The Intellectual Property India on September 18, 2026, issued the Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology.
The following has been stated:
• The Draft Guidelines provide an examination framework for biotechnology inventions covering nucleic acids and gene sequences, proteins and polypeptides, vectors, cells and microorganisms, genetically modified organisms, pharmaceuticals and vaccines, diagnostics, microbial/biochemical processes, tissue engineering, bioinformatics and advanced technologies such as CRISPR, gene editing and synthetic biology. Examiners are required to assess such applications against novelty, inventive step and industrial applicability, along with the non-patentability provisions under Sections 3(b), 3(c), 3(d), 3(e), 3(h), 3(i), 3(j), 3(k) and 3(p) of the Patents Act.
• The Guidelines place particular emphasis on Biodiversity Act compliance. Where an invention uses biological material obtained from India, the application shall disclose its source and geographical origin, and the applicant is required to obtain the requisite approval/registration from the competent authority/National Biodiversity Authority, wherever applicable. Non-disclosure or wrongful disclosure may constitute a ground for opposition.
• For prior-art examination, Examiners are directed to use comprehensive searches involving keywords, IPC classifications and sequence-based searches across patent and non-patent databases. Where nucleotide or amino-acid sequences are disclosed, electronic sequence listings in WIPO ST.26 format are required, and tools such as BLAST, UniProt and FASTA may be used. The Examiner's report is also required to disclose the search string/query used.
• The Guidelines clarify the treatment of product-by-process, sequence and composition claims. A product is not considered novel merely because it is produced through a new process; the product itself shall satisfy novelty requirements. Similarly, a previously disclosed nucleotide/polypeptide sequence may anticipate a subsequent sequence claim even if its function was not previously identified.
• The draft further provides detailed examination principles for inventive step and industrial applicability, including assessment of technical advance, economic significance and obviousness. It contains specific guidance on exclusions under Sections 3(b), 3(c), 3(d), 3(e), 3(h), 3(i), 3(j), 3(k) and 3(p), as well as requirements concerning sufficiency of disclosure, clarity and support of claims, unity of invention and deposition of biological material.
