Gene Patent Guidelines Issued
4:45 p.m. Jan. 5, 2001 PST
The U.S. Patent and Trademark Office released new guidelines on Friday meant to clarify the controversial and ambiguous business of patenting genes.
The rules were intended to help end what has become an acrimonious debate on patenting genes, a multimillion-dollar business for many companies.
They put to rest any question about whether genes can be patented -- making it clear that companies may do so, though they may not patent mere genetic sequences or pieces of genes.
"But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the 'utility' requirement," the new guidelines read.
The guidelines were barely changed from the interim rules issued a year ago, the Patent Office said. They leave biotech companies such as Rockville, Maryland-based Celera Genomics and Human Genome Sciences Inc. free to continue patenting the genes they are racing to identify.
Arguments against the whole idea of patenting genes -- based on the premise that genes are a part of nature and not an invention -- were soundly rejected by the Patent Office.
"Several comments state that a gene is not a new composition of matter because it exists in nature, and/or that an inventor who isolates a gene does not actually invent or discover a patentable composition because the gene exists in nature," said the guidelines.
Another comment expressed concern that a person whose body includes a patented gene could be guilty of patent infringement.
After responding to more than a dozen such comments, the Patent Office said the law clearly allowed for genes to be patented, so long as those genes have been "cloned" or reproduced in the laboratory and their function defined.
"An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature," it said. "Synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound."
The Patent Office said the practice of patenting bits and pieces of nature was not new. "For example, Louis Pasteur received U.S. Patent 141,072 in 1873, claiming 'yeast, free from organic germs of disease, as an article of manufacture'," it said. "Another example is an early patent for adrenaline."
The entire sequence of a gene does not have to be published to get it patented. "Describing the complete chemical structure, i.e., the DNA sequence, is one method of describing a DNA molecule but it is not the only method," it said.
Companies have asked for patents on tens of thousands of human genes. Human Genome Sciences says it holds 159 patents on full-length genes, for example, and has filed applications on more than 16,000 genes.
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