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Treaty On Intellectual Property, Genetic Resources And Associated Traditional Knowledge - A Critical Analysis

Author: LawSphereX

Category: Intellectual Property

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TREATY ON INTELLECTUAL PROPERTY, GENETIC

RESOURCES AND ASSOCIATED TRADITIONAL

KNOWLEDGE: A CRITICAL

ANALYSIS

Harshitha S.S., B.A. LL.B. (Hons.), School of Excellence in Law, The Tamil Nadu Dr. Ambedkar Law University

ABSTRACT

The Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge was the 27th treaty adopted at the Diplomatic Conference of World Intellectual Property Rights on Mary 24, 2024. The Treaty aims to enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with genetic resources and prevent patents from being granted erroneously for inventions based on genetic resources and associated traditional knowledge that are not novel or inventive. This treaty also helps to give due credit to the indigenous communities whose traditional knowledge plays a huge role in IP. This article delves into the salient features of the Treaty, as well as its benefits and criticisms, to provide a balanced perspective.

This article concludes that the Treaty has taken a historic step towards promoting transparency and protecting the Indigenous communities. However, certain steps are required to be taken to rectify the flaws of the Treaty which unfortunately have the potential to defeat the very purpose of the Treaty. Keywords: genetic resources, traditional knowledge, mandatory disclosure requirement, Indigenous communities.

CHAPTER 1:

INTRODUCTION

The historic Treaty on IP, Genetic Resources and Associated Traditional Knowledge was signed on 24th May 2024 at the WIPO Diplomatic Conference. This is the first WIPO Treaty to address the interface between intellectual property, genetic resources and traditional knowledge and the first WIPO Treaty to include provisions specifically for Indigenous Peoples as well as local communities. 1 This treaty has been negotiated for more than two decades and aims to provide more transparency in the IP Field concerning information about genetic resources and associated traditional knowledge. After two decades of negotiations and with collective support this treaty has been adopted at the multilateral fora, with a consensus among more than 150 countries. 2 This Treaty will come into force three months after fifteen eligible parties deposit their instruments of ratification or accession.

3 Currently, only 35 countries have disclosure related requirements for patents; the majority of which have either a weak enforcement mechanism or do not attract penal action, if violated against. In the wake of such inconsistency, developing countries, including India, have been advocating for a robust regime for protecting the intellectual property of indigenous communities. 4 CHAPTER 2: BRIEF TIMELINE: In 1999, developing countries requested the WIPO Standing Committee on the Law of Patents (SCP) to initiate discussions on intellectual property (IP), genetic resources (GRs), and traditional knowledge (TK). In response, the WIPO General Assembly established an intergovernmental committee (IGC) in 2000 as a temporary body to address IP issues related to GRs, TK, and traditional cultural expressions (TCEs). Initially, the IGC was intended as a forum for discussions.

However, in 2009, the WIPO General Assembly extended the IGC’s mandate to include text-based negotiations. Since then, this mandate has been renewed every two years by the General Assembly. Under the mandate, the IGC focused on three distinct texts 1 WIPO member states adopt historic new treaty on intellectual property, Genetic Resources and associated traditional knowledge (2024) WIPO. Available at: https://www. wipo. int/pressroom/en/articles/2024/article_0007. html (Accessed: 21 September 2024).

2 ‘WIPO Treaty, a big win for India and Global South’ (2024). Available at:

https://pib. gov. in/PressReleaseIframePage. aspx? PRID=2021716 (Accessed: 21 September 2024). 3 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 17 “Entry into Force”, May 24, 2024, at 9. 4 Pandey, S. (2024) ‘WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge: A Step Forward, Miles to Go’, NLR Blog, by NLIU Law Review, 20 August. Available at: https://nliulawreview. nliu. ac. in/blog/kitco-and-beyond-evaluating-the-test-of-other-authorities-under-article-12/ (Accessed: 21 September 2024). concerning GRs, TK, and TCEs. Of these, the negotiations on GRs have been successfully concluded with the adoption of a treaty during the recent WIPO Diplomatic Conference.

5 CHAPTER 3: THE TREATY ON IP, GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE: The Treaty aims to improve the transparency and quality of the patent system concerning claimed inventions based on genetic resources and traditional knowledge associated with genetic resources. The treaty may be entered upon by Any State or Inter-governmental Organisation6 through ratification or accession. 7 There is no compulsion on any State to be a party to this Treaty. This Treaty does not allow any reservation clauses like other Treaties. 8

(3.1.)

OBJECTIVES

The objective of this Treaty is to promote the efficacy, transparency and quality of the Patent system in the context of genetic resources (GR) and traditional knowledge associated with GR9. The cornerstone of this Treaty is the disclosure requirement (i.e.) patent applications that involve genetic resources and traditional knowledge associated with GR should disclose their source to prevent protection being granted to applications that lack the element of novelty. If the patents are highly based on traditional knowledge and genetic resources that are already known to everyone or a particular community, the patent will not satisfy the basic requirement of “novelty” and therefore, should be rejected. This Treaty promotes transparency in this aspect and prevents patents from being given to inventions that are not entirely original and an outcome of the Applicant’s ingenuity.10

5 Syam, N and Correa, C.M., Understanding the New WIPO Treaty on Intellectual Property, Genetic

Resources and Associated Traditional Knowledge, page 2, 3rd July 2024, https://www. southcentre. int/wpcontent/uploads/2024/07/PB131_Understanding-the-New-WIPO-Treaty-on-Intellectual-Property-Genetic- Resources-and-Associated-Traditional-Knowledge_EN. pdf (accessed on 16. 08. 2024 at 11:30 hours). 6 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 12 “Eligibility to Become a Party”, May 24, 2024, at 8. 7 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 13 “Ratification and Accession”, May 24, 2024, at 8. 8 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 20 “Reservations”, May 24, 2024, at 10. 9 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 1(a), May 24, 2024, at 2.

10 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 1(b), May 24, 2024, at 2.

The objective of this Treaty is to also comply with other international instruments related to genetic resources and traditional knowledge associated with GR. 11 The Parties to the Treaty have also agreed that the Intellectual Property System is pivotal in promoting innovation, transfer and dissemination of knowledge and economic development to the mutual advantage of providers and users of GR and Traditional Knowledge associated with GR. 12 (3. 2. ) SALIENT FEATURES: (3. 2. 1) DEFINITION CLAUSE: Article 213 of the Treaty serves as the definition clause.

Two important definitions are (i) “Sources of genetic resources” – refers to any source from which the applicant has obtained the genetic resources, such as a research centre, gene bank, Indigenous Peoples and local communities the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depositary of genetic resources. (ii) “Sources of traditional knowledge associated with genetic resources”- means any sources from which the applicant has obtained the traditional knowledge associated with genetic resources such as scientific literature, publicly accessible databases, patent applications and patent publications. (3. 2. 2) DISCLOSURE REQUIREMENT: This Treaty requires the Applicant to disclose, in his patent application, the country of origin of the genetic resources14.

If the genetic resources were obtained from more than one country, the Applicant shall disclose the country from which the genetic resources were obtained. 15 If 11 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, May 24, 2024, at 2.

12 Ibid.

13 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 2, May 24, 2024, at 3. 14 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 3 ”Disclosure Requirement”, May 24, 2024, at 4. 15 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Footnote 2, May 24, 2024, at 4. the country of origin is unknown to the Applicant, he should disclose the source of genetic resources16. The possible sources are mentioned in the definition clause under Article 2. Secondly, if the claimed invention is based on traditional knowledge associated with genetic resources, the Applicant should disclose the Indigenous Peoples or the local community who provided it.

17 For the mandatory disclosure to apply, the invention should be based on the genetic resources or traditional knowledge associated with genetic resources. Article 3 also provides a remedy if in case the information required under Articles 3. 1 and 3. 2 is not known to the Applicant. He is required to make a declaration stating the same. 18 The disclosure requirement under Article 3 prevents patent protection from being given to claimed inventions that are hugely based on genetic resources and traditional knowledge associated with GR and as a result, are not novel or inventive. The Applicants cannot unduly benefit from the knowledge of the Traditional Community or other local communities. This measure will also prevent biopiracy as the rightful owners are duly given credit. This also reduces the burden on the Patent offices to verify the legitimacy of the application.

However, this rule does not apply to patent applications that have been filed before the enforcement of this Treaty. 19 (3. 2. 3) SANCTIONS AND REMEDIES20: The treaty has delegated to the Contracting Parties to formulate appropriate, effective and proportionate legal, administrative and/ or policy measures to address a failure to provide the information required in Article 3 of the Treaty. However, non-disclosure cannot be the sole basis to revoke, invalidate or render unenforceable the conferred patent rights. The Applicants are to be provided with an opportunity to rectify before imposing sanctions unless there is fraudulent conduct or intent.

16 Ibid, Article 3.1 (b).

17 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 3.2(a), May 24, 2024, at 4. 18 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 3.3, May 24, 2024, at 4. 19 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 4 “Non-Retroactivity”, May 24, 2024, at 4. 20 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 5 “Sanctions and Remedies”, May 24, 2024, at 5.

(3.2.4) INFORMATION SYSTEMS:

Article 621 of the Treaty provides for the establishment of Information Systems or databases. It states that the Contracting Parties may introduce databases of genetic resources and traditional knowledge associated with genetic resources after consulting with the Contracting Parties. It is not compulsory but recommended. (3. 2. 5) RELATIONSHIP WITH OTHER INTERNATIONAL AGREEMENTS: This treaty aims to be enforced along with other international agreements relevant to this Treaty. 22 However, nothing in this treaty will modify or amend the provisions of any other treaty. 23 CHAPTER 4: BENEFITS: Firstly, by introducing mandatory disclosure of the origin/ source of genetic resources and traditional knowledge associated with genetic resources, the Treaty prevents the Applicants from unduly benefitting from the knowledge of the Local and Indigenous Communities and plausible biopiracy.

It has led to the fair and equitable sharing of benefits. The treaty aligns with international frameworks, such as the Nagoya Protocol under the Convention on Biological Diversity (CBD), which sets global rules for access and benefitsharing (ABS) of genetic resources. The disclosure requirement ensures that patent applicants comply with access agreements and benefit-sharing obligations that arise under these international agreements. CHAPTER 5: CRITICISMS: Primarily, this Treaty provides for only disclosing or making the process of patenting claimed inventions based on GR and TK associated with GR more transparent but does not take measures to prevent Biopiracy. 21 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 6 “Information Systems”, May 24, 2024, at 5.

22 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Article 7 “Relationship with other International Agreements”, May 24, 2024, at 6. 23 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, Footnote 5, May 24, 2024, at 6.

Secondly, under Article 3. 3 of the Treaty, if applicants are unaware of the sources required for disclosure under Articles 3. 1 and 3. 2, they are only required to submit a declaration stating this lack of knowledge. This provision appears insufficient and may offer a way for applicants to bypass or dodge the mandatory disclosure requirements. Thirdly, the wording of this article is vague, allowing for a high degree of subjectivity24. The Treaty grants contracting parties the flexibility to establish national laws in line with its provisions. However, due to the unclear and lenient language of the Treaty, countries might interpret and implement these laws differently.

For instance: Ø The USA, which is not a signatory to the Convention on Biological Diversity (CBD), might adopt pro-innovation policies that favour inventors and companies, potentially resulting in weaker disclosure requirements. Ø In contrast, India, with its strong protections for genetic resources and traditional knowledge, could impose much stricter disclosure rules to safeguard indigenous communities. Fourthly, it is not mandatory for any State or a Member State of WIPO to sign this Treaty. In addition to this, there are no enforcement mechanisms which might lead to not achieving the objectives effectively. Fifthly, this Treaty applies only to claimed inventions that are directly based on genetic resources and traditional knowledge based on genetic resources. If they do not form a substantial part of the invention, it does not apply to them.

In such scenarios, inventions which use genetic resources and traditional knowledge but do not meet the degree as required by the Treaty, escape the mandatory disclosure. Countries use a variety of formulations in their domestic disclosure requirements on this matter. A common formulation is “use” or “utilization” of GRs or TK associated to GRs. The Basic Proposal suggests the term “based on” with the qualifiers “materially” or “directly”. In the light 24 Pandey, S. (2024) ‘WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge: A Step Forward, Miles to Go’, NLR Blog, by NLIU Law Review, 20 August. Available at: https://nliulawreview. nliu. ac. in/blog/kitco-and-beyond-evaluating-the-test-of-other-authorities-under-article-12/ (Accessed: 21 September 2024).

of the accompanying definition provided for in the Basic Proposal, the addition of qualifiers to “based on” will narrow the trigger for when the disclosure requirement is applicable. 25 Sixthly, this Treaty does not act retrospectively. Therefore, justice is not found for the communities whose traditional knowledge was misappropriated. Lastly, it is not required for patents using Digital Sequence Information (DSI) from GRs should have transparency about the origin. Since most patents based on genetic resources actually rely on DSI rather than the actual physical resources, neither the country nor the source needs to be divulged. However, the Member Countries are at liberty to mandate disclosure for claimed inventions based on DSI. 26 Another suggestion is that WIPO could work towards establishing an International database for Traditional Knowledge. 27

CHAPTER 6:

CONCLUSION

This Treaty is certainly a step towards promoting a more transparent and fair patenting process. It has taken a historic step towards protecting the traditional and local communities and preventing claimed inventions based on genetic resources and associated traditional knowledge which lacks the novelty and inventiveness of the Applicant. However, certain provisions of the Treaty, especially Article 3 that provides for Disclosure Requirement is constructed in an ambiguous way and has indirectly provided the member countries a way to dodge by claiming ignorance regarding the sources of the genetic resources and traditional knowledge which defeats the entire purpose of the Treaty. If this Treaty amends the provisions that provides loopholes to the Member States, this will be a very successful and historic Treaty. 25Tellez, V. M.

(2024) The WIPO Diplomatic Conference for a Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, South Center. Available at: https://www. southcentre. int/policy-brief-129-7-may-2024/ (Accessed: 16 August 2024).

26 TWN Info Service on Intellectual Property Issues (2024) Third World Network, Available at:

https://twn.my/title2/intellectual_property/info.service/2024/ip240506.htm (Accessed: 21 September 2024). 27 India’s opening statement to the WIPO Conference, Available at: chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_42/wipo _grtkf_ic_42_statement_india.pdf (Accessed on 21 September 2024 at 21:40 hours).

REFERENCES

PRIMARY:

1. WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional

Knowledge.

2. The Nagoya Protocol on Access and Benefit-sharing

3 Ministry of Trade and Commerce Press Release

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2021716 4. India’s opening statement in the WIPO Conference, Available at: chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.wipo.int/edocs/mdocs/tk/ en/wipo_grtkf_ic_42/wipo_grtkf_ic_42_statement_india.pdf (Accessed on September 2024 at 21:40 hours). SECONDARY: 5. NLR Blog, by NLIU Law Review, https://nliulawreview.nliu.ac.in/blog/kitco-andbeyond-evaluating-the-test-of-other-authorities-under-article-12/

6. World Intellectual Property Rights https://www.wipo.int/portal/en/index.html

7. Third World Network.

https://twn.my/title2/intellectual_property/info.service/2024/ip240506.htm

8. South Center, Policy Briefs. https://www.southcentre.int/