GM plants and seeds cannot be patented in India: Delhi HC

In a far-reaching decision, and the first on the patentability of genetically modified plants, the Delhi High Court has held that genetically modified plants, genetically modified seeds and gene sequences that provide genetic traits to plants are not patentable subject matter in India.

The decision comes in the ongoing dispute between the Monsanto Group of Companies and the Nuziveedu Group of Companies. Monsanto had filed a suit against Nuziveedu, to prevent the latter company from selling (genetically modified) Bt cotton seeds in India, on grounds that Monsanto had patent rights over the seeds. With this decision, however, Monsanto’s Indian patent 214436 was held to be invalid as it claims were directed to excluded subject matter.

The High Court invalidated Monsanto’s patent on the basis of two key conclusions: Firstly, that transgenic plants that are produced by natural biological processes are not patentable, and that Monsanto cannot assert patent rights over a gene that is part of generations of plants; and secondly, that a genetically modified trait (gene sequence) was nothing but a part of a seed, and that the trait by itself had no intrinsic worth.

In its analysis pointing to the first conclusion, the court held, “the future propagation of the transgenic plants and the subsequent transfer of Bt trait in such plants and consequently the transgenic seeds will be a process of nature, and no step of human intervention can impede such transfer of the sequence”. This effectively prevents Monsanto from claiming patent rights over essentially biological processes by asserting patent rights over underlying gene sequences.

The court noted that while Monsanto had originally applied for a patent on plants and seeds, the Indian patent office had refused such claims and only allowed a patent on location of the gene sequence in the plant DNA. For arriving at its decision, the Bench of Justice S Ravindra Bhat and Justice Yogesh Khanna studied the history of the amendments to Indian patent law, as well as relied upon the interpretation of essentially biological processes under European law. According to a recent amendment to European law, the exclusion of essentially biological processes from patentability also excludes products made by essentially biological processes.

For its second key conclusion, the court found Monsanto’s patent was invalid because it sought to patent merely a genetically modified trait (gene sequence), which was effectively a part of the seed itself. The trait itself was worthless, and the seed, which was effectively central to Monsanto’s claims, was unpatentable, and therefore the patent was invalid.

The court also noted the large financial implications and costs that had been incurred in connection with this patent. It observed that as per central government estimates, from 2010 to 2015, various domestic seed companies paid Monsanto approximately Rs 1600 crores in excess of the actual trait fee fixed by the various state governments. The court acknowledged that the payment of this fee involved questions of contractual rights between Monsanto and various domestic seed companies such as Nuziveedu. But, significantly, the court also found that the payment of license fee to Monsanto by Nuziveedu under the agreement between the two parties was on an assumption that Monsanto’s patent was valid in law. This, according to the court, did not preclude Nuziveedu from challenging the validity of the patent.

The decision of the court does not deprive Monsanto from claiming protection altogether. The court held that compensation for creating the genetic traits that are used for the generation of genetically modified seeds was available under the Protection of Plant Varieties and Farmers’ Rights Act (PPVFR Act). Accordingly, the court allowed Monsanto a three-month window to apply for registration under the PPVFR Act.

The PPVFR Act is a pioneering legislation that recognizes farmers’ contribution in conserving biodiversity and developing new plant varieties, and provides a wide collection of rights not available in any other farmer right legislations.