Section 6 of BDA : Section 6: Application For Intellectual Property Rights Not To Be Made Without Approval Of National Biodiversity Authority

Explanation using Example

Imagine a pharmaceutical company based in the United States, which has conducted extensive research on a plant species indigenous to India, known for its unique medicinal properties. The company has discovered a compound within the plant that can be used to create a new drug to treat a widespread disease. Before the company can file for a patent on this new drug in the U.S. or elsewhere, Section 6 of The Biological Diversity Act, 2002 requires them to obtain prior approval from the National Biodiversity Authority (NBA) in India.

The company submits an application to the NBA for the necessary approval, disclosing the source of the biological resource and the nature of the research conducted. The NBA reviews the application and decides to grant approval, but imposes a benefit-sharing fee and a royalty agreement, whereby a percentage of the profits from the commercialization of the drug will be shared with the local communities in India where the plant species is found.

The pharmaceutical company agrees to the terms set by the NBA and proceeds with the patent application process. The NBA ensures that the approval process is completed within 90 days, and once the patent is accepted (but before it is sealed), the company obtains the endorsement from the NBA. This ensures that the company complies with Indian law, supports the conservation and sustainable use of biodiversity, and provides equitable benefits to the local communities in India.