Filing a patent application is only the beginning of protection. In India, the applicant must respond effectively to the Patent Office’s objections before the application can proceed to grant. This stage is known as patent prosecution.
For pharmaceutical, biotechnology, artificial intelligence (AI), software, and technology companies, a well-prepared response to the First Examination Report (FER) can determine whether valuable research becomes an enforceable patent or an abandoned application.
What Happens After Filing a Patent Application in India?
A typical Indian patent application moves through these stages:
- Filing: The applicant files a provisional or complete specification with the Indian Patent Office.
- Publication: The application is ordinarily published after 18 months from the earliest priority or filing date. Early publication may be requested through Form 9.
- Request for Examination (RFE): Examination does not begin automatically. A Request for Examination is filed in Form 18, or Form 18A where expedited examination is available.
- Examination: The Controller refers the application to an examiner for prior-art searching and substantive examination.
- First Examination Report: The Controller issues the first statement of objections, commonly called the FER.
- Response and hearing: The applicant files arguments, amendments, supporting evidence, and may attend a hearing.
- Grant or refusal: If objections are overcome, the patent is granted. Otherwise, the application may be refused or treated as abandoned.
Under the current Rule 24B framework, the RFE deadline is generally 31 months from the earliest priority or filing date, subject to transitional rules for older applications. The applicant should verify the applicable deadline for each case rather than rely on older 48-month references.
The Indian Patent Office provides official resources for patent filing, public search, and forms and official fees.
What Does an FER Contain?
An FER normally combines substantive, procedural, and formal objections. Each objection should be answered separately and supported by the record.
Novelty and inventive step objections
Novelty asks whether the claimed invention has already been disclosed in a single prior-art reference. Section 2(1)(j) defines an invention as a new product or process involving an inventive step and capable of industrial application. Section 2(1)(l) reflects the global nature of the novelty inquiry.
Inventive step is assessed under Section 2(1)(ja). The invention must involve a technical advance or economic significance, or both, and must not be obvious to a person skilled in the art.
An FER may cite patent publications, journal articles, technical standards, product manuals, or other documents. A strong response does not merely state that the invention is “new.” It maps each claim feature against each cited reference and explains why the complete combination is neither disclosed nor obvious.
Pharmaceutical and biotechnology objections under Section 3(d)
Section 3(d) is particularly important for pharmaceutical and formulation applicants. It excludes the mere discovery of a new form, property, or use of a known substance unless the statutory requirement relating to enhanced efficacy is satisfied.
Objections may arise for:
- New salts, polymorphs, esters, ethers, or isomers.
- Dosage forms and formulations based on known active ingredients.
- New therapeutic uses of known substances.
- Combinations that appear to lack a demonstrated technical or therapeutic advantage.
The response should connect the claimed structural or formulation difference to credible evidence. Comparative dissolution, bioavailability, stability, solubility, release profile, or therapeutic data may be relevant, depending on the invention. Experimental results should be explained through a properly prepared declaration or affidavit where appropriate.
Computer-related inventions and AI objections under Section 3(k)
Section 3(k) excludes mathematical methods, business methods, computer programmes per se, and algorithms. However, a computer-related invention may still be patentable where its substance provides a technical solution to a technical problem and produces a credible technical effect.
For AI, machine learning (ML), and software inventions, the FER may question whether the claims cover only:
- A mathematical model or algorithm.
- A business or administrative method.
- A computer-readable medium containing instructions.
- A generic computer performing conventional processing.
- An abstract input-output relationship without technical implementation.
The response should identify the technical problem, the specific implementation, and the measurable technical result. Relevant effects may include reduced processing time, improved memory use, lower network latency, better data security, improved error correction, enhanced image processing, or more efficient control of a physical device.
The 2025 Guidelines for Examination of Computer Related Inventions should be considered for current AI and software prosecution strategy.
Clarity, sufficiency, unity, and formal objections
The FER may also raise objections relating to:
- Unclear or ambiguous claim language.
- Claims that are not succinct or fairly based on the specification.
- Insufficient disclosure under Section 10(4).
- Failure to disclose the best method known to the applicant.
- Lack of enablement or undue experimentation.
- Multiple unrelated inventions in one application.
- Improper claim format, drawings, sequence listings, declarations, or forms.
- Non-compliance with foreign filing disclosures under Section 8.
- Inconsistencies between the abstract, claims, drawings, and description.
For AI and biotech inventions, sufficiency is especially important. The specification should disclose enough technical detail for a person skilled in the art to perform the invention. This may include model architecture, training data characteristics, pre-processing steps, experimental protocols, formulation parameters, test methods, and comparative results.
FER Response Deadlines and Abandonment Risk
The applicant generally has six months from the date of issuance of the FER to put the application in order for grant under Rule 24B and Section 21.
The period may be extended by up to three months by filing a request in Form 4 with the prescribed fee. The amended 2024 framework has affected the timing mechanics for extension requests. Since portal practice and case-specific rules can matter, applicants should not treat the extension as an invitation to wait.
Failure to respond within the applicable period can result in the application being treated as deemed abandoned. Restoration is not an ordinary substitute for timely prosecution.
In-house teams should diarise at least three dates:
- FER issue date.
- Initial six-month response deadline.
- Final deadline after any valid extension.
A second internal deadline should be fixed at least 30 to 45 days before the legal deadline. The patent attorney, inventor, R&D lead, finance team, and business owner should receive automated reminders.
How to Build a Strong FER Response
A quality response is usually built through the following steps:
1. Prepare an objection matrix
Create a table listing each objection, cited document, affected claim, proposed amendment, evidence required, and responsible technical expert.
2. Amend claims carefully
Claims may be narrowed to incorporate supported technical features. Amendments must remain within the scope of the original disclosure. Section 59 restricts amendments that introduce new matter or expand the original scope.
The amended complete specification should remain clear, consistent, and fairly based on the original specification. Avoid inserting new inventive concepts during prosecution.
3. Distinguish the prior art claim-by-claim
Explain what each reference discloses and, more importantly, what it does not disclose. For inventive-step objections, address the technical problem, the differences, the expected knowledge of the skilled person, and why the claimed combination would not be obvious.
4. Support technical and pharmaceutical arguments with evidence
For pharma applications, comparative data may support enhanced efficacy or an unexpected technical advantage. For AI applications, benchmark results, validation data, error rates, resource savings, latency improvements, and reproducibility evidence can be useful.
An affidavit or declaration may explain test conditions, laboratory protocols, data sources, or the identity and role of the technical expert. Evidence should support the original disclosure and should not be used to introduce an entirely new invention.
5. Consider unity and divisional applications
If the FER identifies multiple inventions, the applicant should assess whether a divisional application is appropriate. Dividing a portfolio can preserve separate commercial opportunities instead of forcing unrelated concepts into one narrow claim set.
Preparing for the Patent Hearing
If objections remain after the written response, the Controller may provide an opportunity of hearing before refusal. Hearing preparation should include:
- A short explanation of the invention and its commercial relevance.
- A claim-by-claim response to the outstanding objections.
- Clean and marked-up amended claims.
- Prior-art comparison charts.
- Experimental or benchmarking evidence.
- A clear fallback position if the primary amendments are not accepted.
The hearing should focus on the decisive issues. Repeating the written response without addressing the Controller’s concern may weaken the application.
What Happens After the FER?
If objections are overcome, the application may proceed to grant. Where amendments are accepted, amended claims or specification pages may be published in accordance with applicable procedure.
After grant, the patent may face a post-grant opposition under Section 25(2), generally within one year from publication of the grant. The patent holder must also pay renewal fees to keep the patent in force. An Indian patent ordinarily has a term of 20 years from the filing date, subject to statutory requirements.
Patent prosecution should therefore be viewed as part of a wider portfolio strategy. Applicants should consider:
- Whether related improvements need separate applications.
- Whether a divisional or patent of addition is suitable.
- PCT (Patent Cooperation Treaty) filing and national-phase deadlines.
- Commercial launch timing and freedom-to-operate risks.
- Consistency between Indian and foreign claim strategies.
- The cost of prosecution compared with the commercial value of the patent.
Common FER Response Mistakes
- Filing a boilerplate reply that does not address each citation.
- Making over-broad or unsupported amendments.
- Treating AI as patentable merely because it uses a neural network.
- Ignoring technical effect and implementation details.
- Relying on Section 3(d) arguments without comparative data.
- Missing the six-month deadline.
- Waiting until the final weeks to consult a patent attorney.
- Failing to align the patent strategy with the product and portfolio roadmap.
Practical Checklist for In-House Teams and Startups
Before approving the response, confirm that the team has:
- Obtained the complete FER and cited documents.
- Verified the FER issue date and response deadline.
- Reviewed every independent and dependent claim.
- Conducted a technical prior-art comparison.
- Identified supported amendment options.
- Collected laboratory, formulation, or benchmark data.
- Confirmed that no new matter is being introduced.
- Checked unity, Section 8, inventor, and formal requirements.
- Prepared hearing notes and fallback positions.
- Reviewed related Indian, PCT, and foreign applications.
One-Roof Patent Prosecution Support
A well-handled FER response can preserve years of research, investment, and market advantage. A lost deadline or poorly drafted amendment can narrow the protection beyond commercial value or end the application entirely.
VS IPR & LEGAL ADVISORS LLP supports pharma companies, formulation manufacturers, biotech teams, AI businesses, SaaS companies, startups, and established enterprises with patent prosecution, FER responses, hearings, divisional strategy, international filings, and IP portfolio management.
Let’s talk about your pending patent application. Call us today, share the FER and relevant deadlines, and leave a message for a structured prosecution review.
Expert and Partner Team
- Mr. Sanjay Trivedi
- Vipul Bhatt
- Harsh K Mehta
For broader business protection, explore the firm’s guide on trademark, copyright, and patent protection or learn more about startup registration support.
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