The American Society for Clinical Pathology (ASCP) has joined the American Civil Liberties Union (ACLU) in a lawsuit challenging the legality of patents on human genes—specifically, patents covering the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer.
The lawsuit was filed against the U.S. Patent and Trademark Office, Myriad Genetics, and Directors of the University of Utah Research Foundation in U.S. District Court in the Southern District of New York on May 12.
“ASCP joined this lawsuit because a fundamental tenet of ASCP is that patients come first,” said ASCP President Barbara J. McKenna, MD, FASCP. “Gene patents violate this principle by creating unjustifiable monopolies on human genetic information that is critical in the diagnosis of many diseases.”
ASCP further asserts that gene patents limit the broad availability of diagnostic tests due to the simple fact that laboratory scientists are prohibited from performing genetic tests because of patent enforcement and the threat of litigation.
As a result, the market is dominated by a single provider, eliminating competition and scientific diversity, which ultimately drives up costs. Gene patents potentially infringe on patients’ rights, denying them access to their own genetic information. Such patents stifle the innovative process, negating further refinement in test methodology, improvements in quality, and access to testing for the uninsured as well as those whose health care coverage requires that testing be reimbursed by a third-party payer.
“In short, the practice of gene patenting harms patients, impedes advances in medicine, and limits those in the practice of pathology and laboratory medicine from doing what they are educated to do—provide high quality health care and engage in research that will enhance the practice of medicine and patient care,” Dr. McKenna said.
The lawsuit states the patents restrict ease of access by giving Myriad 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.
Women who fear they may be at an increased risk of breast and/or ovarian cancer do not have the option to have 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 risksfrom anyone other than the patent holder, whether as an initial matter or to obtain 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.
“Genes are not inventions like new treatments, drugs, diagnostic tests or technology platforms,” said Dr. McKenna. “They are products of nature that exist in all our bodies. No one deserves exclusive patent rights when all they did was uncover something that nature created or that nature does. Einstein couldn’t get a patent on E=mc² even though he worked very hard to discover it.”
More information and the full complaint are available at www.aclu.org/brca and at www.ascp.org/aclu.
