Supreme Court: No patenting human genes unless they are changed

The Supreme Court is hearing a challenge to a company's patents on two genes. Another issue: Who owns the information compiled with gene patents?
The Supreme Court is hearing a challenge to a company's patents on two genes. Another issue: Who owns the information compiled with gene patents? (ALEX BRANDON / AP, File)
Posted: June 15, 2013

The U.S. Supreme Court unanimously ruled Thursday that human genes cannot be patented unless they are changed into something not found in nature after being extracted from the body.

The much-watched case, with University of Pennsylvania researchers as original plaintiffs, had prompted real-world questions from Supreme Court justices in April's oral arguments about what is natural and what is invented.

Justice Sonia Sotomayor suggested that a distinct recipe for chocolate chip cookies might be worthy of a patent, but not naturally occurring ingredients. Justice Samuel A. Alito Jr. wondered about a baseball bat, since it begins as a section of a tree.

A few weeks later, the case got a pop-culture component when the actress Angelina Jolie announced that she had undergone a double mastectomy to decrease the chances of getting breast cancer and urged that lower-cost testing be made available to women of lesser means.

In Association for Molecular Pathology v. Myriad Genetics Inc., Myriad argued that because it removed or "isolated" parts of two genes called BRCA1 and BRCA2 to produce a test for breast and ovarian cancer, it should be granted a patent for all parts of both genes. The U.S. Patent and Trademark Office agreed.

Several groups and patients, including Penn researchers and a woman from Williamsport, Pa., filed suit in 2010 to challenge Myriad's monopoly on the genes and the stifling effect the patents had on developing other testing methods for specific kinds of cancer. Because of the patent, Myriad was the only company with a test, for which it charged $3,000. Though Myriad was quick to say that insurance covered most of the cost and that it gave discounts to many women, there was no other company for women to go to get a second, independent test.

After the case made two trips through the U.S. Court of Appeals for the Federal Circuit, the question the Supreme Court eventually weighed was, "Are human genes patentable?"

In writing the rare unanimous opinion, Justice Clarence Thomas said no.

"Myriad did not create anything," Thomas wrote. "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."

Myriad, a diagnostic company based in Salt Lake City, derived about 73 percent of its revenue from its BRACAnalysis test, and its stock fell 5.63 percent on news of the court's ruling.

Thomas emphasized that synthetic or human-altered DNA - sometimes referred to as complementary DNA and abbreviated as cDNA - is patentable if it meets other appropriate criteria. He also said the opinion should not be used to officiate the many disputes about the validity of patents based on methods of producing something.

"We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual-property protection for our BRACAnalysis test moving forward," Myriad chief executive officer Peter D. Meldrum said in a statement.

Myriad was supported by lobbying groups for dozens of life-sciences companies, which hold thousands of patents, including some on genes. The Biotechnology Industry Organization was happy about complementary DNA remaining patent-eligible, but said the rest of the opinion was troubling.

The Patent Office reacted Thursday evening by giving its examiners new but preliminary guidance on the narrower scope of what is now eligible for a patent.

Thomas cited a cease-and-desist letter that Myriad sent to Arupa Ganguly, director of the University of Pennsylvania's Genetic Diagnostic Laboratory. The lab was developing a different test for diagnosing breast and ovarian cancer. Ganguly was among the original plaintiffs pulled together by the American Civil Liberties Union to file suit in federal court in New York City.

"I am ecstatic," Ganguly said. "It is a victory not only for women who live in fear of getting breast cancer, but for the entire community who want to know if they, or their children, are at risk of genetic diseases - especially rare diseases. It is also a victory for the scientific community, where researchers can now pursue genetic analyses and freely communicate the results back to the patients without fear of a lawsuit."


Contact David Sell at 215-854-4506 or dsell@phillynews.com, or follow on Twitter @phillypharma. Read his blog at www.inquirer.com/ phillypharma.

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