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Patent criticality
The data you did not generate
Do I need experimental results to get a patent?
In chemistry, biotechnology, pharmaceuticals and food technology, several of the objections you will face can only be answered with comparative data. If nobody generated it before filing, the reply becomes an argument where it should have been a table.
Where data is effectively required
Section 3(d) - a new form of a known substance needs evidence of a significant difference in properties with regard to efficacy; for a medicine, therapeutic efficacy judged strictly.
Section 3(e) - a composition needs evidence of synergy: an effect greater than the aggregation of the components, shown by comparison against each component alone.
Inventive step - the technical effect of your difference over the closest prior art is far more persuasive as a measured comparison than as an assertion.
Sufficiency - where a claim covers a range or a class, results at more than one point are what make it credible.
The timing problem
Data generated after the priority date can often still be filed, but it is more vulnerable, and it cannot cure a specification that never mentioned the effect it demonstrates. The safest position is that the effect is asserted in the specification as filed and the data supports it.
The practical consequence is that the decision to run a comparative experiment belongs in the pre-filing conversation, not in the FER reply.
Sections 2(1)(ja), 3(d), 3(e) and 10(4) of the Patents Act 1970.
The Supreme Court has required evidence of enhanced therapeutic efficacy under section 3(d), holding that improved bioavailability alone does not establish it.
Before filing, ask which objections your field always raises, and what evidence answers each. Then generate it.
Filing without the comparative example because the result seems obvious to the inventors.
Specifications that assert an advantage without a single number.
For your next filing, write the comparison table you would want in an FER reply, and see whether you can fill it in.
Sources & further reading
- The Patents Act, 1970 (consolidated to 1 August 2024) — Official IP India text
- Section 3, Patents Act 1970 - what are not inventions — Official IP India section text
- Novartis AG v Union of India, Supreme Court of India, 1 April 2013, (2013) 6 SCC 1
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Educational guidance, not legal advice. This material is published by Ragulika IP for general education and information. It is not legal advice, it does not create a professional-client relationship, and it is not a substitute for advice on your own facts. Patentability, infringement, prosecution strategy and every other IP outcome turn on the specific facts and on the law and Patent Office practice as they stand at the time you act. Please take professional advice before making a decision, and read the underlying provision or judgment before relying on any point stated here.
Last reviewed by Ragulika IP on 2026-08-23. Indian patent law and Patent Office practice change; check the position before you rely on it.