The Office of the Controller General of Patents, Designs and Trade Marks has published draft pharmaceutical patent examination guidelines 2026 for stakeholder comment, with a 15-day window running from the date of the public notice. The draft keeps the twelve-chapter structure of the 2014 guidelines, replaces the IPAB material with court decisions, most of them High Court decisions from 2022 to 2026, and adds an annexure of 45 worked examples.
This article covers the Indian draft only. It reports what the draft says, what it changes from the October 2014 guidelines, and a few points where the draft’s own passages read differently from one another.
What the Office has published and how to respond
The public notice invites all stakeholders to send comments or suggestions on the draft to cgoffice.in@gov.in and llc-ipo@gov.in within 15 days from the date of publication of the notice. The document is a 106-page PDF titled Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, dated 2026.
The notice page on the IP India website does not carry a date of its own. Counting 15 days from the 4 September 2026 publication date, the comment window closes on 19 September 2026. The notice names no format for comments and no reference number.
The 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, and its introduction says the guidelines need updating to incorporate the analysis of the courts. Its closing disclaimer states that the illustrations are not exhaustive, that the Act and Rules prevail in any conflict, and that the case law cited is dynamic. The provisions and claim categories it works through are the same as in 2014, and the introduction now records the Biological Diversity (Amendment) Act, 2023, stating that Section 6 of the Biological Diversity Act (labelled by the draft as the 2023 Act) came into force on 3 August 2023 and makes intellectual property rights from the use of biological resources in India subject to the approval or registration of the National Biodiversity Authority.
Novelty: the Seven Stambhas approach and the salt example
The draft replaces the 2014 paragraphs on implicit disclosure and inherent anticipation with a six-point list and the Seven Stambhas approach from the Delhi High Court’s 28 March 2024 decision in Lava International v Telefonaktiebolaget LM Ericsson, quoted at length. The result is a step-by-step novelty method that examiners are expected to document.
The six points cover prior claiming, the single-document rule, explicit and inherent disclosure, the bar on mosaicing for novelty, and the generic-versus-specific rule in both directions. The seven quoted steps run from understanding the claims, through analysing the prior art and its explicit and implicit disclosures, to assessing material differences across the entire scope of the claims and documenting the analysis with references to the passages relied on.
The fumarate salt example survives from 2014 with a longer analysis: where the prior art discloses the methanesulfonate salt and lists fumaric acid among suitable salt-forming acids without exemplifying the fumarate, the fumarate is implicitly disclosed and not novel. A new example holds that a composition claimed at 10 to 20, 30 to 40 and 40 to 60 per cent is anticipated by a prior composition at 15, 35 and 50 per cent. On combination claims, the draft states that a combination of known active ingredients may be considered allowable where the applicant establishes an unexpected technical effect, such as a synergistic effect, supported by data comparing the combination with the individual ingredients administered separately. On product-by-process claims, the IPAB order relied on in 2014 gives way to the Delhi High Court’s decision in Vifor (International) v MSN Laboratories: the product itself must be novel shorn of the process terms.
Inventive step: three frameworks and one caveat
The draft sets out the four-step test from Lava v Ericsson and the five-step test from Roche v Cipla, then quotes the Delhi High Court’s Division Bench in Sulzer Mixpac v Assistant Controller, decided 1 July 2026, for the proposition that neither is a rigid formula. That caveat is the newest authority in the document.
New in the chapter are the Court of Appeal’s 1972 decision in General Tire v Firestone on the unimaginative skilled technician who has read the whole prior art, the Delhi High Court’s Avery Dennison decision of 4 November 2022 on hindsight, and its Saint Gobain Glass France decision of 11 September 2025 on mosaicing. The 2014 paragraph on “obvious to try” is carried forward unchanged.
The court in Sulzer Mixpac said the five steps in Roche “merely provide guidance” and “cannot be regarded as commandments cast in stone, implicit compliance with which is essential in every case”. The worked examples then apply the four-step method to a methyl-to-ethyl pyrazolone change (non-obvious, because the prior art gave no clue to pharmacological activity), a maleate-to-besylate salt switch (obvious to try, given a list of 53 anions and a document teaching besylate stability), and a platinum catalyst disclosed generically as a noble metal (obvious).
Section 3(d): what the worked examples signal
The Novartis paragraphs on therapeutic efficacy and bioavailability are reproduced as in 2014, and the imatinib mesylate case remains the chapter’s main illustration. What is new is a Delhi High Court direction on how the objection must be framed and nineteen annexure examples showing where the Office would draw the line.
From DS Biopharma v Controller, decided 30 August 2022, the draft quotes the direction that the one specific known substance is to be identified and the manner in which the claimed compounds are new forms ought to be stated by the Patent Office, at least briefly. The annexure preface adds that where enhanced therapeutic efficacy is relied on, the specification may contain comparative data against the closest prior art or known substance, and that such data, where available, shall be taken into consideration.
The examples pair a failing and a passing case for most categories in the Explanation. A potassium salt of letermovir, paracetamol ethyl ether, deuterated pantoprazole supported only by metabolic stability and clearance data, naproxen of 99.9 per cent purity with better flowability and shelf life, and the S-enantiomer of ibuprofen with slightly improved bioavailability all fail. An L-tartrate salt with enhanced efficacy, etoposide malic acid esters with enhanced cytotoxicity, a crystalline form with 44 per cent better tumour volume reduction, S-norketotifen with better efficacy and fewer side effects, and a zinc-curcumin complex with better antioxidant property all pass. A new property of aspirin and a known HPMC pan-coating process fail; jet milling under nitrogen that yields a new crystalline form of ranitidine mesylate passes, under a heading the draft words as the mere use of an unknown process.
Across the examples, physico-chemical advantages and pharmacokinetic markers alone do not carry a new form through, and comparative efficacy data against the known substance does. Readers can compare this with our earlier note on evergreening of pharmaceutical patents in India.
Sections 3(e) and 3(i): combinations, regimens and diagnostics
Two Madras High Court decisions and three Delhi High Court decisions do most of the new work in these chapters, alongside a paragraph treating certain combination claims as method-of-treatment claims and ten annexure examples on the treatment exclusion, four of which find the claim allowable. The public order chapter gains two examples.
On mere admixtures, the draft quotes Novozymes v Assistant Controller, decided 20 September 2023, for the propositions that the exclusion is not limited to compositions formed by aggregating known ingredients and is not limited to independent claims. The annexure adds an obinutuzumab and BTK inhibitor tablet with no synergistic effect shown (fails), a celecoxib and methocarbamol composition with synergistic anti-nociceptive data in rats (passes), and a nanoparticle delivery system whose enhancement factors rise from 43 and 10 to 185 and 267 with the carrier (passes).
On methods of treatment, the draft quotes the Madras High Court in Chinese University of Hong Kong v Assistant Controller, decided 12 October 2023: a process is diagnostic where a person skilled in the art, including a medical doctor, could make a diagnosis for treatment from it; the word is not confined to in vivo diagnosis; and a screening test that identifies the existence or non-existence of a disease qualifies whether or not the person is symptomatic. From the Delhi High Court’s decisions of 9 October 2025 in Sequenom, EMD Millipore and Natera it reproduces a six-point summary: products, kits and devices are outside the exclusion; the excluded processes are those employed by medical practitioners; software-only diagnostic tools go to the computer program exclusion; identifying a regimen for known medicines is excluded; and the section draws no in vivo or in vitro distinction. The same court’s statement that diagnosis includes a negative result is quoted too.
The new paragraph on combination claims states that where a claim is drafted as a combination in certain dosage forms but the invention resides in administering the drugs simultaneously, sequentially or concomitantly, the claim falls within the treatment exclusion. Among the annexure examples, oral metformin, a tooth extraction procedure, oral tenofovir and emtricitabine to reduce the likelihood of HIV infection, and glatiramer acetate for neurological disease fail. A cosmetic method of camouflaging a skin imperfection, a method of blackening grey hair, a microfluidic method of quantifying HIV nucleic acids in a blood sample, and an in vitro colorimetric acetic acid test described as a screening test in cervical cancer diagnosis are found allowable.
Sufficiency, Markush breadth and biological deposits
The sufficiency chapter keeps the 2014 requirement of examples for every compound or at least every genus claimed, and adds three High Court decisions of 2023 to 2025, more indefinite claim terms, and the three Indian depositaries. It also records that the time for referring to a deposit may be extended under the amended Rule 138 by up to six months.
From Saint Gobain the draft takes the point that sufficiency and inventive step operate in distinct spheres. From Regents of the University of California, decided 5 February 2024, and OpenTV v Controller, decided 11 May 2023, it takes the limits on amendment: disclaimer, correction or explanation only; no matter not in substance disclosed originally; narrowing permitted, broadening not; and conversion of method claims into system claims treated as broadening save in exceptional cases. The list of terms to scrutinise for definiteness grows from “near to” and “approximately” to include “thin”, “strong”, “such as”, “at least”, “any”, “can” and “may”.
The Markush example expands the 2014 note that support and sufficiency are distinct: where the working examples are confined to one value of a substituent, the claim lacks support across the genus and a prima facie sufficiency objection also arises. The depositaries listed are the Microbial Type Culture Collection and Gene Bank at CSIR-IMTECH, Chandigarh; the Microbial Culture Collection at NCCS, Pune; and the National Agriculturally Important Microbial Culture Collection at ICAR-NBAIM, Mau. Our guide to the patent examination procedure in India covers the examination timeline.
Unity of invention and divisionals
The unity chapter is about the same length as in 2014 and gains a divisional section. It states four determination rules, distinguishes lack of unity a priori from a posteriori, and states two Markush conditions: a common property or activity, and a common structure across all compounds derived from the formula.
The divisional section quotes the Delhi High Court’s Division Bench in Syngenta v Controller, decided 13 October 2023: a divisional is maintainable where the plurality of inventions is disclosed in the provisional or complete specification, not only in the claims, and no distinction is drawn between a divisional filed on the applicant’s own motion and one filed to meet an objection. It then describes Rule 13(2A) as permitting a divisional out of a divisional, provided it is filed before the grant of the divisional from which it is divided, with the priority date and term counted from the main application, and a divisional out of a provisional specification. Our note on divisional patent applications across jurisdictions gives context.
What the draft drops from 2014
Read side by side, the draft removes every IPAB order the 2014 guidelines relied on and several examples and rules that went with them. Knowing what has gone matters because neither examiners nor applicants will have those passages to cite.
The removed material includes the Fumapharm illustration on second-indication claims; the paragraph directing examiners to ask for the INN of a known substance claimed for a second use; the Enercon passages on inherent anticipation and on the obviousness person and the enablement person; the Fresenius Kabi v Glaxo example on pleading a Section 3(d) ground; the IPAB’s reading of “combination” in the Explanation; the COX-II inhibitor example; the paragraph on method-of-treatment claims converted to product claims during examination; and the three longer sufficiency examples. The 2014 five-element inventive step method gives way to the Lava and Roche formulations. The wider statutory background is in our guide to the Indian Patents Act, 1970.
Points the text itself raises for comment
A stakeholder responding within the window may find it useful to start from passages where the draft reads differently from itself, since those are points the Office can settle by drafting. The following are textual observations only.
First, the scope chapter calls the draft supplemental to the 2014 guidelines while the introduction says the guidelines need updating; the text does not state whether the 2014 document is withdrawn, replaced or retained alongside. Second, the HIV nucleic acid example and the cervical screening example are found allowable as in vitro processes run on a sample or device, while the same chapter quotes the Delhi High Court that the section makes no in vivo or in vitro distinction and the Madras High Court that a screening test identifying the existence or non-existence of a disease qualifies as diagnostic. Third, the Markush unity criteria appear twice: the sufficiency chapter allows a recognised class of chemical compounds as an alternative to common structure, while the unity chapter requires common structure without that alternative.
Fourth, the annexure preface on Section 3(d) says the specification “may contain” comparative efficacy data which “where available, shall be taken into consideration”, while the Novartis passage the chapter quotes says that whether an increase in bioavailability amounts to enhanced therapeutic efficacy must be specifically claimed and established by research data. Fifth, the letermovir salt example ends with the sentence “Prior art teachings & study needs to be elaborated for comparison”, which reads as an editorial note left in the text. Sixth, the toothpaste abrasivity example, whose claim recites imaging, 3D printing and comparing enamel surfaces, is analysed as a prophylactic treatment involving removal of pathogenic bacteria, which the claim as set out does not recite.
This article describes the Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals published by the CGPDTM for comment in September 2026, compared against the October 2014 guidelines, as those texts stand at September 2026 and as verified against the instruments listed under Sources. The draft is not in force, may change before finalisation, and by its own terms yields to the Patents Act, 1970 and the Patents Rules, 2003. This article is not legal advice. Readers should consult a registered patent agent or patent attorney for advice on a specific application.
Sources
- Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026, Office of the Controller General of Patents, Designs and Trade Marks
- Public notice, Draft Guidelines for Examination of Pharmaceutical Applications for Patent, inviting comments within 15 days of publication
- Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, CGPDTM, October 2014
- The Patents Act, 1970 (39 of 1970), as amended up to 1 August 2024, Sections 2(1)(aba), 2(1)(j), 2(1)(ja), 2(1)(ac), 3, 10(4), 10(5) and 16
- The Patents Rules, 2003, updated to 15 March 2024, Rules 13(2A) and 138