INDIAN PATENT OFFICE ISSUES DRAFT BIOTECHNOLOGY PATENT GUIDELINES, 2026: COMPREHENSIVE OVERVIEW

The Indian Patent Office (“IPO”) has published the Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology, 2026 (“Draft Guidelines”), updating the legacy 2013 Guidelines. The 2026 Draft Guidelines serve as an operational guide for examiners and practitioners, consolidating statutory amendments, administrative directives, and extensive judicial precedent from the past 13 years into daily prosecution practice.

Key Administrative, Digital & Compliance Updates

• Mandatory Search Query Transparency: Directs examiners to explicitly disclose the complete search strings, database queries, and parameters used during prior art searches in the First Examination Report (FER).

  
  

• Sequence Listings (WIPO ST.26): Enforces XML-based WIPO Standard ST.26 compliance for sequence listings via WIPO Sequence software.

  
  

• Expanded Budapest Depositories: Formally recognizes the National Agriculturally Important Microbial Culture Collection (NAIMCC) in Mau, Uttar Pradesh, as India's third recognized International Depository Authority (IDA) alongside MTCC and MCC.

  
  

• Biodiversity Act Compliance: Aligns guidelines with the Biological Diversity (Amendment) Act, 2023, confirming that non-disclosure or wrongful disclosure of biological source or origin remains an explicit ground for pre- and post-grant opposition under Section 25.

  
  

• Expanded Technological Scope: Formally covers modern biotech fields including CRISPR/Cas9, synthetic biology, antibody-drug conjugates (ADCs), RNA interference (siRNA), tissue engineering, 3D bioprinting, scaffolds, bio-artificial organs, metabolomics, next-generation sequencing (NGS), and computational genomics.

  
  

Key Judicial Precedents Codified in the Guidelines

• Product-by-Process Claims: Vifor (International) vs. MSN Laboratories (2024) clarifies that a product claimed by process terms is patentable only if the product itself possesses standalone product novelty and inventive step.
  

• Diagnostic Method Exclusion (Section 3(i)): The Chinese University of Hong Kong vs. Assistant Controller (2023) narrows the "diagnostic" exclusion strictly to processes that inherently disclose pathology for human medical treatment.

  
  

• Diagnostic Tools & Kit Eligibility: Sequenom v. Controller, Natera vs. Assistant Controller, and EMD Millipore (2025) confirm that diagnostic products, kits, devices, and screening tools are patent-eligible under Section 3(i).

  
  

• Efficacy & Non-Therapeutic Enzyme Variants (Section 3(d)): Novozymes vs. Assistant Controller (2023) specifies that non-therapeutic enzyme variants fall under Section 3(d) and must demonstrate a material enhancement of efficacy. Natco Pharma vs. Novartis (2024) confirms enhanced bioavailability alone does not prove therapeutic efficacy.

  
  

• Technical Solutions in Agriculture (Section 3(h)): Mitsui Chemicals (2024) and BASE SE (2025) narrow Section 3(h) exclusions by distinguishing conventional farming methods from human-invented technical solutions to agricultural problems.

  
  

• Essentially Biological Processes (Section 3(j)): BTS Research vs. Controller (2025) establishes that determining whether a process is "essentially biological" depends on the totality and impact of human intervention.

  
  

• Section 3(d) Specificity in Objections: DS Biopharma (2022) mandates that examiners explicitly identify the specific known substance when raising Section 3(d) objections.

  
  

• Traditional Knowledge Limits (Section 3(p)): The Zero Brand Zone vs. Controller (2024) clarifies that Section 3(p) prevents monopolizing traditional knowledge without shutting out genuine technological advancements derived from natural sources.

  
  

• Support & Enablement Standards: University of California vs. Controller (2024) limits claim amendments to disclaimers, corrections, or explanations. Raj Prakash vs. Mangatram Chowdhury reinforces enablement requirements for broad claims.

  
  

Moral Exclusions, Enablement, and Section 3 Statutory Alignments

• Moral & Ethical Exclusions (Section 3(b)): Adds explicit illustrative examples barring claims to human embryo destruction (IE-10), CRISPR human germline editing for genetic enhancement (IE-11), and GM peptide herbicides causing severe ecological damage to pollinators (IE-12).

  
  

• Inventions Involving Machine Learning & Biomarkers: Introduces enablement requirements for AI/ML-driven biomarker processing (IE-34), requiring complete disclosure of neural network architectures, feature extraction models, and training methodologies.

  
  

• Antibody Claim Scope & Identity: Adds IE-33, setting strict experimental data support requirements for broad sequence identity ranges (e.g., 80% identity) in antibody CDRs.

  
  

• Computer-Related Inventions in Bioinformatics (Section 3(k)): Re-affirms that computational genomics and data processing methods without tangible technical applications remain excluded under Section 3(k).

Tarun Gandhi

Partner | Attorney at Law

tarun@iprattorneys.com