Can Human Genes Be Patented?
2013-04-15 0:00

By Nina Totenberg | NPR

Same-sex marriage got huge headlines at the Supreme Court last month, but in the world of science and medicine, the case being argued on Monday is far more important. The lawsuit deals with a truly 21st century issue — whether human genes may be patented.

Myriad Genetics, a Utah biotechnology company, discovered and isolated two genes — BRCA 1 and BRCA 2 — that are highly associated with hereditary breast and ovarian cancer. Myriad patented its discovery, giving it a 20-year monopoly over use of the genes for research, diagnostics and treatment. A group of researchers, medical groups and patients sued, challenging the patent as invalid.

There is no way to overstate the importance of this case to the future of science and medicine. In the view of Myriad and its supporters in the biotech and pharmaceutical industries, patents are the keys to making these medical discoveries possible. Their opponents, including leading medical groups and Nobel Prize-winning scientists, contend that Myriad’s patent improperly puts a lock on research and medical diagnostic testing.

The U.S. patent system, authorized in the Constitution, gives temporary economic incentives to inventors to advance science. The general rules of the patent system have been established in statutes and Supreme Court case law for over 150 years. You can’t patent a product of nature or a law of nature. It doesn’t matter that the task was difficult or costly. Nature is immune to patents. So, even though it may have taken Einstein a long time to figure out that E=mc2, he couldn’t have patented that law of nature.

’Could You Patent The Sun?’

Until relatively recently, much of the medical profession disdained patents, except as a means to ensure quality. When Dr. Jonas Salk, the inventor of the revolutionary polio vaccine, was asked in 1955 whether he had a patent on the vaccine, he replied, "There is no patent ... could you patent the sun?"

Myriad Genetics, however, contends that the genes it isolated are not like the sun. Mark Capone, president of Myriad Genetics Laboratories, notes that the 20,000 genes in the human body are part of a 6-foot-long molecule that’s "coiled and compacted and stuffed into each cell." And, he says, "What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer."

The gene is like "a single grain of sand" hidden in a building the size of the Empire State Building, says Gregory Castanias, Myriad’s lawyer. He will tell the justices that isolating the two genes justifies a patent because "it is the final step in an extraordinarily complicated set of inventive actions that led to the creation of this molecule, which had never been available to the world before."

Not so, say those challenging the patent. Human genes are products of nature. They are an essential part of the human body. "All Myriad does is take a part of the body out of the body," says the challengers’ lawyer, Christopher Hansen of the . "It is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn’t entitle you to a patent on kidneys."


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