Draft Biotechnology Patent Examination Guidelines 2026: What the Indian Patent Office Has Proposed

The Indian Patent Office published draft biotechnology patent examination guidelines on 4 September 2026 and has invited comments within fifteen days of the public notice. The 49-page draft runs to twenty-one headings, quotes eighteen Indian court decisions, and works through thirty-six illustrative examples. This article sets out what the draft says, heading by heading.

The draft applies to examination under the Patents Act 1970 in India and covers the same ground as the biotechnology examination guidelines the Office issued in March 2013; it does not say in terms that it will supersede them. It is a draft, and its own disclaimer says the Act and Rules prevail on any conflict.

What the Draft Biotechnology Patent Examination Guidelines Are

The draft is written for Examiners and Controllers, to achieve uniform and consistent examination of biotechnology and allied applications. It describes itself as supplemental to the Manual of Patent Office Practice and Procedure and lists fourteen provisions of the Act it emphasises: the three patentability criteria, nine Section 3 exclusions, and the two Section 10 disclosure and claim requirements.

The closing disclaimer sets the reading rules. The illustrations are not intended to exhaust how the guidelines apply; Examiners are asked to examine case by case without being prejudiced by the illustrations; the Act and Rules prevail on conflict; the guidelines are described as dynamic, to be updated as and when required; and the case law quoted is described as purely dynamic in nature.

The list of typical claim types now names antibody-drug conjugates, CRISPR-based therapeutics, tissue engineering and bio-printing, bioinformatics, and synthetic biology.

Biodiversity Act Compliance and the Intimation Letter

The draft treats Biological Diversity Act compliance and disclosure of the source and geographical origin of biological material as an essential element of biotechnology examination. It refers to the Biological Diversity Act 2002 as amended in 2023 and to the National Biodiversity Authority’s approval or registration requirement for intellectual property rights obtained from Indian biological resources.

On the patent side, the draft records that disclosure of source and geographical origin is mandatory in a patent application, that Form 1 carries a declaration that the necessary permission from the competent authority will be submitted before grant, and that non-disclosure or wrongful disclosure is a ground of both pre-grant and post-grant opposition. It also describes existing practice: when an application is put in order for grant, the Office sends an intimation letter asking for compliance with the Form 1 declaration and for the approval or registration certificate for biological material obtained from India.

Prior Art Search and Sequence Listings

The draft asks Examiners to combine keywords, IPC codes and sequences across patent and non-patent databases, states that a nucleotide or amino acid sequence listing is to be filed electronically in WIPO Standard ST.26 format, and names BLAST, UniProt and FASTA as sequence search tools on commercial and freely available databases.

The sentence practitioners will notice closes the section: the Examiner’s report must mandatorily disclose the search string or query used during the prior art search. The 2013 guidelines had no equivalent sentence. The draft refers to the Examiner’s report and does not say whether the query would also appear in the examination report sent to the applicant.

Novelty and Inventive Step

Novelty is assessed as for any other invention. A product-by-process claim is anticipated by any prior disclosure of the product itself, whatever its method of production, and the draft quotes the Delhi High Court Division Bench in Vifor v MSN Laboratories: it is the novelty of the product that must be established, shorn of the process terms.

Sequence claims follow the same logic. A polynucleotide that was available before the priority date, for example in a library, lacks novelty even if its function was unknown, while a sequence that does not exactly match a prior art sequence is not anticipated by it but remains open to inventive step and Section 3 objections.

For inventive step the draft restates the statutory test, adds that a claim is obvious over a single document or a mosaic, and gives six examples. Four fail: an IL-3 DNA with a single serine-to-proline substitution and no evidence of an unexpected effect; a two-organism galacto-oligosaccharide process where the second document supplies the motivation to combine; a plasmid-removal method using sub-inhibitory silver particles, an obvious extension of known membrane effects; and a pro-insulin variant whose yield of 1.6 to 2.0 mmol/l against 1.0 mmol/l is not treated as an unexpected property.

Two succeed: a humanised anti-CD19 CAR polypeptide, because the specification contains data showing an improved cytokine profile and enhanced tumour reduction over the closest prior art, and a recombinant DNA encoding human interferon alpha-2, because the claimed interferon is thirty times more potent than the alpha-1 analogue. In the two examples that succeed and in two of the four that fail, the outcome turns on whether an unexpected effect over the closest prior art is shown; the other two fail on motivation to combine and on obvious extension of a known mechanism.

Industrial Application and Gene Sequences

A gene sequence, or the protein it encodes, cannot be patented unless the specification discloses a practical application, and the disclosed use must be specific, substantial and credible rather than speculative. The draft quotes the Delhi High Court Division Bench in Cipla v Roche on the meaning of capable of industrial application.

The two examples are the ones the 2013 text used: a hepatitis C virus polypeptide claim allowed because its use was established, against a companion claim to dozens of listed sequences refused for want of any shown use, and a V28 protein claimed as a receptor on predicted structural features and sequence homology, with no ligand disclosed, refused as speculative.

Sections 3(b), 3(c) and 3(d)

Under the morality and public order exclusion, the draft keeps the five non-limiting categories from 2013 and gives a method for deriving pluripotent stem cells from human embryos as the example of commercial use of embryos. Three new examples refuse a method that destroys the embryo, a CRISPR-Cas9 germline edit for enhanced intelligence, and a herbicide that kills pollinators.

Under the discovery exclusion, the draft repeats that products directly isolated from nature are not patentable while processes of isolating them can be, and quotes the Madras High Court in Immunas Pharma for the reading that the qualifier “mere” attaches to discovery of a scientific principle and does not extend to the discovery of a living thing or non-living substance occurring in nature. Four examples apply this, including an isolated lipase where the description identifies no recombinant enzyme.

On the new-form exclusion the draft quotes four decisions, a number matched only by the treatment and diagnosis clause. It quotes the Supreme Court in Novartis on efficacy meaning therapeutic efficacy for a medicine, the Delhi High Court Division Bench in Natco v Novartis on bioavailability not being a direct measure of therapeutic efficacy, the Madras High Court in Novozymes on enzyme variants having to pass the enhancement-of-efficacy filter without a fixed numerical threshold, and the Delhi High Court in DS Biopharma requiring the Office to identify the one known substance and state how the claimed compounds are new forms. The examples include a peptide crystal form with no demonstrated improvement over the known amorphous form, and an ACE2 inhibitor known for SARS-CoV treatment now claimed for COVID-19, treated as a mere new use of a known substance.

Sections 3(e) and 3(h)

On admixtures, the draft quotes the Madras High Court in Novozymes for two points: the clause does not say “known”, unlike its neighbours, so it is not limited to compositions of known ingredients; and it is not limited to independent claims. Both examples refuse compositions whose specifications are silent on a combined effect.

On methods of agriculture and horticulture, the draft keeps the 2013 sentence that conventional methods performed on actual open fields are agriculture, but now quotes two decisions that narrow the clause. The Delhi High Court in Mitsui Chemicals called for a clear distinction between purely agricultural methods and those with a technical or scientific foundation. The Calcutta High Court, in the appeal the draft reports as BASE SE, said that unless the claimed invention is directly and integrally connected to traditional agricultural activities it cannot be excluded, and that the clause calls for a narrow interpretation. The three examples nevertheless all refuse the claim: leguminous inter-cropping, gibberellin treatment of male parent corn plants for hybrid seed production, and spreading harvested water lettuce over soil as a mulch. The analysis of the third example does not refer to either quoted judgment.

Section 3(i): Diagnostic and Treatment Methods

This is the longest section of the draft. It reproduces the Manual’s list of excluded medicinal, surgical, curative, prophylactic, diagnostic and therapeutic methods, then quotes the Madras High Court in Chinese University of Hong Kong and the Delhi High Court’s decisions of 9 October 2025 in Sequenom, EMD Millipore and Natera.

From Chinese University of Hong Kong it takes the reading that “diagnostic” is limited to processes that disclose pathology for treatment, that the word is not confined to in vivo diagnosis, and that a screening test capable of identifying a disease qualifies whether or not the person is symptomatic. From the 9 October 2025 decisions it reproduces a six-point summary: products used for diagnosis or therapy, including kits, equipment, machines and physical products, are outside the exclusion; the exclusion is aimed at processes employed by medical practitioners and para-medical personnel; tools that could be used for diagnosis are patentable, but software-only tools are examined under the computer programme exclusion for technical effect; the words “to render them free of disease or to increase their economic value” qualify only animal treatment; mere identification of a regimen for using medicines is excluded; and methods of treating plants are outside the clause. It also quotes Sequenom on diagnosis including negative diagnosis. Our guide to what Section 3(i) bars discusses these decisions in more detail.

The two examples are a method of treating cancer with gemcitabine and a second agent while monitoring gene signatures, refused as a treatment regimen, and a method of diagnosing early-stage pancreatic cancer by measuring a biomarker’s expression level against a reference, refused as a diagnostic process carried out on the human body.

Sections 3(j), 3(k) and 3(p)

On plants, animals and essentially biological processes, the draft repeats that a conjoined reading with the discovery exclusion means only modified micro-organisms are patentable, and quotes the Calcutta High Court in BTS Research International: a process is essentially biological if it consists entirely of natural phenomena such as crossing, and the totality of human intervention has to be judged as a whole.

Its first example refuses a genetically modified drought-tolerant rice plant, stating that insertion of a transgene does not change the plant’s excluded status and pointing the applicant to the Protection of Plant Varieties and Farmers’ Rights Act. Our earlier note on the patentability of micro-organisms covers the micro-organism carve-out.

On computer programmes and algorithms, the draft says bioinformatics requires special attention and refuses both of its examples: a data processing method that map-transforms chemical and biological descriptor vectors using multivariate analysis or machine learning, described as lacking a technical contribution, and a computer-assisted method of designing an enzyme inhibitor from a three-dimensional structure that leads to no real product. The draft does not cross-refer to the Office’s 2025 computer-related inventions guidelines; our analysis of the 2025 CRI guidelines covers the technical-effect framework the two documents would have to be read together on.

On traditional knowledge, the draft quotes the Madras High Court in Zero Brand Zone: the clause gives defensive protection, “traditional knowledge” is not qualified by “per se”, and the exclusion does not shut out inventions drawing on traditional knowledge where the applicant can show the product or process can no longer be described as traditional knowledge in effect. Background is in our note on traditional knowledge and intellectual property.

Disclosure, Support, Unity and Deposit

The sufficiency section carries over the 2013 doctrine on laundry-list claims, reach-through claims, sequence variants and hybridisation conditions, and adds that the source and geographical origin of biological material must be disclosed to meet the enablement requirement. Two new examples refuse an antigen-binding molecule defined by an 80 per cent CDR3 identity range and a biomarker method built on unspecified machine learning models.

On unity of invention, the draft keeps the a priori and a posteriori tests and adds a paragraph on divisional applications quoting the Delhi High Court Division Bench in Syngenta: a divisional is maintainable where plurality of inventions is disclosed in the provisional or complete specification, whether filed on the applicant’s own motion or to meet an objection. Our comparison of unity of invention across jurisdictions gives the international context.

The deposit section restates the rule for biological material that is not publicly available and cannot be sufficiently described: deposit with an International Depositary Authority under the Budapest Treaty not later than the Indian filing date, with the deposit reference given in the specification within three months of that date. New in the draft is a list of the three Indian IDAs.

The Comment Window and Pending Applications

The public notice invites comments and suggestions within fifteen days from its date of publication, to be sent to cgoffice.in@gov.in and llc-ipo@gov.in. Taking 4 September 2026 as the publication date, the window closes on or about 19 September 2026; anyone intending to comment should confirm the closing date against the notice itself.

For applications already under examination, the draft changes nothing yet. What it does show is which judgments the Office proposes to work from and which fact patterns it has chosen as illustrations. A response to a pending objection under any clause for which the draft quotes decisions can already cite the same decisions. Where a pending claim matches one of the refused examples, in particular the water-lettuce mulch, the ACE2 new-use claim, or the two bioinformatics claims, the applicant should expect the objection the example describes and prepare the comparative data or technical-contribution argument the draft says it looks for.

The table below lists the Section 3 clauses the draft addresses and the decisions each heading quotes.

This article describes the draft guidelines as published on 4 September 2026 and the provisions of the Patents Act 1970 they refer to, verified against the instruments listed under Sources. It is general information and not legal advice; the draft may change before it is finalised, and the position on any particular application depends on its facts.

Sources

1. Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology, Office of the Controller General of Patents, Designs and Trade Marks, 2026, 49 pages, published with the public notice.
2. Public Notice, Draft Biotech Guidelines, Office of the Controller General of Patents, Designs and Trade Marks, (comment window and addresses).
3. Guidelines for Examination of Biotechnology Applications for Patent, Office of the Controller General of Patents, Designs and Trade Marks, March 2013 (the earlier guidelines on the same subject).