In a pivotal judgment involving the interface of biotechnology and intellectual property law, the Delhi High Court dismissed an appeal filed by The Regents of the University of California against the rejection of its Indian patent application for a novel vaccine. The court upheld the Patent Office’s decision refusing the grant on grounds of non-compliance with key statutory requirements under the Patents Act, 1970, including lack of sufficient disclosure, indefiniteness in claims, and ineligibility under Section 3(c) pertaining to naturally occurring substances.
The subject of the patent application was a recombinant Salmonella microorganism-based live vaccine designed to induce immunity against enteric bacterial infections in livestock. Filed as a national phase application under the Patent Cooperation Treaty (PCT) on February 17, 2017, the application traced its priority to a U.S. filing dated August 29, 2014. It aimed to cover genetically modified Salmonella strains with specific gene mutations, including deletions, insertions, or substitutions in genes such as dam, sifA, spvB, and mgtC. These genetically altered strains were claimed to be less virulent and thereby safe for use as live vaccines.
The Indian Patent Office issued its First Examination Report (FER) in March 2021, raising multiple objections: lack of inventive step under Section 2(1)(ja), non-patentability under Sections 3(c), 3(d), 3(e), and 3(i), lack of unity of invention under Section 10(5), and insufficient disclosure under Section 10(4). Despite the applicant’s detailed responses, oral hearings, and submission of amended claims, the Controller rejected the application on July 14, 2022, citing a continued failure to meet the statutory thresholds for disclosure and clarity, as well as concerns that the claims encroached upon naturally occurring biological materials.
The appellant’s legal counsel argued that the claimed invention was not a product of nature, as it involved recombinant strains created through deliberate genetic manipulation. They emphasised that the mutations, particularly in the dam gene and others, were artificially induced and did not arise naturally, thereby distancing the invention from the exclusions of Section 3(c). They further submitted that the specification contained sufficient technical disclosure to enable a skilled person to reproduce the invention, supported by references to specific gene loci and mutation techniques. The University of California also pointed out that similar patent claims had been granted in other major jurisdictions, including the United States and Europe, and that the requirement of deposit under Section 10(4)(d) did not apply since the claimed microorganisms were not inaccessible to the public.
On the other hand, the Controller of Patents, represented by government counsel, maintained that the patent application failed to comply with the fundamental requirements laid down under Sections 10(4) and 10(5) for sufficient disclosure and claim definiteness. The Controller’s order highlighted that the claims encompassed a wide array of possible mutations across multiple genes and strains of Salmonella, including combinations of insertions, deletions, and substitutions, without adequately describing each in the specification. It was argued that the specification primarily described deletion mutations for one strain (S. Typhimurium) and failed to detail the implementation or expected results of insertion and substitution mutations. As a result, a skilled person would be left to engage in undue experimentation, thereby contravening the disclosure standards mandated under Section 10(4).
The High Court, in its detailed judgment, upheld the Controller’s reasoning. The Court reiterated that Sections 10(4) and 10(5) are mandatory provisions, requiring complete, precise, and enabling disclosure of the invention and its scope. Justice Bansal pointed out that while the claims attempted to cover an expansive range of genetically modified microorganisms, the specification did not adequately support this breadth, particularly with regard to insertion and substitution mutations. The Court emphasised that even a sophisticated scientific audience must be able to replicate the invention without undue experimentation—a standard the application failed to meet.
Another critical aspect of the judgment was the interpretation of Section 10(4)(d), which necessitates the deposit of biological material with an International Depository Authority under the Budapest Treaty if it is not publicly available and if disclosure in the specification is inadequate. The Court held that although Salmonella strains themselves might be publicly available, the recombinant strains engineered through complex genetic modification were not. Since these strains were not deposited and could not be replicated with certainty from the limited disclosure provided, the patent application violated the deposit requirement, rendering the invention insufficiently accessible to the public.
On the issue of claim clarity under Section 10(5), the Court found that the claims were drafted too broadly and did not precisely delineate the inventive contribution. Referring to the Supreme Court’s landmark judgment in Novartis AG v. Union of India, the High Court cautioned against “artful drafting” that seeks to widen the claim boundaries beyond the actual technical contribution disclosed. It reiterated that patents are not rewards for speculative theories or abstract claims but for concrete, reproducible innovations made available to the public in exchange for a limited monopoly.
The Court also addressed the Section 3(c) objection, noting that the patent claims, as drafted, could extend to naturally occurring mutations or strains with functional gene loss due to spontaneous mutation or environmental factors. In dismissing the appeal, the Delhi High Court affirmed that the statutory requirements for patentability, particularly biological inventions, must be strictly interpreted to prevent monopolising natural phenomena.
