Supreme Court case asks: Are human genes patentable?

As legal questions go, it is very succinct: Can human genes be patented?

To the uninitiated, and at least two judges, it might seem obvious - or absurd.

How can you get a patent for human genes? Aren't genes part of the human body, part of nature? Can you get a patent for a human leg or kidney, or the sun or the moon?

The U.S. Supreme Court will wrestle with the question of whether human genes are patentable during oral arguments Monday in a case that could have huge implications for people needing cancer testing, scientific researchers, and pharmaceutical organizations, but also agricultural producers, other industries, and, perhaps, individual liberty.

A key precedent in this case was a 1980 Supreme Court decision that dealt with how bacteria are modified so they will soak up oil spills.

The current case is officially called Association for Molecular Pathology v. Myriad Genetics Inc., but the lineup of litigants has changed since the suit was first filed in federal court in New York in 2009. Two University of Pennsylvania researchers and a Williamsport woman with a family history of breast cancer were among the large group of original plaintiffs, though Myriad succeeded in paring the field of opponents.

The court will likely issue a decision before its term ends in June.

Utah-based Myriad Genetics developed a process for separating pieces of genes and their mutations that were already known to be important in diagnosing breast cancer and ovarian cancer, but could indicate 19 other types of cancer. In 1997 and 1998, the U.S. Patent Office approved patents not just on the process - which might alone prompt some dispute - but on the whole genes, which are called BRCA1 and BRCA2.

Drug companies and some patent lawyers are among Myriad's supporters, but so are trade groups for seed companies, including Monsanto and DuPont Pioneer. Those companies are worried that a decision against Myriad might set a legal precedent and allow challenges to their existing patents involving parts of nature.

Research groups, patient advocates, and the American Medical Association, among others, argue that Myriad's assertion of patent rights to the genes stifles future research and the use of existing, lower-cost diagnostic tools because they involve those genes.

Armed with the patent-induced market exclusivity, Myriad charges about $3,000 for a test for which other labs previously charged $200 or less. Jeffrey Rosenfeld, a Penn graduate and an assistant professor of medicine at the University of Medicine and Dentistry of New Jersey, cowrote a paper in the journal  Genome Medicine that suggested "genetic liberty" is in peril.

"Getting an independent second opinion, which is normal, is impossible because Myriad says it's the only test you can use," Rosenfeld said. "There has to be some level of patenting, but this is wrong. They say that the minute they take it out of your body, they own it."

Myriad says that separating pieces of genes requires skilled human intervention and creates a new entity, worthy of a patent, and that 30 years of patent protocol should not be changed.

"Countless companies and investors have risked billions of dollars to research and develop advances under this promise of stable patent protection," Myriad said in its court brief.

Besides research organizations, the American Civil Liberties Union gathered women with breast or ovarian cancer (or those with family histories of either) to file the suit in 2009.

Patenting genes "doesn't make sense," Kathleen Raker said. A Williamsport resident and original plaintiff, Raker's mother and grandmother died of breast cancer.

Penn genetics researcher Arupa Ganguly, an original plaintiff, stopped research and testing an alternative cancer-detection process after receiving Myriad's cease-and-desist letters.

"I have lost so much time since we received the cease-and-desist letter - I don't think I can ever catch up," she wrote via e-mail. "My hope is that going forward no other scientists will ever have to put up with a letter like this."

A District Court judge ruled against Myriad in 2010. The U.S. Court of Appeals for the Federal Circuit, which handles most patent cases, overturned the decision. The Supreme Court vacated that decision only to have the appeals court repeat its earlier decision, by a 2-1 vote. The plaintiffs appealed again to the Supreme Court, hoping the high court will agree with the dissenting appeals court judge, William Bryson, who equated separated pieces of gene with a kidney removed from a living person.

"In its simplest form, the question in this case is whether an individual can obtain patent rights to a human gene," Bryson wrote in his dissent. "From a common-sense point of view, most observers would answer, 'Of course not. Patents are for inventions. A human gene is not an invention.' "