“Laws of nature, natural phenomena, and abstract ideas are not patentable.” —Thomas, Justice 

Facts: After substantial research and expenditure of money and resources, Myriad Genetics, Inc. (Myriad) discovered the precise location and sequence of two naturally occurring segments of deoxyribonucleic acid (DNA) known as BRCA1 and BRCA2. Mutations in these genes can dramatically increase a female’s risk of developing breast and ovarian cancer. The average American woman has a 12- to 13-percent risk of developing breast cancer, but in a woman with the genetic mutations discovered by Myriad the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman’s risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers. For women who are tested and found to have the dangerous mutations of BRCA1 and BRCA2 medical measures can be taken to reduce the risks of breast and ovarian cancer developing. Myriad obtained a patent from the U.S. Patent and Trademark Office based upon its discovery. The Association for Molecular Pathology sued Myriad, seeking a declaration that Myriad’s patent was invalid. The U.S. district court held that Myriad’s claim was invalid because it covered a product of nature and was therefore unpatentable. The Federal Circuit Court of Appeals held that the isolated DNA was patent eligible. The U.S. Supreme Court granted review. 

Issue: Is a naturally occurring segment of DNA patent eligible? 

Language of the U.S. Supreme Court: Laws of nature, natural phenomena, and abstract ideas are not patentable. It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes new compositions of matter that are patent eligible. Extensive effort alone is insufficient to satisfy the demands of § 101. 

Decision of the U.S. Supreme Court: The U.S. Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. The U.S. Supreme Court reversed the decision of the Federal Circuit Court of Appeals on this issue.

Ethics Questions: Will the Supreme Court’s decision affect the amount of research that is conducted to find naturally occurring disease-causing DNA sequences? Should Myriad be compensated by the government for its research costs?