Section 3(j) of the Patents Act, 1970, 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 European Patent Convention (EPC) aligns with the spirit of Section 3(j) of the Indian Patents Act. Article 53 of the EPC prohibits patents on “plant or animal varieties or essentially biological processes for the production of plants or animals”. Rule 26(5) of the EPC further provides a definition of what constitutes an “essentially biological process” for the production of plants or animals. It states that “a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomenon such as crossing or selection”.

Recently, the Madras High Court referenced the EPC Rule in the case of Sakata Seed Corporation v Deputy Controller of Patents and Designs,(CMA (PT) No.30 of 2023, judgment dated 19^th July 2024) and held that the test for determining whether the claimed invention pertains to an essentially biological process is to ascertain whether the process is merely a natural phenomenon or otherwise a biological process, as defined by the European Patent Convention, or whether it involves any intervention.

The Appellant, Sakata Seed Corporation, sought a patent for their invention entitled “Eustoma having Cytoplasmic Male Sterility and Method for Producing Said Eustoma” through Indian patent application number 1221/CHENP/2015. The invention involved a method to produce a new cytoplasmic male sterile Eustoma plant by artificially creating a new combination of the nuclear genome of a cultivated Eustoma species such as Eustoma grandiflorum, and the cytoplasmic genome of a wild Eustoma plant by cytoplasmic replacement technology using successive backcrossing. However, the application was refused by the Controller on the ground that the invention was an essentially biological process and therefore, patent ineligible under Section 3(j) of the Patents Act.

The Court noted that the patent sought by the Appellant was not a mere biological process as the screening and checking of the hybrid seeds and their characteristics moved the invention away from the realm of natural phenomena and it was human intervention at particular points of time that led to the unexpected male sterile characteristics. The Court further noted that even though the Controller had considered the argument of human intervention, the impugned order lacked sufficient reasoning regarding how the human intervention claimed by the Appellant was not sufficient to disqualify the process from being an essentially biological one. For this reason, the Court set aside the impugned order and remanded the matter back to the Patent Office for reconsideration.