The Rights to LifeBy Lynne McAnelly
Vol. 10, No. 4, 1988, pp. 1-4
Agriculture is on the edge of a revolution that could bring changes as profound as the industrial revolution. From soybean growers in Georgia to cattle producers in Arkansas, few Southern farmers will be able to escape its implications.
The engine of this new evolution is biotechnology-our ability to control and manipulate DNA, the genetic blueprint of all living organisms. With this power, it will be possible to use microbes, plants, and animals as living chemical factories, to endow living organisms with new traits, and even to create new kinds of living beings.
These advances in biology have the potential to expand our options for dealing with environmental and agricultural problems and for improving economic opportunities in agriculture. At the same time, however, there are concerns that some new developments may actually limit options for farmers and ranchers. Of concern to many farm organizations and livestock producers is a decision from the U.S. Patent Office in April 1987 that animals can be patented. This was one in a series of administrative and judicial rulings that pave the way for a corporation or individual to own the blueprints which specify living organisms.
The legal and economic consequences of these decisions have raised a number of concerns that have only been heightened by the recent Patent Office issuance of its first animal patent-for a mouse that is especially susceptible to cancer and can be used with great effectiveness in laboratory research. However, the patent for this creature is broader than it seems at first glance. The patent refers to any cancer-causing gene imported into any mammal. The implications are staggering.
Sidebar: Living Organisms and Patent Law
A patent grants monopoly rights to an invention for a specified period of time (seventeen years or longer). However, there are limits on what can be patented. The invention must be novel relative to information available at the time of the patent application. Even if it qualifies as
Page 2"new," the invention cannot be patented if it is obvious to a "person with ordinary skill in the art."
Until 1980, living organisms were not considered patentable. Two separate laws, the Plant Protection Act of 1930 and the Plant Variety Protection Act of 1970, gave limited patent protection to plant varieties, implying to many, including the Patent Office, that Congress did not intend the Patent Act to generally cover living organisms. But in 1980, the Supreme Court ruled that the U.S. Patent Act applied to genetically engineered microorganisms. In 1985 the Patent and Trademark Office extended this ruling to all plants, and, on April 3, 1987, to all animals, excluding humans "for the time being."
It is not clear how patent law will be interpreted with regard to genetically engineered organisms. For example, although things existing at the time of the patent application are not generally considered patentable, things that exist in nature such as hormones, vitamins and proteins have been patented.
Even as seemingly obvious an "invention" as a naturally occurring microorganism isolated and grown in pure culture has been patented. This raises the possibility that existing genes could be patented and leads to questions that cannot be answered about the right of an individual or corporation to own the very genes that make up living organisms. If individual genes can be patented, then important naturally occurring traits that control food production could become private property.
For example, will a patent on a given trait preclude others from pursuing alternate ways of achieving the trait? There also are concerns that broad patents on fundamental traits such as oil production in seeds or milk production in mammals may then apply to all crop plants or animals developed with the trait. For example, a patent on a gene controlling milk secretion in mice might also be applied to cows, goats and horses. It remains for the Patent Office or Congress to decide on the scope of patent protection on living organisms, and the first patent granted is, as already noted, quite broad.
Sidebar: The Economic Power of Patents
The corporation or individual who holds a patent has exclusive rights to the patented object. The patent holder can collect whatever royalties the market will bear and impose restrictions on the use and the reproduction of the item.
The extension of these monopoly rights to the raw materials of agriculture-plants and animals-creates a whole new category of property ownership. And it is a kind of ownership which essentially will be closed to many people now in agriculture, from farmers and ranchers to livestock breeders, and many seed companies.
Due to the relatively high cost of genetically engineered livestock, it would be difficult for patent holders to try to get all their financial return from the initial purchase price. Therefore, according to William Lesser, an agricultural economist at Cornell, "it is highly likely that animal patent
Page 3holders will attempt to enforce patent rights over subsequent generations." According to the Patent Office, royalties would be paid on the sales of patented animals and on all the generations of their offspring produced over the seventeen-year lifespan of the patent. Such an agreement would be binding on the original purchaser and on subsequent purchasers of progeny. Lesser predicts that enforcing patent holders' rights will be feasible in the livestock industry, especially in sectors where good breeding records are already kept.
A difficult issue to be resolved is how to determine the extent and value of expression of the patented characteristics in succeeding generations. A patent does not guarantee that the trait will show up in the offspring. Multigenic traits (most agriculturally important traits such as weight and yield are controlled by many genes) are quite likely to be "diluted" by recombination in subsequent generations.
In addition, patented animals are likely to be more expensive initially than conventionally bred animals. Farmers and ranchers, even those with large operations, will usually not be able to obtain animal patents or to take advantage of the benefits of patented livestock produced through biotechnology.
Another concern of farmers and ranchers is that animal patents will accelerate vertical integration and consolidation in the livestock industry as happened in the seed industry after the 1970 Plant Variety Protection Act. Large pharmaceutical and petrochemical companies have bought out scores of independent seed companies. Predictions are that ten to twenty major corporations will dominate the worldwide seed trade by the year 2000.
Referring to the concentration in the poultry industry, Cy Carpenter of the National Farmers' Union testified to Congress in July 1987, "The almost total control of an industry by so few is a fear that haunts all segments of agriculture, and granting animal patents could turn those fears into a reality."
In order to maintain control over the patent, the holder may decide to sell his animals only to a few select operations. Or the patent holder may decide to buy the means of production. The beef industry, for example, may be ripe for such a consolidation; Iowa Beef Packers, one of the "big three" meat packing companies in the United States, is already considering raising its own cattle. If the livestock industry responds to patent protection as did the seed industry, it would not be surprising to see Iowa Beef Packers acquire the means of production and then in turn be acquired by a major chemical/ biotech corporation such as Monsanto or Mitsubishi.
Farmers will have to cope with extensive paperwork to keep track of progeny from all patented animals for seventeen years through multiple middlemen. As complicated as the situation is with a single patented trait it becomes truly Gordian when an animal has more than one patented trait, each with separate ownership. As a number of livestock producers commented, the prospect of patents on farm animals presents a paperwork nightmare.
And who will be policing the biotechnology companies and the Patent Office? Challenges to Patent Office decisions can be initiated only by someone with a competing patent claim. Such legal means can be long and expensive-beyond the means of many smaller companies and individuals.
The justification for patents is that they are necessary to stimulate research and to provide the necessary incentive to undertake research projects that may or may not pan out. The biotechnology industry warns that without patent protection we risk losing the fruits of our research to foreign competition.
However, despite the absence of patent protection, research in crop and livestock improvement at land grant universities, at USDA labs and on private ranches generated numerous new plant varieties, livestock breeds and champion race horses over the last hundred years. Results from research at public institutions has usually been freely available, in the public domain. Furthermore, market mechanisms exist to protect new breeds developed by livestock producers and to ensure significant financial returns.
Sidebar: Patents and Research
The assumption that patents encourage corporations to engage in novel research directions has been challenged by various authors. For example, research may be channeled to already patented products. Even the new biotechnology research programs in some companies are being driven by patents the company already holds. Many agrichemical companies are developing genetically engineered crop plants that will require the use of herbicides or pesticides that the company already sells. In addition many fear that life sciences research at public institutions may become increasingly directed into production of patentable products with resulting decline in public domain research.
But most worrisome to many in the seed and livestock industries is a growing reluctance on the part of researchers to share information and germ plasm with other labs. This would be devastating to plant breeding research and, in some cases, could endanger the nation's food supply, according to the American Seed Trade Association.
The issue of a foreign edge in patented animals is misleading. Only the U.S. and a handful of Soviet satellite nations currently allow animals to be patented. The European Economic Community specifically excludes animals
Page 4from patent protection. This would not prevent foreign companies from obtaining animal patents in the U.S., however. Thus, as one farm organization pointed out, American farmers could be in the unfavorable situation of paying royalties to foreign biotech companies.
It is worth noting that although humans were excluded from the April 1987 ruling, Charles Van Hom of the Patent Office told the New York Times: "The decision says higher life forms will be considered and it could be extrapolated to human beings. But for the time being, we are not going to consider applications involving human life."
This clearly implies that even human beings may eventually be considered patentable material.
Human genes are already components of biotech products that have been patented. These applications involve using human genes to produce pharmaceuticals such as human insulin and human growth hormone, substances of tremendous benefit. But eventually society may ask, at what point do we cross a barrier in manipulations with human genes?
Sidebar: Response and Remedies
A number of farm organizations including the National Farmers Union, the League of Rural Voters, and the National Farm Organization have expressed concern about the economic impact of animal patents on agriculture. Recently, almost 500 Texas livestock producers told the Texas Department of Agriculture that they are opposed to patents on farm animals.
The decisions granting full patent coverage to plants and animals were judicial and administrative rulings. However, in its 1980 decision the Supreme Court clearly left the door open for congressional action, stating that it is up to Congress to define the limits of patentability by amending the patent law. Many feel that it is time for public debate and congressional action on this issue.
Congressman Charlie Rose of North Carolina has introduced a bill, H.R. 3119, that would impose a two-year moratorium on animal patents. A two-year moratorium would allow time for investigation of the economic impact of animal patents and for discussion of the various issues involved in patenting living organisms. For many years, public dollars have supported the basic research that gave birth to the biotechnology revolution. Farmers and the consuming public deserve consideration of their concerns regarding patents on living organisms.