Introduction
As India transitioned into the neo-knowledge economy based on the creation and subsequent commercialization of Intellectual Property Rights (hereinafter the “IPR”), and the underlying product or process thereof, just and binding observations and interpretations of the corresponding Indian Patent Act (hereinafter the “Act”) are needed for a faster and flawless prosecution. Many of the sections in the Act are subject to individual interpretations, and in the absence of case law from a higher Court, such interpretations are tantamount to individual discretion, something a judicial system should avoid.
Brief Facts of the Case Involving Section 3(j) of the Indian Patent Act
One such unaddressed issue was the interpretation of Section 3(j), which has finally been clarified by the Hon’ble Calcutta High Court in the matter (SR/55/2020/PT/KOL) of BTS Research International Pty Ltd vs. the Controller of Patents & Designs & Ors. The petitioner BTS filed a patent application titled “Method of generating hybrid/ chimeric cells and uses thereof”, wherein a tri-hybrid cell was produced using an artificial process of genetic engineering involving the fusion of three somatic cells of which, at least two cells are of different origin(s), i.e., sourced from a human and a mouse. Although such a process is not natural and mandates human intervention, the concerned Controller of the Respondent held that myeloid progenitor cell and lymphoid progenitor cell appearing in the subject claim were stem cells capable of developing into an organism, therefore, citing the case law in the matter of Nuziveedu Seeds Ltd. & Ors. vs. Monsanto Technology LLC & Ors., such subject matter was under the delineated scope u/s 3(j) of the Act, due to having attributes of naturally occurring parent cells as well as exploiting an existing essential biological process resulting in a tri-hybrid cell from a stem cell. In addition, as such cells are part of nature; objection u/s 3(c) was also raised against the petitioner’s patent application.
Arguments
Before the Hon’ble Calcutta HC, the Petitioner contended the rejection of the patent application by the Controller of Patents and the successive defense of the Respondent before the Hon’ble Court by highlighting procedural as well as technical glitches leading to alleged misinterpretation of the Act, resulting in an allegedly erroneous decision.
On the procedural front, after filing a response to the First Examination Report (FER), and corresponding amendments, there was a re-examination of the application that didn’t lead to the issuance of a Second Examination Report (SER), which is against the mandate u/s 13(3) of the Act. In addition, the Petitioner highlighted that the concerned Controller of the Respondent didn’t pay any heed to the prosecution details of the corresponding European application wherein the subject matter was granted irrespective of the citing of similar documents.
On the technical front, the Petitioner challenged the understanding and interpretation of the Respondent by explaining the tenets of Section 3(j), along with Section 3(c).
Coming to Section 3(j), it bars the patentability of plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. The Petitioners argued that Section 3(i) differs from the provisions of TRIPS by means of the use of the phrase “parts thereof” as a suffix to both “plants” and “animals”, and a null reference to “non-biological and microbiological processes”, whereas Article 53 of the European Patent Commission categorically stated that although plant or animal varieties or essentially biological processes for the production of plants and animals are exception to patentability, the provision doesn’t apply to microbiological process or the products thereof.
In addition to that, the Petitioners submitted that for a process to be considered as “essentially biological”, the entirety of phenomena should have been natural, and to fall within the ambit of “essentially biological”, the overall degree of human intervention including its impact and the results achieved should be estimated, and the invention should be judged “as a whole”.
Further, the Petitioner submitted that the Respondents left no explanation for several unaddressed questions including why the fusion of two different kinds of cells that never occurs naturally should not be considered, how a hybrid cell with a heterogeneous origin from let’s say, human and mouse may be part of a human/ animal body, or how non-natural trihybrid cells fit into the definition of “plants” or “animals” or even “parts thereof”. As no such natural connection exists, there would not be any scope u/s 3(c) of the Act as well.
Section 3(j) and the Human Intervention Test
All these unaddressed queries proved the unsustainability of the order from the Respondents, and correspondingly, the impugned order of rejection was set aside by the Hon’ble Calcutta HC, and the matter has been sent for re-examination under a new officer to be appointed by the Respondent, with all liberties for further amended granted to the Petitioner.
Analysis and Conclusion: Clarifying Section 3(j) of the Indian Patent Act
Analyzing this matter further from the aspect of an unbiased third party having expertise in the art, the Petitioner seems justified in their arguments both in the procedural as well as technical front. When a substantial amendment has already been made to the application by the Petitioner earlier at the time of filing the FER Response to the impugned Application, another examination report should have been issued in the form of a Second Examination Report (SER). Having said so, referring to or abiding by the findings of the issued office actions and the corresponding decisions made for the corresponding applications filed in other jurisdictions is entirely at the discretion of the concerned Controller of the Respondent. As it has only a persuasive impact, the Respondent has all the right to accept or reject any cited document.
Coming to the tenets of Section 3, Section 3(c) bars the patentability of the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature, Section 3(h) bars the methods of agriculture and horticulture, Section 3(i) bars any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products, and Section 3(j) bars plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals, leaving rooms of patentability for some of the inventions including “method of treatment of plants”, “method of cosmetic treatment or even surgeries”, “non-essential biological processes”, “microbial processes”, and “non-biological processes”. However, there is still room for further explanation to serve as guidance for future prosecutions, for example, let’s say regarding the definition and understanding of the phrase “occurring in nature” mentioned in section 3(c).
Coming back to the present case, the Petitioner rightly held that the outcome of Nuziveedu Seeds Ltd. & Ors. vs. Monsanto Technology LLC & Ors., had no impact on this instant case as the crux of the Monsanto invention was a manmade DNA construct that is not naturally found, and can move through progenies. Monsanto tried to protect the plant stably carrying said manmade DNA, which was not possible due to the non-patentability imposed by Section 3(j). This, however, no way could stop the consideration of a man-made synthetic process of artificially fusing somatic cells from different source organisms.
Thus, the present judgment clearly interprets the phrase “essentially biological processes” highlighting the importance of evaluating the extent of human intervention or “human hand” in estimating patent eligibility as well as patentability within the framework of the Indian Patent Act. Especially for the super-sensitive sectors such as pharmaceutical and biotechnology, such judgments serve as guidelines. After all, it was the “human hand” test that opened up the patenting of microorganisms in the USA, and then in almost all the jurisdictions, discussed in the landmark judgment of Diamond vs. Chakrabarty. We hope that near future shall experience a plethora of such judgments taking the Indian IP climate to a new level.
With a legacy of over 79 years in Intellectual Property law, R K Dewan & Co. is a well-established patent law firm in India, serving innovators, researchers, and businesses across sectors. Headquartered in Mumbai and operating through offices in New Delhi, Pune, Chennai, Kolkata, Bangalore, and Indore, RKD supports over 5000 Indian and international clients in securing, managing, and enforcing their IP rights across more than 125 countries. The firm’s team of 175+ professionals offers comprehensive services covering patents, trademarks, copyrights, industrial designs, geographical indications, and plant varieties. RKD handles all aspects of IP—from drafting and prosecution to litigation, brand valuation, oppositions, and anti-counterfeiting measures. An ISO 9001:2015 certified firm, RKD brings structured, efficient, and compliant solutions to every stage of the IP lifecycle.
Source: https://www.linkedin.com/posts/r-k-dewan-%26-co_ip-innovista-activity-7321444881808154624-ZKYE