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 09.03.05.07 to 09.03.05.09 of the Manual deal with three exclusions that affect agritech, medtech and biotech applicants: methods of agriculture or horticulture (section 3(h)), methods of treatment and diagnosis (section 3(i)) and plants, animals and essentially biological processes (section 3(j)). The Manual lists what each excludes and, usefully, what remains patentable.
A method of agriculture or horticulture, a method of medical, surgical, curative, prophylactic, diagnostic or therapeutic treatment of humans or animals, and plants, animals, seeds, varieties and essentially biological processes are not inventions. Instruments and apparatus for surgery, therapy or diagnosis, prostheses, and genetically modified micro-organisms may still be patentable. The Manual is the Patent Office's guidance and does not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as now in force prevail.
Check the current Manual on ipindia.gov.in. For the overview, see what cannot be patented under section 3 and patenting biotech inventions, micro-organisms and genes. For help with an objection, see our patent objection reply service.
Section 3(h): methods of agriculture or horticulture (09.03.05.07)
The Manual's examples of excluded subject matter are: a method of producing a plant, even where it modifies the conditions under which natural phenomena pursue their course (a green-house is given as the instance); a method of producing improved soil by treating soil that has nematodes with a preparation containing specified phosphorothioates; a method of producing mushrooms; a method of cultivating algae; and a method for removal of weeds.
The examiner's question is whether the claim is to a method of cultivation or crop husbandry. The practical response is to claim the apparatus, composition or product that is not itself a method of agriculture, where the specification supports it, and to avoid method claims whose only feature is the cultivation step.
Section 3(i): methods of treatment and diagnosis (09.03.05.08)
The Manual says any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings, or a similar treatment of animals to make them disease-negative or to increase their economic value or that of their products, is not an invention. It then groups what is excluded.
| Category | Manual's examples or description |
|---|---|
| Medicinal methods | Administering medicines orally, by injection, topically or through a dermal patch |
| Surgical methods | An incision for cataract removal without stitches |
| Curative methods | Cleaning plaque from teeth |
| Prophylactic methods | Vaccination |
| Diagnostic methods | Identifying the nature of an illness by history, symptoms and tests; determining the general physical state of an individual, such as a fitness test, is diagnostic |
| Therapeutic methods | Therapy includes prevention as well as treatment or cure |
| Animal treatment | Treating sheep to increase wool yield; artificially inducing body mass of poultry |
| Operations on the body | Any operation needing the skill and knowledge of a surgeon, including cosmetic treatment, termination of pregnancy, castration, sterilisation, artificial insemination, embryo transplants, experimental treatments, removal of organs, skin or bone marrow from a living donor, and any therapy or diagnosis practised on the human or animal body, with methods of abortion, induction of labour, control of oestrus and menstrual regulation |
Three limits on the exclusion matter in practice:
- applying substances to the body for purely cosmetic purposes is not therapy;
- a patent may be obtained for a surgical, therapeutic or diagnostic instrument or apparatus; and
- the manufacture of prostheses or artificial limbs, and taking measurements of them on the human body, are patentable.
The line is therefore between the method practised on the body and the thing used in the method. A claim to "a method of treating condition X by administering compound Y" falls in the exclusion; a claim to a device, apparatus, composition or process of manufacture may not, subject to the other requirements and to section 3(d) for known substances; see section 3(d).
Section 3(j): plants, animals and essentially biological processes (09.03.05.09)
The Manual says plants and animals in whole or any part, other than micro-organisms, including seeds, varieties and species, and essentially biological processes for the production or propagation of plants and animals, are not inventions. It lists the exclusions as plants in whole or in part, animals in whole or in part, seeds, varieties and species of plants and animals, and essentially biological processes for production or propagation of plants and animals.
Micro-organisms, other than those discovered from nature, may be patentable. The Manual gives genetically modified micro-organisms as an example, subject to the other requirements of patentability. Plant varieties are protected under the Protection of Plant Varieties and Farmers' Rights Act, 2002.
For discoveries from nature, see section 3(c) in our companion article. For the 2013 Biotechnology Guidelines on these clauses, see Biotechnology Guidelines 2013, section 3(h), (i), (j), (k) and (p).
How objections are framed and answered
| Objection | A typical reply |
|---|---|
| Claim 1 is a method of treating a disease | Replace with a claim to the composition, device or apparatus, or to a process of manufacture, if supported by the specification |
| Diagnostic method practised on the body | Claim the diagnostic instrument or kit instead |
| Cosmetic application on the skin | Show the use is purely cosmetic and not therapy |
| Claim to a plant, seed, variety or animal | Claim the micro-organism, construct or process of a technical character, not the organism itself, if available |
| Essentially biological process | Show the technical intervention that is not merely natural breeding or propagation |
| Method of cultivation or weed removal | Claim the device or the formulation |
Worked example
Bhatt Dental Systems Pvt Ltd files claims for (1) a method of cleaning plaque from teeth using a sonic scaler, and (2) the scaler itself. The examiner objects to claim 1 under section 3(i) as a curative method, and allows claim 2, since the Manual says patents may be obtained for surgical, therapeutic or diagnostic instruments. The company deletes claim 1. A second application claims a genetically modified bacterium for degrading plastic; the examiner raises no section 3(j) objection because micro-organisms other than those discovered from nature may be patentable.
Need help with a section 3 objection?
Method claims in medtech, agritech and biotech often need to be recast as device, composition or process claims. Our patent objection reply team can advise on the reframing within the application as filed.
Key takeaways
- Methods of agriculture or horticulture are excluded; examples include producing mushrooms and cultivating algae.
- Methods of treatment and diagnosis on humans and animals are excluded, but instruments, apparatus, prostheses and purely cosmetic applications are not.
- Plants, animals, seeds, varieties and essentially biological processes are excluded; micro-organisms other than those discovered from nature may be patentable.
- Plant varieties are protected under a separate Act.
- The Act and Rules as now in force prevail over the Manual.
Read next
- Chapter 9: section 3(d)
- Chapter 9: section 3(l) to (p)
- Biotechnology Guidelines 2013: section 3(h), (i), (j), (k) and (p)
- Patenting biotech inventions, micro-organisms and genes
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.