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80 J. Pat. & Trademark Off. Soc'y 739 (1998)
Gene Therapy and Patents

handle is hein.journals/jpatos80 and id is 753 raw text is: Gene Therapy and Patents John K. Flanagan* I. INTRODUCTION T he transfer of genetic material may one day become one of the most important forms of medicine. A variety of public and private institutions now participate in research and development related to the use of genetic material in therapeutic applications. Hundreds of human gene transfer protocols are being conducted at any given time with the approval of the Recombinant DNA Advisory Committee (RAC) and the National Institutes of Health (NIH). Most of these protocols focus on therapy, while others involve marking and non-therapeutic applica- tions. The therapeutic protocols are primarily concerned with infectious diseases, monogenic diseases and cancer. There are two main approaches to gene therapy, germline and so- matic cell. Germline gene therapy involves attempts to affect the germ cells of a patient such that the genetic alteration will exist in all cells of the organism and would be passed on to each of the offspring of the individual treated. This is the approach which conjures the most con- troversy, principally because it does not simply affect the patient but also impacts descendants of the patient. Germline gene therapy, at least in theory, may allow us to favor certain phenotypes over others and thereby could lead to questionable practices which are out of the realm of medicine and more in tune with playing God in gene pools. The potential uses of germline gene therapy thus involve complex technical and ethical issues.' This approach has been studied to a lesser degree than somatic cell gene therapy, but may become a focus of more re- search in the future. Somatic cell gene therapy involves attempts to affect the somatic cells of a patient such that any genetic alteration will exist only in the cells of the individual and would not be passed on to offspring of that individual treated. This approach stirs less controversy because it affects only the individual. Somatic cell gene therapy is arguably more like *Registered Patent Attorney BA, Molecular, Cellular and Developmental Biology, Flanagan & Flanagan, Jackson Hole, WY I Inder M. Verma, Overview, Somatic Gene Therapy, edited by Patricia L. Chang, CRC Press, Boca Raton, Florida, 1995, 1.

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