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YU News

YU News

Should Genes Be Patented?

Seminar at Cardozo Tackles Thorny Issue of Patenting Breast Cancer Genes A federal lawsuit filed in May by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT), which is housed at Yeshiva University’s Benjamin N. Cardozo School of Law, could alter the current practice of gene patenting by corporations. Challengers to the status quo, along with one defender, participated in an Oct. 19 seminar at Cardozo titled “The Breast Cancer Genes, Patents, and Access.” The evening’s host was Daniel B. Ravicher, associate director of the law school’s Intellectual Property Program and executive director of its PUBPAT—and plaintiffs’ co-counsel in litigation against Myriad Genetics, Inc., and th US Patent & Trademark Office. Patents held by Myriad on genetic mutations commonly known as BRCA1 and BRCA2—which indicate high probabilities of cancers—give the Salt Lake City firm a monopoly on the diagnostic tests, resulting in exorbitant fees and, according to challengers, little incentive to license innovative research elsewhere. “Patenting human genes is counter to common sense, patent law and the Constitution,” said Ravicher, who bases his argument on the First Amendment guarantee of free-flowing information. He added, “Aggressive assertion of gene patents denies patients access to critical medical information and prevents scientists from furthering research into understanding and hopefully one day curing society's most devastating diseases.” Kevin E. Noonan, a Chicago-based molecular biologist and patent lawyer, disagreed with Ravicher and fellow panelists Dr. Adrienne Asch, the Edward and Robin Milstein Professor of Bioethics at YU and director of the Center for Ethics, and Anne-Marie Kunzler, a patient advocate and member of the National Breast Cancer Coalition. Noonan said short of waiting for a patent expiration date, the government could be persuaded to exercise “march-in rights” allowing broader research and testing. “Lawsuits are not the only way,” he said. “Politics is another way.” Kunzler, who lost her medical research job and employee health insurance decades ago after being diagnosed with breast cancer, asked Noonan, “We women, we should march on the White House?” “This is not a women’s issue,” insisted Asch. “Men get breast cancer. Men have connections to women with breast cancer.” Prior to the panel talk, Chicago filmmaker Joanna Rudnick screened a documentary about her own experience a few years ago when, at age 31, Myriad tests revealed that she had inherited a BRCA genetic mutation from her mother. The diagnosis means Rudnick has an 80 percent chance of developing breast cancer and a 50 percent chance of developing ovarian cancer in her lifetime, a risk that can only be reduced by removing her breasts and ovaries, which her doctors recommend she do immediately despite her desire to one day have children. In order to get a second opinion--something impossible to do in the United States due to Myriad's patent entrenched monopoly over the test--Rudnick traveled to Canada where a doctor she declined to name administered an abbreviated genetic test that confirmed the Myriad diagnosis. The fee in Canada was $25. In the documentary, Rudnick asked geneticist Mark Skolnick, founder of Myriad, “Why is the test still $3,000?” Skolnick replied, “That’s a good question.” Asch offered this response: “Private corporations should not own the difference between life and death.” Defendants in the ACLU/PUBPAT lawsuit have filed motions for dismissal. Ravicher said he expects a ruling on those motions by the end of October.