Summary
The Calcutta High Court ruled that inventions involving hybrid or chimeric cells created via artificial processes do not fall within the exclusion under Section 3(j) of the Patents Act. The order sets aside the earlier refusal and directs a fresh review, affirming the patentability of genetically engineered cell technologies in India.
In a recent decision, the Calcutta High Court upheld an appeal filed by BTS Research International Pty Ltd (“BTS”) challenging the rejection by the Assistant Controller of Patents for its patent application on a method involving hybrid/chimeric cells. The appeal pertained to a refusal order dated June 16, 2020, relating to the patent application titled “Method of Generating Hybrid/Chimeric Cells and Uses Thereof.” In its ruling, the Court emphasized that genetic manipulation, being a technical process involving substantial human intervention, did not qualify as an essentially biological process under Section 3(j) of the Act.
Background
The patent application (0041/KOLMP/2012) filed by BTS involved an artificial process for fusing tri-hybrid cells through the fusion of three somatic cells of which at least two are of different types and can be cells of humans and a mouse.
In the impugned order, the Assistant Controller rejected the patent application on the grounds that the invention fell under Section 3(j) of the Act, as it involved the use of cells with attributes of naturally occurring parent cells (human or non-human), thereby deeming the process biological rather than artificial. Additionally, the Assistant Controller held that the invention fell under Section 3(c) of the Act, as it constituted a discovery of a living thing occurring in nature and was therefore not patentable.
BTS challenged the refusal order, contending that Section 3(j) was inapplicable since the tri-hybrid cell had been created through an artificial fusion of three somatic cells using genetic engineering, and therefore did not essentially involve a biological process. BTS further argued that a mandatory Second Examination Report (SER) had not been issued, and that the prior arts had already been considered during European proceedings, where the patent had been granted.
The Controller’s Counsel maintained that the application correctly fell under Section 3(j) of the Act, as the claimed myeloid progenitor and lymphoid progenitor cells were stem cells capable of developing into an organism. To reinforce the position that the mere use of biotechnology or genetic modification does not render a process patentable, the Counsel cited the Nuziveedu Seeds Ltd. v. Monsanto Technology LLC case.
Court’s analysis:
The Court noted that the Assistant Controller erred by failing to issue a mandatory Second Examination Report (SER), in violation of Section 13(3) of the Act. The Court further observed that the five prior arts cited in the FER (First Examination Report) had already been considered by the European Patent Office, pursuant to which the patent was granted. However, the Assistant Controller failed to acknowledge or assess the European proceedings, and instead rejected the application without due consideration.
With respect to the objection under Section 3(j), the Court examined the relevant provisions of the Patents Act that defined what did not qualify as an invention. Specifically, the Court considered the applicability of Section 3(j) in the present case and clarified that the provision excluded only those inventions involving essentially biological processes for the production or propagation of plants and animals. The Court further noted that this exclusion was not limited to plant and animal varieties, but extended to the broader categories of “plants” and “animals” as a whole. Additionally, the Court emphasized the need to assess the overall degree of human intervention and its impact or the results achieved in determining whether a process was “essentially biological”. The Court further observed that genetic manipulation constituted a technical process and that a genetically modified plant or animal, not being the result of an essentially biological process, would fall outside the scope of Section 3(j). Therefore, the Court held that the exclusion under Section 3(j) was to be narrowly and strictly construed in accordance with the limited scope of the provision.
The Court further noted that the Assistant Controller had failed to consider BTS’s arguments that the tri-hybrid cell was created through advanced genetic engineering by fusing three somatic cells—of which at least two were of different types—and not through an essentially biological process. The Court further observed that the impugned order lacked reasoning as to why a hybrid cell was considered to be a part of the human/animal body and failed to address the artificial nature of the process. Additionally, the Court observed that the invention, including its technical specifications and amendments, had been overlooked by the Assistant Controller, and the order proceeded on the erroneous preconception that the invention related solely to stem cells. The Court further noted that the impugned order ignored the fact that tri-hybrid cells, being artificially produced and not naturally occurring, did not fall within the meaning of “plants” or “animals” under the relevant provision. Consequently, the Court held that the Assistant Controller had demonstrated an incorrect and incomplete understanding of the subject invention.
Regarding the citation of Nuziveedu Seeds Ltd. v. Monsanto Technology LLC by the Controller’s Counsel, the Court observed that the nature and extent of human intervention involved in the present case differed significantly, and as such, the two cases were not comparable.
Conclusion
In conclusion, the Court held that the rejection of the patent application under Sections 3(j) and 3(c) of the Patents Act was unsubstantiated and based on a fundamental misinterpretation of the statutory provisions. Accordingly, the impugned order dated 16.06.2020 passed by the Assistant Controller was set aside, and the matter was remanded for fresh adjudication by a different Hearing Officer, with a direction to dispose of the application within 12 weeks from the date of communication of the order.
Citation: BTS Research International Pty Ltd vs The Controller General Of Patents (SR/55/2020/PT/KOL) (H.C. Calcutta April 3, 2025). Available at: https://indiankanoon.org/doc/52802766/
Authored by Dr. Vasundhara Paliwal.