Myriad Genetics: The Supreme Court Rules That Isolated DNA Is Not Patent Eligible

 

 

By Kathleen Williams, Ph.D. and Amy DeCloux, Ph.D.  Members of our Life Sciences Practice Group

 

“The very first official thing I did in my administration – and it was on the very first day of it, too – was to start a patent office; for I knew that a country without a patent office and good patent laws is just a crab, and couldn’t travel any way but sideways or backways.”

Mark Twain, A Connecticut Yankee in King Arthur’s Court
 

The Patent Act of 1793, authored by Thomas Jefferson and clearly a favorite of Mark Twain’s, defined patent-eligible subject matter as “any new and useful art, machine, manufacture, or composition of matter, or any new useful improvement [thereof].” The Act embodied Jefferson’s philosophy that “ingenuity should receive a liberal encouragement.”
 

It is upon Jefferson’s carefully crafted definition of patent-eligible subject matter (codified in §101 of the Patent Act) that the U.S. Supreme Court rested its considerable weight in its ongoing effort to define patent-eligible subject matter.

The court’s long-anticipated decision in Association of Molecular Pathology. v. Myriad Genetics Inc., published on June 13, unanimously supported the premise that a gene in its isolated form cannot be the subject of a U.S. patent:

“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” (emphasis added).
 

The word “merely” is a key to understanding the overall effect—and narrowness–of the decision.
The Myriad litigation was begun by a group of plaintiffs, including the American Civil Liberties Union, who challenged Myriad’s patents by asserting isolated DNA to be a product of nature and thus not patent-eligible subject matter. The plaintiffs sought to invalidate all existing gene patents, to prevent the future issuance of patents claiming human genes, and thereby to eliminate barriers to competition for genetic tests.

While the ACLU achieved its nominal objectives, the Myriad decision should not significantly impede patent protection of genetic tests or commercialization of discoveries in human diagnostics and personalized medicine.

The science of predicting or diagnosing human disease has moved towards identifying mutation in many genes, no one of which on its own is predictive or dispositive. Thus, new diagnostics have moved beyond the isolation of individual genes and incorporate inventions that involve combinations of gene segments, where each gene segment has a naturally occurring sequence but the combination of sequences does not occur in nature. (More)