- within Coronavirus (COVID-19), Real Estate and Construction and Privacy topic(s)
- in India
Introduction
Before there were laboratories, research agencies, and patent offices, people in India used turmeric for wound healing, neem for infection treatment, and plant medicines to balance bodily functions. This practice did not originate in the modern concept of science but rather evolved from observation, experience, and memory.
However, since the last century, this traditional form of knowledge has been threatened by modern-day patent claims abroad. There was much more at stake than just technicalities when the patents for turmeric and neem were issued. Emotional, cultural, and economic considerations were linked because people believed that an aspect of their culture was being taken away.
This moment sparked a national awakening. India recognised that protecting traditional knowledge needed more than just moral arguments; it also required legal recognition within the patent system.
Traditional Knowledge and Its Legal Blind Spot
Traditional knowledge (TK) includes the know-how, skills, practices, and ideas developed by indigenous and local communities over many years. In India, TK is closely linked to daily life and cultural practices, such as in healthcare & agriculture. However, patent systems worldwide depend on certain legal criteria, which include primarily novelty, inventive step, and industrial use. According to Article 271 of the TRIPS Agreement, patents should only be granted for inventions that are new and involve an inventive step. If prior art exists, a patent should not be issued.
The problem lies not in the law, but in access to information. When traditional knowledge exists in ancient texts written in Sanskrit, Arabic, Persian, or Tamil and patent examiners cannot read these languages, the knowledge effectively deemed to disappear from prior art searches. What is ancient becomes legally “new”.
Biopiracy and the Failure of Reactive Legal Remedies
India’s early experiences with biopiracy showed the shortcomings of post-grant legal challenges. Challenging the turmeric and neem patents required extensive paperwork, expert testimony, translation of ancient texts, and years of court cases. Legally, this approach was not feasible and sustainable. In most patent systems, opposing or revoking a patent takes a lot of time and money and has unpredictable outcomes. For developing countries, getting involved in these fights repeatedly puts a huge strain on public resources. The need was clear; prevention was better than cure.
The Legal Foundation of the TKDL
The Traditional Knowledge Digital Library started in 2001 as a joint effort between the Council of Scientific and Industrial Research and the Department of Indian Systems of Medicine & Homoeopathy, now known as AYUSH. Its legal basis closely relates to Section 3(p) of the Indian Patents Act, 19702. This section clearly states that “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components” cannot be patented.
While Indian law rejects patents on traditional knowledge, foreign patent offices lacked the necessary evidence to apply similar rules. The TKDL was created to fill this gap. It did not aim to change international law but to support its proper application.
From Ancient Manuscripts to Prior Art Evidence
The true innovation of the TKDL is its methodology. Ancient medicinal texts were not just digitised, they were organised like patent documents. Each formulation is classified, indexed, and translated into languages widely used in patent examination, including English, French, German, Japanese, and Spanish.
Today, the TKDL contains over 34 million pages of formatted data that cover about 2.26 million medicinal formulations. This change ensures that traditional knowledge counts as documented prior art, thereby meeting the proof requirements of patent offices worldwide.
A significant legal-technical step introduced by India is the Traditional Knowledge Digital Library (TKDL), also known as the Traditional Knowledge Resource Classification (TKRC). Based on the International Patent Classification (IPC) system run by the World Intellectual Property Organisation, the TKRC offers nearly 27,000 subgroups specifically for traditional medicine.
Before this change, the IPC had only one subgroup for medicinal plants, which severely hindered effective patent searches. India’s action led to the establishment of a multilateral task force and, eventually, the growth of IPC subgroups related to traditional medicine from one to over 200.
This reform shows a structural recognition that traditional knowledge is not marginal; it is a valid technological area that deserves clear legal classification.
The TKDL operates under carefully designed Access Agreements with patent offices, including the European Patent Office and the United States Patent and Trademark Office. These agreements have incorporated strict confidentiality rules, ensuring that TKDL content is used only for search and examination purposes and no more.
This controlled-access model takes a careful legal balance. It prevents misuse and public disclosure that may lead to commercial exploitation, while promoting Indian culture and Ayurveda.
Pre-Grant Opposition: A Strategic Legal Advantage
Most patent laws allow third-party submissions during the examination stage. For instance, under European Patent Law, Article-115 of the European Patent Convention permits third-party comments on patentability. The TKDL allows India to make such remarks before granting patents based on substantial evidence from prior art. This strategy significantly reduces the risk of costly legal disputes and prevents an appeal by the applicants. On the other hand, the period for filing oppositions post-grant may extend up to ten years, whereas objections pre-grant may be disposed of within a few weeks.
The Global Biopiracy Watch Mechanism
India has strengthened protection by integrating a global patent monitoring system with the Traditional Knowledge Digital Library (TKDL). This system tracks patent applications related to Indian medicinal systems across different regions, which allow for timely legal action.
From a regulatory perspective, this marks a shift from passive defence to active monitoring, a strategy that few states use in intellectual property. Data from Europe shows that the TKDL has a deterrent effect. Due to such efforts and measures, 100 of patent applications have been withdrawn, changed, or rejected after objections based on the TKDL. Furthermore, studies reveal a significant decline in new patent filings. This trend not only indicates effective enforcement but also a shift among applicants, which is the best sign of regulatory success.
Despite these successes, there is still no comprehensive international legal framework for protecting traditional knowledge. Talks are ongoing under the Convention on Biological Diversity and the TRIPS Council of the World Trade Organisation. Within WIPO, negotiations under the Intergovernmental Committee on Intellectual Property and Genetic Resources seek to create a legally binding instrument. Although reaching an agreement remains challenging, India’s TKDL provides a practical model for closing normative gaps through institutional innovation.
Conclusion: Giving Legal Voice to Living Traditions
The Traditional Knowledge Digital Library is more than just a database. It serves as a legal step that honours history and culture. By translating ancient wisdom into modern legal terms, India has ensured that traditional knowledge is included in the global patent system.
In doing so, the TKDL reaffirms a basic legal principle. Knowledge that belongs to humanity cannot be privatised through ignorance. As nations face the challenge of protecting indigenous heritage in an innovation-driven economy, India’s experience offers a strong example of how law, technology, and culture can coexist.
Footnotes
* Anmol Pandey, 2nd Year Law Student at National Forensic Sciences University
1. 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.5 Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively.
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.
2. 3(p)- an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components or components.
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