Calcutta High Court Rules Hybrid Cell Inventions Exempt from Section 3(j) Patent Exclusion

The Calcutta High Court recently delivered a significant ruling in BTS Research International Pty Ltd v. The Controller General of Patents (SR/55/2020/PT/KOL), clarifying the scope of Section 3(j) of the Indian Patents Act concerning hybrid cell inventions. The Court held that inventions involving hybrid or chimeric cells created through artificial processes do not fall within the exclusion of "essentially biological processes" under Section 3(j).

BTS had filed patent application number 0041/KOLMP/2012 titled “Method of Generating Hybrid/Chimeric Cells and Uses Thereof,” which described an artificial process for fusing tri-hybrid cells by combining three somatic cells, at least two of which were different types, including human and mouse cells. The Assistant Controller of Patents rejected the application on June 16, 2020, citing Sections 3(j) and 3(c) of the Patents Act. The Controller reasoned that the invention involved biological processes related to naturally occurring parent cells and thus was not patentable.

Challenging this refusal, BTS contended that the tri-hybrid cells were produced through advanced genetic engineering and artificial fusion, not through an essentially biological process. BTS also argued procedural lapses, including the failure to issue a mandatory Second Examination Report (SER), and highlighted that the European Patent Office had granted a patent on the same invention after considering relevant prior art.

The Controller’s Counsel maintained that the application fell within Section 3(j) because the claimed progenitor cells were stem cells capable of developing into organisms, and cited the precedent of Nuziveedu Seeds Ltd. v. Monsanto Technology LLC to argue that genetic modification alone does not guarantee patentability.

The Court found that the Assistant Controller erred by not issuing the mandatory SER as required under Section 13(3) of the Patents Act. It further noted that the Assistant Controller failed to consider the European Patent Office’s prior grant and did not adequately assess the prior art or BTS’s arguments.

On the substantive issue, the Court analyzed Section 3(j), which excludes inventions involving essentially biological processes for the production or propagation of plants and animals. The Court clarified that this exclusion applies narrowly and must be strictly construed. It emphasized that genetic manipulation is a technical process involving substantial human intervention, and genetically modified organisms created through such processes fall outside the scope of Section 3(j).

The Court observed that the Assistant Controller had overlooked the artificial nature of the tri-hybrid cell creation process and had incorrectly treated the invention as relating solely to stem cells. The ruling highlighted that tri-hybrid cells, being artificially produced and not naturally occurring, do not qualify as “plants” or “animals” under the statute.

Regarding the reliance on Nuziveedu Seeds Ltd. v. Monsanto Technology LLC, the Court distinguished the present case on the basis of the degree of human intervention involved, finding the cases not comparable.

Ultimately, the Court held that the rejection under Sections 3(j) and 3(c) was based on a fundamental misinterpretation of the law and lacked proper reasoning. The June 16, 2020 refusal order was set aside, and the matter was remanded for fresh adjudication by a different Hearing Officer. The Court directed that the application be disposed of within 12 weeks from the date of communication of the order.

This ruling marks a pivotal development for patent protection of genetically engineered cell technologies in India, underscoring the importance of recognizing artificial processes as distinct from excluded biological processes under the Patents Act.

Citation: BTS Research International Pty Ltd vs The Controller General Of Patents (SR/55/2020/PT/KOL) (Calcutta High Court, April 3, 2025). Available at: https://indiankanoon.org/doc/52802766/