Q.How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?

Body Analysis

Key Challenges in Protecting Traditional Knowledge

• Lack of Codification: Much of India's traditional knowledge was uncodified, making it difficult for international patent examiners to verify as "prior art."
• Biopiracy Cases: Past instances, such as foreign patents granted on the medicinal properties of Turmeric, Neem, and Basmati rice, highlighted the urgent need for defensive protection.
• Collective Ownership: Traditional knowledge is usually held collectively by communities rather than individuals, complicating conventional intellectual property rights (IPR) and benefit-sharing mechanisms.

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Measures Taken by the Government of India

1. Digital Defensive Protection: The Traditional Knowledge Digital Library (TKDL)

• Prior Art Database: Established in 2001, the TKDL is a pioneer global database that translates ancient Indian medical texts into five international languages (English, French, German, Spanish, and Japanese).
• Preventing Wrongful Patents: By documenting over 4 lakh formulations from Ayurveda, Unani, and Siddha, the TKDL provides patent examiners worldwide with proof of "prior art," leading to the rejection or withdrawal of hundreds of faulty patent applications on Indian herbs.
• International Agreements: India has signed access agreements with major patent offices, including the European Patent Office (EPO), US Patent and Trademark Office (USPTO), and UK Intellectual Property Office (UKIPO), allowing examiners to search the TKDL database before granting patents.

2. Legislative and Legal Frameworks

• The Biological Diversity Act, 2002: This Act regulates access to biological resources and associated traditional knowledge. It mandates that foreign entities obtain prior approval from the National Biodiversity Authority (NBA) and ensures fair and equitable benefit-sharing with local communities.
• The Patents Act, 1970 (as amended): Under Section 3(p), an invention which is in effect traditional knowledge or an aggregation of known properties of traditionally known components is explicitly declared non-patentable.
• The Geographical Indications of Goods Act, 1999: This protects traditional products associated with specific geographic regions, preventing unauthorized commercial use.
• The Forest Rights Act, 2006: This act empowers tribal and forest-dwelling communities by recognizing their community rights over forest resources and traditional practices.

3. Institutional Support

• Ministry of AYUSH: Created as a dedicated ministry to promote, regulate, and systematically document traditional Indian medicine systems.
• Research Councils: Specialized national institutes and research councils conduct scientific validation of traditional formulations, reinforcing their status as prior art.

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