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Gene Patenting

"Gene patenting" is a broad term referring to the patenting of genetic sequences such as DNA and RNA, and to alternative forms of DNA such as cDNA (complementary 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. The total number of human genes is estimated to be about 30,000, and it is estimated that up to 20 percent of genes are patented by private companies, the government and even individuals.

USPTO guidelines
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. The guidelines clarified that companies could patent both whole genes as well as pieces of genes but that the patent filer must show specific, credible and substantial uses in order to patent the sequence.

The USPTO has historically allowed patenting of genetic sequences because patent filers have made the case that the isolated sequences are not naturally-occuring.

Implications of patenting on genetic medicine
The AMA is opposed to gene patenting because it has the potential to inhibit access to genetic testing for patients and hinder research on genetic disease. Others believe that gene patents provide incentives for provate company investment in education.

Association for Molecular Pathology v. USPTO

In 2009, the American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, three other health care organizations, and several individuals sued the USPTO, Myriad Genetics, and the Directors of the University of Utah Research Foundation in the United States District Court for the Southern District of New York. The suit challenged the validity of the patents on the BRCA1 and BRCA2 breast cancer susceptibility genes, claiming that the patents are overly broad and in conflict with policies that prohibit the patenting of natural phenomena and basic human knowledge and thought. The AMA filed an amicus curiae brief in support of the plaintiffs.

In 2010, a federal court ruled that several of the BRCA gene patents were invalid. Myriad Genetics appealed the case to the United States Court of Appeals for the Federal Circuit. A ruling is expected in Summer of 2011. The AMA again submitted an amicus curiae brief in support of the plaintiffs in the appeals court.

Medical society resources on gene patenting
AMA CSA Paper on Gene Patents & Licensing

College of American Pathologists (CAP) - Gene Patents Detrimental to Care, Training, Research

Other resources

United States Patent and Trademark Office

USPTO Publishes Final Guidelines For Determining Utility Of Gene-Related Inventions