Inventive Step 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.
Paragraph 8 of the Pharmaceutical Patent Guidelines (October 2014) tells examiners how to judge whether a drug-related invention is obvious. It sets out the skilled person, the ban on hindsight, the role of reasonable expectation of success, a five-point method and six illustrations, three on compounds and salts and three on processes, derivatives and compositions.
Inventive step is decided against all prior art before the priority date, and unlike novelty, documents may be combined (8.3). The test is whether a coherent thread leads from the prior art to the invention: reasonable expectation of success is the crucial factor (8.8). A surprising effect usually shows non-obviousness, but where the solution is chosen from a limited number of predictable options, even a surprising effect does not rescue the claim (8.8). 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. This document dates from October 2014 and cites decisions of the IPAB, which has since been abolished; appeals now go to the High Court (see our post on IPAB dissolution). For the general method, see our article on the Manual's inventive step chapter. If you face an obviousness objection on a drug claim, a patent objection reply should be organised around the five points below.
The statutory frame (paragraphs 8.1 and 8.2)
Under section 2(1)(ja) an invention has an inventive step if it involves technical advance over existing knowledge, economic significance, or both, and is not obvious to a person skilled in the art. The Guidelines refer to the Manual's procedure, which they cite as paragraph 08.03.03; in the Manual of 2019 the corresponding paragraph is 09.03.03. Paragraph 8.2 attributes to the Supreme Court in Novartis v Union of India, as cited, the point that the feature must be one that makes the invention not obvious.
Prior art and combining documents (paragraph 8.3)
Prior art for inventive step is the state of knowledge before the priority date of the claim: any publication anywhere in the world or any use. Unlike for novelty, documents may be combined ("mosaicing") when judging inventive step.
The tests the Guidelines quote (paragraphs 8.4 and 8.5)
The Guidelines quote the Supreme Court in Biswanath Prasad Radhey Shyam v Hindustan Metal Industries, as cited: obviousness must be strictly and objectively judged, and one form of the question is whether the discovery lies so far from what was known that it would not naturally suggest itself to a person thinking on the subject. The second test is whether a competent craftsman or engineer, faced with the problem and given the document, would say "this gives me what I want". The Guidelines also refer to Farbwerke Hoechst v Unichem Laboratories as cited within that passage.
The skilled person and hindsight (paragraphs 8.6 and 8.7)
The skilled person is a hypothetical reader presumed to know all prior art, including non-patent art, to know the technical advancement at that date and to have the skill to run experiments. The Guidelines say this person is not a dullard and has a modicum of creativity. IPAB decisions are cited for the points, as cited in the Guidelines: Fresenius Kabi Oncology v Glaxo Group, Sankalp Rehabilitation Trust v Hoffmann-La Roche and Enercon (India) v Aloys Wobben, the last for the idea that the skilled person is not super-skilled but is able to do more than follow basic instructions.
A practical rule follows from the Guidelines: choosing a better alternative from known alternatives to obtain known results is within what the skilled person would normally do.
On hindsight, the examiner must judge on the priority date and put aside knowledge of the invention.
Reasonable expectation of success (paragraph 8.8)
This is the most important paragraph. The Guidelines say the presence in the prior art of each element is not enough; there must be a coherent thread leading from the prior art to the invention, and "reasonable expectation of success" embedded in the prior art is the crucial determining factor. Obviousness is not avoided merely by showing some unpredictability while there is a reasonable probability of success, and absolute predictability is not required. The paragraph cites IPAB orders in Enercon, Becton Dickinson v Controller of Patents and Ajanta Pharma v Allergan, as cited.
For pharmaceutical inventions, the paragraph adds three points.
- Structural and functional similarity of the product gives the motivation to combine teachings.
- A surprising effect, synergy or prior art prejudice usually shows non-obviousness.
- Obvious to try: when the solution comes from a limited number of identified predictable options, even a surprising effect does not answer the obviousness objection.
The five-point method (paragraph 8.9)
- Identify the inventive concept of the claim.
- Identify the person skilled in the art.
- Identify that person's relevant common general knowledge at the priority date.
- Identify the differences between the prior art cited and the inventive concept.
- Ask whether, without knowledge of the invention, those differences would have been obvious or needed some inventive ingenuity.
The six examples (paragraph 8.10)
| Example | The Guidelines' scenario | Outcome | Reason |
|---|---|---|---|
| 1 | A pyrazolone compound with an ethyl group having analgesic properties; the closest prior art has methyl and no known therapeutic activity | Non-obvious | Swapping methyl for ethyl would have been an obvious chemical change, but nothing in the prior art suggested the resulting compound would be pharmacologically active: no coherent thread, no motivation |
| 2 | A class of selective COX-II inhibitors derived from two prior art compounds, one worse than the other on gastric effects | Non-obvious | Reaching the invention needed two successive changes, and after the second prior compound failed to show selective inhibition, the skilled person would not be motivated to go further: the prior art teaches away |
| 3 | A besylate salt of a compound, where the prior art has the maleate salt, a list of 53 anions, and a document showing besylate gives good stability | Obvious | The skilled person had to try from a limited list, would not be put off by rarity of besylate, and the third document would have motivated trials: obvious to try with reasonable expectation of success |
| 4 | A process that uses platinum as catalyst where the prior art generically names noble metal catalysts | Obvious | Platinum is an equivalent known for similar purposes; it is a known feature applied in an obvious way |
| 5 | A monoester of a known diol using amino acids to improve oral bioavailability, where the prior art did the same for a similar monoalcohol with lysine | Obvious (no technical advancement) | The prior art addressed the same problem for a substantially similar structure and would motivate the skilled person |
| 6 | A daily-dose combination pack where one agent is micronised; the combination, the doses and micronisation of poorly soluble drugs are known | Obvious | Micronising a poorly soluble ingredient to improve delivery is obvious; changing particle size is a mere physical modification for an anticipated effect |
What the examples teach
- Closeness is not enough in itself. In Example 1 a very near neighbour does not make the invention obvious when the prior compound had no activity to point to.
- Teaching away helps the applicant. In Example 2 the failure of the intermediate compound told the skilled person not to proceed.
- A limited list is a trap. In Example 3 the existence of a finite list of salt formers and a document praising the chosen salt made the choice obvious. The same fact pattern raises section 3(d); see our article on paragraph 10.
- Known solutions to known problems are obvious. Examples 5 and 6 show that carrying a known fix to a similar molecule or applying known micronisation is not enough.
What the examiner checks, and what to file
| Examiner's question | What the applicant should show |
|---|---|
| Who is the skilled person, and what do they know at the priority date? | Statement of the field and common general knowledge in the specification or evidence |
| What is the inventive concept? | A clear statement of the problem solved and the solution |
| Is there a coherent thread from the prior art? | Reasons why the prior art gives no pointer, or teaches away |
| Is the effect surprising? | Comparative data against the closest prior art |
| Was the choice made from a short list of options? | Evidence that the options were many or unpredictable |
A worked example (invented)
Dhanvantari Research claims a new ester of a known anti-inflammatory compound, showing in tests a markedly lower stomach irritation than the parent. The examiner combines a document on the parent with one on esters of related drugs for better absorption and says the ester is obvious. Dhanvantari argues that the second document is about absorption, not irritation, that there was no expectation the ester would reduce irritation, and that the comparative data shows an unexpected effect against the closest prior art. This follows the framing of paragraph 8.8: it attacks the coherent thread and shows a result not predictable from the prior art.
Common lapses
- Giving no comparative data against the closest prior art.
- Arguing surprise when the claim is a choice from a short list of equivalents.
- Not stating the skilled person's field and knowledge.
- Treating inventive step and section 3(d) as one argument.
Need help with an obviousness objection on a pharmaceutical claim?
These objections are decided on comparative data and on how the prior art is read. Our team can assess the cited documents, prepare the argument and advise on the data to file. See patent objection reply, and read next on section 3(d) under paragraph 10.
Key takeaways
- Documents may be combined for inventive step, unlike novelty.
- The key question is whether a coherent thread and reasonable expectation of success lead from the prior art to the invention.
- A surprising effect helps, unless the solution is from a limited set of predictable options.
- The skilled person is not a dullard and not super-skilled.
- The IPAB decisions are cited only as illustrations; appeals now go to the High Court.
Read next
- Pharmaceutical Patent Guidelines 2014, paragraph 7: assessing novelty
- Pharmaceutical Patent Guidelines 2014, paragraph 10: section 3(d)
- Manual Chapter 9: inventive step
- What Is Patentable in India: Novelty and Inventive Step
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.