Patent Office releases draft examination guidelines for pharmaceutical and biotechnology patent applications, 2026
The Office of the CGPDTM has published two drafts — Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals and in the Field of Biotechnology, both marked 2026. They are meant to bring uniform examination standards and to take in court decisions. Both are drafts; the Act and Rules prevail in any conflict.
Key facts
- In force
- Drafts — not in force
- Who it affects
- Pharmaceutical and biotechnology companies, research institutions, patent agents and attorneys, opponents in pharma and biotech patent matters
- What it is
- Comments invited
- Section
- Trademark & IP
- Published
- 4 September 2026
In 30 seconds
- Two separate documents, each titled “Draft Guidelines … 2026”, published on the IP India website.
- The pharma draft says it supplements the Manual and the 2014 pharmaceutical, 2013 biotechnology and 2025 Ayush guidelines.
- In a conflict between the Guidelines and the Patents Act, 1970 or the Rules, the Act and Rules prevail.
- The pharma draft addresses Markush claims, section 3(d), section 3(e), section 3(i), sufficiency and unity of invention.
- The biotech draft treats Biological Diversity Act compliance and disclosure of source and geographical origin as an essential element of examination.
- Neither draft prints a last date for comments.
हिंदी में सार
CGPDTM कार्यालय ने फ़ार्मास्यूटिकल और बायोटेक्नोलॉजी क्षेत्र के पेटेंट आवेदनों की जाँच के लिए दो ड्राफ़्ट दिशानिर्देश (2026) प्रकाशित किए हैं। दोनों सिर्फ़ ड्राफ़्ट हैं, लागू नहीं; टकराव होने पर Patents Act और Rules ही मान्य होंगे। फ़ार्मा ड्राफ़्ट में Markush claims, धारा 3(d), 3(e), 3(i) और बायोटेक ड्राफ़्ट में Biological Diversity Act के अनुपालन व NBA की मंज़ूरी पर ज़ोर है। दस्तावेज़ों में टिप्पणी की कोई आख़िरी तारीख़ नहीं छपी है।
What has been published
The Office of the Controller General of Patents, Designs and Trade Marks has published two draft documents on the IP India website:
- Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026
- Draft Guidelines for Examination of Patent Applications in the Field of Biotechnology, 2026
Both are drafts. They show how the Office proposes to guide its Examiners and Controllers; they are not final. Neither document prints a date for comments or a date from which it will apply.
Why the pharma guidelines are being updated
The pharmaceutical draft says many issues in product patenting “are now becoming clear through the decisions of the Hon’ble Courts”, and that there is therefore a need to update the guidelines, incorporating the analysis of the courts, to improve the examination standard and bring harmonious practice among officers.
It describes itself as supplemental to the Manual of Patent Office Practice and Procedure, the pharmaceutical guidelines of 2014, the biotechnology guidelines of 2013 and the Guidelines for Examination of Ayush Related Inventions, 2025. Examiners are asked to examine case by case without being prejudiced by the illustrations, and “in case of any conflict between these Guidelines and the Patents Act, 1970 and the Rules made thereunder, the provisions of the Act and Rules shall prevail”.
What each draft covers
| Subject | Pharmaceuticals draft | Biotechnology draft |
|---|---|---|
| Types of claims discussed | New chemical entities, formulations, combinations and dosage, new forms of known substances (salts, polymorphs, solvates, isomers, pro-drugs), kits, product-by-process, process claims, new use and second indications, method of treatment, selection inventions | Nucleic acids, proteins and antibodies, vectors, cells and organisms, vaccines and biologics, diagnostics, microbial processes, tissue engineering, bioinformatics, gene editing |
| Patentability | Novelty, inventive step, industrial applicability | Novelty, inventive step, industrial application |
| Section 3 exclusions | 3(b), 3(c), 3(d), 3(e), 3(i), 3(j), 3(p) | 3(b), 3(c), 3(d), 3(e), 3(h), 3(i), 3(j), 3(k), 3(p) |
| Disclosure | Sufficiency, clarity and support of claims; unity of invention | Sufficiency, clarity and support; unity of invention; deposition of biological material |
| Examples | Annexure-I: a non-exhaustive indicative list | Illustrations within the chapters |
Markush claims
The pharma draft notes that Markush claims may cover thousands or even millions of variants while only a few compounds have been synthesised and tested. The Examiner is to check, among other things, whether the specification discloses the best representatives known to the applicant, whether the embodiments share a common use or property and a common structure, whether tests for the representatives are provided, and — for product claims — whether at least one process for preparing the compounds is disclosed enabling the whole scope.
Biodiversity compliance
The biotech draft recalls that section 6 of the Biological Diversity Act, 2002, as amended in 2023, makes obtaining IPRs from the use of biological resources from India subject to approval of, or registration with, the National Biodiversity Authority. Form 1 carries a declaration that the necessary permission will be submitted before grant, and non-disclosure or wrongful disclosure of source and geographical origin is a ground of opposition under sections 25(1)(j) and 25(2)(j). When an application is in order for grant, the applicant is sent an intimation to submit the approval or certificate of registration.
What applicants should do
Pharma and biotech applicants and their agents should read the draft that applies to them against their pending claims — especially broad Markush claims and claims to new forms of known substances — and keep NBA approval papers ready where Indian biological material is used. Those who wish to comment should look for the covering notice on the IP India website; the drafts themselves do not say how.
Questions and answers
Are the 2026 pharmaceutical and biotechnology examination guidelines in force?
No. Both documents are titled “Draft Guidelines”. They are proposals and neither prints a date from which it applies.
Do the guidelines override the Patents Act?
No. The pharmaceutical draft says that in case of any conflict between the Guidelines and the Patents Act, 1970 and the Rules, the provisions of the Act and Rules shall prevail.
Do the drafts replace the 2014 pharma and 2013 biotech guidelines?
The pharmaceutical draft describes itself as supplemental to the Manual of Patent Office Practice and Procedure, the 2014 pharmaceutical guidelines, the 2013 biotechnology guidelines and the 2025 Ayush guidelines. It does not say the earlier guidelines are withdrawn.
What does the biotech draft say about Indian biological material?
That compliance with the Biological Diversity Act and disclosure of source and geographical origin is an essential element of examination, and that when the application is in order for grant the applicant is asked to submit the approval or certificate of registration from the competent authority.
Published 4 September 2026. Updated 6 October 2026. This report is for general information and is not professional advice. Read the source document before acting on it.