By SSR Patent Team
There is a quiet but persistent problem in Indian patent prosecution, and Manu Chaudhary v. Controller of Patents and Designs has finally named it. The applicant’s patent (Application No. 201711047431), an oral herbal painkiller composition and its process of preparation, had been refused by the Controller on 22 February 2024. Inventions that draw on Indian biological material must clear the National Biodiversity Authority. That much is settled, and sensible. What has been far less settled is what should happen when the applicant has applied to the NBA in good faith but the approval (which is entirely in the authority’s gift, not the applicant’s) has not issued by the time the office wishes to close the file. Until now, the guidance on this point has been thin, and refusal has too often filled the gap. The Delhi High Court has now held, correctly in our view, that deferral is the correct course.
A distinction that should never have been blurred
The Biological Diversity Act, 2002 and the traditional-knowledge Guidelines make NBA permission a condition of grant. They do not make its absence, at an interim stage, a ground of refusal. That is not a technicality; it is the whole architecture of the scheme. A condition of grant is satisfied at the point of grant. To convert it into an examination-stage guillotine (refuse now, approval or no approval) is to read into the statute a consequence Parliament did not provide. Justice Singh declined to do so, and rightly. The Court found no provision, in either the statute or the Guidelines, requiring refusal in these circumstances, and none was shown to it.
Who should bear the risk of the authority’s timelines?
The deeper question the case answers is one of allocation of risk. An applicant can file her NBA application; she cannot compel the authority to decide it by any particular date. To refuse her patent because the NBA has not yet acted is to make her carry a delay she is powerless to prevent. That is neither fair nor supported by the text. The applicant here did more than the bare minimum: she applied, and she put the acknowledgement before the Controller in writing before the order fell. On those facts, the Court held, refusing the application did not reflect a proper exercise of that discretion.
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Procedure as a shield, not a trap
The same instinct runs through the Court’s treatment of the other grounds. Section 15 was read as a discretion to permit compliance, not a licence to refuse at the first stumble. The objection that the applicant had appeared through the wrong kind of representative (the Respondent’s objection under Sections 128 and 132 of the Patents Act) was treated as a curable defect, to be fixed on remand, not a reason to end the matter. There is a philosophy here worth naming: procedural requirements exist to secure a fair and orderly process, not to defeat otherwise meritorious applications on points that could be put right. It is a principle worth keeping in mind by anyone navigating patent prosecution.
The limits of the win, and why they matter
It would be a mistake to over-read the decision. The Court did not hold the invention patentable; it expressly left the Section 3(p) objection open, and it confined the remand so tightly that no fresh material may be filed beyond the NBA approval itself (approval that, in the event, was granted on 4 July 2024, almost five months after the refusal), and it has directed the Controller to decide within two months of receiving the order. This is a victory on process, not on merits. For anyone tempted to treat Manu Chaudhary as a green light for herbal or traditional-knowledge patents, the caution is plain: the substantive hurdles (novelty, inventive step, the Section 3 exclusions) remain exactly where they were.
The real lesson for applicants
The applicant here prevailed, but only after a refusal, an appeal and a remand, a long and expensive route to a re-hearing she should never have needed. The lesson is not “you can win on appeal.” The lesson is that NBA and ABS compliance, and the timing of it against examination and grant, belong in the filing strategy from day one. Get that right and the question in Manu Chaudhary never arises. Get it wrong and you are litigating your way back to the starting line. That is precisely the kind of foresight good counsel is for.
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Frequently Asked Questions
Biological Material Patents
Not automatically. In Manu Chaudhary (Delhi High Court, 7 February 2026), the Court held that where an applicant has applied to the National Biodiversity Authority in good faith and placed proof of the pending application on record, the Controller should defer the decision rather than refuse the patent. But the outcome turned on the applicant having applied in time and having proved it. Whether your own file meets that standard is a fact-specific assessment best made with counsel before a hearing, not after a refusal.
The Biological Diversity Act, 2002 and the traditional-knowledge Guidelines tie NBA permission to the grant of the patent. That does not mean the timing is a free-for-all: how and when you apply to the NBA, and how you signal that to the patent office during examination, can be the difference between a deferral and a refusal. The safe answer depends on the specifics of your invention and its use of Indian biological material. Advice at the filing stage is strongly recommended.
No, but do not assume it is safe either. Section 3(p) of the Patents Act, 1970 excludes, among other things, subject matter that is in effect traditional knowledge or an aggregation of known properties. In Manu Chaudhary the Court left the Section 3(p) objection open for the Controller to decide afresh, which tells you how fact-sensitive it is. Whether your claims survive depends heavily on how the invention is framed and evidenced, a question worth putting to a patent attorney early.
Sections 128 and 132 of the Patents Act govern who may appear before the Controller, and appearance through the wrong representative can itself become an objection, as it did in Manu Chaudhary, where the Court treated it as a curable defect on remand. Relying on it being curable is a risk you need not take. Proper representation by a registered patent agent or advocate protects the application; we can advise on who should appear and when.
An appeal to the High Court under Section 117A(2) of the Patents Act may lie, as it did in Manu Chaudhary, and can result in the refusal being set aside and the application remanded for fresh consideration. But an appeal costs time and money, and whether you have viable grounds depends closely on the record and the reasons for refusal. If you are facing a refusal, speak to our patents team promptly so the appeal window is not lost.