The Regents of the University of California v. The Controller of Patents, C.A.(COMM.IPD-PAT) 481/2022
Delhi High Court · Dismissed
Refusal of a live recombinant Salmonella vaccine application upheld on every ground and the appeal dismissed. The claims failed sections 10(4)(c) and 10(5) because, even reading the claims with the complete specification, they gave no clear and precise definition of the full scope of the recombinant organisms covered, and the claiming of insertion and substitution mutations was not fairly based on the subject matter disclosed for want of detailed support or working embodiments. On deposit, the Court held that what proviso (ii) to section 10(4) requires to be deposited with an International Depository Authority under the Budapest Treaty is the recombinant organism, not the source bacterium, so the argument that Salmonella is commonly available did not meet the requirement. On section 3(c), the claims were broad enough to cover naturally occurring loss-of-function variants, the specification itself saying the target genes need not be mutated and that expression could be disrupted through upstream regulatory changes; the absence of a pending novelty objection was no answer.