WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge: Analysis of the Mandatory Disclosure Requirement

WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge:

Analysis of the Mandatory Disclosure Requirement

INTRODUCTION

"Success is the sum of small efforts, repeated day in and day out."

—Robert Collier

This quote by Robert Collier reminds us of the importance of every small effort that leads us to success. Similarly, the adoption of the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge is the outcome of continuous efforts made by developing nations, Indigenous communities, and international organizations to regulate the exploitation of traditional heritage in favour of these Indigenous communities. This treaty, however, does not provide any right to the Indigenous people but provides defensive protection by mandating a “disclosure requirement” in patent applications which will protect against obtaining IP rights for TK, further facilitate the ABS (Access and Benefit Sharing), and help to make an international TK database.

Key Definitions:

1) Disclosure Requirement:

As per Article 3 of the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge, under the mandatory disclosure requirement; the applicant of the patent application shall disclose the country of origin of the GRs and Associated TK, and if the country of origin is not known then the source of the GRs.

In case the applicant does not know either of the two things mentioned above, the applicant shall make a declaration regarding the authenticity and truthfulness of the content mentioned in the application as per the guidance of the contracting party.

2) Defensive protection:

Defensive protection is the protection against obtaining intellectual property rights over the traditional heritage of indigenous communities (WIPO, 2015). It can be done in multiple ways such as by forming a database, enacting legislation, and the current disclosure requirement is also a kind of defensive protection. The Traditional Knowledge Digital Library (TKDL) is the Indian medicinal database available in multiple languages and has worked as defensive protection multiple times in the US and Europe since its formation.

3) Access and Benefit Sharing:

The Convention on Biological Diversity defines Access and Benefit Sharing (ABS) as the way by which the Genetic Resources and Associated TK can be accessed and the way of sharing the benefit obtained from the exploitation of these GRs and associated TK (Secretariat of the Convention on Biological Diversity, 2010).

Background:

As mentioned in the definitions above, under the mandatory disclosure requirement, the applicant must disclose the origin of Genetic Resources and Associated TK. The root of this outcome lies in the Elements of The Obligation to Disclose the Source and Country of Origin of the Biological Resources and/or Traditional Knowledge used in an Invention proposal by Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand, and Venezuela (Centre for WTO Studies, 2004). This proposal endorsed the inclusion of a “mandatory disclosure requirement” for the patent application under the TRIPS Agreement. The patenting of the Turmeric plant, neem plant, hoodia plant, etc. highlights the need for disclosure requirements as patent opposition is a costly and time-consuming process (Centre for WTO Studies, 2004). Developing and poor nations cannot afford to go for patent opposition again and again (Centre for WTO Studies, 2004). This provision of the disclosure requirement is going to be a relief for them in terms of time and resources. However, despite these applications, the disclosure requirement is not sufficient to address the issue of the rights of indigenous communities. It is more associated with the strengthening of the patent system at the domestic and international stages than addressing the issues of indigenous communities and their TK.

Research Outline:

This paper is divided into three chapters which will discuss the following key points:

Ø Chapter 1 will discuss the need and importance of the mandatory disclosure requirement.

Ø Chapter 2 will highlight the key issue with the mandatory disclosure clause under the treaty.

Ø Chapter 3 will discuss the author’s insight and the way ahead.

LITERATURE REVIEW

Chapter 1: Need and Importance of Mandatory Disclosure Requirement:

The disclosure requirement under the treaty is a medium to provide defensive protection against the unauthorized exploitation of GRs and associated TK. It stops anyone from claiming IP rights on the GRs of indigenous communities. The following points highlight the need and importance of the mandatory disclosure requirement:

1) Prevention of misappropriation of GRs and associated TK:

The developing nations that own most of the GRs and associated TK see the disclosure requirement as a method of preventing their misappropriation (Rules, 2014). It will eliminate the possibility of cases such as patenting of neem plants in future.

2) Ensuring benefit sharing:

The WIPO treaty on GRs and associated TK in collaboration with the Convention on Biological Diversity and Nagoya Protocol will ensure fair and equitable benefit sharing. The disclosure requirement will disclose where the GRs and/or associated TK hails from. This way the benefit sharing can be dealt with as per the domestic legislation of the respective country (Rules, 2014). In the case of India, the National Biodiversity Authority and the State Biodiversity Boards will ensure fair and equitable benefit sharing with the local communities.

3) Enhance transparency:

It will enhance transparency as it will bar the granting of patents to genetic resources and associated TK. It will disclose the prior art on which the invention is based. Additionally, multiple countries do not have a well-established patent examination system (Rules, 2014). Hence, this disclosure requirement will save their resources and provide the prior information on which the invention is based.

4) Saves time and resources used for patent opposition:

Patents or patent applications based on the TK or GRs require resources and time for opposition and revocation (Centre for WTO Studies, 2004). Most of the developing countries do not have the facility to keep to record of the patented TK and resources to get patents revoked (Rules, 2014). Additionally, it is a time-consuming process. For instance, the patent on the neem plant was granted by EPO in 1994 and opposition was filed in 1995. Finally, the patent was revoked in the year 2000.

5) Strengthening patent system:

Article 3 of the treaty is all about the disclosure of the origin of the GRs and associated TK in the patent applications. Hence, by disclosing the prior art it strengthens the patent examination system. It will help in the verification of the claims mentioned in the patent application.

6) GR and associated TK database:

The disclosure of the origin in the patent application will help from a database of the GRs and associated TK which can further help for future references. The importance of databases can be analysed from the example of the Traditional Knowledge Digital Library (TKDL) database of Indian traditional medicines which has been used to tackle over 300 cases of patent based on TK (CSIR, n.d.).

7) Defensive protection:

As mentioned throughout the paper, the disclosure requirement is a kind of defensive protection to prohibit people from obtaining patents over the GRs and associated TK. It does not allow people to obtain patents or any kind of intellectual property rights over the GRs and associated TK.

Chapter 2: Key issues with and limitations of the mandatory disclosure provisions:

While the mandatory disclosure requirement brings perks as mentioned above, it has its limitations as well which are as follows:

1) No positive protection:

Although it prevents others from obtaining patents over GRs and associated TK, it does not imply that it confers rights to the indigenous communities. This leaves the heritage in the public domain open to be exploited by anyone without any legal implications. The Indigenous communities that nurtured and carried forward the legacy for several generations, do not get recognition or IP rights over it.

2) No obligation on offices to verify the authenticity of the disclosure:

Article 3.5 of the WIPO Treaty says that there should be no obligation on the IP offices to ensure the credibility or genuineness of the disclosure. This clause can create a state of conundrum as it would be difficult to decide on the matter of wrongful disclosure. If any office is not willing to verify the authenticity, who will decide if the disclosure is wrongful or not? This implies that there is legal uncertainty in the provisions of the treaty. The disclosure requirement will not work in the way it should if its authenticity is not verified.

3) Limited to GRs, associated TK and patents:

As the name suggests, the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge is limited to Genetic Resources and Associated Traditional Knowledge. Traditional knowledge has a vast scope. Mere protection of GRs and associated Tk would not resolve the issue. Additionally, the treaty is all about patents. What about the trademark, copyright and other kinds of IP protection? What about the folklore and other kinds of TK which is not ever recognized as intellectual property globally?

4) More focused on strengthening the patent system than the protection of TK:

The name of the treaty indicates that the treaty is about the protection of GRs and associated TK. However, the provisions are more about strengthening the patent system. It would facilitate the patent examination procedure and prior art search and would help in deciding the novelty and inventive step of the invention.

Chapter 3: Author’s Point of View and the Way Ahead:

Chapter 1 and Chapter 2 describe the pros and cons of the mandatory disclosure requirement of the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge. The demand for the disclosure requirement was put forward in 2004 under the Elements of The Obligation to Disclose the Source and Country of Origin of the Biological Resources and/or Traditional Knowledge Used in an Invention proposal and it took 20 years to get that demand fulfilled. Various treaties were enacted and adopted during this period but the disclosure requirement was never considered. Examples include the Nagoya Protocol and the Convention on Biological Diversity. This indicates the reluctance of the industrialized nations to move forward in this field as it will harm their economic interests.

Even after the adoption of this disclosure requirement, there is still legal uncertainty and ambiguity in the provisions of the treaty. It left a loophole in not making it obligatory to verify the authenticity of the disclosure of origin. The limited scope, inherent ambiguity in the provisions, and the reluctance of industrialized nations are such roadblocks that need to be addressed to move forward in this field. The following are the things that can be done to overcome the loopholes in the disclosure requirement:

v Need for a treaty with the purpose solely to protect the TK and only facilitate the patent examination procedure.

v Verification of disclosure must be obligatory for proper implementation of the disclosure requirement.

v There should be no ambiguity in the language of the treaty to avoid the possibility of loopholes.

v Disclosure requirement should be extended to the TK (Lato Sensu) and not just the GRs and associated TK.

v Instead of a separate treaty, the amendment in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity, and Convention on Biological Diversity for incorporation of the disclosure requirement would be more effective and would ensure faster implementation of this provision.

REFERENCE NOTES

Centre for WTO Studies. (2004, September 27). Elements of The Obligation to Disclose the Source and Country of Origin of the Biological Resources and/or Traditional Knowledge Used in an Invention. https://wtocentre.iift.ac.in/Folder/IP-C-W429.doc.

Council of Scientific & Industrial Research. (n.d.). Traditional Knowledge Digital Library (TKDL). Government of India. https://www.csir.res.in/tkdl.

CSIR. (n.d.). Traditional Knowledge Digital Library Unit (TKDL). https://www.csir.res.in/documents/tkdl

Rules, S. (2014). The Convention on Biological Diversity and the Nagoya Protocol: Intellectual Property Implications.

Secretariat of the Convention on Biological Diversity. (2010). Introduction to access and benefit-sharing. https://www.cbd.int/abs/infokit/brochure-en.pdf.

United Nations. (1992). Convention on Biological Diversity. Retrieved from https://www.cbd.int.

United Nations. (2010). Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity. Retrieved from https://www.cbd.int/abs.

WIPO. (2015). Traditional Knowledge and Intellectual Property. https://www.wipo.int/edocs/pubdocs/en/wipo_pub_tk_1.pdf#:~:text=Defensive%20protection%20aims%20to%20stop%20people%20outside%20the,from%20acquiring%20intellectual%20property%20rights%20over%20traditional%20knowledge.

WIPO. (2024, May 24). WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge. https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.

LIST OF ABBREVIATIONS

v CBD: Convention on Biological Diversity

v GRs: Genetic Resources

v TK: Traditional Knowledge

v TKDL: Traditional Knowledge Digital Library

v WIPO: World Intellectual Property Organization