“Subject Invention Not Covered by Section 3(j); Impugned Order Based on Misinterpretation”: Calcutta High Court Sets Aside Rejection of Tri-Hybrid Cell Patent Application
Sanchayita Lahkar
The Intellectual Property Rights Division of the Calcutta High Court, a Single Bench of Justice Ravi Krishan Kapur has set aside an order rejecting a patent application concerning a synthetic cell invention. The order, initially passed by the Controller General of Patents & Designs, had concluded that the invention fell within the prohibitions of Section 3(j) and Section 3(c) of the Patents Act, 1970. The High Court found several procedural and substantive irregularities in the impugned order and remanded the matter for adjudication afresh before a different Hearing Officer.
The application involved a method of generating hybrid or chimeric cells through artificial fusion of somatic cells. The patent was previously denied on grounds that it constituted an essentially biological process and a mere discovery of naturally occurring substances, rendering it non-patentable under Indian patent law.
The appeal under Section 117A of the Patents Act, 1970 arose from an order dated 16 June 2020, rejecting Patent Application No. 0041/KOLMP/2012. The invention titled "Method of generating hybrid/chimeric cells and uses thereof" concerns a tri-hybrid cell developed via fusion of three somatic cells, at least two of which are of different types, including cells from humans and mice.
According to the petitioner, the invention employs genetic engineering techniques and is not derived through a natural or essentially biological process. It was submitted that such artificial fusion involves significant human intervention and cannot be deemed a natural occurrence or a method for propagation of plants or animals.
The rejection of the application was primarily based on the Controller’s finding that the invention fell under Section 3(j), which excludes from patentability "plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals." The Controller reasoned that because the somatic cells used retained attributes of their parent organisms, the resultant cell fell within this provision.
The Controller also held that the invention fell within Section 3(c) of the Act, which excludes the discovery of living or non-living substances occurring in nature. The petitioner argued that the conclusions were erroneous and failed to account for the artificial nature of the tri-hybrid cell and the technical interventions involved in its development.
Further, the appellant raised a procedural issue, noting that although a response had been filed to the First Examination Report (FER), no Second Examination Report (SER) was issued in accordance with Section 13(3) of the Patents Act. The appellant referred to the precedent in Oyster Point Pharma Inc vs. The Controller of Patents and Designs & Anr.,
MANU/WB/1544/2023, where it was stated: "The statutory mandate of section 13(3) must be followed regardless of the consequences and the ultimate result thereof."
Additionally, the appellant submitted that all prior art references cited in the FER had also been examined by the European Patent Office, which granted the corresponding patent. Despite this, the Controller did not consider the findings of the European proceedings.
The respondents countered that the myeloid and lymphoid progenitor cells in question are stem cells capable of developing into organisms and thus fall under Section 3(j). In support, they cited Nuziveedu Seeds Ltd. & Ors. vs. Monsanto Technology LLC & Ors., 2018 SCC OnLine Del 8326.
Justice Kapur observed several substantive and procedural errors in the Controller’s decision. It was recorded that no Second Examination Report had been issued despite re-examination following the FER, contrary to the statutory mandate.
The court also noted that the prior art references, while identical to those considered in the European patent application, had been ignored in the impugned order. "Despite the five prior art documents being cited as prior arts in the European proceedings, the respondent authorities failed to even consider the outcome of the European proceedings or refer to the same which had granted the subject patent," the court stated.
On the interpretation of Section 3(j), the court analysed its legislative background and compared it to Article 27.3(b) of the TRIPS Agreement and Article 53(b) of the European Patent Convention. The court recorded: "Section 3(j) was introduced by way of the Patents (Amendment) Act, 2002... the TRIPS provision does not allow members to exclude microorganisms and non-biological and microbiological processes from patent protection."
Justice Kapur noted that "The impugned order does not deal with how the subject invention is by nature an essentially biological process for propagation or production of any plant or animal." It was observed that the subject invention involves "advanced genetic engineering techniques where three somatic cells are fused of at least two are of different types which could be cells of humans or of a mouse."
The court further stated: "There is no reasoning in the impugned order as to why a hybrid cell is considered to be a part of the human/animal body. The impugned order does not also deal with the artificial process involved in the subject invention." It was recorded that the approach taken by the Controller was predetermined and failed to consider the actual specification and scientific process of hybridization.
Citing precedents including Plant Bioscience/Broccoli, T 83/05, G 2/07, and Monsanto Technology LLC vs. The Controller of Patents & Designs & Anr., the court reiterated that human intervention and technical steps are vital in distinguishing between natural and non-natural processes.
"The overall degree of human intervention in the process has to be taken into consideration. As such, the totality of human intervention and its impact or the results achieved is what is required to be determined. Thus, an invention has to be judged as a whole," the court recorded.
It was also found that the conclusion under Section 3(c) was unjustified. The court noted: "The conclusion of applicability under section 3(c) of the Act is without basis and ignores the technical intervention or human step in the subject application."
The court concluded that the impugned order was unsustainable. The following directive was issued:
"The matter is remanded to the Controller for adjudication afresh. In view of the pre-determined approach of the Hearing Officer in passing the impugned order it would be appropriate that the matter be heard by a different Hearing Officer."
The appellant was granted liberty to amend the application and submit additional documents. The court further directed:
"The Hearing Officer is requested to dispose of the subject application within a period of 12 weeks from the date of communication of this order. It is made clear that there has been no final adjudication on the merits of the case and all issues are left open to be decided afresh and in accordance with law."
Advocates Representing the Parties
For the Petitioners: S. Majumdar, Advocate; Paritosh Sinha, Advocate; K.K. Pandey, Advocate; Mitul Dasgupta, Advocate; Amrita Majumdar, Advocate; Soumya Sen, Advocate; T. Das, Advocate
For the Respondents: Swatarup Banerjee, Advocate; Sukanta Ghosh, Advocate; Sariful Haque, Advocate
Case Title: BTS Research International Pty Ltd Vs. The Controller General of Patents & Designs, Mumbai & Ors.
Case Number: IPDPTA 56 of 2023
Bench: Justice Ravi Krishan Kapur
[Read/Download order]
