Key points
- The draft, published on 4 September 2026, would replace the 2013 biotechnology guidelines. It is not yet final.
- Examination reports must disclose the examiner’s search strings, and sequence listings should be filed in WIPO ST.26 format.
- Products isolated from nature remain unpatentable under section 3(c). Modified products need data showing what the change achieves.
- Methods of diagnosis stay excluded, but kits, devices and other diagnostic products can be patented, following the Delhi High Court’s 2025 decisions.
On 4 September 2026 the Office of the Controller General of Patents, Designs and Trade Marks published the Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology, 2026, together with draft guidelines for pharmaceutical applications, and invited comments within 15 days. The draft would replace the Guidelines for Examination of Biotechnology Applications for Patent issued in 2013. At the time of writing, the final version has not been published.
Guidelines do not change the law. The draft says so itself: if it conflicts with the Patents Act, 1970 or the Patents Rules, 2003, the Act and the Rules prevail. But examiners and Controllers work from guidelines, so they shape the objections an applicant meets in an examination report. Much of the draft restates High Court decisions of the last few years, which makes it a useful map of where Indian biotech patent law now stands.
What the draft covers
The draft has 21 sections and 36 worked examples. Its list of the subject matter examiners should expect is noticeably more modern than the 2013 text: antibodies and antibody–drug conjugates, viral vectors, stem cells and genetically modified organisms, nucleic-acid therapeutics such as siRNA and CRISPR-based products, tissue engineering and bio-printing, bioinformatics (including metabolomics and next-generation sequencing), gene editing with CRISPR and TALENs, synthetic biology and RNA interference.
Searches: more transparency
- Search strings in the report. Examiners are to search patent and non-patent databases using keywords, classification and sequences, and the examination report “must mandatorily disclose” the search string or query used. Applicants will be able to see how the prior art was found, and argue gaps in the search.
- Sequence listings. Under rule 9(3) of the Patents Rules, sequence listings must be filed in electronic form. The draft says they should be in the WIPO Standard ST.26 format, and that examiners should search sequences with tools such as BLAST and FASTA and databases such as UniProt.
Biological material from India
The draft devotes a section to the Biological Diversity Act, 2002, as amended in 2023. Under section 6 of that Act, obtaining intellectual property rights from the use of biological resources from India requires the approval of, or registration with, the National Biodiversity Authority. The Patents Act adds its own requirements:
- the specification must disclose the source and geographical origin of any biological material used in the invention (section 10(4)(d)(ii)(D));
- Form 1 contains a declaration that the necessary permission will be submitted before grant, and when an application is put in order for grant the Office asks for the NBA approval or certificate of registration;
- failing to disclose, or wrongly disclosing, the source or geographical origin is a ground of opposition before and after grant (sections 25(1)(j) and 25(2)(j)).
Applicants who use Indian biological resources should start the NBA process early, because it can hold up grant of an application that is otherwise allowable.
Novelty: sequences and product-by-process claims
- Sequences. A sequence that was publicly available before the priority date, for example as part of a library, lacks novelty even if its function was not known. A sequence that differs from the prior art is not anticipated, but the prior art still counts for inventive step and the section 3 exclusions.
- Product-by-process. A product defined by the process that makes it is new only if the product itself is new. The draft relies on the Delhi High Court’s Division Bench decision in Vifor (International) Ltd v. MSN Laboratories (7 February 2024): a new process does not make an old product new, and the applicant must show, with technical evidence, that the product has distinct properties.
Inventive step: show what was unexpected
The worked examples make the Office’s approach clear. A single amino-acid substitution in a known protein, with no evidence of an unexpected effect, is treated as obvious. So is a higher yield of a modified pro-insulin that the examiner does not regard as unexpected. By contrast, a structurally close interferon that is thirty times more potent than its prior-art analogue, and a CAR-T construct whose specification includes data on an improved cytokine profile and greater tumour reduction, are both accepted as inventive. The lesson for applicants is to put comparative data in the specification as filed.
Industrial application: a credible use
A gene or protein is patentable only if the specification discloses a use that is specific, substantial and credible, not speculative. The draft cites the Delhi High Court’s decision in Cipla v. F. Hoffmann-La Roche (2015). An expressed sequence tag described only as a “gene probe” or “chromosome marker” fails this test; one disclosed as a probe for diagnosing a specific disease may pass.
The section 3 exclusions
| Clause | What the draft says |
|---|---|
| 3(b): public order and morality | Excludes processes for cloning humans, modifying the human germline (including CRISPR editing of human embryos), methods that destroy human embryos such as deriving stem cells from them, and products that seriously harm the environment, such as a spray that kills pollinators. |
| 3(c): discoveries | Micro-organisms, nucleic acids, proteins and enzymes isolated directly from nature are not patentable; processes for isolating them can be. Following the Madras High Court in Immunas Pharma v. Assistant Controller (6 March 2024), the word “mere” does not soften the exclusion for living and non-living substances occurring in nature. |
| 3(d): new forms of known substances | For medicines, “efficacy” means therapeutic efficacy (Novartis v. Union of India, Supreme Court, 2013), and better bioavailability alone is not enough (Natco Pharma v. Novartis, Delhi High Court, 24 April 2024). For non-therapeutic enzyme variants, the applicant must show a material enhancement of efficacy (Novozymes v. Assistant Controller, Madras High Court, 20 September 2023). The Office must identify the known substance it relies on (DS Biopharma, Delhi High Court, 2022). Crystal forms of known polypeptides, and new uses of known substances, are caught. |
| 3(e): mere admixtures | Following Novozymes, the exclusion is not limited to mixtures of known ingredients or to independent claims. A composition needs evidence of an effect beyond the sum of its parts. The examples reject a mixture of two known nematode-control fungi, and a four-protein composition, for lack of such evidence. |
| 3(h): agriculture | Conventional methods performed in open fields are excluded. The Delhi High Court (Mitsui Chemicals, 2024) has drawn a line between farming methods and technical solutions to agricultural problems, and the Calcutta High Court (2025) has favoured a narrow reading of the clause. |
| 3(i): treatment and diagnosis | Methods of treatment and diagnosis of humans are excluded, whether performed in vivo or in vitro (Chinese University of Hong Kong, Madras High Court, 2023). Following the Delhi High Court’s October 2025 decisions in Sequenom, EMD Millipore and Natera, diagnostic products, kits and devices remain patentable, “diagnosis” includes ruling a condition out, dosage regimens are excluded, and software-only diagnostic tools are examined under section 3(k). Treating plants is not covered by 3(i). |
| 3(j): plants and animals | Plants and animals are excluded even if genetically modified; plant varieties are protected under the Protection of Plant Varieties and Farmers’ Rights Act, 2001 instead. Modified micro-organisms can be patented. Whether a process is “essentially biological” depends on the totality of human intervention (BTS Research International, Calcutta High Court, 3 April 2025). |
| 3(k): computer programs and algorithms | Bioinformatics methods that only correlate data with machine-learning models, or design compounds on a computer without producing anything, are objected to. See our note on the 2025 Computer Related Inventions Guidelines. |
| 3(p): traditional knowledge | Inventions that are, in effect, traditional knowledge are excluded, though inventions that draw on it are not automatically barred (The Zero Brand Zone v. Controller, Madras High Court, 5 July 2024). |
Disclosure and claim scope
- Laundry lists and reach-through claims. A gene claimed for a long list of unrelated diseases, or a screening method claimed together with whatever compounds it may find, will be objected to unless the specification supports each use.
- Variants and hybridisation. Claims to variants should be limited to those sharing a disclosed, specific activity, and claims defined by hybridisation need the conditions spelled out.
- Antibodies. An antibody defined by a percentage identity in its CDRs needs data showing that antibodies across that range actually bind, and therapeutic or diagnostic antibody claims need evidence of the target’s role in the disease.
- AI-based methods. A method that analyses biomarker data with neural networks must describe the type and architecture of the models and how they are trained, or it will be found insufficient.
- Later developments do not help. Sufficiency is judged at the date of the complete specification, and amendments must stay within what was originally disclosed (Regents of the University of California v. Controller, Delhi High Court, 5 February 2024).
Unity of invention and divisionals
Applications claiming many sequences often lack unity, either on their face (no shared technical feature) or after the search (the shared feature is already known). The draft adopts the Delhi High Court Division Bench decision in Syngenta v. Controller (13 October 2023): a divisional application can be filed for any invention disclosed in the provisional or complete specification, not only one that appears in the claims.
Deposits of biological material
If the invention uses biological material that is not publicly available and cannot be described well enough in words, it must be deposited with an International Depositary Authority under the Budapest Treaty no later than the date of filing in India, and the deposit must be referred to in the specification within three months of filing. India’s depositary authorities are the Microbial Type Culture Collection and Gene Bank (CSIR-IMTECH, Chandigarh), the Microbial Culture Collection (NCCS, Pune) and the National Agriculturally Important Microbial Culture Collection (ICAR-NBAIM, Mau).
What applicants should do now
- Put comparative data in the specification: efficacy for section 3(d), synergy for section 3(e), and unexpected effects for inventive step.
- Claim what you made, not what you found: engineered, recombinant or modified products, and the processes for making them.
- If you use biological resources from India, apply to the National Biodiversity Authority early, and disclose source and geographical origin.
- File sequence listings in ST.26 format.
- For diagnostics, claim the kit, reagent or device rather than the method of diagnosing.
- For AI-based methods, describe the models, their architecture and their training.
- Make any deposit before filing in India.
- When the examination report arrives, read the search strings as closely as the citations.
The final guidelines may differ from the draft, and we will update this note when they are published. For help with a biotechnology application, see our patents practice and the Patent FAQs.
Sources
This article is for general information and states the law as at 12 October 2026. It is not legal advice. For advice on your situation, contact the firm. Published by BRB Legal.
