Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Patents As industry moved from genetic engineering research to product de- velopment, they encountered uncertainty about patent protection for their inventions. Clearly, the processes used in creating a specific re- combinant microorganism were patentable. But what about the genet- ically engineered microorganisms themselves, such as those designed to degrade of] spills or combat soil-borne diseases? Could these novel life forms be patented? For many years, Section 101 of the Patent Law has provided protection for any process, machine, manufacture, or composition of matter that meets certain criteria. Yet as Rene D. Tegtmeyer, assistant commissioner for patents of the U.S. Patent and Trademark Office, explained, it had been widely thought that the section did not apply to plants and other living things. In 1930 the Plant Patent Act was passed to allow patent protection for certain asexually propagated plants. The distinction was made between asexually and sexually propagated plants, because at that time it was not thought possible to produce a stable, uniform line through sexual reproduction. Those ideas were rf~vi~H Once -rim , ~ in 1970 Congress passed the Plant Variety Protection Act, which allowed protection of some sexually reproduced plants. The act specifically excluded bacteria, fungi, tuber-propagated plants, uncultivated plants, and first-generation hybrids. In some situations, a genetic engineering company might prefer to rely on trade secret protection rather than apply for a patent. The ad- vantage is that the trade secret need not be revealed and that such protection lasts indefinitely. The drawback is that if the secret is made public, either through legal or illegal means, then protection is lost. For these reasons, trade secret protection might prove inadequate or inap- propriate for genetic engineering. Many of the products could be "re- 73
74 GENETIC ENGINEERING OF PLANTS verse engineered" that is, a competitor could use the product to de- duce the original process. In addition, academic researchers might balk at trade secret protection, as they wouIcl not be able to publish their results. Patents, too, have their drawbacks. Under patent law the applicant must have an invention that is new, useful, and unobvious and must describe the invention in sufficient detail to allow a person skilled in the field to use or operate it without undue experimentation. The dis- closure requirement was a balance struck by Congress to encourage invention both by protecting the rights of the inventor and by making new technical information publicly available so that others can learn from it. Patents provide the holder with exclusive rights to an invention for 17 years. During this time, if the patent is infringed, the holder has legal recourse. In most cases, patents would seem to be the preferred method of nrot~rtin~ s'~n~tir ~n~n~rin~ technolo~v Te~tmever said. "Inventions rat O 0~ On = ~ Oil --On , In this field have a goon prospect tor relatively long commercial fire or usefulness though requirements for pre-marketing approval may be a factor in some areas. Competition will be heated; new entrants to the field will be many; market potentials are huge; and research and de- velopment is expensive. Genetic engineering is a suit tailor-made for the patent system." But first, the uncertainties had to be resolved. The Test Case The test case was a patent application filed in 1972 by Ananda Chak- rabarty, a General Electric scientist. By transferring plasmids from sev- eral bacteria into one bacterium, he had endowed this bacterium with the ability to degrade oil. His patent application included claims for the process used to engineer the new bacterial strain, for the carrier material to be used with the modified bacteria, and the genetically engineered bacterium itself. The U.S. Patent and Trademark Office granted a patent on the process and the carrier but denied a patent on the bacterium on the grounds that living organisms are not patentable subject matter under Section 101. The Court of Custom and Patent Appeal then ruled that a patent could not be denied solely because the invention was a living organism. In its 1980 Diamond v. Chakrabarty ruling, the Supreme Court upheld the decision, affirming that genetically engineered microorganisms are pat- entable. The court ruled that "the relevant ctistinction was not between living and inanimate things but between products of nature, whether
PATENTS 75 living or not, and human-made inventions." In other words, human intervention determines whether an organism is patentable subject mat- ter. Questions seem certain to arise concerning how much human inter- vention is necessary before an organism qualifies as subject matter that can be protected by patent. The Patent and Trademark Office has said that it will clecide which genetically engineered organisms are patentable on a case-by-case basis. Other issues may complicate the patenting of biotechnology products. For one, the applicant must demonstrate that the invention is novel and not obvious to someone having ordinary skills in the field. Yet "the very scope and complexity of the field and its rapid growth creates difficulty in determining what ordinary skill is at any time and what is obvious or novel," Tegtmeyer said. Similarly, the requirements for full disclosure of the "best mode" for using or creating the invention may also prove difficult. It may not be possible to adequately describe a microorganism or plasmid, or the genetic engineering processes. In those cases, a sam- ple must be available to the public. ~ ~ ~ 1 {A Patent Activity Difficulties aside, the Chakrabarty decision has greatly increased pat- ent activity in the field of genetic engineering. A number of patent applications were suspended pending resolution of the case; those and new applications have since been processed. Now some 500 applications related to genetic engineering are pending. More are expected: patent Top Assignees in Genetic Engineering (Class 435/172), 1979-1982 Assignees Percent Upjohn Co. Ortho Pharmaceutical Corp. Ajinomoto Co., Inc. President and Fellows of Harvard College Regents of University of California Research Corp. Cetus Corp. Genentech, Inc. Noda Institute for Scientific Research Agroferm Ag All Other Organizations (44) 9.7 7.1 5.3 4.4 4.4 3.6 2.7 2.7 2.7 1.8 47.0 SOURCE: U.S. Patent and Trademark Office.
76 GENETIC ENGINEERING OF PLANTS 32 70 in ~ 60 UJ <` 50 O 40 us 30 m be 20 10 o ~ Go/ ~ ~ Organizations I= u) 28 0 24 ~ N _ 20 ~ O: 16 0 LL 12 o to llJ Q m in 4 O 1973 1974 1975 1976 1977 1978 1979 1980 198 1 1982 YEARS U.S. patenting activity on genetic engineering (Class 435/172~: 1973-1982. Courtesy of U.S. Patent and Trademark Office. 60 in uJ 40 cat 30 20 10 Cl All Technologies (all Classes) Genetic Engineering _ ~ Growth Between 1980 and 1982 as Compared to the 1 973-1982 Total Comparative trends in U.S. Foreign Origin, 1980-1982 patenting: Percent growth and foreign origin. Courtesy of U.S. Patent and Trademark Office. activity in genetic engineering is increasing at roughly twice the rate of other technologies. A sizeable portion of U.S. patents are issued for inventions developed in other countries. From 1980 to 1982, the percentage of foreign patents issued for genetic engineering was lower than that for other technolo- gies. "This seems to indicate a concentration of genetic engineering inventiveness in the United States at this time," Tegtmeyer said.
