Locking the genome: U.S. Supreme Court weighs whether a private company can patent human DNA material


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You own your DNA.

But who owns your genes? Or, more accurately, who owns the patent rights to certain genes and DNA fragments, strands of natural genetic code that are valuable because of their utility in disease testing and other forms of medical research?

Last month, the American Civil Liberties Union and a host of co-plaintiffs appeared for oral argument before the U.S. Supreme Court in a suit challenging a Salt Lake City genetics company that owns patents on two human genes.

The question before the justices, in Association for Molecular Pathology v. Myriad Genetics, is whether naturally occurring genes are patentable, and, specifically whether Myriad should be allowed to maintain its patents on isolated, though unaltered, fragments of human DNA.

The court is expected to rule in June, and the reverberations of its finding might be felt broadly. Twenty percent of all human genes, a startling 24,000 molecular sequences, are protected under U.S. patents, according to a 2005 study published in Science magazine. Many of these patents were issued during the biotech boom of the 1980s and 1990s.

The plaintiffs contend the gene patents are unconstitutional, because a product of nature cannot be patented.

Among those filing amicus briefs with the court was the American Medical Association, which argued: "Patents on human genes impede the provision of health care, thwart public health objectives, shackle innovation and violate ethical tenets."

Gene patent holders, the association continued, have prevented physicians and laboratories from offering genetic testing for medical conditions including breast cancer, hearing loss, Alzheimer's, leukemia and neurodegenerative disorders.

"The care available to patients should not be restricted because the naturally occurring building blocks of human biology have been inappropriately patented. Opportunities for scientific research and medical care based on human genes must remain available to all and exclusive to none," said Jeremy Lazarus, president of the American Medical Association, in a statement prior to oral argument.

The diagnostic tests cost upwards of $3,000, which the plaintiffs said prohibits many women from taking the test, from discovering they are at risk and even from preventing their own demise.

People who view the human genome as "our common heritage" tend to see these patents as unethical, wrote Robert Cook-Deegan, a professor of genome ethics, law and policy at the Institute for Genome Sciences and Policy at Duke University, in a recent article for the Hastings Center, a nonpartisan bioethics research institution. Dr. Cook-Deegan wrote that patenting DNA segments could become problematic if it make the cost of genetic tests and therapies prohibitive.

Another concern is that patents could inhibit biomedical innovation, he wrote.

The patented genes under consideration in the Supreme Court case are associated with breast and ovarian cancer. Using a patient's blood sample, scientists can extract these two genes, known as BRCA1 (frequently pronounced "braca one") and BRCA2 ("braca two"), isolating them from their cellular structure.

They then can run diagnostics on these DNA fragments to test for the presence of particular mutations, which would indicate that an individual has a significantly higher risk of contracting breast and ovarian cancer.

The process used to extract the genes -- sequences of nucleotides -- is not proprietary. It is used nationwide. But once BRCA1 and BRCA2 genes have been isolated in any U.S. laboratory, Myriad owns them.

Myriad also has exclusive ownership of the gene mutations and of the diagnostic tests used to screen for mutations. The company has sent "cease and desist" letters to other labs that had tested the BRCA genes for deleterious mutations. Myriad claims the pursuit of such patents is a funding incentive and clears the way for innovations in science.

During oral argument on April 15, Chief Justice John Roberts suggested to Myriad attorney Gregory A. Castanias that all his client had done was take a sequence of naturally occurring molecules and snipped them off at the top and bottom.

Mr. Castanias responded by equating Myriad's proprietary innovation to the creation of a wooden baseball bat: "A baseball bat does not exist until it is 'isolated' from the tree. And it takes human ingenuity and intervention to decide where to start and stop cutting the tree to form the bat."

He went on to say, "There was invention in the decision of where to begin the gene and where to end the gene. That was not given by nature."

Christopher A. Hansen, an attorney for the plaintiffs, posed to the court that: "One way to address the question presented by this case is what exactly did Myriad invent? And the answer is nothing ... the genes themselves, [where] they start and stop, what they do, what they are made of, and what happens when they go wrong are all decisions that were made by nature, not by Myriad."

One woman who spoke at an ACLU teleconference prior to oral argument said she believed that Myriad's exclusive patent on BRCA testing could cost her life.

The woman, Kathleen Maxian, explained that when her younger sister was diagnosed with breast cancer at 40, her extended family was devastated. Sisters and cousins began fleshing out medical histories to determine how prevalent breast cancer was in their family tree.

Meanwhile, Ms. Maxian's sister, Eileen Kelly, underwent genetic testing to see if she carried a rare mutation which would indicate that the breast cancer was hereditary and also that she was also at risk of contracting ovarian cancer.

One in 9 women will develop breast cancer in their lifetime. But only a tiny percentage of breast cancer is hereditary, meaning it is caused by an inherited gene mutation that renders a female up to 85 percent more susceptible to breast or 40 percent susceptible to ovarian cancer in her lifetime.

The Myriad test, Ms. Maxian and Ms. Kelly believed, would determine if grandmothers, mothers, aunts, sisters, cousins and daughters were also at high risk. When Ms. Kelly's results came back negative, her older sister said, "We breathed a collective sigh of relief." That relief, as Ms. Maxian tells it, was short lived.

Two years later, at 47, Kathleen Maxian was diagnosed with advanced stage ovarian cancer and was told by doctors she had a 20 percent chance of surviving five years. After surgery to remove the cancer, which had spread to her abdomen, Ms. Maxian's gynecological oncologist said, "Your mother mentioned your sister had breast cancer." Ms. Maxian said, yes, but her sister had been tested and her cancer was not hereditary.

Apparently Eileen Kelly had not been given the full battery of tests, according to court records. When Ms. Kelly went back to her genetic counselor with the new information that her older sister had ovarian cancer, they ran a second test, BARD, which existed at the time of Ms. Kelly's original testing but was made unavailable because of Myriad's patent.

Supreme Court observer Lyle Denniston, on his well-read SCOTUS blog, explained why this is a thorny legal issue:

"No one on the court was in doubt that Myriad would have been entitled to a patent if it found some unique way to make use of the genes it has isolated, but the justices drew a sharp distinction between creative applications and the core natural item, the gene itself. But [the] Myriad case in some ways involves a patent that sort of straddles the two," he wrote.

legalnews

Gabrielle Banks: pggbanks@gmail.com.


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