Case Citation: BTS Research International Pty Ltd vs. The Controller General of Patents & Designs, Mumbai & Ors., IPDPTA 56 OF 2023, High Court at Calcutta, Judgment on: 03.04.2025, Justice Ravi Krishan Kapur.
Summary: BTS Research International Pty Ltd filed an appeal under section 117 of the Patents Act, 1970, against an order dated June 16, 2020, rejecting their patent application (no. 0041/KOLMP/2012). The invention claimed is titled “Method of generating hybrid/chimeric cells and uses thereof,” which specifically involves the creation of a tri-hybrid cell by artificially fusing three somatic cells, including at least one human cell and potentially a non-human cell (like a mouse cell). The appellant argued that this process involves significant human intervention and is not merely a biological process for producing or propagating plants or animals.
The Controller General of Patents rejected the patent application based on section 3(j) of the Patents Act, which addresses non-patentable inventions related to biological processes and living organisms. The rejection was largely premised on the argument that the hybrid cells retained attributes of their parent cells, thereby classifying the processes involved within those excluded from patentability. The order stated that the resultant hybrid cell falls under the categorization of a structural and functional unit of the organism from which the cells were taken and considered as a product of essentially biological processes.
In arguing against the rejection, the appellant contended the following:
- The impugned order was based on a misinterpretation of the Patents Act.
- Following a response to the First Examination Report (FER), a Second Examination Report (SER) should have been issued, as mandated by the law.
- Prior art documents cited in the examination had been acknowledged in European proceedings where the patent had been granted, yet this was ignored in the impugned order.
- Section 3(j) was deemed inapplicable, arguing that the application involves substantial human intervention and does not constitute an essentially biological process.
Conversely, the respondents maintained that the hybrid cells in question are derived from stem cells capable of developing into organisms and provided adequate reasoning for the applicability of section 3(j). They referenced the decision in Nuziveedu Seeds Ltd. & Ors. vs. Monsanto Technology LLC & Ors., supporting their stance.
The judgment highlighted several critical points:
- It stressed the failure of the examination authorities to issue a SER after the objections to the FER were raised, which contravenes the statutory mandates.
- The findings from European patent proceedings and prior art documentation were not duly considered, despite their relevance to the assessment of the patent application.
- The Court underscored that the rejection order lacked substantial reasoning regarding how the invention constituted an essential biological process, thereby misapprehending the nature of the invention as involving significant human intervention.
Ultimately, the Court found the impugned order to be flawed, unsubstantiated, and based on a fundamental misinterpretation of the sections of the Patents Act. The patent application was therefore remanded for fresh adjudication, with the direction that it be heard by a different Hearing Officer and be decided afresh while allowing the appellant to amend and submit additional documents.
