable sharing of the benefit derived from such use, if so required by the national legislation of the provider country.
Many megadiverse countriesFootnote 44 regard patent disclosure requirements as a crucial measure to encourage patent applicants to comply with requirements for prior informed consent and mutually agreed terms.Footnote 45 Such new patent disclosure requirements – especially when mandatory – may lead to changes in the attitudes and behaviour of inventors. Thus, they may reinforce the effects of an ABS system and reduce the free-riding incentives to freely obtain a benefit from someone else's genetic resources or traditional knowledge without adequate compensation or proper authorization. Ultimately, this should help in preventing their misappropriation.
Admittedly, the major limitation of such patent disclosure mechanisms is that there is no international legally binding obligation to use them.Footnote 46 Hence, in most user countries a large majority of patent applications associated with biological or genetic resources do not divulge their origin.Footnote 47 Furthermore, it would be unfair not to acknowledge that the lack of fair and equitable benefit sharing is also, at least partly, a consequence of poorly regulated access in the provider countries. Despite these various factors, there are other important limitations to the effective use of extant patent disclosure requirements, which could be more easily mitigated. At present, many patent disclosure requirements that pre-date the Nagoya Protocol apply only to genetic resources and traditional knowledge the provenance of which is the same country that has established the patent disclosure requirement. Indeed, under the Nagoya Protocol, if a party designates its patent/IP office as a compliance checkpoint under Article 17, then the (geographical) scope of the requirement should at least encompass all genetic resources originating from any other contracting parties. This relatively simple fine-tuning of existing legislation could allow the fulfilment of a core monitoring requirement of the Nagoya Protocol on ABS, while also enabling wider synergies with the IP system.
3. THE RELATIONSHIP BETWEEN ABS OBLIGATIONS AND PATENT DISCLOSURE REQUIREMENTS FOR GENETIC RESOURCES AND TRADITIONAL KNOWLEDGE
Given the concerns about illegal access to genetic resources and traditional knowledge under the CBD and its Nagoya Protocol, new patent disclosure requirements focus primarily on the legal status of genetic resources and traditional knowledge – that is, whether they have been acquired legally, subject to prior informed consent and mutually agreed terms, if that is required by the provider country. However, a conventional duty of disclosure already exists within the patent system with regard to information that is ‘material’ to the examination of each patent claim. This conventional disclosure does not normally require disclosure of the origin or source of genetic resources and traditional knowledge, because such information is often not strictly relevant to enable the invention or support the claims.Footnote 48
Thus, the distinctive feature of additional patent disclosure requirements related to genetic resources and traditional knowledge is their primary focus on information or documentation that may concern the legal status of genetic resources and traditional knowledge and the circumstances under which such resources or knowledge have been acquired by the applicant. Since this information is not typically required for the substantive examination of patentability, in most cases it is not considered requisite to satisfy the ‘sufficiency of disclosure’ requirement under conventional patent law. On the other hand, new patent disclosure requirements relating to genetic resources and traditional knowledge may enhance compliance with standard requirements for patent protection, in particular, the requirement of ‘novelty’. A proper scope of disclosure of information related to genetic resources and traditional knowledge may help to ensure that relevant ‘prior art’ is considered in the examination of the patent application, so reducing the risk that patents are erroneously awarded for inventions that lack novelty.
A core issue to be considered when introducing new patent disclosure requirements is how to frame an appropriate interface between ABS legislation and the patent system. How might disclosure requirements be designed to promote mutual supportiveness, synergies and complementarity between the implementation of ABS mechanisms and obligations, on the one hand, and the innovation incentives of the patent system, on the other? Countries vary in terms of their biodiversity endowment, research and biotechnology capacity, level of public and private R&D spending and biocultural sensitivities, as well as their national IP examination capacities. While there is clearly no one-size-fits-all approach, a growing number of countries have been demanding some degree of harmonization through a new legally binding international IP instrument or instruments, which have been under discussion since 2000 at the WIPO Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.Footnote 49
In the context of global biodiversity law, as anticipated in the previous section, patent disclosure requirements can be used principally as a tool to monitor the utilization of genetic resources and associated traditional knowledge, namely as a compliance checkpoint under Article 17 of the Nagoya Protocol. They can help in promoting user compliance with ABS obligations. In doing so, they may facilitate the diffusion of a quasi-extraterritorial application of the ABS standards adopted by the provider countries in the user countries,Footnote 50 as an emerging global environmental law practice that aspires to achieve a higher standard of global fairness and justice between countries, and with indigenous peoples and local communities alike.
4. THE ABC OF PATENT DISCLOSURE REQUIREMENTS: SUBJECT MATTER, SCOPE, AND TRIGGERS
In national patent or IP legislation, various concepts are used to define the subject matter of disclosure. Diverse terms are used, such as genetic resources, biological resources, traditional knowledge, traditional knowledge associated with genetic resources, indigenous knowledge, as well as processes or products derived from or developed with them. The use of such terms and their definitions parallels or is directly derived from national biodiversity legislation on ABS, which, in turn, implements global environmental law standards. Hence, biodiversity law exerts an important influence on the development of IP legislation in this area,Footnote 51 despite the fact that the communities of practitioners operating in the technical legal fields of IP and ABS are quite far apart.
At the international level, genetic resources are defined in the CBD as ‘genetic material of actual or potential value’, and ‘genetic material’ as ‘any material of plant, animal, microbial or other origin containing functional units of heredity’.Footnote 52 The latter expression is commonly understood to require the presence of coding DNA in the genetic material,Footnote 53 so may exclude many gene products at the sub-organism level, non-DNA molecules as well as proteins, which do not contain ‘functional units of heredity’.Footnote 54
On the other hand, the term ‘traditional knowledge’ may refer generally to knowledge resulting from intellectual activity in a traditional context and include know-how, practices, skills, and innovations. It is not limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources.Footnote 55 For example, South Africa defines traditional knowledge as ‘the knowledge that an indigenous community has regarding the use of an indigenous biological resource or a genetic resource’.Footnote 56
The Nagoya Protocol also defines the term ‘derivative’ as ‘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.Footnote 57 Thus, some countries would rely on the above definition of ‘derivative’ to expand the range of biochemicals that are covered by ABS provisions beyond those that are genetic resources in a strict sense (such as a naturally occurring protein).Footnote 58 Similarly, user countries may decide to monitor also the utilization of derivatives through a patent disclosure requirement.
With regard to the scope of a patent disclosure requirement, many countries require only the disclosure of genetic resources and traditional knowledge that originate within their own territoryFootnote 59 or region.Footnote 60 The impact of such patent disclosure requirements may be rather limited, since a patent applicant who files an application for an invention that is based on a genetic resource or traditional knowledge originating from a another country (or region, as applicable)Footnote 61 will not be subject to checks. A majority of compulsory patent disclosure requirements of a substantive nature enacted prior to the entry into effect of the Nagoya Protocol belong to this category.Footnote 62
In countries that are party to the Nagoya Protocol the introduction of new patent disclosure requirements as a checkpoint mechanism is only one of several possible options to enable fulfilment of their monitoring obligations. However, if such requirements are introduced, then their scope must at least encompass genetic resources that originate from any other contracting party. Thus, the designation of a country's patent/IP office as a compliance checkpoint under Article 17 of the Nagoya Protocol is an example of a situation where the geographical scope of a patent disclosure requirement must be defined based on reciprocity.Footnote 63
Finally, it is important to consider the possible trigger of a disclosure obligation. The function of the trigger is to identify markers of ‘proximity’ that create a boundary within which benefit-sharing requirements and any related compliance-monitoring obligations will apply. Under what circumstances should a patent examiner or other receiving office demand additional disclosure related to genetic resources or traditional knowledge from the applicant? Three possible triggers can be identified in national laws: when the patent application or claimed invention (i) includes the utilization of genetic resources and/or traditional knowledge; or (ii) is derived from genetic resources and/or traditional knowledge; or (iii) is based on genetic resources and/or traditional knowledge or directly based on them.Footnote 64
5. IMPLEMENTING GLOBAL BIODIVERSITY LAW EXIGENCIES AND STANDARDS: MONITORING ABS COMPLIANCE VIA THE INTERNATIONAL IP SYSTEM
The above sections have succinctly examined the key policy objectives and the principal features of new patent disclosure requirements for genetic resources and associated traditional knowledge, and their relation to global biodiversity law. The remainder of this commentary considers the question of their compatibility with two of the most important international intellectual property law treaties, which have contributed to globalizing substantive and procedural patent standards, respectively: the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)Footnote 65 and the WIPO PCT.Footnote 66
5.1. The WTO TRIPS Agreement
In 1994, a critical milestone for the development of the international IP system as we know it today was the adoption of the WTO TRIPS Agreement.Footnote 67 This Agreement required, for the first time, members of the multilateral trade system to introduce harmonized intellectual property rules within their domestic law. In particular, it required, inter alia:
• the application of the general provisions and basic principles of the multilateral trading system to international IP, such as national treatment and most-favoured-nation treatment principles;
• the application of minimum standards of protection for IP rights; and
• the introduction of enforcement-related provisions, while also affording the possibility of resolving IP-related disputes between member states through the WTO dispute settlement mechanism.
Under the TRIPS Agreement, patent protection must be available for eligible inventions that are new, involve an inventive step, and can have an industrial application. Article 27 of the TRIPS Agreement calls on WTO members to provide patent protection for both products and processes, and forbids discrimination among different fields of technology. Patent protection must be provided for at least 20 years. WTO members have also agreed that plants, animals and all essentially biological processes for their production may be excluded from patentability. However, if members do so, they are required to provide for the protection of plant varieties either by patents or by an effective sui generis system. Therefore, countries are free to choose either to provide patent protection for new plant varieties or to adopt a sui generis system, for which the most successful and widely disseminated model is the Convention of the International Union for the Protection of New Plant Varieties (UPOV Convention).Footnote 68 Furthermore, the mainstream interpretation of Article 27 of the TRIPS Agreement is that governments would generally be required to issue patents for microbiological inventions and for microbiological processes for the production of plants and animals.Footnote 69
Interestingly, Article 27.3(b) of the TRIPS Agreement also presents a built-in review mechanism, which was triggered in 1998. In 2001, paragraph 19 of the Doha Ministerial Declaration instructed the WTO TRIPS Council ‘to examine, inter alia, the relationship between the TRIPS Agreement and the [CBD], the protection of traditional knowledge and folklore, and other relevant new developments raised by members’.Footnote 70 Under this negotiating mandate, most developing countries supported the proposal to amend the TRIPS Agreement to include a mandatory obligation in patent applications to disclose the origin of genetic resources and traditional knowledge. The most recent proposals and discussions of the WTO TRIPS Council have focused on amending Article 29 of the TRIPS Agreement – instead of Article 27.3(b) – with the view to including a requirement that the applicant submit evidence of compliance with the prior informed consent and benefit-sharing provisions of the CBD.Footnote 71 The Council has also recently considered the possibility of pursuing plurilateral initiatives to overcome almost two decades of standstill on this issue at the multilateral level.Footnote 72
In the absence of an amendment to the TRIPS Agreement that would expressly regulate how to introduce new patent disclosure obligations related to genetic resources and associated traditional knowledge, if any, in the multilateral trading system, the question of their current compatibility with the TRIPS Agreement is a critical issue. In general, patent disclosure requirements can be provided either as substantive or procedural requirements.Footnote 73 Substantive requirements broadly relate to the actual nature of the invention, including considerations for assessing compliance with the standards set for patentability. As we have seen earlier, there are three patentability requirements under TRIPS: novelty, inventive step, and industrial application. Therefore, it is unlikely that a new patent disclosure requirement on genetic resources and traditional knowledge, added as a ‘fourth’ substantive standard for the patentability of gene-based inventions, could be compatible with the TRIPS Agreement as such. However, not all ‘substantive’ requirements have strictly to do with the qualities of the invention. Some deal with such issues as inventorship, entitlement to apply for or be granted a patent and other interests in a patent right. Hence, if it were crafted within the latter category, even a substantive patent disclosure requirement on genetic resources and associated traditional knowledge (that is, not concerned directly with the examination of the qualities of the invention as such) could be permissible under the TRIPS Agreement. Similarly, patent disclosure requirements regarding genetic resources and associated traditional knowledge that are framed as formality requirements are also generally acceptable – and accepted – under the TRIPS Agreement.Footnote 74
5.2. The WIPO PCT
New patent disclosure requirements on genetic resources and associated traditional knowledge should also be considered in light of their possible compatibility with the PCT.Footnote 75 As we will see, an analysis of relevant PCT provisions leads to altogether different – even rather spectacularly contrary – conclusions regarding the compatibility of patent disclosure requirements with international IP law from those resulting from scrutiny under the TRIPS Agreement.
According to WIPO, the PCT ‘assists applicants in seeking patent protection internationally for their inventions, helps Patent Offices with their patent granting decisions, and facilitates public access to a wealth of technical information relating to those inventions. By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in [152] countries’.Footnote 76 The PCT is very widely used by international patent applicants and the fees generated by the PCT system amounted to nearly 300 million Swiss francs in 2016 and 2017.Footnote 77
As regards the possibility of introducing additional patent disclosure requirements in conformity with relevant PCT provisions, due regard must be given to Article 27 PCT, which stipulates the conditions under which ‘special’ national requirements can be introduced. The above article states:
(1) No national law shall require compliance with requirements relating to the form or contents of the international application different from or additional to those which are provided for in this Treaty and the Regulations.
[…]
(5) Nothing in this Treaty and the Regulations is intended to be construed as prescribing anything that would limit the freedom of each Contracting State to prescribe such substantive conditions of patentability as it desires . . . . any Contracting State is free to apply, when determining the patentability of an invention claimed in an international application, the criteria of its national law in respect of prior art and other conditions of patentability not constituting requirements as to the form and contents of applications.
(6) The national law may require that the applicant furnish evidence in respect of any substantive condition of patentability prescribed by such law.
The face value of the above provisions is that under the PCT additional substantive patent disclosure requirements related to genetic resources and associated traditional knowledge are generally allowed. For example, India has included special requirements in its national ‘chapter’ to be complied with during the national phase.Footnote 78 In particular, the applicant shall declare if ‘[t]he invention as disclosed in the specification uses the biological material from India’ and must confirm that ‘the necessary permission from the competent authority shall be submitted … before the grant of the patent’.Footnote 79
In contrast, in accordance with Rule 51bis of the PCT Regulations,Footnote 80 only a closed list of additional national requirements would be allowed, which leaves a relatively narrow margin for manoeuvre to argue that an additional procedural or formality patent disclosure requirement would be compatible with the PCT. In particular, Rule 51bis of the PCT Regulations states that ‘the national law applicable by the designated office may, in accordance with Article 27 [of the PCT] require the applicant to furnish [inter alia, …] (ii) any document relating to the applicant's entitlement to apply for or be granted a patent’.
Arguably, legal access – or the absence thereof – to a genetic resource or associated traditional knowledge, which underpins or is used in the claimed invention, can have implications for the applicant's entitlement to apply for or be granted a patent. However, despite the above argument – and the possibility of requiring additional documentation or evidence only if the receiving office reasonably doubts the veracity of the indications or declaration concerned – Article 27(4) PCT further provides:
Where the national law provides, in respect of the form or contents of national applications, for requirements which, from the viewpoint of applicants, are more favorable than the requirements provided for by this Treaty and the Regulations in respect of international applications, the national Office, the courts and any other competent organs of or acting for the designated State may apply the former requirements, instead of the latter requirements, to international applications, except where the applicant insists that the requirements provided for by this Treaty and the Regulations be applied to his international application.
In sum, even if a new formality requirement related to patent disclosure of genetic resources and associated traditional knowledge is allowable under the PCT,Footnote 81 an international applicant may always refuse, at least in principle, to be subject to such less favourable requirement, including in the context of post-grant opposition or invalidation proceedings, where applicable.Footnote 82
6. CONCLUSIONS: IMPLICATIONS FOR GLOBAL ENVIRONMENTAL LAW
This commentary concludes that a balanced and proactive use of current mechanisms and flexibilities that are available within the international IP system can further its synergetic implementation with key biodiversity-related instruments such as the CBD and its Nagoya Protocol. However, it also argues that several ‘systemic’ limitations will persist. These include the elusive multilateral consensus on priorities for the unaccomplished reform of the multilateral trading system and, via the mandate of the WTO TRIPS Council, the review of provisions concerning the patentability of plant and animal inventions, the protection of new plant varieties, and the relationship between the TRIPS Agreement and the CBD.Footnote 83
Similarly, there are no compromises within easy reach at the WIPO IGC on IP and genetic resources, traditional knowledge and folklore, including on the subject of its normative work on IP and genetic resources. In an attempt to consider some form of global minimum standards for harmonized patent disclosure requirements, protracted IGC negotiations have now stretched over almost two decades.Footnote 84 No significant concessions are in sight, particularly from entrenched corporate interests and opponents in a few developed countries.Footnote 85 Hence, the current top-down approach for such harmonization has not yet fully proven its worth, at least for those countries and stakeholders waiting to achieve, within a reasonable time, a multilateral outcome of a legally binding nature.
However, new global standards of transparency, fairness, equity and justice may already be construed through a bottom-up approach at the national and regional levels. The adoption and diffusion of implementable common standards and ‘best practices’ concerning the disclosure of genetic resources and associated traditional knowledge in patent applications are crucially important elements in this endeavour. The globalization of such standards and ‘best practices’ can immediately be brought to fruition by the countries that have already adopted some form of patent disclosure through relatively minor fine tuning of their national disclosure measures.
At present, many pre-Nagoya patent disclosure requirements apply only to genetic resources and traditional knowledge the provenance of which is the same country that established the patent disclosure requirement. Indeed, under the Nagoya Protocol, if a contracting party designates its patent or IP office as a compliance checkpoint under Article 17, then the geographical scope of the requirement should at least encompass all genetic resources originating from any other parties. This relatively simple fine tuning of existing legislation could allow the fulfilling of a core monitoring requirement of the Nagoya Protocol, while also enabling wider synergies with the IP system. The pervasive effects of such bottom-up harmonizationFootnote 86 and an improved interface with the ABS system, in turn, can ease an effective user-compliance monitoring system for ABS checkpoints and Competent National Authorities in user and provider countries alike.
Efforts to support the implementation of the Nagoya Protocol and related regulatory instruments are well under way at the national level.Footnote 87 National and regional level initiatives can provide a powerful impulse for the development of a new generation of patent disclosure requirements that are directly connected to ABS legislation, such as in FranceFootnote 88 and Ethiopia,Footnote 89 among others. Likewise, the progressive development and reform of domestic IP systems that have introduced additional disclosure requirements, coupled with duly designed interfaces with international IP treaties, particularly the WIPO PCT system, hold potential for diffusing the effects of any single national disclosure on a much wider scale across multiple jurisdictions. This is because inventions that belong to the same patent family,Footnote 90 for which an initial single disclosure of origin is triggered, can technically be traced in all countries where a subsequent filing is made. This potentially pervasive effect of disclosure not only supports efforts to monitor user compliance under the Nagoya Protocol, but also enables defensive protection strategies of other provider countries.Footnote 91 Such strategies can effectively be used against the misappropriation of genetic resources and traditional knowledge that occurs in any other country – regardless of whether or not such country is a party to the Nagoya Protocol.
A global environmental law practice that aspires to achieve a higher standard of global fairness and justice between countries and with indigenous peoples and local communities is developing progressively. The global environmental law standards of transparency, fairness, equity and global justice, which have emerged in the field of biodiversity law, have exercised an undeniable influence and attraction on the international political discourse in international IP policy making at WIPO and the WTO. However, their impetus has still to travel a long way towards global justice and the realization of more inclusive development pathways for indigenous peoples and local communities (IPLCs) who help us to conserve 80% of biodiversity on our planet.Footnote 92 By examining the key challenges and opportunities arising from the implementation of additional patent disclosure requirements, this commentary reaches the conclusion that, in the long run, they are an important technical stepping-stone in helping IPLCs and biodiversity-rich developing countries to benefit from the dividends arising from the commercial use of biodiversity.