9 judgments of the Delhi High Court, the Calcutta High Court and 1 other court applying Patents Act s.3(c), from 2023–2025, each with a headnote by BRB Legal.
Interim injunction granted restraining a biosimilar of Nivolumab during the pendency of the suit. The Court weighed that the patent was valid in fifty countries and had been sustained against challenge in thirty, that it had been granted only after fourteen years, which itself shortened the limited monopoly, that a pre-grant opposition by an association of which the defendant is a member had been rejected, and that the defendant had been under injunction for more than a year and had no manufacturing licence until December 2024.
Refusal of an application for a method of generating hybrid cells set aside. The Court held that tri-hybrid cells, being synthetic and not naturally occurring, do not fit the description of plants or animals under section 3(j), and that the impugned order failed to engage with the contention that the cell is by its nature not an essentially biological process for propagation or production of a plant or animal. The conclusion under section 3(c) was equally baseless because it ignored the technical intervention and human step involved, that provision operating independently to declare naturally occurring living and non-living things inherently unpatentable. Monsanto was distinguished as concerning a man-made DNA construct inserted into plants so as to pass into future generations, a different extent of human intervention.
Refusal set aside and remanded. The Controller had noted but given no reasons for rejecting the applicant's contention that the nucleotide sequences were synthesised, and had inferred from the absence of conjugated detectable labels on two of the claimed primer sequences that they must have been discovered or taken from a natural source and so were excluded by section 3(c). The Court held that this conclusion warranted re-examination.
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.
Refusal of an anti-CD38 antibody application set aside. On section 3(c) the Court held that the claims could not be treated as the discovery of a non-living substance occurring in nature merely because the organism specified in the sequence listing was homo sapiens; that conclusion would be justified only if the appellant had found a hitherto unknown antibody and isolated it from nature, whereas the antibody here was developed on a transgenic mouse platform and the annotation recorded the most homologous organism. On inventive step the Court found no basis for the conclusion that the invention lacked technical advancement, the appellant having shown structurally novel CDR sequences and functional advances in cytotoxicity and tumour inhibition supported by expert affidavits, and the cited prior art having been before the ISA, the EPO and the USPTO.
Refusal of a monoclonal antibody under section 3(c) set aside and the invention directed to proceed to grant. The exclusion reaches the discovery of a living thing or non-living substance occurring in nature, which means it applies only where the applicant has found a hitherto unknown substance and isolated it from nature; the words occurring in nature must be given meaning and redundancy is not to be imputed to Parliament. Passing that filter does not guarantee grant, and the real challenge for a synthesised antibody is novelty and technical advance, for which the sequences, especially the complementarity determining regions, may need comparison with known antibody sequences, with the other exclusions and section 2(1)(j) still to be satisfied. Here the antibody was engineered, by replacing murine genetic material with human genetic material in transgenic mice, immunising them with an engineered antigen and fusing splenocytes with myeloma cells, so it was plainly not isolated from a human being; inventiveness was asserted in the resulting antibody targeting a specific epitope, not in the hybridoma technology. That the sequence listing named homo sapiens as the organism of origin under the applicable WIPO standard did not make the antibody naturally occurring.
Companion to Imclone, decided the same day by the same judge, setting aside a section 3(c) refusal of an antibody binding A-beta oligomer and directing grant. The exclusion applies only where a hitherto unknown substance has been identified and isolated from nature, and the expression occurring in nature cannot be robbed of meaning. The antibody here was generated by preparing an engineered antigen, immunising mice with it and fusing material from their inguinal lymph nodes with myeloma cells by the hybridoma process, so it was engineered rather than isolated; inventiveness was asserted in the antibody targeting a specific epitope, not in the hybridoma technology. The applicant's answer on the sequence listing was accepted: the organism of origin recorded at identifier 213 is merely indicative of the origin of the protein, even where the protein is recombinant or synthetically obtained, and the sequence itself at identifier 400 is what identifies the listing.
Refusal of an anti-obesity composition application under sections 2(1)(ja), 3(c) and 3(p) set aside on the ground of fairness. The Controller had circulated two prior art documents, but at the hearing relied on four more that were never put to the applicant, and then rejected the application relying on all of them. The doctrine of fairness is indispensable wherever a civil right is involved, and the right to have an invention patented cannot be refused on materials used behind the applicant's back. The submission that circulating traditional knowledge risks it passing into the wrong hands was no answer.
A section 3(c) refusal was set aside where the Controller concluded from the sequence listing that all the claimed sequences were obtained from a moth, without engaging the applicant's case that the peptides are chemically synthesised and do not occur in nature. An order on an application for grant must contain cogent reasons, reached after engaging with the contentions of the applicant.
