Section 3 explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Paragraphs 14 to 18 of the Biotechnology Patent Guidelines (March 2013) apply five more exclusions to biotechnology claims: agriculture and horticulture methods, treatment and diagnosis, plants and animals, bioinformatics and traditional knowledge. Each is illustrated by an example from the Office's own practice.
Section 3(h) excludes conventional methods performed on open fields (para 14). Section 3(i) excludes treatment and diagnosis, and a claim worded as a combination of drugs is caught if its substance is the method of giving them (para 15). Section 3(j) excludes plants, animals and essentially biological processes, and a cell-based composition is caught if the cell is the real product (para 16). Section 3(k) is dealt with in paragraph 17, which is older than the CRI Guidelines 2025. Section 3(p) catches claims that are in effect traditional knowledge (para 18). The Guidelines are the Patent Office's guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as now in force prevail.
The Office revises its guidelines, so check the current version on ipindia.gov.in. This document dates from March 2013. For the same exclusions in the Manual, see our article on section 3(h), (i) and (j). A section 3 objection on a biotechnology claim can be answered through a patent objection reply.
Section 3(h): methods of agriculture and horticulture (paragraph 14)
The Guidelines say a method of agriculture or horticulture is not patentable, and that conventional methods performed on actual open fields are to be treated as such. The example is a method of growing leguminous plants as inter-cropping to improve soil fertility by raising its nitrogen content: an agriculture method, excluded.
Section 3(i): methods of treatment and diagnosis (paragraph 15)
The Guidelines list, from the Manual, the methods that are excluded: medicinal, surgical, curative, prophylactic (such as vaccination), diagnostic and therapeutic methods, methods of treating animals to rid them of disease or raise their economic value, operations needing a surgeon's skill and any therapy or diagnosis practised on the body. They add that applying substances purely for cosmetic purposes is not therapy, and that instruments and apparatus for surgery, therapy or diagnosis, and prostheses, may be patented.
A drafting trap is stated plainly: sometimes the claims are worded as a combination or composition of drugs in dosage forms, but the invention resides in administering the individual drugs simultaneously, sequentially or together. The claim then falls under section 3(i).
The example is a method of monitoring drug response in a cancer patient treated with a drug combination by detecting a gene signature of at least two response markers. The Office treats it as a diagnostic method of human beings or animals, which is barred.
Section 3(j): plants, animals and essentially biological processes (paragraph 16)
The Guidelines restate that plants and animals in whole or in part (other than micro-organisms), including seeds, varieties and species, and essentially biological processes for producing or propagating them, are not patentable. Read with section 3(c), only modified micro-organisms that do not constitute a discovery of a living thing occurring in nature are patentable. Claims on essentially biological processes of growing plants, germination of seeds, or the development stages of plants and animals are objected to under section 3(j).
| Example in the Guidelines | Outcome | Reason |
|---|---|---|
| A therapeutic composition whose effective ingredient is ex vivo educated autologous immune cells, with an optional carrier, diluent or excipient | Excluded under 3(j) | The educated cells alone are the final product, since the other ingredients are optional; wording a claim as a composition with routine carriers does not change that |
| A method of producing pure hybrid seeds by crossing a fertile male parent with a sterile female parent and harvesting the seeds | Excluded | Cross-breeding is an essentially biological process |
The first example matters for cell therapy and vaccine applicants. A claim to cells in a "composition" does not escape section 3(j) if the carrier is incidental.
Section 3(k): bioinformatics (paragraph 17)
The Guidelines note that bioinformatics, a field combining information technology and biotechnology, needs special attention under section 3(k). They give two examples, both excluded as a mathematical method or computer programme per se:
- A data processing method that transforms characteristic vectors of a chemical compound and a biological substance by multivariate analysis to improve correlation. The references to chemical and biological substances are only the meaning of the data, not technical implementation details, and no product results.
- A computer-assisted method of designing an inhibitor from the three-dimensional structure of an enzyme's active site, which does not lead to a real product.
This paragraph is older than the CRI Guidelines 2025, which replaced the Manual's section 3(k) guidance and now govern the examination of computer related inventions. Bioinformatics claims should be read against that newer text; see our article on the CRI Guidelines, scope and the four limbs of section 3(k). The Act and Rules as now in force prevail.
Section 3(p): traditional knowledge (paragraph 18)
The Guidelines restate that an invention which in effect is traditional knowledge, or an aggregation or duplication of known properties of traditionally known components, is not patentable, and say separate guidelines cover traditional knowledge. The example is serum of pigeon said to have anti-paralysis activity. A published ethnobiology article records the use of pigeon blood for treating paralysis, so the claim is traditional knowledge or an aggregation of known properties of a traditionally known component. For those guidelines see our article on the six guiding principles.
What the examiner checks, and what to file
| Examiner's question | What the applicant should show |
|---|---|
| Is the method an open-field agricultural method? | A technical process outside the field, or a product claim |
| Is the claim a method of treatment or diagnosis in a different form? | A product, a composition with a real structural contribution, or an apparatus |
| Is the active ingredient a plant, animal or part of one, or only an educated cell? | A claim to a modified micro-organism or a process that is not essentially biological |
| Is the bioinformatics claim only data processing? | A technical implementation and a product or technical effect, assessed under the CRI Guidelines 2025 |
| Is the claim in effect traditional knowledge? | Evidence that the effect or composition goes beyond the traditional source |
A worked example (invented)
Amrit Cellworks claims a composition of patient-derived immune cells with an optional buffer. The examiner objects under section 3(j) by reference to the NK T cell example. Amrit's specification also describes a genetically modified micro-organism that produces the signalling molecule used to educate the cells, and a purification process for it. Amrit amends to the modified micro-organism and the process. The claims no longer rest on cells taken from a patient.
Common lapses
- Claiming a drug combination when the novelty lies in the administration schedule.
- Adding "a carrier" to a cell claim and expecting it to turn into a composition.
- Claiming a breeding step as a process of producing hybrids.
- Treating bioinformatics output as a product.
Need help with a section 3(i), (j) or (p) objection?
These objections are answered by moving the claim to a product, a modified micro-organism or a technical process the specification supports. Our team can review the specification and prepare the reply. See patent objection reply, and read next about the section 3(b) to (e) exclusions in the same Guidelines.
Key takeaways
- Conventional open-field methods are excluded under section 3(h).
- A drug combination claim whose substance is administration falls under section 3(i).
- A cell composition is caught under section 3(j) if the cell is the final product.
- Bioinformatics claims should now be assessed under the CRI Guidelines 2025.
- A claim duplicating a traditional use is excluded under section 3(p).
Read next
- Biotechnology Patent Guidelines 2013, paragraphs 10 to 13: section 3(b), (c), (d) and (e)
- CRI Guidelines 2025: scope, terms and the four limbs of section 3(k)
- Manual Chapter 9: section 3(h), (i) and (j)
- TK and Biological Material Guidelines 2012: the six guiding principles
Disclaimer: Based on the manuals and guidelines published by the Office of the Controller General of Patents, Designs and Trade Marks that are named in the article, as consulted on 4 October 2026. They are guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as amended (including the 2024 amendment rules) prevail, and the current versions on ipindia.gov.in should be checked. This article is general information, not legal advice; check the official text before acting.