Section 3(c) of the Patents Act, 1970 excludes the mere discovery of a scientific principle, the formulation of an abstract theory, or the discovery of any living thing or non-living substance occurring in nature from patentability. However, the distinction between discovering a naturally occurring substance and developing a product through scientific and technical intervention becomes important in inventions relating to biotechnology. Where a claimed invention involves synthetic or recombinant biological material, the Patent Office must examine the nature of the claimed subject matter and the extent of human intervention before applying the exclusion under Section 3(c). At the same time, such inventions must independently satisfy the other requirements of patentability under the Act.
The appeal against the refusal of a patent application filed by Pioneer Hi-Bred International Inc. for an invention relating to insecticidal proteins and methods for their use was allowed by the Delhi High Court. The Court examined the patent specification along with the finally amended claims and found merit in the appellant’s contention that the claimed invention related to synthetic polypeptides involving substantial human intervention and specific features such as amino acid substitutions. The Court observed that Section 3(c) of the Patents Act, 1970 excludes from patentability the mere discovery of a scientific principle, the formulation of an abstract theory or the discovery of any living thing or non-living substance occurring in nature.
The Court examined the sole ground of refusal under Section 3(c) and noted that the respondent Controller had failed to properly consider the appellant’s submissions that the exclusion applies to the discovery of naturally occurring subject matter and does not extend to inventions produced through substantial human intervention. The Court also questioned the refusal of the entire patent application based on objections confined to Claims 3 and 4, without examining independent Claim 1 and the remaining claims. The Court found that such incomplete examination of the entire set of claims constituted a fundamental flaw in the impugned order, warranting remand.
Setting aside the impugned order, the Court directed the respondent Controller to re-examine the entire set of claims on merits. Allowing the appeal in Pioneer Hi-Bred International Inc. vs Controller of Patents [C.A.(COMM.IPD-PAT) 35/2024], decided on July 22, 2026, the Delhi High Court found the respondent’s assertion that the Patents Act does not empower the Controller to allow claims in part or segregate valid claims from invalid claims to be without merit. The Court observed that such an assertion was “neither here nor there” and held that the matter involved incomplete examination of the entire set of claims, warranting remand.
Appellant’s Case
The appellant, Pioneer Hi-Bred International Inc., submitted that the claimed invention relates to isolated or recombinant nucleic acid molecules capable of encoding PIP-72, as well as corresponding PIP-72 polypeptides produced under synthetic conditions involving significant human intervention. The appellant argued that the respondent Controller had committed a procedural error in refusing the entire application, as the impugned order was based solely on objections to Claims 3 and 4, without considering Claims 1 and 2 and 5 to 8. The appellant also submitted that the Controller had overlooked its request dated February 7, 2024, to delete Claims 3 and 4 and consider three sets of auxiliary claims.
Controller’s Response
The respondent Controller submitted that the impugned order suffers from no legal infirmity. The respondent contended that Section 3(c) specifically excludes from patentability, 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 and therefore, bars patenting of naturally occurring nucleic acid sequences or polypeptides, even if isolated or produced recombinantly, if they are identical to their natural counterparts. The respondent Controller submitted that Claim 3 of the instant application relates to a recombinant PIP-72 polypeptide having at least 80% identity to SEQ ID NO: 2 and Claim 4 depends on it.
The respondent submitted that the specification itself shows that SEQ ID NO: 2 is a naturally occurring polypeptide isolated from Pseudomonas chlororaphis. A claim for “at least 80% identity” also covers the 100% identical natural sequence. Merely calling it “recombinant” does not change the fact that the substance remains the same as what exists in nature. The respondent maintained that even if a naturally occurring sequence is produced through recombinant techniques, it would not take the resulting polypeptide outside the scope of Section 3(c). Therefore, Claims 3 and 4, which encompassed naturally occurring PIP-72 polypeptides, were barred under Section 3(c).
The respondent Controller further maintained that the Patents Act does not empower the Controller to allow claims in part or segregate valid claims from invalid claims. According to the respondent, where an applicant fails to amend claims that do not comply with the provisions of the Act, the Controller is entitled to refuse the entire application under Section 15. Therefore, the refusal was procedurally correct and lawful.
Analysis and Findings of the Court
The Court examined the complete specification and the amended claims and noted that the claimed invention was directed at providing isolated or recombinant nucleic acid molecules capable of encoding PIP-72. The Court found that the appellant claimed a nucleic acid molecule or a polypeptide produced under synthetic conditions involving significant human intervention, capable of mimicking the activity of PIP-72. The Court observed that the essence of the impugned order was that even if a naturally occurring sequence is prepared in a laboratory using molecular biology techniques and human intervention, the resultant protein or polypeptide, if identical in structure to a naturally occurring sequence, would be excluded from patentability under Section 3(c) of the Act.
The Court found merit in the appellant’s contention that the respondent Controller had failed to consider the synthetic nature of the claimed polypeptides and specific features such as amino acid substitutions. The Court noted that the Controller ought to have considered the appellant’s submissions regarding substantial human intervention in producing the claimed recombinant polypeptides. The Court referred to the ruling of the Madras High Court in Immunas Pharma v. Assistant Controller of Patents and Designs [2024 SCC OnLine Mad 480], wherein it was held that the statutory exclusion under Section 3(c) concerns the discovery of a non-living substance occurring in nature. The expression “discovery” denotes finding something which already exists, rather than something produced, engineered or manufactured. Accordingly, the exclusion applies to the identification and isolation of a hitherto undiscovered non-living substance occurring in nature and does not extend to subject matter produced through substantial human intervention.
Applying the principles discussed in Immunas Pharma and Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, the Court found that the respondent Controller ought to have examined the appellant’s detailed submissions regarding the nature of the claimed invention. The appellant had specifically pointed out that dependent Claims 2 and 4 contemplated 1 to 17 amino acid substitutions at various positions when compared to SEQ ID NO: 2, the naturally occurring sequence. The Court observed that these submissions, which were relevant to determining whether the claimed subject matter was merely a discovery of something occurring in nature, had not been properly considered by the respondent Controller.
The Court also agreed with the appellant that the respondent Controller had not examined the application completely. The specific objection under Section 3(c) was confined to Claims 3 and 4, and no reasons were given for refusing independent Claim 1 and the remaining claims. The Court rejected the respondent’s submission that the Controller had no power to reject an application after segregating valid claims from invalid claims, observing that such an argument was “neither here nor there”. The Court held that the matter involved incomplete examination of the entire set of claims and therefore deserved to be remanded.
Decision of the Court
Setting aside the impugned order dated February 19, 2024, the Court ruled that the patent application required complete examination and fresh consideration. The Court directed the respondent Controller to examine the entire set of claims, issue a fresh notice of hearing to the appellant and proceed further in accordance with law.
Conclusion
The decision reiterates that Section 3(c) of the Patents Act, 1970 is directed at the mere discovery of naturally occurring subject matter and that the distinction between discovery and inventions produced through substantial human intervention must be carefully examined. In the present case, the Court found that the respondent Controller had failed to consider the appellant’s submissions regarding the synthetic and recombinant nature of the claimed polypeptides, including the amino acid substitutions distinguishing them from the naturally occurring sequence.
The Court also found that refusal of an entire patent application based on objections confined to particular claims, without examining the remaining claims, constituted an incomplete examination. The Controller was required to consider the entire set of claims and the relevant submissions of the applicant before arriving at a conclusion on patentability.
The Delhi High Court accordingly set aside the refusal order and remanded the matter for fresh examination within five months. The ruling reinforces the importance of proper examination of biotechnology inventions under Section 3(c), particularly where the claimed subject matter involves substantial human intervention. However, the Court clarified that it had expressed no opinion on the merits of the patent application, leaving the question of patentability to be determined by the Controller upon reconsideration.
Author: DPS Parmar