Summary
Pioneer Hi-Bred International Inc., a global agricultural biotechnology company, sought an Indian patent for insecticidal proteins designed to protect crops from pests such as the western corn rootworm. The Controller of Patents refused the entire application under Section 3(c) of the Patents Act, holding that claims to a “recombinant” polypeptide with high sequence identity to a natural protein amounted to an unpatentable discovery of something occurring in nature. The Delhi High Court found that the refusal rested on an incomplete examination, since several claims had never been objected to, and that the Section 3(c) patentability question itself required a closer look at the amino acid substitutions distinguishing the claimed molecule from its natural counterpart. The court set aside the order and remanded the application for fresh, complete examination within five months. The ruling matters because it sharpens the line between an unpatentable “mere discovery” and a genuinely engineered biotechnological invention, an issue with wide implications for India's growing agri-biotech and pharmaceutical patent filings.
Background
A patent application can spend a decade moving through the Indian Patent Office only to be refused in a single stroke over an objection that touched barely half its claims. That is precisely what confronted the Delhi High Court in an appeal testing how far Section 3(c) of the Patents Act, 1970 (“Patents Act”) stretches when a claimed invention resembles something nature already made, and how far a Controller may go in refusing an application when Section 3(c) patentability is contested only for part of the claim set.
Pioneer Hi-Bred International Inc. (“Pioneer”) filed Indian Patent Application No. 201617008869, titled “Insecticidal Proteins and Methods for Their Use,” on 14 March 2016, seeking protection for recombinant nucleic acid molecules and polypeptides, described as Pseudomonas Insecticidal Protein-72 (PIP-72) variants, engineered to control pests such as the western corn rootworm while sparing beneficial organisms. A Request for Examination followed on 10 August 2017, and the First Examination Report (“FER”) issued on 7 August 2020 raised objections under Section 3(c), 3(d), 3(h) and 3(j) of the Patents Act, alongside novelty and disclosure objections.
Pioneer progressively amended its claims from 52 down to eight, but a hearing notice maintained the Section 3(c) objection specifically against claims 3 and 4, which described a “recombinant PIP-72 polypeptide” with at least 80% sequence identity to SEQ ID NO: 2, a naturally occurring polypeptide isolated from Pseudomonas chlororaphis. By order dated 19 February 2024, the Controller of Patents (“Controller”) refused the application in its entirety, holding that the claimed identity range swept in the 100% identical natural sequence and therefore amounted to an unpatentable discovery. Pioneer appealed under Section 117A of the Patents Act before the Delhi High Court.
Issues
-
- Whether the Controller could refuse the entire application under Section 15 of the Patents Act when the Section 3(c) objection was raised only against claims 3 and 4, leaving claims 1, 2 and 5 to 8 unaddressed.
- Whether claims to a “recombinant” polypeptide sharing at least 80% sequence identity with a naturally occurring protein fall within the Section 3(c) bar on the “discovery of any living thing or non-living substance occurring in nature.”
- Whether dependent claims specifying 1 to 17 amino acid substitutions from the natural sequence took the invention outside the scope of “mere discovery.”
Pioneer’s Arguments
-
- The impugned order suffered from an error apparent on the face of the record, rejecting claims 1, 2 and 5 to 8 despite no objection ever being raised against them.
- Pioneer had offered, by email dated 7 February 2024, to delete claims 3 and 4 and proceed with auxiliary claim sets, but the Controller did not engage with this request.
- Relying on Immunas Pharma v. Assistant Controller of Patents and Designs (Madras High Court), Pioneer argued that Section 3(c) targets only the process of finding a hitherto undiscovered natural substance, not a synthetic molecule created through significant human intervention.
- The claimed PIP-72 polypeptide was produced using molecular biology techniques, and dependent claims 2 and 4 expressly recited 1 to 17 amino acid substitutions distinguishing it from the natural SEQ ID NO: 2 sequence.
Controller’s Arguments
-
- Section 15 empowers the Controller to refuse an application that fails to meet the requirements of the Patents Act, and the statute contains no mechanism to sever valid claims from invalid ones.
- Claim 3’s language of “at least 80% identity” necessarily encompassed the 100% identical natural sequence, so labelling the polypeptide “recombinant” could not change its underlying identity to a substance occurring in nature.
- Reliance was placed on Regents of the University of California v. The Controller of Patents (Delhi High Court), where similarly broad claims covering naturally occurring bacterial mutations were held non-patentable under Section 3(c).
- Pioneer had been given the opportunity to delete claims 3 and 4 but declined, leaving the Controller no option but to refuse the application in its entirety.
Court’s Analysis
An Incomplete Examination Cannot Support a Complete Rejection
The court observed that claim 1 was an independent claim against which no objection had ever been raised, yet the impugned order refused the application without engaging with claims 1, 2 and 5 to 8 at all. The court noted that the Controller’s position, that the Patents Act contains no power to sever valid claims from invalid ones, missed a more basic problem: the order reflected an incomplete examination of the full claim set rather than a reasoned assessment of each claim on its own merits. The court held that this alone warranted remand, since an applicant is entitled to a decision on every claim actually pressed, not a blanket refusal traced to objections against only two of eight claims.
Section 3(c) Patentability Turns on ‘Mere’ Discovery, Not Resemblance to Nature
Turning to the substantive question of Section 3(c) patentability, the court found considerable force in Pioneer’s reliance on Immunas Pharma v. Assistant Controller of Patents and Designs (2024 SCC OnLine Mad 480), where the Madras High Court reasoned that the word “discovery” implies finding something that already exists rather than producing or engineering it, and that the phrase “occurring in nature” confines the exclusion to identifying and isolating a hitherto undiscovered natural substance.
The court further observed that this reading drew support from Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, where the word “mere” in Section 3(c) was read to qualify both limbs of the provision, so that only a mere discovery, without more, attracts the bar. Applying this framework, the court opined that the Section 3(c) patentability analysis in the impugned order had not squarely addressed dependent claims 2 and 4, which specified 1 to 17 amino acid substitutions distinguishing the claimed PIP-72 polypeptide from the natural SEQ ID NO: 2 sequence, a distinction going to whether the invention was merely found in nature or synthesised with sufficient human intervention to escape the exclusion.
The court reasoned that overlapping sequence identity could not be treated as conclusive of non-patentability without engaging with the structural differences pleaded by Pioneer. At the same time, the court stated that it was not deciding the merits of Section 3(c) patentability for these claims, leaving that determination to a fresh examination by the Controller.
Findings
In view of the observations and the arguments presented by both the parties, the Delhi High Court held that:
-
- The impugned order dated 19 February 2024 is set aside for failing to examine claims 1, 2 and 5 to 8, against which no objection had been raised.
- The Controller shall carry out a complete examination of the entire set of eight claims, including a fresh assessment of Section 3(c) patentability for claims 3 and 4 in light of the amino acid substitutions pleaded by Pioneer.
- A fresh hearing notice shall be issued to Pioneer, and the entire exercise, including a reasoned order, shall be completed within five months.
- No opinion is expressed on the merits of whether the claimed PIP-72 polypeptide is excluded under Section 3(c), leaving that question open for the Controller’s fresh determination.
- The appeal is allowed and disposed of on these terms.
Case Citation: Pioneer Hi-Bred International Inc. v. The Controller of Patents, C.A.(COMM.IPD-PAT) 35/2024, Delhi High Court, decided on 22 July 2026. Available at https://indiankanoon.org/doc/69727938/
Authored by Gaurav Mishra, Patent Attorney, BananaIP Counsels