The Supreme Court Case That Will Determine The Future Of Gene Patenting

The Supreme Court is set to review a case in which it will determine whether the bio-pharmaceutical company Myriad Genetics Inc. may legally patent two cancer-related human genes, paving the way for a decision that will have broad-based economic and regulatory ramifications for the biotech and drug industries — as well as for the millions of Americans whose health care may increasingly depend on such cutting-edge innovations.

Back in August, the D.C. Federal Circuit Court of Appeals ruled by a 2-1 margin that Myriad could patent the detection of two genes, BRCA1 and BRCA2, that have been linked to a heightened chance of breast and ovarian cancer in women. While Myriad and other bio-tech firms argue that such patenting is necessary to spur and protect innovation in diagnostic medical testing, critics — including the ACLU, AARP, and the AMA — warn that it could actually have the opposite effect, stifling the standardization of such testing methods and commoditizing naturally-occurring human biology:

Peter Meldrum, Myriad’s chief executive, said in a statement that the Supreme Court’s ultimate decision could affect the providing of medical treatment to hundreds of millions of people. He said Myriad’s own diagnostic test has helped nearly 1 million people learn about their risk of hereditary cancer.

“The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation,” he said.

Many outside groups supported the petitioners, including the AARP, the American Medical Association, the American Society of Human Genetics, the March of Dimes Foundation, the National Breast Cancer Foundation and several women’s health groups.

“Some critics say it is unjust to give a company a monopoly over something as intrinsic to people’s health as their genes,” said Josephine Johnston, a research scholar at The Hastings Center, a independent bioethics research institute in Garrison, New York, who is not involved in the Myriad case.

“From an ethics perspective, one could argue that genes are owned by everybody, and that patenting them amounts to a commodification of an element of the human body,” she added.

The D.C. appellate court’s ruling also harbors a potential conflict with an earlier Supreme Court finding in which the court found that a pharmaceutical company could not patent “observations about natural phenomena.”