Gene patenting

"Gene patenting" is a broad term referring to the patenting of either a process that involves isolation of DNA (where DNA refers to either DNA or associated materials such as RNA) as well as to a chemical substance related to DNA.

Background
After it was announced in June 2000 that the human genome was almost completely mapped, private and public entities unleashed a flood of patent requests for genes and small pieces of gene sequences (known as expressed sequence tags, or ESTs).

While the total number of "working" human genes is expected to be somewhere between 28,000 and 100,000, it represents only about four percent of the total human genome. The remainder of the genetic information is made up of sequences whose functions are currently unknown but may have future uses. In short, ownership of them now may benefit the patent holder later, when their function is determined.

In January 2001, the United States Patent and Trademark Office issued guidelines aimed at stopping companies’ frivolous attempts to patent genes they had sequenced before establishing a particular use for them.

USPTO guidelines
Issued in January 2001 after extensive public comment, the guidelines clarified that companies could patent both whole genes as well as pieces of genes but not ESTs. Further, the patent filer must show specific, credible and substantial uses in order to patent the gene.

The PTO allows patenting of discoveries from nature as long as they are isolated and purified. As of 2000, it had issued patents on more than 6,000 genes - about 1,000 of them human genes - dating back more than 10 years. Many of the first genes to be patented took years to isolate. The development of high-speed gene sequencing techniques has allowed genes as well as fragments of genes to be discovered extremely quickly, without the need to know the functions of the proteins produced by the genes.

Implications of patenting on genetic medicine
Some physicians fear if too many genes receive patents, genetic testing of patients could become prohibitively expensive. Although the technological knowledge exists to develop such tests, much work remains to produce them. And if license fees associated with the use of each test are charged through many different companies, each owning one or more genes, then this technology may never be used effectively to help patients.

On the flip side, if no protection is provided to the industry, then research and development costs may not be recouped, reducing incentive for investment within the biotechnology industry.

Medical society resources on gene patenting
AMA CSA Paper on Gene Patents & Licensing
American College of Medical Genetics (ACMG) Position Statement on Gene Patents
College of American Pathologists (CAP) - Gene Patents Detrimental to Care, Training, Research

Other resources
United States Patent and Trademark Office
Patent Appilications - Utility Examination Guidelines (Federal Register: January 5, 2001, Volume 66, Number 4, Page 1092-1099)
USPTO Publishes Final Guidelines For Determining Utility Of Gene-Related Inventions
Primer: Genome and Genetic Research, Patent Protection and 21st Century Medicine, from BIO, July 2000