A Primer on Intellectual Property Rights and Agricultural Biotechnology

Intellectual property refers to products of the mind. Inventions, computer programs, publications, videotapes, and music are all examples of intellectual property. Intellectual property rights afford a time-limited legal protection to artistic, scientific, technological, or economic products. Copyrights, trademarks, design patents, utility patents, plant patents, plant breeders' rights, and trade secret laws are some of the ways of protecting intellectual property rights. The type of intellectual property to be protected and the legal and administrative system of the country where the right is being sought affect the extent of rights, such as the scope of the protection and the geographical limits to and duration of the rights.

In plant breeding, patents and plant breeders' rights have generally been the most important forms of intellectual property protection. As the biotechnological revolution unfolds, however, copyrights are becoming more important because the databases that hold information about plant genes can often be copyrighted. Such copyrights do not, however, affect trade in products developed using the protected information. U.S. state trade secret laws have been used to protect in-house breeding materials such as the inbred lines of maize used as parents of hybrids, but these laws do not protect against independent discovery or reverse engineering of products by their purchasers. Hence, patents afford stronger protection than trade secret law for innovation embodied in products. Trademarks are used for the protection of brand names of biotechnologies, such as Monsanto's Roundup ReadyJ technology or Aventis's Liberty7 and LibertyLink7 technologies. Trademarks only protect the names and other symbols denoting products or technologies, not the technologies themselves.

PATENTS
The patent right is generally considered the most powerful tool in the intellectual property system, enabling the patent holder to exclude all others from making, using, selling, or offering to sell the invention in the country that granted the patent right or importing it into that country, if it is made elsewhere, for as long as the patent remains valid. To be patentable, an invention must satisfy the criteria of novelty, nonobviousness, and utility or industrial application. In addition, an inventor is required to describe the invention to the public in a manner sufficiently clear and complete for the invention to be reproduced by another person skilled in the art.

While many member countries of the World Trade Organization are still in the process of implementing a protection system for plants, the United States and Europe have led the way in allowing utility patents for plants, particularly for transgenic plants. In 1985, the U.S. Patent Office Board of Appeals ruled that asexually and sexually propagated seeds, plants, and tissue culture could be protected by utility patents. More recently, the European Patent Office has held that transgenic methods and plants are not per se unpatentable.

PLANT BREEDERS' RIGHTS
Plant breeders' rights (PBRs), or plant variety protection, are a form of intellectual property protection for plants offered in most developed countries and a growing number of developing countries. While countries differ in how they implement PBRs, the laws usually grant protection to varieties that are novel, distinct, uniform, and stable. Thus, the variety must not have been previously sold, be clearly distinguishable from previous varieties, be uniform, and breed true to type. The holder of a plant breeder's right has a legal monopoly over commercialization of that variety for a prescribed length of time, allowing the recovery of the cost of breeding commercially valuable new plant varieties. Although the details of protection vary from country to country, in general, the sale, reproduction, import, and export of new varieties of plants are encompassed. Exceptions may be made, however, for research, breeding of new varieties, and use of seed saved by a farmer for replanting. Moreover, in some countries, if a protected variety is used as the basis for a transgenic plant, the latter is covered by the plant breeder's right if it constitutes a variety "essentially derived" from the protected variety.

CONTRACTUAL AND TECHNOLOGICAL PROPRIETARY TOOLS
In addition to the legal protection afforded by patents and plant breeders' rights, contractual provisions may be used to extend or establish intellectual property rights. Such contracts include

• material transfer agreements between technology developers and third parties, which limit the transfer and use of materials such as vectors, genes, and plants developed by the transferor;
• bag label contracts between the manufacturer and the buyer of seed, for example, which limit further uses of purchased material that would otherwise be allowable;
• technology use agreements between technology suppliers and farmers, which typically control the right to plant a given seed on a specific area of land for a certain period of time; and
• licenses between patent or property holder and licensee, which are negotiated grants of some or all of the holder's rights, such as allowing the use and sale of the technology.

There are also a number of genetic technologies that impose technical limits on farmers' use of seeds from their harvest to replant or to sell for replanting. The most common is production of hybrid crops that generally have a lower yield through loss of "hybrid vigor" if replanted. Modern alternatives include genetic use restriction technologies that confer sterility on replanted seeds 'popularly dubbed terminator technologies' and others that allow reproduction but prevent expression of proprietary traits until the plant is treated with a specific chemical activator.