Both drafts are dated 4 September 2026 according to the trade press and the commentary on them, and neither is law. The Patents Act, 1970 and the Patents Rules prevail over both texts on any conflict, as is the case for guidelines generally.
What the Office has published
The Office's news page carries a public notice for each draft: Draft Guidelines for Examination of Pharmaceutical Applications for Patent and Draft Guidelines for Examination of Biotechnology Applications for Patent. Both asked stakeholders to comment within 15 days of publication of the notice, so the comment window has closed by now. The news listing shows October 2026 dates (07-10-2026 and 08-10-2026), which do not match the 4 September date of the documents, and which date governs is not clear from the Office's pages.
The trade press reports that the pharmaceutical draft aims at better "quality, consistency and uniformity of scrutiny" among examiners. Its PDF could not be read as text at the time of writing, so nothing below describes its provisions.
The biotechnology draft in numbers
Published commentary on the biotechnology draft describes a 49-page document with 21 headings, 18 Indian court decisions and 36 illustrative examples. It covers the same ground as the March 2013 biotechnology guidelines and names newer technologies such as antibody-drug conjugates, CRISPR-based therapeutics and synthetic biology.
Per the commentary, two procedural points are new: the examiner's report must disclose the search string or query used, which the 2013 guidelines did not require, and sequence listings are to be filed electronically in WIPO Standard ST.26.
Point by point against the 2013 text
According to the commentary, the draft differs from the 2013 guidelines unevenly. On novelty it identifies no difference. On inventive step the draft restates the statutory test and adds that a claim can be obvious over a single document or a mosaic of documents, with six examples (four refused, two allowed). On sufficiency under Section 10 the draft carries over the 2013 doctrine on laundry-list and reach-through claims, and adds that the source and geographical origin of biological material must be disclosed to meet enablement. Two new refused examples sit here: an antigen-binding molecule defined by an 80 per cent CDR3 identity range, and a biomarker method built on unspecified machine learning models. This comparison rests on the commentary, not on a reading of the draft itself.
Section 3(d) and the other exclusions
Per the commentary, Section 3(d) is handled through four decisions: Novartis in the Supreme Court (efficacy means therapeutic efficacy for medicines), Natco v Novartis (Delhi High Court Division Bench, 2024: bioavailability is not a direct measure of therapeutic efficacy), Novozymes (Madras High Court, 2023: enzyme variants must pass the efficacy filter, with no fixed numerical threshold) and DS Biopharma (Delhi High Court, 2022: the Office must identify the one known substance it relies on).
On Section 3(i), the commentary says the draft draws on the Delhi High Court decision of 9 October 2025 in Sequenom, EMD Millipore and Natera: physical diagnostic kits fall outside the exclusion, while software-only diagnostic tools are examined under the computer programme exclusion.
On divisionals, the commentary reports that the draft relies on Syngenta (Delhi High Court Division Bench) for the view that a divisional is maintainable where a plurality of inventions is disclosed in the specification. Earlier posts on this blog set out how divisionals work in the country: Filing a Divisional Application in India - Part 4.
Who is affected
Applicants and patent owners with antibody, gene-editing, cell and tissue, or bioinformatics claims are the main audience. Generic and biosimilar manufacturers are affected from the other side, because, per the commentary, the draft addresses how Section 3(d) applies to new forms and variants of known substances. The pharmaceutical draft concerns the same groups, but only its stated purpose is reported above.
What changes in practice
The draft is not law and changes nothing for pending applications today. The items below are what the commentary reports as new, and they would matter only if the draft is adopted in this shape; this note has not read the draft itself and draws no further conclusions.
- The examination report would disclose the search string or query used.
- Sequence listings would be filed electronically in WIPO Standard ST.26.
- Examples and court decisions listed in the draft would serve as reference points for examiners, according to the commentary.
What stays open
Sections 3(b) and 3(k) get new refused examples, including a germline-editing claim and two bioinformatics claims, but no decisions are quoted for either, which makes them the least predictable part of the text. A readable copy of the pharmaceutical draft is needed for a point-by-point reading. Examination reform has been a recurring theme here since the 2019 proposal to amend the Rules (see Indian Government's Proposal to Amend Patent Rules 2003), and the full run of earlier posts sits in the India category. What matters next is the final text, and whether the search-string disclosure survives it.