TK and Biological Material Guidelines 2012: how the Patent Office screens and classifies traditional knowledge applications, who examines them, the Form 1 declaration on biological material and the National Biodiversity Authority permission

TK 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.

In 2012 the Patent Office issued strict instructions to its examiners and Controllers on applications that rely on traditional knowledge (TK) or biological material. This article covers the first and last parts of that document: the background and legal basis, how applications are screened and allotted, what the examiner searches, and the rules on the Form 1 declaration and permission from the National Biodiversity Authority (NBA). The novelty and inventive step principles are in the next article.

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.

The 2012 Guidelines tell examiners to screen and classify traditional knowledge applications specially, have them handled by a named Controller and examiner in each group, search the Traditional Knowledge Digital Library, and object if the source and geographical origin of biological material is not disclosed. No patent is to be granted where the invention uses biological material from India without NBA permission. The Guidelines were written under the Biological Diversity Act, 2002; the Act as amended in 2023 should be checked, and Form 1 was substituted in 2024.

Why the Guidelines were issued (paragraphs 1 to 6)

The opening paragraphs record a concern that patents had been granted on traditional knowledge, particularly in Ayurveda, Unani and Siddha, and on Indian biological resources, without proper care for the law, while other offices were refusing such patents on the basis of TKDL evidence. They mention India's work internationally and the access agreements India has signed with several patent offices. On the legal basis they say that traditional knowledge is in the public domain, so an application relating to it does not qualify as an invention under section 2(1)(j); that section 3(e) bars mere admixtures; and that section 3(p) bars an invention that is in effect traditional knowledge or an aggregation or duplication of known properties of traditionally known components. They add that section 3(b), (c), (d), (f), (h), (i) and (j) are also of relevance.

On biological resources, the Guidelines quote section 6(1) of the Biological Diversity Act, 2002 as it then stood: a person may not apply for an intellectual property right for an invention based on research or information on a biological resource obtained from India without the previous approval of the NBA, with a special rule for patents allowing permission after acceptance but before sealing. Paragraph 5 says applications that contravene the law can be refused under section 15 or opposed before grant under section 25(1) clauses (d), (f) and (k), granted patents can be revoked after grant on the matching clauses of section 25(2), and non-disclosure or wrong mention of the source or geographical origin of biological material is a ground under clause (j) of both. The Act as amended in 2023 should be checked before any filing; this article does not describe the 2023 amendment.

Screening, allotment and who examines (paragraphs 7 to 12)

Paragraphs 7 to 12 are internal office steps, in short: an applications section must identify and classify every TK application and give it an IPC code so that it reaches the right technical group; mistakes are corrected through the Group Leader and Technical Head; and the Group Leader of the group acts as Controller for all TK cases and picks one examiner for them, with pending cases re-allotted to that pair. For an applicant, the effect is that your application is read by officers who are expected to know the TK literature, and that screening as "Traditional Knowledge" is an administrative step to help examination, not a finding on patentability (paragraph 7).

What the examiner does (paragraphs 13 to 17)

• Search. In every case on TK or biological material the examiner must make a thorough search for anticipation in the Traditional Knowledge Digital Library and other databases. If a citation comes from TKDL, an English translation of it is sent with the examination report (paragraph 13).
• Patentability. Section 3(c), (e), (i), (j) and (p) are to be strictly applied (paragraph 15).
• Disclosure. The specification is examined critically for full and particular disclosure of the invention and how it is performed, with working examples, and the method the applicant considers most suitable, as section 10(4) requires (paragraph 16). If the source and geographical origin of the biological material is not disclosed, an objection is to be raised under section 10(4) (paragraph 17).

For the section, see our article on section 10 and disclosure of biological material. Our patent drafting and filing service can help prepare the source and origin statement and the supporting records for a TK or biological material application.

The Form 1 declaration and NBA permission (paragraphs 18 to 23)

The Guidelines explain the steps in order:

1. The declaration. Form 1 carries a declaration that the invention uses biological material from India and that the necessary permission of the competent authority will be submitted before grant. From 1 January 2005 every application had to contain the declaration either affirmed or cancelled out. If it is left unattended, a fresh Form 1 is to be insisted on; if the omission is noticed later, an objection is raised (paragraph 18).
2. Declaration affirmed. The examiner raises the NBA permission objection in the first examination report if permission has not been filed, or at any later stage, and no patent is granted until the permission is submitted (paragraph 19).
3. Declaration cancelled and specification says the material is not from India. The specification is amended to add a separate heading or paragraph at the beginning of the description stating that the material is not from India and giving the country of source and geographical origin (paragraph 20).
4. Declaration cancelled but the specification says the source or origin is India. NBA permission is required (paragraph 21).
5. The rule. No patent is granted without the NBA permission where the invention uses biological material from India, or the specification's disclosure says the source or origin is India (paragraph 22).
6. Exemption circular. The Guidelines reproduce a 2012 circular of the Controller General: the 2009 exemption for medicinal plants applies only when they are traded as commodities, is not available where they are used as ingredients for medicine, and approval of the NBA should be sought for any biological resource derived from India and used in an invention (paragraph 23).

What has changed since

Form 1 was substituted by the Patents (Amendment) Rules, 2024. As described in our article on the forms as substituted in 2024, the new Form 1 still contains a declaration on use of biological material from India and the permission to be submitted before grant. The Act and Rules as now in force prevail; use the current Form and see how to file Form 1. The Guidelines also refer to the Biological Diversity Act, 2002 and its penal provision; the Act as amended in 2023 should be checked, and no penalty is stated here.

Public lists (paragraphs 24 and 25)

The Guidelines direct that the Office publish on its website a list of pending TK applications, once published under section 11A, with application number, filing date, title and applicant, and a list of patents granted on TK applications from 1 July 2012, with patent number and dates. The lists were to update automatically from the screening field.

What the examiner checks, what you show

A worked example

Sattva Botanicals Pvt Ltd files for a skin-care gel based on a leaf extract from a plant collected in a named Indian district. It affirms the Form 1 declaration on use of biological material from India and states the plant, part and district in the specification. The first examination report raises two points: TKDL shows a traditional use of the leaf for skin care, and NBA permission has not been filed. Sattva narrows its claims to a new extraction process and files the permission. If it had cancelled the declaration while the specification still named an Indian district, the Guidelines say permission would still be required.

Common lapses

• Leaving the Form 1 declaration blank or inconsistent with the specification.
• Naming no source or geographical origin for biological material.
• Assuming medicinal plants are exempt from NBA permission.
• Not searching TKDL before filing.
• Treating screening as TK as a decision on patentability.

Need help with a TK or biological material filing?

Source disclosure and permissions are easier to arrange before filing than after the first examination report. If you want your specification and Form 1 reviewed for a TK or biological material application, speak to our patent drafting and filing team.

Key takeaways

• TK applications are screened, allotted to a named Controller and examiner, and searched in TKDL.
• Source and geographical origin of biological material must be disclosed in the specification.
• No patent is granted without NBA permission where the material is from India.
• The 2012 text was written under the 2002 Act; the Act as amended in 2023 should be checked.
• Form 1 was substituted in 2024; use the current form.

Read next

• Ayush Guidelines 2025: scope, provisions and filing
• TK Guidelines 2012: novelty and inventive step, the six principles
• Chapter 9: section 3(l) to (p) and traditional knowledge
• How to file Form 1

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.