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Attorney in Gene Patent Ruling Examines Far-Reaching Implications

Monday, September 9, 2013

The lead American Civil Liberties Union (ACLU) lawyer who successfully fought to ensure that human genes could not be patented will discuss the recent Supreme Court ruling and the far-reaching implications for pathology, laboratory medicine, and patient care at ASCP 2013 Chicago, Sept. 18–21.

“There will be a lot of fighting about the breadth of the Supreme Court decision, but there is no longer any doubt that patenting a gene found in nature is not possible in the United States.”
—Chris Hansen, J.D.

Chris Hansen, J.D., the architect of the landmark gene patent lawsuit against Myriad Genetics’ right to patent the BRCA1 and BRCA2 genes, will discuss the court ruling on Wednesday, Sept. 18, from 2 p.m. to 2:50 p.m. at the Hyatt Regency Chicago.

Mr. Hansen, who represented ASCP and 19 other plaintiffs in the lawsuit, challenging Myriad Genetics’ right to patent human genes, will participate in a session moderated by Lee Hilborne, MD, MPH, DLM(ASCP)CM FASCP, a former ASCP President. Myla Lai-Goldman, MD, FASCP, Chief Executive Officer and President of GeneCentric Diagnostics in Durham, N.C., will also serve on the panel.

“There will be a lot of fighting about the breadth of the Supreme Court decision, but there is no longer any doubt that patenting a gene found in nature is not possible in the United States,” says Mr. Hansen, who initially urged the ACLU to take up the case and developed the strategy for the arguments in the lawsuit.

On June 13, the U.S. Supreme Court ruled that patents on two genes associated with hereditary breast and ovarian cancer were invalid. The Court’s unanimous decision found that naturally occurring DNA is a product of nature and not patent eligible merely because it has been isolated. The Court also ruled that cDNA, which is synthetically-made DNA, is patent eligible because it is not naturally occurring. Some cDNA patents may not be patent eligible where the cDNA is indistinguishable from natural DNA. The Court expresses no opinion on whether cDNA is otherwise patentable.

Determining which genes are “natural” and whether cDNA is patentable likely will continue to be fought in the courts, according to Mr. Hansen.

At ASCP 2013 Chicago, Mr. Hansen will tell the dramatic history of the court battle: years of arguing the case at the district court level, reaching out to professional medical organizations such as ASCP, gathering a coalition of plaintiffs, and the ultimate challenge of bringing the case before the Supreme Court.

At its core, the ongoing case questioned Myriad Genetics’ right to patent BRCA1 and BRCA2, two genes that correlate to significantly increased rates of breast and ovarian cancer. The patents did for a time allow Myriad to be the exclusive U.S. commercial provider of screening assays for these genes and permit the company to determine the terms and price for testing, making it impossible for women to access alternative tests or obtain a second opinion about their results. The patents also gave Myriad the authority to prohibit researchers from investigating these genes without first gaining permission.

 “We expect that the precedent will open the doors for professionals who want to work with genes that up to this point have been patented,” said Dr. Lai-Goldman.The ruling allows scientists and others trying to market newer tests to provide individuals with knowledge about their personal risk for a variety of illnesses.”