Summary
Released together with the pharmaceutical draft on 5 September 2026, the biotechnology draft guidelines update the Patent Office's 2013 Guidelines for Examination of Biotechnology Applications for Patent. Where the 2013 guidelines were largely doctrinal, the 2026 draft is built almost entirely around worked illustrative examples - thirty-six in total, and folds in roughly a dozen judicial decisions from 2023 through 2025, several concerning gene-editing, antibody and cell-therapy technologies that simply did not feature in patent litigation when the 2013 guidelines were written. This post walks through the structure of the draft, its treatment of novelty, inventive step, industrial applicability, the Section 3 exclusions most relevant to biotech (3(b), (c), (d), (e), (h), (i), (j), (k) and (p)), sufficiency of disclosure, unity of invention, and biological material deposit requirements, and highlights what has changed since 2013.
Background: From Dimminaco to CRISPR
Indian biotechnology patenting traces its modern origins to the Calcutta High Court’s 2002 ruling in Dimminaco AG v. Controller of Patents and Designs, which held that a process yielding a live vaccine could be patentable even though the end product contained a living microorganism, applying the “vendibility test.” The Patents (Amendment) Act, 2002 formally brought biochemical, biotechnological and microbiological processes within the scope of patentable subject matter, and India’s accession to the Budapest Treaty the same year introduced the deposit mechanism for biological material that cannot be adequately described in words. The Biological Diversity Act, 2002, as amended in 2023, layered on a benefit-sharing and disclosure regime administered by the National Biodiversity Authority.
The 2013 Guidelines for Examination of Biotechnology Applications for Patent were the Patent Office’s first attempt to give examiners a consistent framework for this fast-moving field. Since then, the underlying science has moved from recombinant proteins and monoclonal antibodies toward newer fields such as CRISPR-Cas9 gene editing, CAR-T cell therapies, RNA interference and synthetic biology. The 2013 guidelines could not meaningfully anticipate any of these. The courts have filled part of that gap: Novozymes, Immunas Pharma, the Chinese University of Hong Kong, BTS Research International, the Zero Brand Zone traditional-knowledge ruling, and the October 2025 Sequenom-EMD Millipore-Natera trilogy each bear directly on how biotech claims are examined today. The 2026 draft consolidates this case law into a single document supported by thirty-six illustrative examples spanning the entire biotechnology claim landscape.
Structure of the 2026 Draft
The draft is organised into twenty-one sections. These cover an introduction to biotechnology as a discipline (Section 1), a brief history of biotech patenting in India (Section 2), Biological Diversity Act compliance obligations (Section 3), and the relevant statutory provisions (Section 4). Section 5 sets out the categories of claims typically filed, including nucleic acids, proteins and polypeptides, vectors and constructs, cells and organisms, pharmaceuticals and vaccines, diagnostics, microbial and biochemical processes, tissue engineering and bio-printing, bioinformatics, and advanced technologies such as CRISPR, TALENs, synthetic biology and RNA interference. The remaining sections address prior art search methodology including sequence-listing requirements under WIPO Standard ST.26 (Section 6), novelty (Section 7), inventive step (Section 8), industrial applicability (Section 9), the Section 3 non-patentability exclusions running through Sections 10 to 18, sufficiency of disclosure, clarity and support (Section 19), unity of invention (Section 20), and deposit of biological material (Section 21).
Novelty and Inventive Step: From Sequence Claims to CAR-T Constructs
On novelty, the draft addresses product-by-process claims through the same Vifor v. MSN Laboratories framework used in the pharma guidelines. It also adds biotechnology-specific treatment of sequence claims. A prior disclosure of an identical polynucleotide or polypeptide sequence anticipates novelty even without any indication of its activity, since the earlier sequence “inherently possesses” that activity. A fragment that does not exactly match a prior art sequence is not anticipated by it, though it may still fail on inventive step or Section 3 grounds.
The inventive step illustrations are considerably more technically current than anything in the 2013 guidelines. One example works through a humanised anti-CD19 chimeric antigen receptor (CAR) polypeptide, finding an inventive step over the closest prior art CAR construct because the specification provided experimental data showing an improved cytokine profile and enhanced tumour reduction, outcomes a skilled person could not have predicted from the cited art. Another example addresses an improved galacto-oligosaccharide production process using a combination of Bullera singularis and Saccharomyces sp. microorganisms, finding the combination obvious because a second prior art document already taught that Saccharomyces sp. consumes glucose and would motivate a skilled person to combine it with the first microorganism to solve exactly the yield problem claimed. A third example on IL-3 protein variants, and a fourth on interferon alpha-2 (thirty times more potent than the prior art interferon alpha-1 analogue), together illustrate the now-familiar principle that a single amino acid substitution is obvious unless it produces an unexpected or surprising technical effect supported by data.
Industrial Applicability: Speculative Function Is Not Enough
Section 9 reiterates, through the Delhi High Court’s 2015 ruling in Cipla Ltd v. F. Hoffmann-La Roche Ltd, that industrial applicability requires a specific, substantial and credible use, not a merely predicted or speculative one. The illustrative examples make this concrete for gene and protein claims: a claim to a hepatitis C virus polypeptide fragment with a disclosed antigenic determinant was held sufficiently enabled and allowable, whereas a parallel claim covering “any” polypeptide selected from a list of dozens of sequence IDs, with no established use for the vast majority of them, was refused for lack of industrial applicability. A further example addresses ESTs (expressed sequence tags), holding that a fragment whose disclosed use is merely as a “gene probe” or “chromosome marker” does not satisfy industrial applicability, whereas use as a probe for diagnosing a specific disease would.
Section 3(b), 3(c) and 3(d): Morality, Discovery, and Efficacy in the Biotech Context
Section 3(b) exclusions are illustrated through examples on human embryo destruction for stem cell derivation, germline editing of human embryos using CRISPR-Cas9 for enhancement purposes, and a genetically modified peptide-based herbicide that would harm pollinating insects and thereby threaten biodiversity and food security. All three examples are held contrary to morality or seriously prejudicial to human, animal, plant or environmental health.
On Section 3(c), the draft applies the Madras High Court’s 2024 ruling in Immunas Pharma, Inc. v. Assistant Controller of Patents, which held that the word “mere” in Section 3(c) qualifies only “discovery of a scientific principle” and not the discovery of a living thing or non-living substance occurring in nature. This means an isolated natural substance remains excluded even where something more than bare discovery is involved, unless the claim goes beyond the isolated substance itself. Illustrative examples on an isolated Bacillus species, a cardiac-development peptide isolated from horseshoe crab perivitelline fluid, and a lipase enzyme isolated from a naturally occurring microorganism (with no recombinant modification) are all held non-patentable on this ground.
Section 3(d) is analysed through the same Novartis efficacy framework used in the pharma guidelines, but with biotech-specific illustrations: a pro-insulin variant with a shortened C-peptide is held obvious where the only claimed advantage is a yield improvement from 1.0 to 1.6-2.0 mmol/l, since a yield difference of this magnitude does not constitute an “unexpected property,” whereas a claimed human interferon alpha-2 that is thirty times more potent than its closest prior art analogue is held non-obvious precisely because of that dramatic, data-backed differential.
Section 3(e) and 3(h): Aggregation Claims and the Narrowing of “Agriculture”
On Section 3(e), the draft applies the Madras High Court’s Novozymes ruling holding that the exclusion for “mere admixture” is not confined to compositions of previously known ingredients, nor to independent claims. Any composition claim that merely exhibits the aggregate properties of its constituents falls within the exclusion, regardless of how the ingredients are otherwise characterised.
Section 3(h) receives an important interpretive narrowing through two 2024-2025 rulings. The Delhi High Court in Mitsui Chemicals Inc v. Controller of Patents called for a “nuanced and detailed analysis” distinguishing a genuine method of agriculture from an innovative technical solution to an agricultural problem that happens to be implemented in a field. The Calcutta High Court’s 2025 ruling in BASE SE v. Deputy Controller of Patents and Designs goes further, holding that Section 3(h) reflects a legislative intent to preserve traditional, public-interest farming and gardening activities from monopolisation, and that unless a claimed invention is “directly and integrally connected” to traditional agricultural activity, it should not be excluded. This is a materially narrower reading than examiners may previously have applied to any process touching a field or crop.
Section 3(i): The Same October 2025 Trilogy, Applied to Biotech Diagnostics
The biotech draft incorporates the identical Chinese University of Hong Kong and Sequenom-EMD Millipore-Natera framework used in the pharma guidelines, with biotech-specific illustrations on cancer treatment combinations (excluded as methods of treatment) and quantitative PCR-based biomarker diagnostic methods for pancreatic cancer (excluded as diagnostic processes carried out on the human body, notwithstanding that the method involves a molecular assay rather than a traditional clinical examination). The consistent thread, as in the pharma guidelines, is that diagnostic and therapeutic kits, kits, kits, and diagnostic devices remain patentable; the diagnostic or therapeutic process itself, however sophisticated the underlying molecular biology, does not.
Section 3(j): Plants, Animals, and “Essentially Biological” Processes
Section 3(j) excludes plants and animals in whole or in part, other than micro-organisms, along with essentially biological processes for their production. The draft applies the Calcutta High Court’s 2025 ruling in BTS Research International Pty Ltd v. Controller General of Patents & Designs, which held that whether a process is “essentially biological” turns on the totality of human intervention and its impact on the result achieved, judged as a whole rather than by characterising each individual step in isolation. Illustrative examples confirm that a genetically modified drought-tolerant rice plant remains excluded under Section 3(j) regardless of the sophistication of the transgene insertion technique, though it may be protectable under the Protection of Plant Varieties and Farmers’ Rights Act instead. They also confirm that a hybrid seed production method relying on cross-breeding of male-fertile and male-sterile parent lines is an essentially biological process. Notably, a pharmaceutical composition whose active ingredient is an antigen-presenting dendritic or macrophage cell is properly objected under Section 3(j) even though it is framed as a composition claim, since the cell itself is the active ingredient.
Section 3(k) and 3(p): Bioinformatics Algorithms and Traditional Knowledge
Section 3(k) is applied to bioinformatics claims that reduce to computational data-processing steps without a demonstrated technical contribution or tangible product. Examples include a data processing method correlating chemical and biological information through multivariate analysis or machine learning, and a computer-assisted method for designing enzyme-inhibiting compounds based on three-dimensional structural modelling. Both are held to fall within the computer-program-per-se exclusion where they do not produce a real product.
Section 3(p) draws on the Madras High Court’s 2024 ruling in The Zero Brand Zone Pvt. Ltd. v. Controller of Patents, which held that the word “mere” does not qualify “traditional knowledge” in Section 3(p) the way it qualifies “computer programme” in Section 3(k), and that the “in effect” language is intended to prevent circumvention of the exclusion by disguising traditionally known components or their properties within a claim. The pigeon-serum illustrative example, a claimed anti-paralytic serum derived from pigeon blood traceable to published ethnobiological literature documenting exactly this traditional use, remains a clean and memorable illustration of how Section 3(p) operates in practice.
Sufficiency, Unity of Invention, and Deposit of Biological Material
The sufficiency-of-disclosure section addresses the familiar problem of “laundry list” claims, such as a gene or protein linked to an implausibly long and unrelated list of potential disease targets without disclosed data for each. It also addresses “reach-through” claims that seek to protect compounds not yet identified at the time of filing but potentially identifiable through the applicant’s disclosed screening method. On unity of invention, the draft works through both a priori lack of unity (three unrelated promoter DNA sequences sharing no common structural feature) and a posteriori lack of unity (a shared technical feature that turns out to be already known in the prior art, and therefore incapable of unifying otherwise distinct inventions).
The deposit provisions restate the Budapest Treaty framework, including deposit no later than the Indian filing date, with reference to the deposit added to the specification within three months. The draft also lists India’s three International Depository Authorities: the Microbial Type Culture Collection and Gene Bank (MTCC) at IMTECH Chandigarh, the Microbial Culture Collection (MCC) at NCCS Pune, and the National Agriculturally Important Microbial Culture Collection (NAIMCC) under ICAR at Mau Nath Bhanjan.
What Has Changed Since the 2013 Guidelines
-
-
- Thirty-six worked illustrative examples spanning gene sequences, CAR-T constructs, CRISPR-edited organisms, antibody variable regions, and microbial processes, covering technologies that were nascent or non-existent in patent prosecution when the 2013 guidelines were drafted.
- Incorporation of roughly a dozen judicial rulings from 2023 through 2025, including the Madras High Court’s Novozymes, Immunas Pharma and Zero Brand Zone decisions, the Calcutta High Court’s BTS Research International and BASE SE rulings, and the October 2025 Delhi High Court trilogy on Section 3(i).
- A materially narrower reading of Section 3(h) “method of agriculture,” requiring a direct and integral connection to traditional farming activity before the exclusion applies. This is a more applicant-favourable standard than the broad-brush approach the 2013 guidelines implied.
- Explicit treatment of “essentially biological process” under Section 3(j) as a totality-of-human-intervention inquiry, rather than a step-by-step characterisation exercise.
- A worked illustration of Section 3(j) applied to cell-based pharmaceutical compositions (antigen-presenting cell compositions), addressing a claim-drafting pattern that has become common in cell-therapy applications but was not addressed in 2013.
- Cross-referencing with the companion 2026 Pharmaceutical Guidelines for shared provisions such as Section 3(i), so that examiners are pointed to a single, consistent interpretive source across both fields.
-
Conclusion
Where the 2013 biotechnology guidelines were written for a patent landscape still dominated by recombinant proteins and first-generation monoclonal antibodies, the 2026 draft is unmistakably written for the CRISPR and cell-therapy era, while simultaneously tightening the interpretive screws on morality exclusions, natural-substance discoveries, and traditional-knowledge claims through a decade of intervening case law. Applicants prosecuting gene-editing, CAR-T, antibody-engineering or plant biotechnology patents in India should expect examiners to apply the “essentially biological process,” Section 3(c) “discovery” and Section 3(d) efficacy standards considerably more rigorously than before. As with the pharmaceutical guidelines, this document remains in draft form and open for public comment before finalisation.
Stakeholder Comments / Suggestions
The guidelines are presently in draft form and open to stakeholder comment; applicants and industry bodies with a stake in biotechnology related invention would do well to review the full text and make representations before it is finalised. Any comments/suggestions on the Draft Guidelines for Examination of Biotechnology Applications for Patent muts be sent to cgoffice.in@gov.in and llc-ipo@gov.in on or before September 19, 2026.
Click on the links below to access the pdf version and the word accessible version of the Draft Guidelines.
Case Citations Referenced in the Draft Guidelines
-
- Dimminaco AG v. Controller of Patents and Designs, AID No. 1 of 2001, Calcutta HC (2002)
- Vifor (International) Limited & Anr v. MSN Laboratories Pvt Ltd & Anr, FAO(OS)(COMM) 159-161/2023, Delhi HC (7 Feb 2024)
- Cipla Ltd v. F. Hoffmann-La Roche Ltd. & Anr, RFA(OS) 92/2012 & 103/2012, Delhi HC (27 Nov 2015)
- Immunas Pharma, Inc. v. Assistant Controller of Patents, (T) CMA(PT) No.118 of 2023, Madras HC (6 March 2024)
- Novartis AG v. Union of India & Others, Civil Appeal Nos. 2706-2716 of 2013, Supreme Court (1 April 2013)
- Natco Pharma Ltd v. Novartis AG and Anr, FAO(OS)(COMM) 178/2021, Delhi HC (24 April 2024)
- Novozymes v. Assistant Controller of Patents & Designs, (T) CMA(PT) No. 33 of 2023, Madras HC (20 Sept 2023)
- DS Biopharma Limited v. The Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 6/2021, Delhi HC (30 Aug 2022)
- Mitsui Chemicals Inc v. Controller of Patents, C.A.(COMM.IPD-PAT) 196/2022, Delhi HC (23 Feb 2024)
- BASE SE v. Deputy Controller of Patents and Designs, IPDPTA/3/2023, Calcutta HC (16 Sept 2025)
- The Chinese University of Hong Kong v. Assistant Controller of Patents, CMA(PT) No.1 of 2023, Madras HC (12 Oct 2023)
- Sequenom Inc. & Anr v. The Controller of Patents, C.A.(COMM.IPD-PAT) 13/2022 & 448/2022, Delhi HC (9 Oct 2025)
- EMD Millipore Corporation v. Assistant Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 7/2021, Delhi HC (9 Oct 2025)
- Natera Inc. & Anr v. Assistant Controller of Patents & Designs, C.A.(COMM.IPD-PAT) 16/2023, Delhi HC (9 Oct 2025)
- BTS Research International Pty Ltd v. The Controller General of Patents & Designs, IPDPTA 56 of 2023, Calcutta HC (3 April 2025)
- The Zero Brand Zone Pvt. Ltd. and others v. Controller of Patents and others, (T) CMA(PT) No.146 of 2023, Madras HC (5 July 2024)
Authored by Gaurav Mishra, Patent Attorney, BananaIP Counsels