Sponsored by the U.S. Department of Energy Human Genome Program
Human Genome News Archive Edition
Human Genome News, March 1994; 5(6)
Patents have been called the lifeblood of the biotechnology industry for good reason-protection of investment is crucial in an industry where product research is expensive, imitation is fairly easy, and the potential value of particular genes and their protein products is high. Patents traditionally have provided companies with incentives to risk time and money in research and development. Life forms such as genes, cells, and even some animals have been held patentable since 1980, when a divided Supreme Court affirmed (by a 5-to-4 vote) the granting of a patent for an oil-dissolving bioengineered microbe. This decision stimulated the burgeoning biotechnology industry, whose annual revenues now approach $6 billion and are projected to reach $50 billion by the year 2000.
Human genes and their products can be extremely valuable. A case in point is the huge success of Epogen, a genetically engineered version of the kidney hormone erythropoietin that stimulates the production of red blood cells in the body. Synthesized by the biotechnology company Amgen, Inc., Epogen is used by thousands of people who are on dialysis because of kidney failure and thus unable to make sufficient erythropoietin. Epogen has generated over $400 million in domestic sales for Amgen, and the potential for foreign sales has been estimated at $500 million to $1.2 billion. Amgen isolated the protein and determined the sequence for the gene while trying to produce a product having the properties of erythropoietin. The company has owned the rights to the erythropoietin gene since 1987.
Patents encourage the investment of resources by providing a monopoly to the inventor and prohibiting competitors from making, using, or selling the invention without a license. This monopoly is limited to 17 years in the United States, subject to extension in the case of patented drugs and medical devices. By granting exclusive rights, patents allow inventors to disclose their information safely, give information on technical advances to competitors and the general public, and avoid duplication of efforts.
The patentability of inventions under U.S. law is first determined by the Patent and Trademark Office (PTO) in the Department of Commerce. A patent application is judged on four criteria. It must be "useful" in a practical sense (the inventor must identify some useful purpose for the invention); "novel" (i.e., not known or used before the filing); and "nonobvious" (i.e., not an improvement easily made by someone trained in the relevant area). The invention must also be described in sufficient detail to enable one skilled in the field to use it for the stated purpose (sometimes called the "enablement" criterion).
In the United States, patent priority is based on the "first to invent" principle: whoever made the invention first (and can prove it) is awarded property rights for the 17-year period. Inventors have a 1-year grace period to file after they publish. All other countries except the Philippines, however, follow a "first inventor to file" rule in establishing priority when granting patents.
While previous patents were granted for genes whose full sequences and functions were known, new methodology now enables researchers to partially characterize genes where no function is known. Beginning in the summer of 1991 NIH filed for patents on over 6000 gene fragments. Questions arose over the issue of when, from discovery to development into useful products, exclusive rights to genes could be claimed. The 300- to 500-base gene fragments, called expressed sequence tags (ESTs), represented only 10 to 30% of the average cDNA, and the genomic genes are often 10 to 20 times larger than the cDNA. In addition, the original chromosomal locations and biological functions of the full genes identified by ESTs were unknown in most cases.
In 1992 and 1993, some of the NIH EST patent applications were rejected by PTO for not meeting the requirements outlined above. Although NIH announced recently that it would not appeal the rejections, questions concerning gene patenting continue to generate much debate in the scientific and biotechnology communities.
[Denise Casey, HGMIS]
The electronic form of the newsletter may be cited in the following style:
Human Genome Program, U.S. Department of Energy, Human Genome News (v5n6).
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.
Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.