- Case number
- (T)CMA(PT) No.126 of 2023
- Court
- Madras High Court
- Date of judgment
- Judge
- Senthilkumar Ramamoorthy
- Outcome
- Set aside
Headnote
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.
Headnote by BRB Legal, written from the judgment: a summary for reference, not legal advice. Read the judgment itself before relying on it.