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Abstract

A revolution in genetics has been occurring since Watson and Crick discovered the structure of the double helical DNA molecule. The explosion of knowledge about the human genome and the development of technology to clone human genes have raised issues concerning whether knowledge about genes can be owned and, thus, whether genes or information about them can be patented. The main issues in the human genome controversy concern how much of the genome is subject to patent control and how this control will affect future research and the development of new products. In order to defeat patent law in the service of profit, biotech corporations have patented singular genes and gene fragments while acknowledging that DNA itself cannot be patented. Proponents of patent protection believe that patents are the “engine” that drives great discoveries. The defenders argue that it was costly for researchers to develop the data, and now they are merely recouping their initial investment. The incentive to perform even the most basic research in genetics would not exist if the patent system were not available to provide the protection and nurturing that new inventions require. On July 29, 2001, CBS television network broadcast on Sixty Minutes an examination the controversy. A biotech firm was attempting to patent naturally occurring genes. When 60 Minutes sent a letter to the firm to clarify the issue, the firm claimed that ”…the patent has not resulted in any financial gain…” for the non-profit organization. The letter further stated that two subjects who contributed the genetic material were not considered as co-owners of the material because “…they did not contribute intellectually to the discovery…” of the genetic mutation. Laurie Anderson, a patent attorney and advisor to Congress, stated that doctors are searching world-wide and that they view their patients as treasure troves whose blood can be used to find lucrative genes. She contended that patents should not be applied to the products of nature because these products are not inventions. The United Stated Constitution established the patent system to reward and protect inventors. Until recently, the idea of scientific research products and results being viewed as private property, as opposed to openly shared public knowledge, would have appeared absurd. After Jonas Salk discovered the polio vaccine, he was asked why he did not attempt to patent it. In reply, he said, “Can you patent the sun?” Ironically, today the Salk Institute holds hundreds of patents on the products of scientific investigations. Science has changed from one of altruism to one of capitalism. Greed is now a cultural value in the health care system, and that the system needs to return to that altruistic approach. A return to an altruistic approach in genetic research, however, appears to be unlikely in an age in which a gene responsible for Epogen, a drug used in kidney treatment is worth more than a billion dollars in annual revenue for that holder of the patent and the manufacturer. Even in less lucrative fields, the “gold rush” is on. Scientists had been doing pure research long before there were such lucrative economic incentives. Allowing patents on genes has changed medicine forever and completely altered scientific thought. Usually in scientific endeavors, researchers share scientific knowledge so that many independent and competent people may be working on a cure for a specific disease. This is not now the case with the existence of overreaching gene patents, where the individual who identifies the gene controls subsequent research and marketing of that knowledge. The U.S. Patent and Trademark Office is violating its own guidelines and previous court decisions by granting patents to individuals and companies seeking to patent gene and partial gene sequences. Genes are physical phenomena that the courts have defined as subject matter that is not patentable. The only exception, which is patentable, is a novel gene sequence, including the processes and technology utilized in it’s creation, where a human being actually intervenes to create or develop the new sequence or process. That, however, is not what a number of biotech firms are attempting to patent. The subject matter that they wish to monopolize is the mapping and descriptions of gene and partial gene sequences, which occur in nature. The most obvious solution is for the Patent Office to reject biotech firms patent applications on such subject matter, and, as an added safeguard, for active, involved citizens to petition their legislative representatives to pass laws preventing biotech firms from patenting naturally-occurring genes and partial gene sequences. This may then reverse the recent trend toward scientific secrecy and restore the free flow of scientific knowledge between laboratories doing genetic research.

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