High Court of Delhi | Decided: 22 July 2026, C.A.(COMM.IPD-PAT) No. 35 of 2024, Bench: Hon’ble Ms. Justice Jyoti Singh
Background
Pioneer Hi-Bred International Inc., the appellant, filed Indian Patent Application No. 201617008869 on 14 March 2016 in respect of an invention titled “INSECTICIDAL PROTEINS AND METHODS FOR THEIR USE.” The invention related to novel genes encoding pesticidal proteins specifically Pseudomonas Insecticidal Protein-72 or PIP-72 and the nucleic acid sequences encoding them, which are useful in preparing pesticidal formulations and in the production of transgenic pest-resistant plants.
The background of the invention disclosed that biological control of insect pests using microbial agents provides an environmentally friendly and commercially attractive alternative to synthetic chemical pesticides. Certain species of microorganisms including Bacillus thuringiensis had been successfully used in agriculture but provided resistance only to a narrow range of insect pests. Insects could also develop resistance to existing insecticidal compounds, creating a need for new pesticidal proteins with different ranges of insecticidal activity. The claimed invention sought to address this need by providing isolated or recombinant nucleic acid molecules capable of encoding PIP-72 polypeptides including amino acid substitutions, deletions, insertions and fragments thereof together with transgenic plants expressing these pesticidal sequences.
A Request for Examination was filed on 10 August 2017. The First Examination Report issued on 7 August 2020 raised objections of lack of novelty and non-patentability under Sections 3(c), 3(d), 3(j) and 3(h) of the Patents Act, 1970, as well as insufficiency of disclosure, against various claims. Specifically, claims 10 to 19 pertaining to isolated polypeptide and recombinant polypeptide were objected to under Section 3(c). The appellant filed a response amending the claims and renumbering them. A hearing notice was thereafter issued objecting to certain claims for lack of clarity and conciseness and raising the Section 3(c) objection against claims 3, 4, 6 and 7 relating to isolated polypeptide and recombinant polypeptide. Following the hearing, the claims were further amended and renumbered as claims 1 to 8. By the impugned order dated 19 February 2024, the Controller refused the entire application under Section 15 of the Patents Act, 1970 on the ground of non-patentability under Section 3(c), even though the Section 3(c) objection had been specifically raised only against claims 3 and 4. No objection had been raised against claims 1, 2 and 5 to 8. The appellant also pointed out that prior to the impugned order it had, vide email dated 7 February 2024, requested the Controller to delete claims 3 and 4 and accept three sets of auxiliary claims for consideration a request which the Controller did not address.
The Controller’s reasoning in the impugned order was that claim 3 recited a recombinant PIP-72 polypeptide having insecticidal activity against Western corn rootworm where the PIP-72 polypeptide comprised an amino acid sequence having at least 80% identity to SEQ ID NO: 2. Since a percentage identity of more than 80% included within its ambit a polypeptide with 100% identity to SEQ ID NO: 2 which was a naturally occurring polypeptide isolated from Pseudomonas chlororaphis the Controller held that even if synthesised in the lab, the final outcome would be identical to naturally occurring PIP polypeptides encompassed in the broad ambit of claims 3 and 4. The Controller found that the appellant had not excluded such natural polypeptides from the ambit of the claim or restricted the claim to particular polypeptides which were non-natural and accordingly held that claims 3 and 4 were non-patentable under Section 3(c). On the question of rejecting the entire application despite the objection being limited to claims 3 and 4, the Controller reasoned that the Patents Act did not empower the Controller to allow claims in part and that the appellant had been given an opportunity to delete claims 3 and 4 but had chosen not to do so.
Issues for Determination
- Whether the Controller committed a legal error by rejecting the entire patent application including claims 1, 2 and 5 to 8 in the absence of any objection having been raised against those claims and whether the matter required remand for complete examination.
- Whether the Controller correctly applied Section 3(c) of the Patents Act, 1970 in holding that claims 3 and 4 which claimed a recombinant PIP-72 polypeptide with at least 80% identity to a naturally occurring sequence were non-patentable on the ground that such claims encompassed polypeptides identical in structure to naturally occurring sequences, even when produced by molecular biology techniques involving substantial human intervention.
- What is the correct scope and interpretation of Section 3(c) of the Patents Act, 1970 in relation to synthetic or recombinant non-living substances produced with significant human intervention and whether the exclusion under Section 3(c) applies to inventions that are directed to man-made or synthetic polypeptides sharing structural resemblance with naturally occurring sequences.
Key Holdings of the Court
First, the Court held that the Controller committed a fundamental error by rejecting the entire patent application including claims 1, 2 and 5 to 8 in the absence of any objection having been raised against those claims. Perusal of the claims showed that claim 1 was an independent claim and no objection had been raised against its patentability. The rejection of the entire application on the basis of objections confined only to claims 3 and 4 reflected incomplete examination of the entire set of claims. The respondent’s argument that the Controller had no power to allow claims in part by excluding claims which could not be granted was rejected as neither here nor there. The matter accordingly deserved to be remanded for complete examination.
Second, the Court held that there was merit in the appellant’s contention that the Controller had erred in applying Section 3(c) to the invention without properly considering the detailed submissions brought forth by the appellant. The claimed invention was directed to providing isolated or recombinant nucleic acid molecules capable of encoding a PIP-72 polypeptide what was being claimed was a nucleic acid molecule or polypeptide produced in synthetic conditions with significant human intervention that could mimic the activity of PIP-72. The Controller had completely ignored the portions of dependent claims 2 and 4 where it was clearly stated that the encoded PIP-72 comprised 1 to 17 amino acid substitutions at various positions when compared to SEQ ID NO: 2, the naturally occurring sequence. Irrespective of the nature of the polypeptide, the claimed invention was directed and restricted to a synthetic, man-made polypeptide sharing property resemblance with the natural peptide, not to the natural polypeptide itself.
Third, drawing on the Madras High Court decision in Immunas Pharma v. Assistant Controller of Patents and Designs and this Court’s decision in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, the Court affirmed the correct interpretation of Section 3(c). The statutory prescription in Section 3(c) is the discovery of any living thing or non-living substance occurring in nature. The word discovery implies finding something which already exists and not producing, engineering or making something. The present continuous form occurring in nature indicates that the exclusion applies only to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature. A man-made, synthetic, recombinant substance produced through substantial human intervention and molecular biology techniques is not a discovery of a non-living substance occurring in nature. The exclusion under Section 3(c) is not intended for such man-made substances. If the substance is man-made and novel, it would have been created or invented, not discovered and would not surmount the Section 2(1)(j) definition of invention hurdle in any event.
Fourth, the Court set aside the impugned order dated 19 February 2024 and remanded the matter to the Controller with a direction to carry out complete examination of the entire set of claims, issue a fresh notice of hearing to the appellant and proceed further in accordance with law. The entire exercise was directed to be completed within five months from the date of the order. The Court expressly clarified that it had not expressed any opinion on the merits of the case. The appeal was allowed and disposed of.
Statutory Provisions Involved
Section 3(c) of the Patents Act, 1970 provides that the following shall not be regarded as inventions within the meaning of the Act the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature. The Court examined the scope of this provision in the context of synthetic or recombinant polypeptides produced by molecular biology techniques. Drawing on the decisions in Immunas Pharma and Diamond Star Global, the Court affirmed that the exclusion under Section 3(c) is confined to the discovery of living things or non-living substances occurring in nature in their natural form and does not extend to substances that are man-made, engineered or produced through substantial human intervention. The word mere in Section 3(c) qualifies both limbs of the provision and the word discovery imports the finding of something which already exists rather than the creation of something new.
Section 15 of the Patents Act, 1970 empowers the Controller to refuse an application seeking grant of a patent if the application does not comply with the provisions of the Act. The Controller had invoked this provision to refuse the entire application after finding claims 3 and 4 non-patentable under Section 3(c). The Court found this exercise of the power under Section 15 to be erroneous in the present case on the ground that objections had only been raised against claims 3 and 4 and the remaining claims had not been examined at all.
Section 117A of the Patents Act, 1970 confers a statutory right on an applicant for a patent to file an appeal before the High Court against an order of the Controller under Section 15 of the Act refusing the grant of a patent. This provision was the jurisdictional basis of the present appeal.
Section 2(1)(j) of the Patents Act, 1970 defines invention as a new product or process involving an inventive step and capable of industrial application. The Court referred to this provision in the context of the interpretation of Section 3(c), noting that a man-made synthetic substance if novel and inventive would be required to satisfy the Section 2(1)(j) definition and would not be excluded by Section 3(c) in any event.
Section 10(4)(c) and Section 10(5) of the Patents Act, 1970 governing the completeness, clarity and conciseness of patent specifications were referred to in the context of the procedural history of the application, as these provisions had formed the basis of certain objections raised in the hearing notice regarding claims 3, 4, 8 and 9.
Reasoning of the Court
The Court’s reasoning proceeded on two distinct grounds the procedural error in rejecting the entire application and the substantive error in applying Section 3(c).
On the procedural ground, the Court’s reasoning was straightforward and dispositive. The Controller’s own impugned order acknowledged that the Section 3(c) objection was confined to claims 3 and 4. The order itself recorded that it was concluding that the requirement of the objection raised in the hearing notice with respect to non-allowability of claims directed towards recombinant PIP-72 polypeptide that is claims 3 and 4 had not been complied with. Yet the operative order refused the grant of patent for the entire application. Claim 1, which was an independent claim, had attracted no objection whatsoever. There was therefore no basis in the impugned order for the rejection of claims 1, 2 and 5 to 8. The respondent’s attempt to justify the wholesale rejection on the ground that the Patents Act did not permit the Controller to allow claims in part was not accepted. The Court characterised the situation as one of incomplete examination rather than a deliberate exercise of discretion and held that the proper remedy was remand for complete examination of all claims.
On the substantive Section 3(c) ground, the Court’s reasoning was informed by two judicial precedents whose analysis of the scope of Section 3(c) it found instructive and applicable. From Immunas Pharma, the Court drew the principle that the statutory language discovery of any non-living substance occurring in nature contains within itself the answer to the question of its scope. The noun discovery imports the finding of something which already exists and not the producing, engineering or making of something. The present continuous form occurring in nature indicates that the exclusion is directed at finding a hitherto undiscovered natural substance by identifying and isolating it from nature. A synthetic version of a substance produced through molecular biology techniques with substantial human intervention is not being discovered it is being created or engineered. It therefore falls outside the ambit of Section 3(c). The Court also noted the Immunas Pharma observation that the real challenge for a patent application in respect of a synthesised non-living substance lies in establishing novelty, technical advance and not patent eligibility under Section 3(c).
From Diamond Star Global, the Court adopted the reading that the word mere in Section 3(c) qualifies both limbs of the provision and that it is only mere discovery of a living thing or non-living substance occurring in nature that falls within Section 3(c). The Court also drew on the observation in Diamond Star Global that Section 3(c) must be interpreted as it stands and that an overly expansive application of Section 3(c) to synthetic substances produced with human intervention would be inconsistent with the statutory text.
Applying these principles, the Court found merit in the appellant’s specific factual arguments. The appellant’s claims were not directed to discovering or isolating a naturally occurring polypeptide. They were directed to producing a synthetic, recombinant polypeptide with insecticidal activity through molecular biology techniques involving substantial human intervention. The dependent claims 2 and 4 expressly specified that the encoded PIP-72 comprised 1 to 17 amino acid substitutions at various positions when compared to the naturally occurring sequence SEQ ID NO: 2. The Controller had completely ignored this aspect of the claims and had failed to appreciate that the claimed invention was restricted to a synthetic man-made polypeptide sharing property resemblance with but distinct from the natural peptide.
Doctrinal Significance
The Pioneer Hi-Bred judgment makes contributions to Indian patent law in two areas the procedural limits of the Controller’s power to reject applications under Section 15 and the substantive scope of Section 3(c) in the context of synthetic biological inventions.
On the procedural question, the judgment provides useful clarification that the Controller’s power to refuse an application under Section 15 must be exercised in a manner proportionate to the objections actually raised and examined. Where specific claims are the subject of Section 3(c) objections but other independent claims have attracted no objection, the wholesale rejection of the entire application without examining those unchallenged claims constitutes incomplete examination rather than a proper exercise of the Section 15 power. This principle has practical significance for patent applicants in the biotechnology and molecular biology space who often file multi-claim applications covering a spectrum of subject matter and who are entitled to expect that the Controller’s examination will address each claim or set of claims with the specific objections that attend it.
On the substantive question, the judgment contributes to the developing body of Indian judicial authority interpreting Section 3(c) in the context of modern biotechnological inventions. By affirming and applying the analysis in Immunas Pharma and Diamond Star Global, the Court has reinforced the principle that Section 3(c) is directed at the discovery of naturally occurring substances in their natural form and does not extend to synthetic or recombinant substances created through substantial human intervention even if they bear structural resemblance to naturally occurring counterparts. This is an important clarification for the biotechnology and agricultural science industries where many patent applications involve engineered versions of naturally occurring biological molecules. The judgment makes clear that the appropriate forum for contesting such applications is the examination of novelty and inventive step under Section 2(1)(j) rather than the categorical exclusion under Section 3(c).
The Court’s express refusal to express any opinion on the merits while remanding is also noteworthy it ensures that the Controller approaches the fresh examination with an open mind and that the appellant retains the full benefit of its right to have each claim examined on its individual merits.
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