Prelude

Traditional forms of intellectual property rights exist for a variety of creative and inventive items and processes that indigenous people, local communities, and governments want protected. These consist of inherited traits, customary wisdom, and cultural manifestations. The entirety of a community's knowledge and customs related to its economy, culture, and religion are referred to as these traditional forms of assets. They are regarded as belonging to the community as a whole and do not specifically belong to any one person.

For instance, a customary medical treatment, a folk song from the native people, or any creation made using genetic resources. Traditional knowledge includes things like marks, symbols, design, science, medicine, and literacy based on customs. Examples of traditional knowledge include the identification of therapeutic qualities of plants, the use of particular plants therein, and harvesting techniques. In order to achieve sustainable development, traditional knowledge—particularly that which is connected to biodiversity and genetic resources (GRs)—is also regarded as crucial. This information is passed down from generation to generation.

The Convention on Biological Diversity (CBD) defines genetic resources as components of biological materials that have valuable genetic information and are able to reproduce or be reproduced. For instance: materials originating from plants, animals, or microorganisms, including agricultural products, animal breeds, and medicinal herbs.

The United Nations Declaration on the Rights of Indigenous Peoples is the primary international agreement that safeguards these intellectual property rights. According to this Declaration, indigenous people are entitled to the exercise of their rights without facing discrimination of any type, including that based on their identity or place of origin. Indigenous people also have the right to preserve, manage, safeguard, and expand their intellectual property related to traditional knowledge, cultural expressions, and cultural heritage, according to Article 31 of this Declaration. There have been ongoing discussions in the international arena over the ownership, carriers, and custodians of these intellectual property assets, but protecting these types of IP is vital for a number of reasons.

SIGNIFICANCE

In addition to preserving their cultural vibrancy, traditional knowledge is deeply ingrained in many nations throughout the world and is essential to their well-being and sustainable growth.

According to the World Health Organization, 80% of the world's population receives their primary medical treatment from traditional medicine, and traditional knowledge is essential to their survival.

Vital to the preservation of the genetic resources needed for the community's ongoing survival. The locals have embraced the traditional wisdom to preserve and make use of the ecological richness in their environment.

Both the preservation of intellectual variety and biodiversity depend on acknowledging the inventiveness of traditional cultures.

Protecting traditional knowledge, traditional culture expression and genetic resources

To safeguard intellectual property, one must acknowledge and use one's exclusive rights to prevent others from performing specific actions. Non-proprietary kinds of protection such as moral rights, fair compensation plans, and anti-unfair competition can also be included in IP protection.

National laws vary, particularly when it comes to patenting, despite numerous international accords aimed at balancing intellectual property protection.

The United States of America expanded the scope of patent protection to include genetically modified organisms, a move that is opposed by many other nations. Furthermore, the requirements for disclosing information about this invention vary throughout nations.

A major topic of discussion in the field of intellectual property protection, particularly with regard to how much TRIPS harmonizes and broadens the law, is these variations in how different countries apply the law.

Human rights protection of traditional knowledge

Using intellectual property techniques, traditional knowledge has been protected by two protective paradigms.

The original legal framework that guards against unauthorized exploitation of intellectual property rights pertaining to traditional knowledge.

To stop alleged abuses like bio piracy, for instance, databases containing traditional knowledge are being created to provide proof that traditional knowledge is prior art.

These databases aid in the safeguarding of traditional knowledge rights since such knowledge is disclosed to the public and so offers some degree of protection. To control the usage of TK, several societies have enacted their own laws.

The second protective paradigm—often referred to as "positive protection"—is attained through the enactment of new sui generis laws through legislation or by utilizing the current legal framework.

Some have contended that granting these groups eternal rights may provide constitutional challenges for some nations, such as the United States.

Many other nations use already-existing legislation, such as the Environmental Management Act and other TK-related measures, to conserve traditional knowledge.

Many nations, meantime, remain unsure and have maintained that, in order to preserve their unique identities, religious and cultural heritage, the type of protection should refer to collective human rights.

Objectives of the Treaty

The Treaty's goals are as follows:

Improve the patent system's effectiveness, clarity, and quality with regard to genetic resources and related conventional knowledge.

Stop the granting of patents for innovations that, in relation to these resources and knowledge, are not truly novel or inventive.

Disclosure Requirement under the Treaty

According to the Treaty, the following disclosure obligations must be met:

The nation of origin of any genetic resources or traditional knowledge used in an invention must be disclosed by patent applicants. If it is traditional information, they also have to reveal the identity of the local community or indigenous people who possess it.

The applicant must make a declaration if they are unsure of the source.

Sanctions and Remedies

Every nation needs to have procedures in place to deal with disclosure errors by using a correction method.

Except in cases where fraud is proven, in which case post-grant sanctions might be applied, applicants must be given the opportunity to make corrections.

A patent cannot be revoked or declared invalid due to nondisclosure.

Information Systems

In order to assist patent offices in verifying information, nations can establish databases containing genetic resources and traditional knowledge.

Conditions and authorization may apply to access to these information systems.

Implementation and Review

Every four years, the treaty must be reviewed to make sure it is still applicable and effective.

The Treaty may be implemented by member states in accordance with their own national legal frameworks.

Relationship with Other Agreements

The pact will cooperate with existing global accords pertaining to traditional knowledge and genetic resources.

Participation

The treaty is open for adoption by any WIPO member state.

Both local communities and Indigenous Peoples are encouraged to participate by the treaty.

Read Treaty: https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf

Ground-breaking or Toothless Tiger?

On May 24, 2024, WIPO finally adopted a Treaty on Intellectual Property (IP), Genetic Resources (GR), and Associated Traditional Knowledge (TK), marking 25 years after Colombia first raised the topic of protecting the IP rights of indigenous communities and 14 years since the Text-based discussions on the accord began. The Treaty was adopted at the just concluded Diplomatic Conference on Genetic Resources and Associated Traditional Knowledge, 2024. It is the result of regular negotiations conducted by the WIPO's special body, the Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore (IGC), to develop a tool to safeguard indigenous peoples' rights regarding GR and related TK through an IP framework.

The upshot of years of intense discussions, as is clear, is the Treaty. If you've been out of the loop on this issue, the Treaty is the first global agreement that requires disclosure for inventions that use traditional knowledge and genetic resources. Considering this, it makes sense that there appears to be a lot of joy about the Treaty's final text being decided. The devil is in the details, as is often the case, though.

In this instance, despite the overall jubilant feelings around the Treaty, there are some aspects that warrant worry, such as the requirement for signing nations to consent to waive certain patent quality standards that are already required by nations like India! Prior to delving into that, let us first take a moment to review the goals of the Treaty.

Mandatory  Disclosure of Source/ Origin of GK and Associated TK

The Treaty requires the source of the GR or related TK to be disclosed on two fronts:

1) The applicant must reveal the nation of the GR when a claimed invention is based on one.

2) If it is based on a related traditional knowledge, it must identify the native people or local group that provided the related traditional knowledge.

The Treaty offers the applicant some leeway by stating that, in the event that neither of these sources is available, the applicant may provide any source of GRs or related TKs from which they have acquired the necessary information or resource (Art. 3.1(b) and 3.2(b) r/w Art. 2). Additionally, the applicant may make a declaration claiming that even this information is not available, coupled with an assurance that the information in the declaration is genuine and accurate to the "best knowledge" of the applicant.

Does this cover the majority of inventions based on synthetic biology, which are anticipated to occur in the upcoming decades? It's unclear. The Treaty requires the Contracting Parties to give applicants guidance on how to comply with the disclosure requirement and to give them the chance to correct any inaccurate or erroneous disclosures. This three-tier approach to the disclosure requirement is in addition to these requirements.

Why Do We Need a System of Mandatory Disclosure of GRs and Associated TK?

Patents are awarded as a result of a social contract that allows the inventor to benefit from exclusivity over their idea in exchange for having to reveal the most effective way to use it. Because these inventions are made using culturally sensitive materials, there is an additional duty to indigenous groups in the framework of GR and related TKs, in addition to the wider public.

Mandatory disclosure requirements are important to prevent the theft of genetic resources (GR) and related traditional knowledge (TK) within the framework of the Convention on Biological Diversity. They contend that the requirement may help to strengthen substantive assessments and might help to spot instances in which access to these resources was obtained unfairly and without the required informed permission. These defenses also hold true in the current circumstance.

Provisions on Sanctions and Remedies

Given the reasoning above, the current disclosure requirement appears to be more of a formality for the patent offices. This comprehension is made more difficult when we consider both the responsibility and the list of penalties for failing to disclose the aforementioned information. According to the Treaty, a Contracting Party cannot withdraw a patent if the requirement to reveal this information is not met, with the exception of situations in which the applicant withheld the origin out of deceit (Article 5.3 r/w 5.4). This clause would necessitate a comprehensive revision of pertinent legislation in numerous nations, such as India, that enforce penalties for nondisclosure.

As per Article 3.5 of the Treaty, the Contracting Parties are not required to impose any requirement on their offices to verify the validity of the disclosure, but they are free to decide on post-grant sanctions or remedies if the application is discovered to be fraudulent. We are left wondering, however, how the office will ascertain whether or not the revelation was made with fraudulent purpose in light of this.

Don't sanctions and remedies apply to the remaining, making it ineffective?

What Does this Mean for India?

Should India decide to ratify, these clauses will force us to weaken some of our most important protections against invalid patents. The Patent Act currently allows for the filing of a pre-grant opposition to the failure to disclose the source of origin (Section 25(1)(j)) and the revocation of a granted patent for failing to disclose this information (Section 64 (1)(p)). These provisions would be invalid under Articles 3 and 5 of the current Treaty, which stipulate that an applicant may withhold disclosure of the source of origin if it is unaware of it and that a patent application may not be denied on the basis of such withholding, unless the withholding is fraudulent.

India may experience a spike in patent applications as a result of these regulations, particularly from applicants from nations with advanced synthetic biology and bioprospecting sectors. It is important to remember that this increase will come at the expense of eliminating vital safeguards against applications that lack merit. Expressing a reservation regarding these commitments, or announcing their non-applicability to India, would have been one way for India to escape the dilemma of refusing to accept them entirely. Regretfully, as Art. 20 of the treaties prohibits reservations, no contractual party may exercise this flexibility.

Issues with the Treaty

The argument for and against requiring mandatory disclosure is as old as Colombia's plan to safeguard its genetic and biological resources, if not older. A number of industrialized nations, including the United States, the European Union, and Japan, vehemently opposed the Colombian Proposal's proposal to impose a mandatory disclosure obligation. In other places such as the WTO, the US has persistently voiced its purported concerns over this criterion, claiming that it placed unnecessary additional burdens on the applicants.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) from Switzerland and other US-based associations, such as the American Intellectual Property Law Association (IPLA), made similar claims during the 2024 Diplomatic Conference. Despite the fact that those who supported the obligation were successful in getting it included in the Treaty, it appears that those who opposed it ultimately had the last laugh given how weak it is.

Similar to the foundational text, the Treaty's definition of "confidential information" (Article 3.6) is ambiguous, which could create positive ambiguity. The clause on "exception and limitations" that permitted parties to vary from their duties in the interest of the public good has been removed from the Treaty. These problems are urgent enough to warrant their own in-depth blogs discussing the ramifications.

Way Forward

Despite being dramatic, the treaty is really a procedural throat-clearing; there is still a lot of actual work to be done. This unexpected shock, which resulted from genuine anger with the IGC's sluggish progress over the years, has highlighted the intriguing prospect of successfully completing these protracted negotiations.

In addition to Europe (Germany, France, Belgium, Spain, Sweden, Italy, and Switzerland), over 30 countries have already enacted disclosure laws pertaining to genetic resources (and the traditional knowledge that is frequently associated with them).

Except in cases of fraudulent activity or purpose as specified by national legislation, the Contracting Parties to the Treaty shall establish measures in case of failure to supply the required information and shall afford applicants the chance to remedy any missing information. When there is fraudulent intent in connection to the Treaty's disclosure requirement, sanctions or post-grant remedies may be granted.

In accordance with their national circumstances, the Contracting Parties to the Treaty may also create databases of genetic resources and traditional knowledge related to them, after consulting, when appropriate, with Indigenous Peoples, local communities, and other interested parties.

Three months after the fifteen contracting parties submit their instruments of ratification or accession, the Treaty will come into effect. Applications for patents filed prior to the Treaty's implementation are not subject to any obligations under it.

Please feel free to reach out to one of our subject matter experts at info@effectualservices.com

to explore, how we can help you & make the world a better place to live in !!!

Effectual’s GENETIC RESOURCES & TRADITIONAL KNOWLEDGE RESEARCH FRAMEWORK is a deep dive into this ecosystem and shall help you understand the intricacies of this nascent innovative domain with insights backed with credible data sources. Some ways we can help include, but not limited to - Performing any previous art or freedom to operate searches to help you better grasp the environment surrounding your invention or business endeavors. If certain methods of IP protection are more appropriate for your technological or business goals, we can help you strategize effectively to plan for future & in making continuous innovation a part of your working model.