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U.S.: ACLU Will Take Gene Patent Case to Supreme Court

WASHINGTON, Oct 14 2011 (IPS) - When Jaydee Hanson, then-bioethics director for the United Methodist Church, spoke out publicly against gene patents over 15 years ago, some in the biotech industry compared his stance to the Catholic Church’s persecution of Galileo, the 15th century astronomer who discovered the moons of Jupiter.

Hanson and 200 other religious leaders had released a statement that DNA in the human body and animals are natural objects and should not be subject to patenting.

Patent supporters in the biotech industry disagree, arguing that “isolated copies” of genes outside the human body should be patentable and that the prospect of intellectual property rights on genes serves as incentive for further research.

On Wednesday, the American Civil Liberties Union (ACLU) announced it would ask the Supreme Court to rule on a patent by Myriad Genetics, a genetic diagnostics company based in Salt Lake City, Utah, on “isolated” BRCA-1 and BRCA-2 genes, two genes that can have mutations linked to breast, ovarian and prostate cancers.

Those with a stake in the case say any ruling from the court would have a major impact on patient care, scientific research, and rights to access human genetic information, as well on legal doctrine.

Larger questions

Biotech industry stakeholders in the case argue "isolated" genes outside of the body are inherently different than those inside the body.

The Pharmaceutical Research and Manufacturers of America (PHRMA), an industry group based in Washington, wrote the following in a court brief it filed supporting the right of Myriad Genetics to its gene patents.

"The claimed inventions are not the 'handiwork of nature,' but are instead the product of human intervention and are, thus, patent eligible," PHRMA wrote in the brief, which it provided to IPS in August.

From nature's handiwork to the moons of Jupiter, metaphors of gene patenting reference powerful cultural symbols in an unfolding story about society and biology – and just who will have access to related knowledge in the future.

Back in 1995, it did not take Hanson long to find a metaphor in the Galileo anecdote that would illustrate his own view.

"What the patent office has been doing is granting Galileo patents on the moons of Jupiter," Hanson told IPS. "You might get the patent on the tools you used to find them, but you shouldn't get a patent on what you found."

The gene patenting case has been moving up through lower courts since 2009, when the ACLU first filed a civil suit in a district court in the state of New York arguing that Myriad’s patent on the genes should be invalidated.

District judge Robert Sweet agreed with the ACLU in 2010, but Myriad appealed, and the Federal Circuit Court of Appeals overturned Sweet’s ruling in July, with two out of three judges siding with Myriad, affirming the company’s right to patents on the two “isolated” BRCA genes linked to breast cancer.

Facing a mid-December deadline to appeal the lower court’s ruling to uphold gene patents, the ACLU decided to move forward with the appeal in time for National Breast Cancer Awareness Month in October, said Sandra Park, an ACLU attorney working on the case.

“We consulted with our clients and made the decision to move forward, given the importance of the issues to patients and scientists,” Park told IPS, adding that the Supreme Court would likely make a decision in the spring of 2012 about whether it will hear the case.

More than 4,000 genes have been patented, including copies of genes that make up 20 percent of the human genome, according to Hanson, who now works as a policy director for the International Centre for Technology Assessment (ICTA). In the past, Hanson and ICTA have successfully challenged patents on a beagle and other animals.

In September, Myriad sent the following comment to IPS: “Myriad defended its position in the courts and recently had a favourable outcome. We believe that isolated DNA and cDNA are patent-eligible material, as both are new chemical matter with important utilities which can only exist as a product of human ingenuity.”

With its patents, Myriad holds exclusive rights in the U.S. to test the BRCA-1 and BRCA-2 genes for mutations and provide that information to doctors and patients. Those mutations place women at a much greater risk of developing breast cancer and some men at greater risk of developing prostate cancer.

ACLU: Patents make tests cost-prohibitive and block research

The ACLU represents a group of 20 other plaintiffs, including geneticists, pathologists and breast cancer survivor advocates, who maintain that the patents block patient care.

They argue that patients shouldn’t have to pay for genetic information they could use to make life-or- death decisions, such as whether to get a mastectomy, especially when other genetic testing providers could offer that information if Myriad didn’t have exclusive rights to sequence the genes.

Five to 10 percent of breast cancer cases are linked to mutations on the BRCA-1 or BRCA-2 genes, and those with the mutations have an 85 percent risk of developing cancer. Some insurance policies cover the tests, but other plans, especially those providing insurance for the poor, don’t.

According to Park, Myriad chose not to enter into contracts with about half of all insurance programs in states that cover low-income people.

Ellen Matloff, a genetic counselor at Yale for over 15 years and a plaintiff in the ACLU case, said the cost of the test was a real issue for many of her patients.

According to her, “comprehensive” breast cancer test from Myriad for other breast cancer mutations costs 3,400 dollars and a supplementary test for the BRCA-1 and BRCA- 2 genes, called the BART test, costs 700 dollars. Matloff said that 95 percent of patients she recommends for supplementary testing don’t end up being tested because of its high cost.

“I know that we are missing mutations,” Matloff told IPS, adding that the BRCA gene mutations are passed down maternally and paternally. “It is going to impact them, their children, their siblings their grandchildren, their nieces and nephews, and from a clinician’s standpoint it is horrifying.”

Gene patenting opponents also argue that in a new era in which full- genome sequencing is getting faster and cheaper, patents stand in the way of access to new knowledge about how certain genes are related to disease.

“The whole next phase of [research in] genetics and disease is to understand how genes work together,” Hanson told IPS. “It is a huge task, and the patents just interfere with it.”

Matloff expressed a similar concern that advanced knowledge about genes without access to that knowledge could create problems for patients and care providers.

“It is almost like saying, ‘we have your genes right in front of us, it came out of your body, but we are not allowed to look at it, we’re not allowed to interpret it, and we are not allowed to give the information back to you,'” Matloff said.

“It’s kind of like saying two of your genes are in jail, but we are not allowed to report this information to you, even though it would save your life.”

*This is the first in a series of articles on gene patenting.

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