U.S. Issues New Patent Guidelines on Genes 

Reuters 5jan01

WASHINGTON  - 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 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 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 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, posted on the Internet at http://www.access.gpo.gov/su_docs/aces/fr-cont.html

``Another comment expressed concern that a person whose body includes a patented gene could be guilty of patent infringement.''

In response after response 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 is 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.

US Patent Offie Press Release 4jan01

USPTO PUBLISHES FINAL GUIDELINES

FOR DETERMINING UTILITY OF GENE-RELATED INVENTIONS

The United States Patent and Trademark Office (USPTO) today announced that the agency's "Utility Examination Guidelines" have been finalized and will be published in tomorrow's Federal Register. The final Guidelines issue after extensive public comment, and differ little from interim Guidelines published in December, 1999. The USPTO's patent examiners follow these Guidelines when examining patent applications for compliance with the patent statutes.

The utility Guidelines are applicable to all areas of technology. However, they are particularly relevant in areas of emerging technologies, such as gene-related technologies, where uses for new materials that have not been fully characterized are not readily apparent.

The Guidelines are expected to be available for the public to read/download on the Federal Register website, http://www.access.gpo.gov/su_docs/aces/fr-cont.html, on January 5, 2001. The USPTO will post copies of the Guidelines on its website, http://www.uspto.gov, as soon as possible after Federal Register publication.

Final Guidelines for use by examiners in determining compliance with the written description provisions of patent law will also be published in the Federal Register on January 5, 2001. Guidelines for written description will be posted on the USPTO website after Federal Register publication.

Contact: Brigid Quinn 703-305-8341