Supreme Court: Natural Human DNA is Not Intellectual Property

On Thursday in Washington D.C., the Supreme Court ruled on a landmark case that will have implications for years to come for commerce, science, and the legal standing of the human genome. Members of the Supreme Court unanimously ruled that human genes, the DNA instructions in our cells that make us who we are, cannot be patented as property right-protected information by biotechnology companies.

While the Supreme Court decided that naturally occurring human DNA cannot be patented, the ruling also left open the possibility of patenting synthetic DNA, which is a victory for biomedical and biotechnology firms hoping to make profits from tweaking the human genome to prevent diseases such as cancer.

According to the Associated Press, the ruling "sets a fair and level playing field for open and responsible use of genetic information," according to Dr. Robert B. Darnell, the president and science director of the New York Genome Center. "At the same time, it does not preclude the opportunity for innovation in the genetic world, and should be seen as an important clarifying moment for research and the healthcare industry." 

The case was brought against Myriad Genetics Inc. by medical researchers. Myriad Genetics Inc., a Salt Lake City-based company, owned seven patents on two genes linked to breast and ovarian cancer. Myriad Genetics is probably best known recently for screening for the same kind of cancer that prompted Angelina Jolie to undergo a double mastectomy after finding that she had an extremely high risk of developing breast cancer.

Justice Clarence Thomas wrote Thursday's mixed decision. On the subject of unaltered human DNA, Thomas declared, "We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." Laws of nature, natural phenomena, and abstract ideas are all not patentable, according to the court.

Synthetically created DNA, however, can be patented because, as Thomas wrote, "it is not naturally occurring." Synthetically created DNA is called cDNA, or complementary DNA. Complementary DNA is created when parts of the gene are edited out, and it's not simply DNA that is extracted and isolated from the human body. Patents are eligible on cDNA because it's not naturally occurring. As Thomas said, a lab technician "unquestionably creates something new when cDNA is made."

The two decisions, both positive and negative for biomedical and biotechnology firms, are not expected to greatly damage large swathes of those industries. "The decision is likely to have the greatest impact on diagnostic/genetic screening patents similar to those at issue in Myriad, but the ruling will impact the patent-eligibility of other newly discovered compounds that are 'isolated' from nature, such as medicinal compounds isolated, beneficial proteins isolated form human or animal sources, and beneficial microorganisms isolated form soil or the deep sea," said Courtenay Brinckerhoff, a lawyer at Foley & Lardner.

Advocates against patenting DNA were pleased by Thursday's ruling, according to the Associated Press report. "Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, speaking for the American Civil Liberties Union Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

Dr. Jermey A. Lazarus, of the American Medical Association, praised the ruling as well: "Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights."