Patentability Paradox – Bt Cotton’s Impact on Indian IP Law

January 9, 2026
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Patents

Introduction

The Legal Dispute between Monsanto LLC and Nuziveedu Seeds Limited (NSL) changed the IP (Intellectual Property) landscape in India but still left many questions unanswered, especially on section 3(j) of the Indian Patents Act, 1970 (hereafter referred to as Act). In 2015 after the government of India’s cotton seed price control order Nuziveedu seeds stopped paying trait fees to Monsanto as per the sublicense agreement as the government capped the trait fees from 163 to ₹174 to mere ₹49. Because of that Monsanto cancelled the agreement, sued on patent and trademark infringement grounds to Nuziveedu seeds. Nuziveedu Seeds contested Monsanto’s decision to unilaterally terminate the agreement, citing the government’s price control order, and challenged the validity of Monsanto’s patent validity as it is explicitly prohibited to patent plants and animals under section 3 (j) under the Act.

Background of the case:

The use of Monsanto’s patented nucleic acid sequence (NAS) technology (Patent No. 214436) for genetically modified Bt cotton seeds was sublicensed to Nuziveedu in 2004. The arrangement was terminated in 2015 due to disagreements over royalties under India’s pricing control system. Monsanto sued for patent infringement, so Nuziveedu would not employ its technology and trademarks. Nuziveedu filed a counter suit under the provisions of Protection of PVA and Farmers” Rights Act 2001, invoking as the patent infringed upon Section 3(j) of the said Act which specifically excludes plant variety, seeds and “essentially biological processes”.

Cause of Dispute:

The Cotton Seeds Price (Control) Order, introduced by the Indian government in 2015, reduced the trait fees for Bt cotton seeds from ₹163-₹174 to ₹49 per packet and set a maximum retail price (MRP). Nuziveedu Seeds claimed this order changed their agreement’s financial terms, citing Article 11.03 (Required renegotiation of agreements under “Modification by Legislation” to comply with statutory price controls) of the sub-license agreement, and refused to pay the original fees. wherefore Monsanto LLC nullified their sub-license agreements in November 2015, stating that Article 11.03 required both parties to renegotiate and that order did not relieve contract obligations.

Legal Proceedings:

Monsanto maintains Nuziveedu was using its patented nucleic acid sequence (NAS) technology by employing the “BG” and “BG II” trademark subsequently which were deceptive transliterations in the agreements which were similar to its registered trademarks after the agreements with them has concluded. Nuziveedu countered that the technology was based on naturally occurring bacterial genes, asserting that Monsanto’s patent violated Sections 3(j) and {3(h) of the Patents Act, 1970 excludes “a method of agriculture or horticulture” from patentability} of the Act. They argued that “BG” and “BG II” were generic terms and defended their lower trait fees by citing excessive royalty requests from Monsanto and the Cotton Seeds Price (Control) Order of 2015.

Patentability. — [Image Sources: Shutterstock]

Delhi High court single judge bench upheld the patent validity in 2016 and directed Nuziveedu to pay government-set trait fees but, the division bench of the same court struck down the patent under section 3(j) of act and directed that Monsanto has to go in for protection under PPVFR Act. In 2019, a Supreme Court judgement restored a single bench order of the Delhi HC citing patent validity, required expert evidence, and remanded for trial on technical merits.

Key legal Concerns?

The primary question is whether gene editing is an excluded biological process, as argued by Nuziveedu Seed, or if it may be regarded as a patented chemical process, as asserted by Monsanto?

As per the Act, Section 3(j) Plants and biological processes are excluded to patent. The text states that patentability is denied to

“plants and animals in whole or any part thereof other than microorganisms, including seeds, varieties, species, and essentially biological processes for production/propagation of plants and animals.”

In this legal battle Supreme Court ruled that patent revocation could not be made in a summary and expert testimony was necessary. The need to strike a balance between statutory constraints and intellectual property rights was highlighted by the Supreme Court’s remand for trial, which left important issues about gene patentability unanswered. For biotech patents, Section 3(j) is still controversial and necessitates expert interpretation tailored to each instance.

Way Forward

Amend Section 3(j) to explicitly define terms like “essentially biological processes” and “chemical processes”. For instance: Exclude patents on natural propagation methods (e.g., traditional breeding) and Allow patents on synthetic genetic sequences and technical interventions ({e.g., CRISPR} a genetic engineering technique that allows scientists to modify the DNA of living organisms selectively) that do not rely on biological reproduction.

To align with international guidelines such as those used by the European Union we need to clearly separate what counts as a “technical” invention and what is considered a “biological” process. Courts should set up tests to make these distinctions, and this process involves a lot of human creativity, like gene editing done in a lab might be eligible for a patent. On the other hand, if the invention relied on natural reproduction of growing seeds, it might not qualify for a patent under Sec 3(j).

Refer to technical experts during patent disputes to assess scientific nuances and Encourage seed companies (like Monsanto) and Indian seed producers (like Nuziveedu) to negotiate fair licensing terms for gene-edited traits, avoiding prolonged litigation and Ensure agreements protect farmers’ rights to reuse seeds, as guaranteed under India’s Protection of Plant Varieties and Farmers’ Rights Act.

Focus on individual pieces of genetic material like synthetic DNA, rather than whole plants. Companies should stop making claims about biological reproduction, such as growing seeds. For instance, Monsanto can patent the Cry2Ab NAS as a chemical product but should not claim ownership over the seeds produced through hybridization, this approach would have yielded different legal results. The Supreme Court should conclusively rule on Whether synthetic genetic sequences qualify as “chemical processes” under patent law. The threshold of human intervention required to avoid Section 3(j) exclusions. Supreme court should set the precedential clarity on these aspects.

In the European Union the European Patent Office allows patents on transgenic plants created via technical processes (e.g., CRISPR) but excludes those produced through natural breeding. This aligns with Monsanto’s argument but contrasts with the Delhi High Court’s reasoning. In Bowman v. Monsanto (2013), the U.S. Supreme Court upheld patents on self-replicating seeds, emphasizing that replication requires human intervention. This diverges from India’s stricter exclusion of biological processes.

Are there Procedural Protections in Indian Patent Cases?

During the review process courts require that patent applications shortcomings be communicated openly. In the case of Microsoft Technology Licensing LLC v. Assistant Controller of Patents (2024), the Delhi High Court stressed that objections must be mentioned expressly in the First Examination Report (FER) or hearing notifications so that applicants can adequately address the concerns. It is considered that it is procedurally unfair and against natural justice principles to rely on new grounds without previous notice or to fail to disclose important “prior art” (such as Document D2 in the Microsoft case).

Indian courts are refraining from replacing trial courts or patent office technical judgment. In its warning against judicial overreach, the Supreme Court emphasized that appellate courts should only get involved where there has been a “patent error of law.” Courts evaluate irreparable injury convenience and prima facie legitimacy in matters involving temporary injunctions but they do not make a definitive decision on technical merits at the preliminary stage and this is causing hindrance in patent litigations.

In order to help courts in complex disputes and guarantee that rulings are based on specialist expertise, technical experts are often appointed under Section 115 (appoint an independent scientific adviser), of the Patents Act. Unless there is clear disrespect for the evidence, courts defer to trial court conclusions on factual matters such as “innovative step or novelty” but the procedural delays and absence of standard operating procedure is dragging the litigation to years.

With stringent deadlines and required pre-trial mediation the “Commercial Courts Act of 2015” expedites patent disputes cutting down on delays and promoting trial-stage resolution. Even though arbitration clauses are present in the agreements technical aspects is pushing them towards higher courts where expert testimony is missing.

Conclusion:

In order to alleviate India’s backlog of IP disputes, the specialized patent trial courts seek to improve efficiency and expertise further. Because of these delays and over-enthusiastic adjudication and different Courts ruling varying judgements, important technical questions were left even after a decade of legal battle. Finally, Monsanto’s patent expired, and after this expeditious litigation. In 2021, finally, Monsanto and Nuziveedu reached an “amicable settlement” after the prolonged unfruitful litigation, leaving many unanswered questions with the court.

The Monsanto vs. Nuziveedu struggle stands a pitfall of an inflexible IP frame to manage disruptive technologies. Indian courts have done the right thing in preserving agrarian equity, but ambiguity in the legislative framework leads to supremacy. There is an urgent need for a next-generation IP regime that balances the incentivization for innovation with ensuring access to biotechnologies for sustainable development.

Author: Akella Lakshmi Narasimha Murthy, in case of any queries please contact/write back to us via email to [email protected] or at IIPRD.

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