September 2007: BT Brinjal approved by the Genetic Engineering Approval Committee. 1 st transgenic edible crop to be introduced into India. February 2008: SC revoked its earlier ban on the approval of large-scale field trials of transgenic crops. Monsanto Holdings Pvt Ltd: key player in transgenic crops, promotes such crops in India through Mahyco -Monsanto Biotech (a 50-50 joint venture between Monsanto and Maharashtra Hybrid Seeds Company). Transgenic crops have a characteristic dependence on the following factors: IP rights health issues environmental hazards economic concerns
Transgenic crops in light of IP rights MONOPOLIZATION Protection and registration of IP rights with respect to transgenic crops may create monopolisation over such seeds or methodologies in regard to such crops or over the crops themselves FARMERS Will directly affect the rights of farmers. Farmers will have to buy climate-tolerant seeds for every crop cycle and will not be allowed to store or exchange seeds for replanting. 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 .
Monsanto Co v McFarling ( McFarling II) 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'.
Farmers' rights under Indian law Protection of Plant Varieties and Farmers' Rights Act 2001 (PPVFR) Rights of farmers (mentioned in Section 39 of the act) are 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 will be deemed to be entitled to save, use, sow, re-sow, exchange, share or sell his or her farm produce, including the seed The farmer's variety will be entitled to registration if the application contains declarations as specified in clause (h) of Section 18(1).
Effect of GM crops on farmers Possible health problems???? Yields have remained low in some cases. 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. The production, distribution and control of seeds are regulated by the Seeds Act 1966, which makes no mention of GM seeds . Virtually no legal framework for monitoring the activities of multinationals that are creating monopolies in dealing with GM seeds. Transgenic crops can lead to the destruction of indigenous varieties of crops. The production of crops resistant to certain pests and weeds may lead to 'superbugs' and ' superweeds ' that are immune to existing methods of pest and weed management.
Claim: GM crops are supposed to be more nutritious and better in taste Need: Proper mechanism to check issues such as health hazards , long term benefits (exist or not). IP rights protection (offered to technology for developing transgenic crops) MUST balance the public rights and environmental issues. Proper enforcement of laws relating to the protection of farmers' rights and interests (also giving due credit to the patentees). 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.
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. 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. 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.
According to the Act, the term 'variety' means "a plant grouping except micro organism within a single botanical taxon of the lowest known rank, which can be:- ( i ) defined by the expression of the characteristics resulting from a given genotype of that plant grouping (ii) distinguished from any other plant grouping by expression of at least one of the said characteristics (iii) considered as a unit with regard to its suitability for being propagated, which remains unchanged after such propagation; and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety". Plant Varieties and Farmers' Right Act,2001
Main provisions
The Central Government shall establish an Authority to be known as the 'Protection of Plant Varieties and Farmers’ Rights Authority' for the purposes of this Act. There is a 'Plant Varieties Registry ' for the purpose of facilitating the registration of varieties at such places, as the Authority may think fit. A Register called the 'National Register of Plant Varieties' shall be kept at the head office of the Registry. Names of all the registered plant varieties + names and addresses of respective breeders + the rights of such breeders in respect of the registered varieties + particulars of the registered variety ( its seed or other propagating material ) along with specification of salient features.
An application to the registrar for registration of any variety shall be made by:- Any person claiming to be the breeder of the variety Any successor of the breeder of the variety any person being the assignee of the breeder of the variety in respect of the rights to make such application; or Any farmers or group of farmers or community of farmers claiming to be the breeder of the variety; or Any person authorized in the prescribed manner by a person specified above to make application on his behalf; or Any university or publicly funded agricultural institution claiming to be the breeder of the variety.
A new variety shall be registered under this Act, if it confirms to the criteria of novelty, distinctiveness, uniformity and stability (DUS) . A new variety shall be deemed to be – Novel: if, at the date of filing of the application for registration for protection, the propagating or harvested material of such variety has not been sold or disposed of by or with the consent of its breeder or his successor for the purposes of exploitation of such variety - ( i ) in India, earlier than one year; or (ii) outside India, in the case of trees or vines earlier than six years, or in any other case, earlier than four years. Distinct: if it is clearly distinguishable by at least one essential characteristic from any other variety whose existence is a matter of common knowledge in any country at the time of filing of the application. Uniform: if subject to the variation that may be expected from the particular features of its propagation it is sufficiently uniform in its essential characteristics. Stable: if its essential characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each such cycle.
Every application for registration shall Be with respect to a variety: State the denomination assigned to such variety by the applicant Be accompanied by an affidavit sworn by the applicant that such variety does not contain any gene or gene sequence involving terminator technology Contain a complete passport data of the parental lines along with the geographical location in India from where the genetic material has been taken and information relating to the contribution, if any, of any farmer, village community, institution or organization in breeding, evolving or developing the variety Be accompanied by a statement containing a brief description of the variety bringing out its characteristics of novelty, DUS, as required for registration Be accompanied by such fees as may be prescribed Contain a declaration that the genetic material or parental material acquired for breeding, evolving or developing the variety has been lawfully acquired; and
Every applicant shall, along with the application for registration made under this Act, make available to the Registrar such quantity of seed of a variety for registration of which such application is made, for the purpose of conducting tests to evaluate whether seeds of such variety along with parental material conform to the standards as may be specified by regulations.
The certificate of registration issued under the Act shall be valid for 9 years in the case of trees and vines and 6 years in the case of other crops and may be reviewed and renewed for the remaining period on payment of such fees Total period of validity shall not exceed:- In the case of trees and vines, 18 years from the date of registration of the variety In the case of extant variety, 15 years from the date of the notification of that variety by the Central Government under the Seeds Act, 1966 In other cases, 15 years from the date of registration of the variety. No registration of a variety shall be made under this Act in cases where prevention of commercial exploitation of such variety is necessary to protect public order or public morality or human, animal and plant life and health or to avoid serious prejudice to the environment.
At any time, after the expiry of three years from the date of issue of a certificate of registration of a variety, any person interested may make an application to the Authority alleging that the reasonable requirements of the public for seed or other propagating material of the variety have not been satisfied OR seed or other propagating material of the variety is not available to the public at a reasonable price and pray for the grant of a compulsory licence to undertake production, distribution and sale of the seed or other propagating material of that variety. The duration of the compulsory licences may vary from case to case keeping in view the gestation periods and other relevant factors but in any case it shall not exceed the total remaining period of the protection of that variety.
A right established under this Act is infringed by a person:- Who, not being the breeder of a variety registered under this Act or a registered agent or a registered licensee of that variety, sells, exports, imports or produces such variety without the permission of its breeder or within the scope of a registered licence or registered agency without permission of the registered licensee or registered agent, as the case may be; Who uses, sells, exports, imports or produces any other variety giving such variety, the denomination identical with or deceptively similar to the denomination of a variety registered under this Act in such manner as to cause confusion in the mind of general people in identifying such variety so registered. Any person who applies any false denomination to a variety or indicates the false name of a country or place or false name and address of the breeder of a variety registered under this Act in the course of trading such variety, shall be punishable with imprisonment or with fine or with both.