Moving Beyond "Isolated" Gene Patents

• Published in: Science (American Association for the Advancement of Science) Vol. 341; no. 6142; pp. 137 - 138
• Main Authors: Rai, Arti K., Cook-Deegan, Robert
• Format: Journal Article
• Language: English
• Published: Washington American Association for the Advancement of Science 12.07.2013; The American Association for the Advancement of Science
• Subjects: Amicus curiae briefs; Calculus; chemical composition; Complementary DNA; courts; Deoxyribonucleic acid; DNA; Economics; federal government; Genes; Genetics; Genomes; Innovation; Intellectual Property; Introns; Judicial rulings; Logic; Molecules; Pathology; PERSPECTIVES; Solicitors; Solicitors general; Strikes; Supreme Court decisions; United States; United States > US; United States
• ISSN: 0036-8075; 1095-9203
• DOI: 10.1126/science.1242217

The U.S. Supreme Court decides that not all gene patents are alike—what does this mean for research, innovation, business, and patients? On 13 June 2013, the United States Supreme Court handed down its highly anticipated decision in Association of Molecular Pathology (AMP) v. Myriad Genetics ( 1 ). A unanimous Court held that genes and the information they encode are not patent-eligible subject matter “simply because they have been isolated.” Hewing closely to the position of the U.S. solicitor general, who represents the executive branch of the federal government before the Supreme Court, the Court argued that DNA that has merely been isolated (genomic DNA or gDNA) is a “product of nature” and not eligible to be patented, whereas DNA with introns removed (complementary DNA or cDNA) is patent-eligible (introns are DNA sequences that do not encode a gene product). The Court also appeared to adopt the solicitor general's underlying economic logic that drawing the difficult line between what subject matter should and should not be patent-eligible requires respecting the “delicate balance” that patent law strikes between patent claims that create incentives for innovation and claims that block further innovation. Under this “well-established” balancing approach, gDNA claims that cover broad categories of information rather than “the specific chemical composition of a particular molecule” are suspect. Informational content is, however, only one factor in the calculus.