(CN) – In a federal lawsuit that could affect research and funding of genetic medicine, cancer victims say the U.S. Patent and Trademark Office should not have allowed Myriad Genetics to patent the human genes BRCA1 and BRCA2. Clinics and medical organizations joined in the suit filed by American Civil Liberties Union, saying an effective monopoly has been granted to Myriad denying women the ability to get second opinions on potentially fatal diseases.
Plaintiffs include the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Psychology, the College of American Pathologists, Breast Cancer Action, Boston Women’s Health Book Collective, and 14 individuals.
Among the plaintiffs is a 43-year-old woman who was diagnosed with cancer in both breasts. She says Myriad would not process her test because her insurance company would not cover it.
Another plaintiff, a 39-year-old woman with breast cancer, says she could not get a second opinion because “Myriad is the only laboratory in the country that can provide full sequencing.”
A third plaintiff, 32, says she was diagnosed with “aggressive breast cancer” but had to wait two years for testing, because her insurance company did not cover the test.
“(G)enes determine, in part, the structure and function of every human body,” the complaint states. “This case challenges the legality and constitutionality of granting patents over the most basic elements of every person’s individuality.
“The gene parents that are challenged in this case are patents covering the BRCA1 and BRCA2 genes, which relate to an increased risk of breast and/or ovarian cancer. Ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical laboratory tests that benefit patients in the emerging era of personalized and predictive medicine. The patents make ease of access more restricted. Because of the patents, Myriad has the right to prevent clinicians from independently looking at or interpreting a person’s BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer.
“Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder.
“Women are thereby prevented from obtaining information about their health risks from anyone other than the patent holder, whether as an initial matter or to choose a second opinion. The patents also prevent doctors or laboratories from independently offering testing to their patients, externally validating the test, or working cooperatively to improve testing. Many women at risk cannot even be tested because they are uninsured and/or cannot afford the test offered by Myriad.”
Patenting of human genes has been a controversial process since it became possible. Defenders of the process – including the defendant Patent Office – say it’s the only way to assure funding for medical research, as private companies would not undertake the expensive research without a chance of profits on the far end.
Critics say that modern gene sequencing machines and other advances, plus a loose patent office, make it possible for big pharmaceutical companies to patent thousands of genes without knowing what they do, thereby obstructing research by others, who could be sued for doing worthy research.
The Patent Office itself has been criticized as being far too ready to grant patents, including famous patents for things such as a crustless peanut butter and jelly sandwich and a “method of swinging on a swing.”
One problem, critics say, is that the Patent Office is underfunded, patent examiners are overworked, and examiners’ paychecks are tied to the number of patents they approve, creating incentive and pressure for sloppy work. This is the argument Adam Jaffe and Josh Lerner make in their book, “Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress, and What to Do About It.”
Patents can be granted for inventions that must be novel, nonobvious and useful. Critics of the system point out that human genes are not novel, and patentees who submit patents for genes en masse often do not know what uses they may have – but the Patent Office grants patents anyway.
This lawsuit challenges the very nature of the patent process in genetics: “The patents cover the human genes themselves. In this respect, the cover the healthy gene and numerous variations of the gene, some of which Myriad identified, some of which it did not, and some of which have not yet been identified. Some of those variations correlate with an increased risk of breast and ovarian cancer. Some do not. The patents also cover any new methods of looking at the human genes that might be developed by others, the concept of comparing one BRCA1 or BRCA2 gene to another BRCA1 or BRCA2 gene for the purpose of discerning differences and the correlations found in nature between mutations in the human gene and an increased risk of breast or ovarian cancer.
“The patenting of human genes, the concept of looking at or comparing human genes, and correlations found in nature between certain genes and an increased risk of breast cancer and/or ovarian cancer violates long established legal principles that prohibit the patenting of laws of nature, products of nature, and abstract ideas. These patents also violate the First Amendment and Article I, section 8, clause 8 of the United States Constitution.”
Plaintiffs want sections of seven patents declared invalid and unenforceable. They are represented by Christopher Hansen with the ACLU.