Introduction
Every patent applicant in India knows the process well enough. The Patent Office examines your application, raises objections in a First Examination Report, and you file a detailed response addressing each one. A hearing follows. You file post-hearing written submissions. And then you wait for the Controller's order.
What happens, though, when that order arrives and does not address a single argument you made? What if it simply reproduces the same objections you had already answered, as though your response was never filed?
That is precisely what happened to VIB VZW, a Belgium-based life sciences research institute, when it pursued a patent in India for a method of oral delivery of therapeutic proteins. The Controller of Patents rejected the application in March 2025 without engaging with any of the applicant's submissions. VIB appealed under Section 117A of the Patents Act, 1970. In May 2026, Justice Jyoti Singh of the Delhi High Court set aside the rejection order, holding that a refusal which ignores the applicant's responses violates the principles of natural justice and defeats the examination process altogether.
The Invention
The application was titled "Means and Methods for Oral Protein Delivery."
To understand why this invention was worth patenting, a brief scientific context helps. Therapeutic proteins are the active ingredients in biologics and antibody-based medicines. They are large, complex molecules that do not survive digestion. When a patient swallows them, the stomach and intestines break them down before they can reach the bloodstream and do their work. This is why most protein-based medicines are administered by injection. The convenience of oral delivery simply has not been available for this category of drugs.
VIB's invention proposed a solution. The formulation used dried yeast culture medium as a protective matrix around the therapeutic protein. Specifically, the invention concerned dried pharmaceutical formulations obtained by drying yeast culture medium containing recombinant proteins fused to an IgA Fc domain. The yeast extracellular medium surrounding the protein would slow or prevent degradation in the gastrointestinal tract, making oral administration viable. A notable claimed advantage was that the protein did not require purification before use, which simplifies the production process considerably.
How Patent Examination Works in India
The Patents Act, 1970, and the rules framed under it establish a structured process for patent examination. The Patent Office first issues a First Examination Report listing its objections to the application. The applicant then files a response addressing those objections. If the matter is not resolved on paper, the Controller schedules a hearing at which the applicant can argue their case orally. After the hearing, the applicant may file post-hearing written submissions to consolidate their arguments. The Controller then passes a final order either granting or refusing the patent.
This structure exists for a reason. It gives the applicant a genuine opportunity to be heard. It requires the Controller to engage with the arguments placed before them before reaching a conclusion. The process is not a formality. It is a substantive exchange, and the final order is supposed to reflect that exchange.
When the final order does not reflect that exchange, the process has broken down.
The Rejection Order: Three Problems
The Controller refused the application on March 28, 2025. On examination, the rejection order carried three separate and serious flaws.
The Applicant's Arguments Were Never Addressed
The first and most fundamental problem was that the refusal order reproduced the original objections from the First Examination Report and did not address the applicant's responses to those objections. VIB had filed a detailed reply to the FER. It had also filed post-hearing written submissions. Both documents engaged substantively with the Controller's concerns. None of that engagement was reflected in the final order.
The court held that not according any consideration to the points raised by the applicant is not only a violation of the principles of natural justice but also defeats the entire purpose of calling for a response to the FER and permitting filing of post-hearing written submissions.
So, if the Patent Office goes through the exercise of inviting the applicant to respond and then ignores that response entirely, the examination process has been reduced to theatre. The applicant has been given the appearance of a hearing without the substance of one.
A Factual Error That Was Not Even Contested
The second problem was a factual error that the refusal order should never have contained.
The Controller rejected the application partly on the ground that the applicant had not disclosed the source and geographical origin of the biological material used in the invention. This objection is based on a legitimate regulatory concern. India's patent law, read alongside the Biological Diversity Act, 2002, requires applicants to disclose the geographical origin of biological material, particularly where that material originates from India, to prevent biopiracy.
The difficulty here is that VIB had expressly stated in both its reply to the First Examination Report and in its post-hearing written submissions that the biological material originated from Belgium and was not sourced from India. This disclosure was on record. It was made not once, but twice. The Controller's order rejected the application on a ground that the applicant had already addressed, and the order gave no indication that the Controller had read those submissions at all.
Justice Singh described this as a "glaring fallacy" in the impugned order. It is a strong characterisation, and it is justified. An error of this nature in a speaking order suggests that the submissions were not reviewed before the order was passed.
The Inventive Step Analysis Was Missing
The third problem concerned the inventive step objection.
Under Section 2(1)(ja) of the Patents Act, 1970, an invention must involve a "feature of invention" that has technical advance compared to existing knowledge, or has economic significance, or both, and must make the invention not obvious to a person skilled in the art.
Indian courts have developed a structured approach for examining whether a claimed invention meets this standard. The Delhi High Court in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. [2016 (65) PTC 1 (Del)] laid down a five-step test that patent authorities are required to follow. That test requires the Controller to: identify the person skilled in the art in whose perspective the question of obviousness is to be assessed; identify the inventive concept embodied in the patent; impute to that person the common general knowledge available at the priority date; identify the differences between the cited prior art and the claimed invention, determining whether those differences are mere routine steps or something more; and then assess whether those differences, even viewed with knowledge of the alleged invention, constitute steps that would have been obvious to the ordinary skilled person, specifically to rule out hindsight.
Each step serves a purpose. The framework prevents a Controller from simply comparing the invention to prior art documents and concluding that the invention "looks obvious" without structuring that analysis properly. The fifth step, in particular, guards against the well-known problem of hindsight bias: the tendency to conclude that an invention was obvious only because you already know it was achieved.
The VIB rejection order did not follow this framework at all. It did not identify the person skilled in the art. It did not identify the closest prior art in any structured way. It did not examine the distinctions VIB had drawn between the cited prior art and its own claims. VIB had argued specifically that the cited prior art documents did not disclose the particular combination of membrane filtration of yeast culture medium followed by drying the unpurified medium to create an orally deliverable formulation with a protective matrix effect. That argument required a proper analysis of what the prior art actually disclosed and how it compared to the claimed invention. No such analysis appeared in the order.
VIB had also relied on objective evidence against obviousness: its Pichia-derived dried culture medium formulation had shown superiority over plant-derived compositions in clearing a specific bacterial infection (F4+ETEC). This kind of secondary evidence, demonstrating that the invention achieves results that would not have been predicted from the prior art, is relevant to the question of non-obviousness. Justice Singh observed that the impugned order gave no indication that this point had even been considered.
What the Court Held
The Hon'ble Court allowed the appeal in part, set aside the refusal order dated March 28, 2025, and directed the Controller to conduct a fresh examination of the application after giving VIB a new hearing. A reasoned, speaking order must be passed within four months.
The court further directed that the Controller must decide the matter independently, without being influenced by either the earlier refusal order or by the observations made in the High Court's judgment. This is a standard direction in patent remand orders, designed to ensure that the fresh examination is genuinely fresh and not a re-run of the same flawed analysis with minor adjustments.
Why This Judgment Matters to Practitioners
The judgment does not decide whether VIB's invention deserves a patent. That question goes back to the Patent Office for a proper determination. What the judgment decides is a procedural and constitutional question: what minimum standards a patent rejection order must meet before it can be sustained.
Those standards are not onerous. The Patent Office is required to read the applicant's response, engage with its arguments, and explain in the order why those arguments were accepted or rejected. It is required to follow the established legal framework when examining inventive step. It is required to get the basic facts right, particularly where those facts are expressly on record.
Where those requirements are not met, the rejection is vulnerable on appeal. This has a practical implication for anyone going through the Indian patent examination process. The response to a First Examination Report and the post-hearing written submissions are not administrative formalities. They are a record. Every argument made in those documents is preserved. If the final order does not engage with that record, it can be challenged before the High Court under Section 117A of the Patents Act, and the Court will examine whether the Controller discharged the minimum obligation of a quasi-judicial authority: to consider what was placed before it.
The judgment also reinforces the mandatory nature of the F. Hoffmann-La Roche five-step test for inventive step. It is not enough for a Controller to assert that an invention is obvious. The five-step framework must be applied and its application must be visible in the order.
Conclusion
This is not a complex judgment and it does not lay down new law. What it does is apply well-established principles to a situation where those principles had been plainly disregarded. Patent examination in India is a quasi-judicial process. An authority exercising quasi-judicial power must act fairly, must consider the material before it, and must explain its decisions with reasons. An order that mechanically reproduces objections without engaging with responses does not meet that standard. It is not a reasoned order. It is a repetition of a preliminary view, dressed up as a final decision.
Hence, applicants must document every argument in every submission, because that record is your appellate ground if the examination fails.
Case: VIB VZW & Anr v. The Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 30/2025, Decided: May 2026
Disclaimer: This post is for informational purposes only and does not constitute legal advice. Readers should consult a qualified legal professional for advice specific to their circumstances.
~ Adv. Koushik Chittella
© All Rights Reserved
Disclaimer: None of the contents of this post constitute legal advice.