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ACLU patent case could have far-reaching consequences
NEW YORK—Should biotech companies like Salt Lake City, Utah-based Myriad Genetics be allowed to patent a pair of genes closely linked to breast and ovarian cancer? Myriad claims it "owns" the genes and argues that without the right to patent and profit, biotechnology as we know it would vanish.
But Christopher A. Hansen, an American Civil Liberties Union (ACLU) lawyer, argues, "Patenting a gene is unconstitutional."
This is the crux of what could become a national debate in 2010, with deep ramifications to the biotechnological, genetic, pharmaceutical, medical and healthcare industries far into the future.
In The Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., the plaintiffs challenged the right to patent genes in a lawsuit filed May 12, 2009. A hearing was held in the U.S. District Court for the Southern District of New York, with Judge Robert Sweet presiding. Sweet is expected to make a decision within 60 days. If the case goes to trial, the fate of Myriad and all companies holding gene patents would be in the hands of a jury.
The lawsuit was filed on behalf of breast cancer and women's health groups, individual women and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals, says Hansen, lead counsel.
The named defendants include Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes BRCA1 and BRCA2, which are associated with breast and ovarian cancer. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are "products of nature," and therefore, cannot be patented.
"Allowing patents on genetic material imposes real and severe limits on scientific research, learning and the free flow of information," Hansen says. "Patenting human genes is like patenting e=mc2, blood or air."
Mutations along the BRCA genes are responsible for most cases of hereditary breast and ovarian cancers, according to the lawsuit. Many women with a history of breast and ovarian cancer in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes before deciding on a treatment plan which includes undergoing preventive mastectomies or ovary removal.
The patents granted to Myriad provides the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes, Hansen says, and he argues that Myriad's "monopoly" on the genes makes it impossible for women to access alternate tests, or even get a second opinion about their results. Furthermore, one diagnostic test costs as much as $3,700—which is out of reach to women without the means to pay for it.
Myriad is hardly alone. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses, Hansen says.
Co-counsel Daniel B. Ravicher says, "Patents on human genes should never have been granted in the first place. Genes are identified, not invented."
The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes—in fact, about 20 percent of our genes are patented, Hansen says. A gene patent prevents anyone from studying, testing or even looking at a gene that limits scientific research and genetic testing.
Several major organizations, including the American Medical Association, the March of Dimes, the American Society for Human Genetics and Nobel Prize winners Joseph Stiglitz and Sir John Sulston, have filed friend-of-the-court briefs in support of the ACLU and the Public Patent Foundation's (PUBPAT) case.
"Without the patents, there wouldn't have been the financial incentive to create the tests," says Richard M. Marsh, Myriad executive vice president and general counsel.
Parties who have filed amicus briefs in support of Myriad include the Biotechnology Industry Organization (BIO); BayBio; Celera; Coalition for 21st Century Medicine; Genomic Health; the Genetic Alliance; Rosetta Genomics; and George Mason University.
"We believe we have a compelling argument that our isolated DNA claims are patent-eligible under the Patent Act, and our method claims are also patent-eligible based on the recent Federal Circuit Court decision in Mayo v. Prometheus," Marsh says. "This case has little to do with the cost of testing. While Myriad is currently profitable, we spent many years incurring substantial operating losses, and finally, in the twilight of our patent term, we are finally recouping our investment.
"However, this is exactly how the patent system works," Marsh adds. "It gives companies an incentive to spend vast capital dollars (which would not be done but for patent protection), to promote the underlying science and progress of the invention, and hopefully, by the end of the patent term, the patent holder has been able to obtain a return on its investment."
Once the patent expires, society then gets the collective benefit of all of the efforts to promote and increase general research, insurance coverage, patient and physician knowledge and understanding about predisposition testing for hereditary cancers, he says.
"One thing Myriad is proud of is the fact that due to our efforts, 90 percent of our testing is now covered by insurance, so the test has become accessible and affordable to patients," Marsh says. "For those without insurance and who cannot afford testing, Myriad has a financial assistance program providing free testing. "
The issue of gene patents took the national stage Feb. 4, when 26 organizations representing innovations in American life sciences sent a letter to Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, "to express grave concerns about certain recommendations in the Secretary's Advisory Committee on Genetics, Health and Society's (SACGHS) Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.
While the controversial report indicates that gene patents and licensing practices concerning such patents have not had an adverse impact on patient access to genetic tests, it nevertheless includes a controversial proposal to exempt gene patents from infringement liability.
"By undermining the value of gene-based patents, these recommendations would chill future investment and innovation in this area, and would unfairly upset the investment-backed expectations of current patent owners and licensees," the letter states.
At a press conference held in Washington, D.C., on Feb. 3, BIO President and CEO Jim Greenwood stood with former Sen. Birch Bayh, co-author of the Bayh-Dole Act; Dr. Brian Stanton, a member of the SACGHS Task Force; Dr. Jim Davis, executive vice president, general counsel an secretary of Human Genome Sciences Inc.; and Dr. Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University. Greenwood said the recommendation to exempt gene patents "would undermine the U.S. patent system, and the Bayh-Dole technology transfer system … would discourage investment in biotech innovation, hobble the transfer of federally-funded research, undermine university research programs and harm patients who are waiting for life-saving therapies and diagnostics yet to be developed."