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

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

 by Amy DeCloux Ph.D. and Kathleen M. Williams Ph.D.

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

Excerpt:

"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., 133 S. Ct. 2107 (U.S. 2013) [an enhanced version of this opinion is available to lexis.com subscribers], 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.

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Dr. Amy DeCloux is an associate at Sunstein Kann Murphy & Timbers LLP is an associate whose practice focuses on the prosecution of patents in the fields of immunology, cellular and molecular biology, biochemistry, pharmaceutical formulations, diagnostics, and medical devices. She also assists in the preparation of patentability, infringement and freedom-to-operate analyses, as well as performing IP diligence for corporate transactions. She is registered to practice before the United States Patent and Trademark Office and has argued before the Board of Patent Appeals and Interferences at the USPTO.

Dr. Kathleen M. Williams is an intellectual property attorney at Sunstein Kann Murphy & Timbers LLP who specializes in complex legal issues surrounding the protection of discoveries in the life sciences. Her technology focus spans biology, chemistry, and materials sciences; molecular biology, biochemistry, medicinal chemistry, pharmacology, and devices in the areas of biotech, pharmaceuticals, therapeutics, diagnostics, nanotechnologies, bio-energy, cleantech and medicine.