The Hidden Complexity of Biodiversity Compliance: Interpreting ‘Access’ Under the Biological Diversity Act

India’s Biological Diversity Act, 2002 (BDA) was enacted with a powerful objective: to protect the country’s rich biological resources and ensure that benefits arising from their use are fairly shared with local communities. Over time, the Act has become a cornerstone of India’s environmental and intellectual property (IP) regulatory framework particularly because it directly intersects with the world of patents, research, biotechnology, and bio-innovation.

Among its various provisions, Section 6 of the BDA, read with the Biological Diversity Rules, 2024, imposes an especially significant requirement: Any person seeking intellectual property rights (IPRs) based on research or information derived from Indian biological resources must obtain prior approval from the National Biodiversity Authority (NBA).

This appears straightforward on paper. Yet in practice, a deep and persistent complexity arises around one key term: “access.” The interpretation of what constitutes “access” to biological resources or associated knowledge has become one of the most challenging compliance questions faced by researchers, startups, corporations, and IP professionals.

This article unpacks the hidden legal and operational complexities of this requirement, explores how ambiguity around “access” affects innovation, and highlights the compliance challenges that deserve greater attention from regulators and stakeholders.

Understanding the Legal Architecture: Section 6 and Rule 16

Section 6 of the BDA mandates that no person shall apply for any intellectual property right in or outside India for an invention based on any research or information on a biological resource obtained from India without prior approval of the NBA.

The recently updated Biological Diversity Rules, 2024, particularly Rule 16, reinforce this requirement by detailing the procedure, timelines, and documentation necessary for securing this approval.

Together, these provisions ensure that commercial gains arising from India’s biological wealth do not escape regulation or benefit-sharing obligations.

But before any compliance obligation can be triggered, one key question must be answered:

When can an applicant be said to have “accessed” biological resources or associated knowledge from India?

Why the Definition of “Access” Is Critical

The entire legal obligation hangs on this term. If a person has accessed biological resources or associated knowledge, they fall under Section 6.If not, they may be outside the scope of the Act.

The stakes are high:

• Patents filed without NBA approval can be challenged or revoked.

• Companies may face penalties for non-compliance.

• Delays in approvals can stall investments, product launches, or collaborations.

• Misinterpretation can lead to over-compliance or under-compliance, each carrying its own risks.

Thus, clarity on “access” becomes essential to the smooth functioning of the innovation ecosystem.

The Core Challenge: What Does “Access” Actually Mean?

The Act defines access broadly as obtaining biological resources or associated knowledge for research, commercial utilization, or biosurvey. Yet, this broadness itself is the root of compliance uncertainty.

1. Does published or publicly available information count as “access”?

One of the most debated questions is whether a person who relies solely on published literature, traditional knowledge databases, or existing scientific data is considered to have accessed knowledge under the BDA.

If a researcher cites an article describing the medicinal properties of a plant found in India even if the researcher has never directly collected or interacted with the biological resource, does Section 6 still apply?

Some argue yes, because the Act covers “information” about biological resources. Others argue no, since no physical or direct engagement occurred.

The Rules of 2024 do not fully address this ambiguity.

2. What if the resource is sourced from outside India but originally native to India?

For example, a microorganism originally isolated in India but deposited in an international culture collection years ago.

If a foreign laboratory provides a sample today, is this “access from India”?

The BDA focuses on biological resources accessed from India, not necessarily resources originating from India. But the distinction remains difficult to apply consistently.

3. What about digital sequence information (DSI)?

With the rise of genome sequencing, researchers often work with digital genetic data rather than physical samples.

The Act predates widespread DSI usage, and the Rules of 2024 still do not fully clarify whether:

• Accessing genome sequences online,

• Using AI-generated biological pathway data, or

• Working with virtual biological models

constitutes “access.”

This is a major compliance blind spot.

4. Does basic taxonomic identification amount to access?

For instance, if a botanist identifies a plant species mentioned in a patent application but does not physically collect or study the plant, is this considered “access”?

The answer remains unclear.

Why This Ambiguity Matters for Innovation and IP

When a legal framework is unclear, it creates three major problems:

1. Researchers and startups face uncertainty and fear of penalties.

Universities and young innovators worry that a misinterpretation may invalidate their patents or expose them to legal action. This discourages research in sectors like:

• Biotechnology

• Pharmaceuticals

• Nutraceuticals

• Agriculture

• Environmental technologies

2. Corporates may engage in over-compliance to avoid risk, increasing costs and delays.

This results in:

• Unnecessary NBA approval filings

• Delayed patent applications

• Hesitation to explore bio-based innovations

3. The regulatory burden shifts to patent examiners and attorneys.

Patent professionals must determine whether:

• The invention is “based on” biological resources

• The applicant has “accessed” such resources

• NBA approval is mandatory

This significantly increases procedural overhead and legal scrutiny.

The Way Forward: Reducing the Hidden Complexity

To foster innovation while protecting biodiversity, India needs clearer guidance from the NBA or the Ministry of Environment.

Possible steps include:

• Issuing clarificatory guidelines on what qualifies as “access.”

• Defining the scope of information vs. physical resource access.

• Providing specific rules for digital sequence information (DSI).

• Creating an exemption list for commonly used published data.

• Establishing a fast-track approval system for IP filings.

Such reforms would boost research confidence, encourage bio-innovation, and avoid unnecessary compliance bottlenecks.

Conclusion

The Biological Diversity Act, 2002 plays a vital role in safeguarding India’s biological wealth and ensuring fair benefit sharing. But its effectiveness depends on how clearly its key terms especially “access” are understood and applied. Today, the ambiguity surrounding this term creates significant operational challenges for researchers, companies, and IP professionals.

As bio-based innovation continues to expand, the need for predictability, clarity, and consistency in biodiversity compliance becomes more urgent. Addressing the hidden complexity of “access” is not just a legal necessity, it is essential for India’s scientific progress, global competitiveness, and equitable use of its rich biodiversity.