Patents on Plants and Seeds: India and Comparative Law

1. India: section 3(j) of the Patents Act

Section 3(j) 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”. Three consequences:

• No patent on a plant, seed or variety as such; these go to the PPV&FR Act.
• Micro-organisms are patentable (as TRIPS requires), and so are non-biological and microbiological processes.
• Genetically modified genes, DNA constructs and transformation methods may be patentable if they are inventions and not “parts of plants”. Where that line lies is the question in the Monsanto litigation.

2. Monsanto v. Nuziveedu (Supreme Court, 2019)

Monsanto held an Indian patent on a nucleic acid sequence encoding a Bt insecticidal protein (the Bollgard II trait in cotton) and the method of inserting it into the plant genome. After disputes over trait fees, Nuziveedu and other seed companies continued to sell Bt cotton seed, and Monsanto sued for infringement. The defendants counterclaimed that the patent was invalid under section 3(j), arguing that the DNA, once inserted, becomes part of the plant and seed, and that the PPV&FR Act is the only route for protecting such traits.

• A single judge of the Delhi High Court (2017) granted interim relief on terms.
• A Division Bench (2018) went further and held that the claims were not patentable under section 3(j), because the nucleic acid sequence could not exist independently of the plant; protection lay only under the PPV&FR Act.
• In Monsanto Technology LLC v. Nuziveedu Seeds Ltd., 2019 INSC 35, the Supreme Court set aside the Division Bench’s judgment. It held that the Division Bench should not have decided the validity of the patent summarily, at the stage of an appeal against an interim order, without a trial on expert evidence. The single judge’s order was restored and the suit was sent back for trial on all issues, including section 3(j).

The Supreme Court therefore did not decide whether Bt gene patents are valid. The question whether a gene construct is a “part of a plant” remains open, and the decision shows the overlap between the Patents Act and the PPV&FR Act.

3. United States: cumulative protection

• Plant Patent Act, 1930: patents for distinct and new asexually reproduced plants (35 U.S.C. §161).
• Plant Variety Protection Act, 1970: PBR certificates from the Department of Agriculture for sexually reproduced and tuber-propagated varieties, with a farmers’ saved-seed exemption and a research exemption.
• Utility patents: Diamond v. Chakrabarty (US Supreme Court, 1980) held a genetically engineered bacterium patentable: “anything under the sun that is made by man” (quoting the legislative history). The Patent Office’s Board applied this to plants in Ex parte Hibberd (1985).
• J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. (US Supreme Court, 2001): utility patents may be granted on sexually reproduced plants; the PPA and PVPA do not exclude them. Breeders can therefore choose patents, which have no farmers’ or research exemption.
• Bowman v. Monsanto Co. (US Supreme Court, 2013): a farmer who bought commodity soybeans and planted them to grow Roundup Ready plants infringed; patent exhaustion does not permit making new copies of a patented seed by planting it.

4. Canada

In Harvard College v. Canada (Commissioner of Patents) (Supreme Court of Canada, 2002) the oncomouse was held not patentable because higher life forms are not a “manufacture” or “composition of matter”. But in Monsanto Canada Inc. v. Schmeiser (Supreme Court of Canada, 2004) a farmer who saved and planted seed containing Monsanto’s patented herbicide-tolerance gene was held to have infringed the patent on the gene and modified cells, by using it, even though the plant itself could not be patented. No damages were payable because he had made no profit from the trait. The case shows how a gene patent can in practice control the plant.

5. Europe

• Article 53(b) EPC: European patents are not granted for plant or animal varieties or essentially biological processes for the production of plants or animals (with exceptions for microbiological processes and their products).
• Biotech Directive 98/44/EC, Article 4: plant varieties are not patentable, but inventions concerning plants are patentable if their technical feasibility is not confined to a particular variety. A gene trait that works in many varieties can therefore be patented.
• EPO case law: in G 2/07 and G 1/08 (Broccoli and Tomato I, 2010) the Enlarged Board held that a process of sexual crossing and selection is “essentially biological” even if it includes a technical step such as marker-assisted selection. In G 2/12 and G 2/13 (Tomato and Broccoli II, 2015) it held that the products of such processes could still be patented. After the EU institutions objected, the EPO amended Rule 28(2) in 2017, and in G 3/19 (Pepper, 2020) the Enlarged Board held that plants exclusively obtained by essentially biological processes are not patentable (for applications filed after 1 July 2017).
• Community Plant Variety Rights under Regulation (EC) No 2100/94, granted by the Community Plant Variety Office at Angers, provide a UPOV 1991 regime with a remunerated farm-saved seed exception and a breeders’ exemption; the Unified Patent Court Agreement includes a limited breeders’ exemption for patents.

6. Comparative table

How this is examined

Use this note in essays on TRIPS Article 27(3)(b), on GM crops, or on the distinction between PBRs and patents. Cite section 3(j) word for word, explain Monsanto v. Nuziveedu accurately (the Supreme Court did not decide validity), and give the US, Canadian and EU positions with one case each.