"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).
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.
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 private company investment in education.
Association for Molecular Pathology v. USPTOIn 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. The AMA again submitted an amicus curiae brief in support of the plaintiffs in the appeals court. In July 2011, the Court of Appeals reversed the federal court decision, ruling that the genes were patentable. After reconsideration of the case in light of the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision, the Court of Appeals upheld its decision. In April of 2013, the U.S. Supreme Court considered the case. The AMA again supported the plaintiffs in an amicus curiae brief. In June of 2013, the Supreme Court ruled that naturally-occuring genes are not patentable, invalidating the patents held on BRCA1 and BRCA2. The AMA welcomed the Supreme Court's decision.
Medical society resources on gene patenting
AMA CSA Paper on Gene Patents & Licensing
Other resourcesUnited States Patent and Trademark Office