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Question #15

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

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The Government of India has taken several measures to protect traditional knowledge of medicine from patenting by pharmaceutical companies. Some of these measures include:

  1. Traditional Knowledge Digital Library (TKDL): The Government of India, in collaboration with the Council of Scientific and Industrial Research (CSIR), has created a TKDL. This digital repository contains comprehensive information on traditional Indian medicine, such as Ayurveda, Unani, and Yoga. It aims to prevent the wrongful granting of patents on existing traditional knowledge by providing evidence to patent offices around the world.

  2. Prior Informed Consent (PIC) and Benefit-Sharing: The government has emphasized the importance of obtaining prior informed consent from local communities and indigenous tribes before commercial exploitation of their traditional knowledge. It has also introduced benefit-sharing mechanisms to ensure that local communities receive fair compensation for their contributions.

  3. Traditional Knowledge Resource Classification (TKRC): The TKRC system has been developed to categorize traditional knowledge resources and create a reliable database. This helps in identifying potential patent infringements and enables the government to take necessary legal actions.

  4. Strengthening Patent Examination Procedures: The government has provided guidelines to patent examiners to ensure that patents are not granted on traditional medicinal knowledge that is already in the public domain. These guidelines help examiners in assessing the novelty and non-obviousness of traditional knowledge-based inventions.

  5. International Cooperation: The Government of India actively participates in international forums, such as the World Intellectual Property Organization (WIPO), to encourage discussions on the protection of traditional knowledge. India advocates for the inclusion of safeguards in international patent systems to prevent misappropriation of traditional medicinal knowledge.

These efforts by the Government of India aim to uphold the rights of indigenous communities and protect traditional medicinal knowledge from being patented by pharmaceutical companies without appropriate recognition or benefit-sharing.

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The Government of India is employing a multi-pronged approach to protect traditional knowledge of medicine from patenting by pharmaceutical companies. Some of the key measures include:

1. The Traditional Knowledge Digital Library (TKDL):

  • This database, launched in 2001, contains information on traditional Indian medicine systems like Ayurveda, Siddha, Unani, and Yoga.
  • It allows patent offices around the world to access and verify the authenticity of traditional Indian knowledge before granting patents.
  • This preempts pharmaceutical companies from claiming intellectual property rights on existing medicinal knowledge.

2. The Traditional Knowledge Digital Library (TKDL):

  • This database, launched in 2001, contains information on traditional Indian medicine systems like Ayurveda, Siddha, Unani, and Yoga.
  • It allows patent offices around the world to access and verify the authenticity of traditional Indian knowledge before granting patents.
  • This preempts pharmaceutical companies from claiming intellectual property rights on existing medicinal knowledge.

3. The Geographical Indications (GI) tag:

  • This tag protects the origin and unique characteristics of products from specific geographical locations.
  • Traditional medicinal products like turmeric from Erode and Darjeeling tea are protected under this system.
  • This helps prevent misappropriation of traditional knowledge and promotes fair trade practices.

4. The Patents Act, 1970:

  • Section 3(d) of the act explicitly prohibits the patenting of medicinal formulations that are based on traditional knowledge.
  • This provision ensures that pharmaceutical companies cannot exploit traditional Indian medical knowledge for commercial gain.

5. The Biological Diversity Act, 2002:

  • This act emphasizes the protection of India's biodiversity and the associated traditional knowledge.
  • It prohibits the biopiracy of medicinal plants and other biological resources used in traditional medicine.

6. Collaboration with international organizations:

  • India collaborates with organizations like the World Intellectual Property Organization (WIPO) to raise awareness about traditional knowledge protection and share best practices.

7. Public awareness campaigns:

  • The government actively promotes awareness about traditional medicine and its importance to the Indian cultural heritage.
  • This encourages public participation in safeguarding traditional knowledge and reporting potential infringements.

8. The Traditional Knowledge Digital Library (TKDL):

  • This database, launched in 2001, contains information on traditional Indian medicine systems like Ayurveda, Siddha, Unani, and Yoga.
  • It allows patent offices around the world to access and verify the authenticity of traditional Indian knowledge before granting patents.
  • This preempts pharmaceutical companies from claiming intellectual property rights on existing medicinal knowledge.

Challenges and limitations:

Despite these efforts, the protection of traditional knowledge remains a complex and challenging issue. Some of the challenges include:

  • Lack of awareness and documentation: Many traditional medicinal practices are not documented, making it difficult to prove prior art and prevent patenting.
  • Limited access to the TKDL: While the database is an important tool, its accessibility and effectiveness can be limited.
  • International legal complexities: Harmonizing different legal systems and ensuring recognition of traditional knowledge across borders is difficult.
  • Commercial exploitation: Even with protection measures, there is always a risk of pharmaceutical companies finding loopholes or engaging in unethical practices.

Moving forward:

To strengthen the protection of traditional knowledge, continued efforts are needed in:

  • Documenting and digitizing traditional knowledge: This requires active collaboration with communities and traditional healers.
  • Raising awareness and promoting education: Public awareness about traditional knowledge and intellectual property rights is crucial.
  • International cooperation: Stronger collaboration with other countries and organizations is essential to establish a more robust global framework for traditional knowledge protection.
  • Developing innovative and ethical approaches: Finding sustainable solutions that balance the preservation of traditional knowledge with its responsible commercialization is critical.

By implementing these strategies, the Government of India aims to ensure that traditional knowledge of medicine continues to be protected for future generations and that its benefits reach both the community and the nation.

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The Government of India has taken several measures to protect traditional knowledge of medicine from patenting by pharmaceutical companies:

  1. Traditional Knowledge Digital Library (TKDL): The TKDL is a digital database that documents traditional knowledge of Ayurveda, Unani, Siddha, and Yoga (AUSY) in a format that is understandable to patent examiners. This prevents pharmaceutical companies from claiming novelty and patenting traditional knowledge. The TKDL is a collaboration between the Council of Scientific and Industrial Research (CSIR) and the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH).
  2. TKDL-Monitoring and Protection System: This system enables the scanning of international patent applications to identify attempts to patent traditional knowledge. The system helps to prevent misappropriation of traditional knowledge by pharmaceutical companies and ensures that patents are not granted for existing traditional knowledge.
  3. Access and Benefit Sharing (ABS) Regime: The ABS regime, under the Biological Diversity Act, 2002, ensures that benefits are shared equitably when traditional knowledge is used for commercial purposes. This regime requires pharmaceutical companies to obtain prior informed consent from local communities and share benefits with them when using traditional knowledge.
  4. Protection of Plant Varieties and Farmers' Rights Authority (PPV&FR Authority): This authority protects the rights of farmers and breeders over plant varieties, including those used in traditional medicine. The authority ensures that pharmaceutical companies cannot patent plant varieties without the consent of the original breeders or farmers.
  5. National IPR Policy (2016): The policy recognizes the importance of protecting traditional knowledge and encourages the use of traditional knowledge for innovation, while ensuring that benefits are shared fairly with the original knowledge holders.
  6. International Cooperation: India has been actively engaging with international organizations, such as the World Intellectual Property Organization (WIPO), to promote the protection of traditional knowledge globally.
  7. Legislative Framework: The Indian Parliament has enacted laws, such as the Indian Patents Act, 1970, and the Biological Diversity Act, 2002, which provide a framework for protecting traditional knowledge from misappropriation.
  8. Institutional Mechanisms: The Government of India has established institutions, such as the National Biodiversity Authority (NBA) and the Indian Council of Medical Research (ICMR), to oversee the protection of traditional knowledge and ensure that benefits are shared equitably.
  9. Community-led Initiatives: The Government of India has encouraged community-led initiatives, such as the establishment of community biodiversity registers, to document and protect traditional knowledge at the grassroots level.
  10. Capacity Building and Awareness: The Government of India has been conducting workshops, training programs, and awareness campaigns to educate stakeholders, including researchers, industry representatives, and local communities, about the importance of protecting traditional knowledge.

These measures demonstrate the Government of India's commitment to protecting traditional knowledge of medicine from patenting by pharmaceutical companies and ensuring that benefits are shared equitably with local communities.