Navigating TKDL Guidelines, Indian Patents Act, NBA, and Examination Approach

Traditional knowledge encompasses a diverse range of cultural and scientific insights, spanning songs, stories, folklore, rituals, and indigenous languages, alongside expertise in medicinal properties, agriculture, forestry, fisheries, healthcare, and environmental management. Given India's rich tapestry of traditional knowledge, it is important to safeguard this heritage from monopolization, preserving centuries-old wisdom for future generations.

TKDL, an acronym for the Traditional Knowledge Digital Library, represents a pivotal initiative by the Government of India aimed at safeguarding traditional knowledge from exploitation through patenting abroad. Traditional knowledge, passed down through generations within communities, is the cornerstone of TKDL's mission. Focused on Ayurveda, Unani, Siddha, and Yoga, TKDL systematically documents various facets of traditional knowledge, including formulations, medicinal plants, and treatment methodologies. This comprehensive documentation is housed within a digital library accessible to patent examiners worldwide. By providing access to this repository, TKDL facilitates rigorous prior art searches, enabling examiners to prevent the granting of patents on traditional knowledge.

Considering the legal landscape in patent prosecution within the framework of TKDL, it is essential to underscore the protective mechanisms established by both the Indian Patents Act of 1970 and the National Biodiversity Act to safeguard traditional knowledge. Provisions within the Indian Patents Act, including Section 2(1)(ja) and Section 3(e), delineate subject matter ineligible for patent protection. Notably, Section 3(p) expressly precludes inventions characterized as traditional knowledge or derivative aggregations of known properties from patentability. Moreover, the Controller General of Patents, Designs, and Trade Marks (CGPDTM) has issued TKDL guidelines, articulating six guiding principles for assessing the patentability of claims associated with traditional knowledge. These measures collectively reinforce the protection of traditional knowledge and mitigate the risk of its misappropriation through patenting.

1.?????? Principle 1 stipulates that claims related to the extraction or isolation of active ingredients from plants, where the use of such plants is already documented in Traditional Knowledge, lack novelty and inventiveness.

2.?????? Principle 2 elucidates that combining plants with known therapeutic effects for treating the same disease is deemed obvious if all plants involved are previously recognized for their medicinal properties.

3.?????? Principle 3 establishes a presumption of obviousness when a known active ingredient is already acknowledged for treating a specific disease, suggesting that a combination product containing this ingredient for the same purpose lacks inventive merit.

4.?????? Principle 4 clarifies that determining the optimum or workable ranges of traditionally known ingredients through routine experimentation does not qualify as inventive. Additionally, it underscores that isolating a single component from multiple ingredients known for the same therapeutic activity is not inventive.

5.?????? Principle 5 states that when multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, then simply eliminating one component will not be considered as inventive.

6.?????? Lastly, Principle 6 asserts that combining known ingredients from Traditional Knowledge for treating a disease would logically result in a more effective product compared to individual application, based on the additive effect of their therapeutic properties.

The National Biodiversity Authority (NBA) of India has issued guidance regarding the notification issued on 26th October 2009, clarifying that commodities listed therein fall under the purview of the Biological Diversity Act when employed as medicinal ingredients, irrespective of their trade classification. Controllers/Examiners within the Office of CGPDTM are directed to diligently abide by this directive, obtaining NBA approval for any Indian-derived biological resources utilized in patent applications. Consequently, applicants utilizing such resources must file Form III with the NBA to secure either approval or a No Objection Certificate (NOC).

In addition to the examiners of patents worldwide, the Patent attorneys should consider TKDL while drafting patent applications, particularly concerning novelty-related issues. It is crucial for attorneys to conduct thorough searches within the TKDL database to ascertain whether the proposed invention incorporates elements of traditional knowledge. If traditional knowledge is identified, attorneys must carefully evaluate whether the invention meets the criteria for patentability as outlined in the Indian Patents Act and the TKDL guidelines. This proactive approach can help prevent potential conflicts during the patent prosecution process and ensure that the patent application aligns with the legal requirements, ultimately enhancing the likelihood of successful patent grant.

Mokshada Joshi, Patent Attorney