Pioneer Hi-Bred International Inc v Controller of Patents (2026)

Summary

“This appeal is filed on behalf of the Appellant under Section 117A of Patents Act, 1970 ... challenging impugned order dated 19.02.2024 passed by the Respondent, whereby Indian Patent Application No. 201617008869 has been rejected on ground of non-patentability under Section 3(c) of 1970 Act.” (para 1) “The claimed invention relates to novel genes that encode pesticidal proteins and the pesticidal proteins and nucleic acid sequences that encode them are useful in preparing pesticidal formulations as also for production of transgenic pest-resistant plants.” (para 10) “First Examination Report (FER) was issued by the Patent Office on 07.08.2020 and response was filed by the Appellant on 03.05.2021.” (para 2) “During the hearing, claims 1-11 were amended and renumbered as claims 1-8 and finally, by the impugned order, all claims were refused despite objection being raised only with respect to claims 3 and 4.” (para 3) The Respondent had held that “even if a naturally occurring sequence is prepared in the lab using molecular biology techniques and by human effort and intervention ... but if the lab synthesised protein/polypeptide is identical, in terms of structure, i.e. its amino acid sequence, to the naturally occurring sequences, then it cannot be distinguished from the naturally occurring sequence” (para 12).

The Court held that “Claim 1 is also an independent claim and no objection was raised qua its patentability” and that “this is a case of incomplete examination of the entire set of claims and therefore, the matter deserves to be remanded” (para 13). Of Immunas Pharma v Assistant Controller of Patents and Designs (2024), it concluded that “the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from the nature” (para 16), and held that “there is merit in the contention of the Appellant that Respondent ought to have considered the detailed submissions” and that “the Respondent ought not to have ignored portions of dependent claims 2 and 4” (para 17). “Accordingly, the impugned order dated 19.02.2024 passed by the Respondent is set aside. Respondent shall carry out complete examination of the entire set of claims and thereafter issue a fresh notice of hearing to the Appellant and proceed further in accordance with law.” (para 18) “Appeal is allowed and disposed of.” (para 19)

What the court decided

1. Procedure. Prosecution history. “It is stated that in the FER” (“First Examination Report”) “objection of lack of novelty was raised qua claim 36 owing to prior art D2 and qua claims 1-52 in view of prior arts D1-D5.” “Appellant filed a response to FER with amended claims 1-52 renumbered as claims 1-11.” “Objection of non-patentability under Section 3(c) was raised qua claims 3, 4, 6 and 7 relating to ‘isolated polypeptide’ and ‘recombinant polypeptide’. During the hearing, claims 1-11 were amended and renumbered as claims 1-8 and finally, by the impugned order, all claims were refused despite objection being raised only with respect to claims 3 and 4.” (para 3)
2. The claimed invention. “The instant Indian Patent Application No. 201617008869 was filed in respect of invention titled ‘INSECTICIDAL PROTEINS AND METHODS FOR THEIR USE’. The claimed invention relates to novel genes that encode pesticidal proteins and the pesticidal proteins and nucleic acid sequences that encode them are useful in preparing pesticidal formulations as also for production of transgenic pest-resistant plants.” The specification, reproduced by the Court, stated: “In particular, isolated or recombinant nucleic acid molecules are provided encoding Pseudomonas Insecticidal Protein-72 (PIP-72) polypeptides including amino acid substitutions, deletions, insertions, and fragments thereof, and combinations thereof.” (para 10)
3. The appellant’s case. The Appellant submitted that the “Impugned order rests solely on objections to claims 3 and 4, yet subject application has been rejected in entirety” and that “Without entering into the merits of rejection of claims 3 and 4, Respondent has erred in refusing the subject application, overlooking the request of the Appellant made vide email dated 07.02.2024 to delete claims 3 and 4 and accept three sets of auxiliary claims for consideration.” (para 4) It added that the “Impugned order does not reflect which limb of Section 3(c) was invoked by the Respondent to refuse the application.” (paras 4–5)
4. The Controller’s reasoning. The impugned order, reproduced by the Court, held that “even if a naturally occurring sequence is prepared in the lab using molecular biology techniques and by human effort and intervention ... but if the lab synthesised protein/polypeptide is identical, in terms of structure, i.e. its amino acid sequence, to the naturally occurring sequences, then it cannot be distinguished from the naturally occurring sequence.” Of claim 3 it held: “Here, a percentage identity of more than 80 percent includes in its ambit, a poypeptide with 100% identity to SEQ ID No. 2, i.e naturally occuring polypeptide.” and “Further, the applicant has not excluded such natural polypeptides from the ambit of the claim or has not defined or restricted the claim to particular polypeptides which are non-natural.” It concluded: “Therefore, I hereby order that the grant of a patent is refused for patent application No. 201617008869 under section 15 of the Act.” (para 12)
5. Earlier grants of similar claims. The impugned order stated that “the applicant should note that decision in any patent application is taken by a Controller after following the due process of law and based on the facts and circumstances of the case and documents on record.” (para 12)
6. The Respondent’s case. The Respondent submitted that “Section 15 of 1970 Act empowers the Controller to refuse an application seeking grant of patent, if it does not qualify or meet the requirements of the provisions of the 1970 Act”, that “A claim for ‘at least 80% identity’ also covers the 100% identical natural sequence” and that “Merely calling it ‘recombinant’ does not change the fact that the substance remains the same as what exists in nature.” (para 6) Of Regents of the University of California v The Controller of Patents, C.A.(COMM.IPD-PAT) 481/2022, it urged that the “Court upheld the Patent Office’s refusal on the ground, inter alia, that the claims were so broad that they covered Salmonella with naturally occurring, endogenous loss-of-function mutations and thus fell within Section 3(c).” (paras 6–7)
7. Refusing the whole application. The Respondent argued “that Patents Act does not empower the Controller to allow claims ‘in part’ by excluding claims which cannot be granted” and that “Appellant was granted an opportunity to delete Claims 3 and 4 but it chose not to do so and there was no option but to refuse the entire application under Section 15 as there was no power to segregate valid claims from invalid claims.” (para 8) The Court held: “The argument on behalf of the Respondent that Controller has no power to reject an application after segregating the valid claims, is neither here nor there”. (paras 8, 13)
8. Claims never objected to. “The first and foremost contention raised by the Appellant is that sans any objection against claims 1 and 2 and 5 to 8, the same could not have been rejected. The specific objection under Section 3(c) was qua claims 3 and 4 and there was no justification to reject the application in entirety. Perusal of the claims shows that Claim 1 is also an independent claim and no objection was raised qua its patentability.” The Court held that “to my mind, this is a case of incomplete examination of the entire set of claims and therefore, the matter deserves to be remanded.” (para 13)
9. The competing positions. “In a nutshell, the case of the Appellant is that the invention does not qualify as a mere discovery of living thing or a non-living substance in nature and the claimed polypeptide only arises as a result of substantial human intervention and does not occur naturally.” (para 14) “The essence of the impugned order essentially is that even if a naturally occurring sequence is prepared in a lab using molecular biology techniques and by human effort and intervention but if the resultant protein/ polypeptide is identical in its structure to the naturally occurring sequences, then the claimed invention cannot be patented owing to proscription under Section 3(c) of 1970 Act.” (paras 14–15)
10. Man-made substances and section 3(c). Of Immunas Pharma v Assistant Controller of Patents and Designs (2024) the Court said that “The Madras High Court in Immunas Pharma (supra) examined the ambit and scope of Section 3(c) in the Indian statutory context while also examining the judgments of the US Supreme Court in this regard and the observations will be instructive.” The Madras High Court, as reproduced, had held that “While it could be argued that this qualifier is only intended to underscore that the exclusion would not apply to a non-living substance that is man-made, in my view, said explanation does not withstand close scrutiny because such non-living substance, if man-made and novel, would not be discovered; it would be created or invented.” and “If man-made but not novel, it would be produced and not discovered. It would also not surmount the Section 2(1)(j) hurdle and the Section 3(c) exclusion is clearly not intended for such non-living substances.” (para 15)
11. Meaning of discovery. The Madras High Court, as reproduced, had held that “Both the use of the noun ‘discovery’- which implies finding something which already exists and not producing, engineering or making something - and the use of the present continuous form ‘occurring in nature’ indicate that the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature.” (para 15) The Court held: “The conclusion that one draws from the judgment is that the statutory prescription in Section 3(c) is ‘discovery of any ... non-living substance occurring in nature’ and the word ‘discovery’ implies finding something which already exists and not produced, engineered or made and therefore, the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from the nature.” (paras 15–16)
12. Proof of non-occurrence in nature. “The Court posed to itself a question whether a patent applicant is required to establish that such non-living substance never occurs in nature and observed that the guidance was in Section 3(c) itself and the answer is in the negative.” (para 16)
13. Eligibility and patentability distinguished. The Madras High Court, as reproduced, had held that “Ultimately, it should not be lost sight of that Section 3(c) is confined to patent exclusions or ineligibility and passing through such filter does not guarantee the grant of patent.” and that “The real challenge with regard to a patent application in respect of a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty, technical advance and not patent eligibility.” (para 15)
14. Obiter. Width of functional claims. The Madras High Court, as reproduced, had observed that “the other legitimate concern from the Indian Patent Office perspective, in the context of monoclonal antibodies, could be to closely examine the width of claims so as to ensure that very broad claims focused entirely or largely on functionality are not allowed because that could impede instead of fostering inventiveness in future.” (para 15)
15. ‘Mere’ in section 3(c). The Court found Diamond Star Global Sdn. Bhd. v Joint Controller of Patents and Designs, 2023 SCC OnLine Del 1879, “also helpful in understanding the proposition”, and reproduced its holding that “The word ‘mere’, as used in the opening part of the said Clause would apply, in my opinion, both to the first part, i.e. ‘discovery of a scientific principle or the formulation of an abstract theory’ as well as to the second part, i.e. ‘discovery of any living thing or non-living substances occurring in nature’. It is only mere discovery of a living thing, or non-living substance occurring in nature which, therefore, according to me, would fall within the second part of Section 3(c).” (para 16)
16. The guaiacol illustration. The passage from Diamond Star Global reproduced by the Court continued: “if someone were to seek a patent for guaiacol, it would be possible to reject the application on the ground that guaiacol is a substance occurring in nature and, therefore, even if it had not been earlier discovered, the mere discovery of guaiacol was not patentable as an invention, in view of the proscription contained in Section 3(c).” and “Where, however, the Controller has erred is in failing to observe that the appellant was not seeking to merely patent wood vinegar obtained from the Rhizophora apiculata tree.” (para 16)
17. The two sides of patent grant. The reproduced passage from Diamond Star Global also stated that “On the one hand, the very raison d’ etre of patent is fostering of scientific temper, and protection of the inventive faculties of persons” and that “On the other, the grant of a patent results in a monopoly, in the patent holder, of the right to use the invention during the life of the patent, thereby excluding its availability to all others who may desire to create something similar.” and that “The task of the authority who is approached with an application seeking grant of a patent - and of the Court seized with a challenge to the decision of the said authority - is, therefore, often to balance these two considerations, and ascertain whether the claimed invention genuinely represents an ‘inventive step’ over existing knowledge in the form of prior art.” (para 16)
18. New product after Novartis. Recording the law declared in Novartis AG v Union of India (2013), the reproduced passage from Diamond Star Global stated that “The Supreme Court, therefore, advocates according, to the expression ’new product or process’ in Section 2(1)(j), an expansive, rather than a restrictive, interpretation, and Article 141 of the Constitution of India makes that interpretation binding on every authority lower in the judicial hierarchy, including this Court.” and that “The claims of the appellant are interdependent, not independent, and have to be seen as such.” (para 16)
19. Human intervention and amino-acid substitutions. “Therefore, in light of the aforesaid judgments, there is merit in the contention of the Appellant that Respondent ought to have considered the detailed submissions bringing forth that the objective of the claimed invention is to provide isolated or recombinant nucleic acid molecules capable of encoding a PIP-72 and what was being claimed was a nucleic acid molecule or a polypeptide, produced in synthetic conditions with significant human intervention that can mimic the activity/action of PIP-72 and also that the Respondent ought not to have ignored portions of dependent claims 2 and 4, where it is clearly stated that encoded PIP-72 comprises of 1 - 17 amino acid substitutions at various positions when compared to SEQ ID NO: 2 i.e. naturally occurring sequence and therefore, irrespective of the nature of polypeptide, the claimed invention is directed as well as restricted to a synthetic, man-made polypeptide, sharing property resemblance with the natural peptide.” (para 17)
20. Procedure. Remand and disposal. “In view of the aforesaid reasons, the patent application requires complete examination and hence, fresh consideration. Accordingly, the impugned order dated 19.02.2024 passed by the Respondent is set aside. Respondent shall carry out complete examination of the entire set of claims and thereafter issue a fresh notice of hearing to the Appellant and proceed further in accordance with law. The entire exercise will be completed in not later than 5 months from today.” (para 18) “Appeal is allowed and disposed of.” (paras 18–19)

What the court did not decide

“It is made clear that this Court has not expressed any opinion on the merits of the case.” (para 18)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 11 October 2026.