jeudi, décembre 16, 2010

India: Transgenic crops and IP rights

Transgenic crops and IP rights

Contributed by Singh & Associates


Genetically modified (GM) crops are crops in which genetic engineering(1) is used to introduce the characteristic held within the genetic code of a micro-organism into a plant genome. The first GM crop was a tomato; since then, several crops have been genetically modified worldwide, including corn, soybeans and cotton. Bacillus thuringiensis (BT) is a naturally occurring bacterium that produces crystal proteins that are lethal to insect larvae. In India, the first BT GM crop to be developed was cotton in March 2002. Today, India is a prominent player in the area of research and experimentation into GM crops. In September 2007 BT Brinjal was approved by the Genetic Engineering Approval Committee(2) and cleared the proposals of biotechnology safety rules.(3) Further, in February 2008 the Supreme Court revoked its earlier ban on the approval of large-scale field trials of transgenic crops.(4) BT Brinjal is the first transgenic edible crop to be introduced into India.

Monsanto Holdings Pvt Ltd is a key player in transgenic crops and promotes such crops in India through Mahyco-Monsanto Biotech (a 50-50 joint venture between Monsanto and Maharashtra Hybrid Seeds Company).(5) Transgenic crops have a characteristic dependence on the following factors:

  • IP rights;
  • health issues;
  • environmental hazards; and
  • economic concerns.

Transgenic crops in light of IP rights

The protection and registration of IP rights over biotechnological processes with respect to transgenic crops may create monopolisation over such seeds or methodologies in regard to such crops or over the crops themselves. If created, such monopolies will directly affect the rights of farmers and may also adversely affect the earth's biodiversity. Farmers will have to buy climate-tolerant seeds for every crop cycle and will not be allowed to store or exchange seeds for replanting.(6)

Patents have been granted for DNA sequences from plants such as nutmeg, cinnamon, rubber, jojoba and cocoa, and the list is bound to grow as DNA sequencing becomes routine.(7) These patents are owned by biotech companies and, when farmers buy these crops, they must sign an agreement that prohibits them from using or replanting the seeds for the following season, which means that the seeds cannot be stored and must be bought again for replantation.

In Monsanto Co v McFarling (McFarling II)(8) McFarling, a farmer, obtained 1,000 bags of Monsanto's round-up-ready GM soybean seed from his local seed store. There was a technology agreement between McFarling and the company "not to save any crop produced from this seed for replanting". Contrary to the terms of the technology agreement, during two successive growing seasons, McFarling saved the second-generation seed from his soybean crop and replanted it. It was alleged that by saving and replanting, McFarling had infringed Monsanto's patents numbers 435 and 605 and had breached the technology agreement. The court upheld Monsanto's patent licensing practice of forbidding farmers from saving seeds from GM crops for replanting.

In India, patent number 232681 has been granted to the process which makes GM cotton resistant to insect damage. The invention is named as 'Cotton Event Mon15985 and Compositions and Methods for Detection'.

In the recent landmark European Court of Justice judgment in Monsanto v Cefetra(9) it was held that no protection should be given to patented DNA sequences in areas where they are not performing the specific function for which they were patented.

Farmers' rights under Indian law

The protection afforded to plant varieties is excluded from the realm of Section 3(j) of the Patent Law(10) and is instead covered under the separate Protection of Plant Varieties and Farmers' Rights Act 2001, which was enforced for that purpose.

The monopolisation of crops directly affects the rights of farmers. These rights are mentioned in Section 39 of the act as follows:

  • A farmer who has bred or developed a new variety will be entitled to registration and other protection in a similar manner as a breeder of a variety under this act;
  • A farmer who is engaged in the conservation of genetic resources of land races and wild relatives of economic plants and their improvement through selection and preservation will be entitled in the prescribed manner or with recognition and reward from the National Gene Fund, provided that the material so selected and preserved has been used as a gene donor in varieties registrable under this act;
  • A farmer will be deemed to be entitled to save, use, sow, re-sow, exchange, share or sell his or her farm produce, including the seed of a variety protected under this act, in the same manner as he or she was entitled before the coming into force of this act, provided that the farmer shall not be entitled to sell a branded seed of a variety protected under this act;(11) and
  • The farmer's variety will be entitled to registration if the application contains declarations as specified in clause (h) of Section 18(1).(12)

The planting of transgenic crops will lead farmers to depend on multinational corporations to buy the crops. This would be contrary to the farmers' right to save, re-sow, share or sell the variety of crops. Furthermore, if farmers replant, exchange or sell such transgenic seeds, they can be sued by these multinationals.

Effect of GM crops on farmers

GM crops have had the following effects on farmers:

  • Working on GM sowing farms can affect the physical health of farmers by way of itches and rashes;(13)
  • In some cases yields have remained low even after farmers have reverted to sowing wheat on their farmland;(14)
  • Farmers cannot re-sow the crops to replant the crop even after being given the right to re-sow under Section 39 as referred to above;
  • The cost of GM crops is high; it is not economical for farmers to buy them. The GM cotton seeds cost Rs1,850 per packet, even though it was not an edible crop. If BT Brinjal had been accepted in the market, it would have cost even more;(15) and
  • The production, distribution and control of seeds are regulated by the Seeds Act 1966, which makes no mention of GM seeds. This means that there is virtually no legal framework for monitoring the activities of multinationals that are creating monopolies in dealing with GM seeds.(16)

Transgenic crops also simultaneously affect the flora and fauna. They can lead to the destruction of indigenous varieties of crops. Foods produced using biotechnology have not been established as safe and are not adequately regulated. The production of crops that are resistant to certain pests and weeds may lead to 'superbugs' and 'superweeds' that are immune to existing methods of pest and weed management.


GM crops are supposed to be more nutritious and better in taste; however, if this is the case, why is the majority of the population not ready to accept them? It seems that acceptance may cause much greater harm to farmers, the environment, biodiversity and the economy. If GM crops are required to be introduced, a proper mechanism to check issues such as health hazards and whether such engineered crops are beneficial in the long term must be enforced. If IP rights protection is offered to technology for developing transgenic crops, it should balance the public rights and environmental issues with the monopolistic rights. There should be proper enforcement of laws relating to the protection of farmers' rights and interests, and at the same time due credit should be given to the rights holders and patentees. For example, according to the Patent Office guidelines, in order to safeguard farmers' interests, terminator gene technology, which prevents the re-cultivation of crops, is not patentable under Section 3(b), which states that any invention that is contrary to public order or morality, or which causes serious prejudice to human, animal or plant life or health or to the environment, shall not be regarded as an 'invention' for the purposes of the Patents Act.

For further information on this topic please contact Manoj Kumar Singh at Singh & Associates by telephone (+91 11 4666 5000), fax (+91 11 4666 5001) or email (


(1) Genetic engineering, also called genetic modification, is the human manipulation of an organism's genetic material in a way that does not occur under natural conditions. It involves the use of recombinant DNA techniques, but does not include traditional animal and plant breeding or mutagenesis.

(2) The apex body constituted in the Ministry of Environment and Forest under the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells in 1989.

(3) As prescribed by the Department of Biotechnology of the Ministry of Science and Technology, Government of India.

(4) See

(5) See

(6) See

(7) See

(8) 363 F3d 1336 (Fed Cir 2004).

(9) C-428/08, July 6 2010.

(10) The following are not inventions within the meaning of this act: plants and animals in whole or any part thereof other than micro-organisms, but including seeds, varieties and species and essentially biological processes for the production or propagation of plants and animals.

(11) For the purposes of Clause IV, 'branded seed' means any seed that is put in a package or any other container and labelled in a manner indicating that such seed is of a variety protected under this act.

(12) Every application for registration under Section 14 must contain a declaration that the genetic material or parental material acquired for breeding, evolving or developing the variety has been lawfully acquired.

(13) "Farmers chip in against BT Brinjal",

(14) Ibid.

(15) See

(16) Ibid.