Patenting of Human Genes and Living Organisms: The Socio-Political Situation in the United States of America

Abstract

Molecular biology has made tremendous advances in its ability to understand and manipulate biological processes, both in vitro and in vivo. The capability to change life forms, cells, plants and animals, has aroused many concerns: religious, environmental, economic and sociological. As part of these concerns, attention has been directed to the patenting of inventions associated with these new biological advances. As will be discussed, under U.S. law as it is understood at present, most, if not all, molecular biological inventions will fullfill the statutory requirement of being patentable subject matter. Therefore, under the laws of the United States, there is no impediment to filing for inventions in the field of molecular biology, regardless of the nature of the particular invention and obtaining a patent, assuming that the other requirements for patentability are met. The types of inventions in molecular biology extend over a broad ambit, involving compositions such as nucleic acids and proteins, genetically modified plants and animals, methods of producing these products, and methods of treating animals, including humans. Each of these categories of inventions has raised varying degrees of concerns, the least of which being the compositions.