India’s pharmaceutical industry is increasingly investing in herbal and plant-based formulations, blending traditional knowledge with modern delivery systems. However, patenting such innovations in India presents unique challenges, particularly under Section 3(p) of the Patents Act, the National Biodiversity Act (NBA), and scrutiny from the Traditional Knowledge Digital Library (TKDL).
While they serve as protective mechanisms, they also introduce procedural hurdles for patent applicants. This article outlines strategic approaches and recent case law to help innovators secure patent protection for herbal compositions while respecting India’s biodiversity and traditional knowledge frameworks.
NBA Compliance: Evolving Rules Under the 2023 Amendment
The Biological Diversity (Amendment) Act, 2023 and Rules 2024–2025 have streamlined compliance for Indian entities while tightening obligations for foreign applicants.
The Biological Diversity Act, 2002, amended in 2023, mandates NBA approval for any invention involving:
- Biological resources sourced from India
- Associated traditional knowledge
Key Sections:
- Section 6(1A): Mandatory registration before patent grant
- Section 6(1B): Approval required before commercialization
Key Provisions:
- Indian entities: No prior NBA approval needed before grant; registration required before commercialization.
- Foreign entities: Must obtain NBA approval before patent grant.
- Turnover-based benefit sharing:
- ₹5–50 crore: 0.2%
- ₹50–250 crore: 0.4%
- Above ₹250 crore: 0.6%
SOP for Patent Applicants
- File Form III via ABS e-filing portal with Fee: ₹500
- Timeline: NBA must dispose of applications within 90 days
- Benefit Sharing: Based on turnover slabs and species value
While no formal expedited route exists, emergency-based fast-track approvals may be granted by NBA in cases like pandemics or national interest.
Case Example: IN1859/DEL/2015 – Essential Oils Patent
The Delhi Patent Office initially required NBA approval, arguing essential oils were biological resources. The applicant successfully argued they were value-added products, leading to patent grant.
Castor Oil Case – NGT (West Zone)
Castor oil was ruled not exempt under Section 40, requiring benefit-sharing payments to the State Biodiversity Board.
TKDL Screening: A Defensive Tool for the Patent Office
The TKDL contains over 400,000 formulations from Ayurveda, Unani, Siddha, and Yoga. It is actively used to reject claims overlapping with traditional knowledge and other indigenous systems.
Impact on Patent Applications
- TKDL acts as prior art, leading to rejection of claims based on known traditional uses.
- Cited under Section 3(p) of the Patents Act: TK-based inventions are not patentable if they lack novelty or inventive step.
Key Judicial Interpretation: Zero Brand Zone Pvt. Ltd. v. Controller of Patents (Madras HC, July 2024)
The Madras High Court upheld the rejection of a patent application for an eco-friendly lamp made from panchagavya and herbal leaves, ruling that the claimed invention merely aggregated known properties. The Court emphasized that even if the combination had utility, it lacked technical advancement beyond traditional knowledge.
Claim Drafting Strategies to Avoid Section 3(p) Rejections
- Demonstrate Synergy or Unexpected Technical Effect
- Show enhanced efficacy, bioavailability, or stability.
- Include comparative experimental data.
- Characterize Novel Extracts or Compounds
- Isolated compounds must be structurally novel and not disclosed in TKDL.
- Demonstrate distinct therapeutic properties.
For Example: A patent claim for “Chamaemeloside” isolated from Roman chamomile was rejected because the compound’s therapeutic use was already known in Ayurveda. However, if a structurally novel compound with new activity is isolated, it may pass the inventive step test.
- Avoid Obvious Combinations
- Combining herbs with similar known uses is considered obvious unless the formulation shows unexpected results or novel delivery mechanisms.
Best Practices include:
- To conduct TKDL prior art search using the TKRC system.
- Cite and differentiate from TKDL disclosures in the specification.
- Refer to AYUSH texts and databases like PubMed and CSIR’s OSDD.
Exemptions
TKDL is not a regulatory body, so exemptions do not apply. However, if TK is used as a starting point for innovation, and the invention goes beyond known knowledge, it may be patentable.
Intersection of NBA and TKDL: A Dual Compliance Challenge
Patent applications involving biological resources and traditional knowledge must navigate both NBA and TKDL scrutiny. Failure to comply can lead to:
- Pre-grant opposition under Sections 25(1)(j) and 25(2)(j)
- Penalties under Section 55 of the BDA (up to ₹10 lakh or 5 years imprisonment)
Conclusion:
Pharma companies developing herbal formulations in India must adopt a scientifically rigorous and legally strategic approach. Success depends on:
- Claiming novel compositions with demonstrable synergy.
- Avoiding TKDL overlap through thorough prior art searches.
- Navigating NBA compliance with clear documentation and exemption strategies.
By aligning traditional wisdom with modern innovation and respecting India’s biodiversity and IP laws herbal formulations can be patented not as folklore, but as future-ready therapeutics. NBA and TKDL are not just regulatory hurdles they are guardians of India’s heritage. With the right strategy, patent applicants can align innovation with compliance, ensuring both protection and progress.
Disclaimer: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Authors:
Rahul Bagga, Partner
Nisha Wadhwa, Principal Associate