The Delhi High Court has upheld the Controller’s order refusing a patent application under Section 3(c) of the Patents Act, 1970, as certain claims of the application were too broad and thus would also cover naturally existing variants of the microorganism. Further, according to the Controller, the claims were not sufficiently disclosed as required under Sections 10(4) and 10(5) of the Patents Act.
The inventive concept covered in the subject patent application was a vaccine composition for inducing an immune response in a subject to a Salmonella microorganism, where it claimed both genetically modified Salmonella microorganisms used in the vaccine composition and the vaccine itself.
The Court in Regents of the University of California v. Controller of Patents noted that the claims of the subject patent application covered and encompassed various types of loss of function mutations in selected genes of Salmonella microorganisms.
Observing that the detailed description clarified that the target genes do not necessarily need to be deliberately mutated as long as the expression of the native gene product is functionally disrupted in some way, the Court was of the view that this broadened the scope of the subject patent application to include any method of gene disruption, and thus non-patentable under Section 3(c).
The High Court in its judgement dated 21 February 2025 was also of the opinion that it was crucial to have sufficient disclosure to define the scope of subject patent application and to make sure that the subject patent application does not cover naturally mutated Salmonella microorganism, which is excluded under Section 3(c).
Hence, according to the Court, the lack of specific disclosures in respect of insertion and substitution mutations resulted in insufficiency of disclosure, thus rendering the subject patent application non-compliant with the mandatory requirements under Section 10(4)(a).
It was also observed that partial disclosure as made in the subject patent application will also not be sufficient to enable a person skilled in the field of microbiology to perform the invention as mandated under Section 10(4)(b) of the Act, without additional guidance. It was also held that the claims of the subject patent application failed to fulfil the requirements under Sections 10(4)(c) and 10(5).
The High Court hence held that unless the subject patent application has been sufficiently disclosed with enabling disclosure and with clear claims, there shall be a serious prejudice that the endogenous mutations claimed in the subject patent application could cover those present naturally and would consequently be non-patentable under Section 3(c) of the Act.
It may be noted that the Court also held that every requirement under Sections 10(4) and 10(5) is mandatory for the complete specification of a patent application to be valid in India.