Supreme Court rules that genes cannot be patented

Cost of cancer test may fall as a result

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In a unanimous decision, the U.S. Supreme Court on Thursday struck down a Utah company's patent on a naturally occurring human gene that can signal whether a woman has an elevated risk of contracting breast or ovarian cancer.

The opinion for the court, written by Justice Clarence Thomas, calls into question patents on thousands of human genes: In all, applicants have sought patents for ownership of one-quarter of all human DNA.

"The court's decision today represents a fairly straightforward application of their 'product of nature' doctrine," said Sandra Park, a senior attorney with the ACLU Women's Rights Project and co-counsel for the plaintiffs in Association for Molecular Pathology v. Myriad Genetics Inc. The court has held, under this doctrine, that a product of nature cannot be patented.

The ruling means patients will have wider access to diagnostic testing at a lower cost, said Harry Osterer, a plaintiff on the case and a professor of pediatrics, pathology and genetics at the Albert Einstein College of Medicine of Yeshiva University.

"I think that we will see a much more even playing field with regard to genetic testing. It will drive down costs and improve quality and will help as a society to feel more of the impact of the genomics revolution."

Richard Marsh, general counsel for Myriad Genetics, the Salt Lake City molecular testing company that has owned patents on BRCA 1 and BRCA 2 genes since 1995, said, "Obviously, we are disappointed with the outcome" regarding isolated DNA. However, he added, since the Supreme Court upheld the company's patents on complementary DNA, or cDNA, "we don't believe the outcome in this case with have a negative impact on the company's operations. We believe we will continue to have a strong intellectual property position with respect to our BRAC Analysis testing."

Myriad Genetics stock dropped 5.6 percent Thursday on the NASDAQ. The cDNA is primarily used in pharmaceuticals and agriculture. It is DNA that is introduced into other cells to create new genetically engineered products, including genetically modified foods or lab-engineered drugs, such as insulin and growth hormone.

The ruling applies to women like actress Angelina Jolie, who recently went public with her family history of hereditary cancer, women who may be able to put a positive test result to use because they would qualify for more frequent mammograms or prophylactic, or preventative, mastectomies and salpingo oophorectomies, surgical removal of the ovaries and fallopian tubes.

The court's ruling will have an immediate impact for women like Bryna Siegel Finer of Squirrel Hill, for whom seven of nine family members who sought BRCA 2 testing found they were positive for the deleterious gene mutation predisposing them to breast and ovarian cancer. Because of her family's Ashkenazi Jewish ancestry, they had a greater likelihood of having this particular gene mutation.

Ms. Siegel Finer's father had the mutation, his sisters had breast and ovarian cancer, and his brother had pancreatic cancer -- which is also related to the BRCA 2 gene. Her father also had a cousin who had breast cancer. Ms. Siegel Finer's cousin was diagnosed with breast cancer at 29. And Ms. Siegel Finer discovered she had early stage breast cancer in January, when she was getting evaluated for prophylactic mastectomies. She had the mastectomies and a preventative hysterectomy, which included removal of her ovaries.

Ms. Siegel Finer, 36, sought testing seven years ago when she was a graduate student. Her cousin had found a Jewish organization in New York that subsidized the cost of Myriad's BRCA test, which typically is about $4,000. But as a grad student in English, Ms. Siegel Finer couldn't come up with the remaining $400 after the subsidy.

"I was fortunate my parents had $400 to give me. If I hadn't gotten tested, I would have breast cancer growing inside of me right this minute, and I wouldn't have been eligible to be getting mammograms at 35, which is when I found out I had tumors all over the place," said Ms. Siegel Finer, now an assistant professor of English at Indiana University of Pennsylvania. Many insurance companies do not cover mammograms until a patient is 40. Women like Ms. Siegel Finer may now be able to afford testing and even pay for a second opinion.

Although the gene mutation is rare, the Supreme Court ruling will have a ripple effect. There are 134 women on the email list for the Pittsburgh chapter of FORCE, a national organization that provides information and resources for individuals and families affected by hereditary breast and ovarian cancer, which filed an amicus brief in support of the plaintiffs.

Unlike Ms. Siegel Finer, Robin Karlin, co-director of the FORCE chapter, did not know of any family history of breast or ovarian cancer but found out when her 22-year-old son had genetic testing done and found out he was positive for the BRCA 1 mutation. Ms. Karlin, who subsequently tested positive for the same mutation, dug through her family history and found at least one relative who had died of ovarian cancer. She went on to get prophylactic mastectomies and a salpingo oophorectomy.

Myriad's attorney, Gregory A. Castanias, argued in April that the isolated DNA should be eligible for patents, 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, said in oral argument, "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."

The implications of the ruling may extend to many other gene patents, including the genes that track for the likelihood of spinal muscular atrophy and heritable arrhythmia.

Spinal muscular atrophy is a fatal disease in infants that can be tested for in utero, but, prior to Thursday's ruling, only by the company that owns that patent. Genetics labs that don't hold the patent may not test for the gene that carries information about heritable arrhythmia, which causes sudden cardiac death. The American College of Medical Genetics told its members a few weeks ago that when they sequence someone's genome, "They should absolutely tell them about their risk of sudden cardiac death," said Dr. Osterer, the plaintiff who is a professor at Albert Einstein. "And yet if we did that, we would [have been] infringing on the various patents for these genes."

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