Monsanto Technology LLC v Nuziveedu Seeds Ltd.

• Monsanto held Indian Patent No. 214436 for a nucleic acid sequence encoding the Cry2Ab insecticidal protein (Bt gene) used in transgenic cotton
• Monsanto licensed this technology to Indian seed companies including Nuziveedu Seeds Ltd. through sub-licence agreements
• Disputes arose over licence fees (trait value); Nuziveedu terminated the agreements and continued using the technology
• Monsanto filed for patent infringement; Nuziveedu defended by arguing the patent was invalid under Section 3(j)
• The Delhi High Court Division Bench held that once the patented gene was inserted into a plant, the resulting seed/plant fell within Section 3(j)

1. Whether a patent on a nucleic acid sequence (Bt gene) is excluded from patentability under Section 3(j) of the Patents Act, 1970 on the ground that the gene, once inserted into a plant, becomes part of a "plant or animal" or "essentially biological process."

• The Division Bench erred in deciding the question of Section 3(j) applicability at the interlocutory stage without a full trial
• The question is a complex mixed question of fact and law requiring trial
• The Supreme Court set aside the Division Bench order and restored the Single Judge's order
• The matter was remitted for trial on merits
• The Court did not express any opinion on whether Section 3(j) applies to the patent

The question of whether a patent claiming a nucleic acid sequence is excluded under Section 3(j) when that sequence is incorporated into a plant variety is a complex question that cannot be determined at an interlocutory stage. The interaction between patent rights in a gene construct and the exclusion of plants, animals, and essentially biological processes from patentability requires a full trial with evidence.