By Lucy Rana and Aastha Suri
India has redrawn how it examines biotech patents for the first time since 2013. If you own a portfolio in pharma, biologics, biosimilars or diagnostics, the draft changes what will get granted in India — and what won’t.
On 4 September 2026, the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) published draft guidelines for examining biotechnology patent applications, replacing guidance that had stood since 2013. They are not law yet. But they tell you how Indian examiners will read your applications, and for a brand owner deciding where to file and how to draft, that is often more useful than the statute itself.
Why this matters to brand owners
Examination guidelines shape grant rates, claim scope and, in the end, the commercial exclusivity that sits behind a product in the Indian market. The 2013 version predated CRISPR, most of the recent diagnostics case law, and the current thinking on biologics. The 2026 draft closes that gap and, in doing so, it hardens the Patent Office’s position in several areas that touch revenue directly.
What the draft actually changes
Three things stand out. It engages head-on with modern technology: CRISPR, synthetic biology, antibody-drug conjugates, tissue engineering, bioinformatics and machine learning all appear by name. It writes recent court decisions into each examination test, so an objection will increasingly arrive with a judgment attached. And it tightens procedure: examiners must now disclose the search string behind an objection, and sequence listings are expected in the WIPO ST.26 format.
Diagnostics: the biggest shift for molecular-Dx owners
If your portfolio includes molecular or companion diagnostics, start here. Drawing on the Madras High Court in Chinese University of Hong Kong and the Delhi High Court’s consolidated ruling in Sequenom, EMD Millipore and Natera, the draft treats methods of diagnosis as non-patentable under Section 3(i) — including in-vitro methods, screening of asymptomatic persons where the test is capable of identifying the existence or non-existence of a disease for treatment, and tests that return a negative result. What survives is the product side: kits, devices, tools and reagents that meet the ordinary tests. The takeaway for brand owners is to move value into product and kit claims and away from method-of-diagnosis claims, and to expect software-only diagnostic tools to be pushed into the computer-program exclusion.
Section 3(d) now reaches biologics, biosimilars and enzymes
Section 3(d) long the gatekeeper against small-molecule evergreening is now pointed squarely at biologics, biosimilars, vaccines and enzyme variants. The draft applies the Supreme Court’s efficacy test from Novartis by analogy, and leans on Natco v. Novartis (enhanced bioavailability is not enhanced therapeutic efficacy) and Novozymes (enzyme variants must show enhancement of the known efficacy, judged by the substance’s function or purpose). In practice, new forms, variants, and crystalline or 3D-structure claims for medicines will need therapeutic-efficacy data, while non-therapeutic enzyme variants must demonstrate material enhancement of the efficacy relevant to their intended use. Any 3(d) objection should at least name the specific known substance it is built on (DS Biopharma).
Plants, seeds and agri-biotech: still outside the Patents Act (but modified micro-organisms remain patentable)
Genetically modified plants and seeds remain outside the Patents Act under Section 3(j); protection there runs through the Protection of Plant Varieties and Farmers’ Rights Act instead. Agricultural methods stay excluded under Section 3(h), though the draft adopts the narrower reading from Mitsui and BASF, which leaves room for genuinely technical solutions to agricultural problems.
Gene editing, CRISPR and the morality line
Gene-editing claims that touch the human germline, or methods that destroy human embryos, are used in the draft as textbook examples of what Section 3(b) blocks on morality grounds. Product and process claims around gene editing can still survive, provided they are drafted clear of those lines.
Bioinformatics and AI in biology
Purely computational, algorithmic or machine-learning methods without a real technical effect or tangible product fall under Section 3(k). And where a claim depends on a machine-learning model, the draft expects the specification to disclose the model’s architecture and training as a matter of sufficiency under Section 10, an easy requirement to miss on AI-adjacent biotech filings.
Compliance you cannot skip: biodiversity, ST.26 and deposits
Two compliance points carry real downside. Where an invention uses biological material from India, disclosure of source and geographical origin is mandatory, and non-disclosure or wrongful disclosure is a ground of opposition under Sections 25(1)(j) and 25(2)(j). National Biodiversity Authority approval is handled separately through the Form 1 declaration and a pre-grant intimation letter. Separately, biological material that cannot be described sufficiently must be deposited with a Budapest-Treaty International Depository Authority by the filing date; three IDAs are located in India, including NAIMCC in Uttar Pradesh.
The case law now built into examination
The most structural change is that the draft hard-wires more than twenty recent decisions into the examination workflow – including around sixteen from 2022 to 2025, from Vifor on product-by-process claims to Syngenta on divisional applications. For brand owners, that means an examiner’s objection will more often come with a judgment behind it, and responses will need to engage with the law, not just the science.
What brand owners should do now
- Review pending Indian filings for two exposures in particular: diagnostics method claims, and Section 3(d) risk on biologics and variants.
- Rebalance diagnostics portfolios toward kit, device, reagent and product claims.
- Line up therapeutic-efficacy data to support new-form, variant and crystal-structure claims.
- For AI-enabled inventions, make sure the specification discloses the model architecture and training.
- Complete biodiversity approvals, source-of-origin disclosure and any required deposits early, to avoid opposition exposure.
The consultation window
The CGPDTM invited stakeholders to comment within 15 days of the 4 September 2026 publication. The window is short, so brand owners with a meaningful Indian portfolio may wish to feed views in quickly — directly or through counsel while it remains open.
Frequently Asked Questions
India's Draft Biotechnology FAQ
They are draft guidelines published by India’s patent office (CGPDTM) on 4 September 2026, replacing the 2013 version, setting out how examiners will assess biotechnology patent applications. They are not yet law.
The Section 3(d) efficacy standard is applied to biologics, biosimilars, vaccines and enzyme variants. New forms and variants of medicines will need therapeutic-efficacy data to be patentable, while non-therapeutic enzyme variants must show material enhancement of the efficacy relevant to their intended use.
Methods of diagnosis, including in-vitro tests and screening of asymptomatic persons where the test is capable of identifying the existence or non-existence of a disease for treatment, are excluded under Section 3(i). Diagnostic kits, devices and products can still be patented if they meet the usual tests.
No. GM plants and seeds are excluded under Section 3(j); protection is available under the Protection of Plant Varieties and Farmers’ Rights Act instead.
Review Indian portfolios for diagnostics-method and Section 3(d) exposure, shift value into product and kit claims, prepare efficacy data, and complete biodiversity and deposit compliance.
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