ASCP and CAP Joins ACLU Lawsuit Opposing Gene Patents
The American Society for Clinical Pathology (ASCP) and the College of American Pathologists (CAP) have joined the American Civil Liberties Union and at least 18 other plaintiffs 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 May 12 against the U.S. Patent and Trademark Office (PTO), Myriad Genetics, and Directors of the University of Utah Research Foundation in U.S. District Court in the Southern District of New York.
“ASCP joined this lawsuit because a fundamental tenet of ASCP is that patients come first,” says 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 asserts that gene patents limit the availability of diagnostic tests since laboratory scientists are prohibited from performing genetic tests because of patent enforcement and the threat of litigation. Also, the market is dominated by a single provider, eliminating competition and scientific diversity and driving up costs, the group says. ASCP adds further that gene patents potentially infringe on patients’ rights by denying them access to their own genetic information as well as stifling innovation and refinement in test methodologies and quality and hindering access for the uninsured and those whose health care coverage requires reimbursement by a third-party payer.
According to CAP, patients are adversely affected because Myriad restricts most laboratories from providing full gene testing, forcing patients and their physicians to rely solely on Myriad to provide the test.
“As medical specialists in the diagnosis of disease, pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve,” says CAP spokesperson, Jeffrey A., Kant, MD, PhD, immediate past chair of CAP/ACMG Biochemical and Molecular Genetics Resource Committee and professor of pathology and human genetics at the University of Pittsburgh Medical Center.
“When patents are granted, a single lab only is authorized to do the test unless the test is licensed to other labs,” Kant adds. “In these cases, high licensing fees can be so prohibitive they prevent physicians and other laboratories from providing diagnostic services or developing improved tests.”
Myriad Genetics General Counsel Richard Marsh says company officials were surprised to be served with the lawsuit yesterday. “And I think it’s fair to say that the industry [was surprised] in light of the fact that, since 1980, the patent office has issued tens of thousands of gene and gene-based patents, “ attorney Marsh says. “But there’s been a lot of discussion with respect to the policy issue of patenting genes. There’s been bills introduced by the Congress. Congress has discussed [them], which is an appropriate forum to be discussing these policy-type issues. To our knowledge, this is the first time a suit of this nature has been brought. “
Though he was just having a chance to review the complaint and specific claims,” attorney Marsh made this statement: “This case is obviously about the policy of patenting genes or granting gene-based patents. That’s really the core issue of the case. As I mentioned before, we think this policy decision has already been decided by Congress and decided by the PTO, and if there’s a change in that, that’s Congress’s prerogative to make that. But at this point, without having had a chance to digest the complaint, it’s premature for Myriad to make any specific comments on the individual allegations of the complaint.”
The lawsuit states that 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 initially obtaining information about their health risks from anyone other than the patent holder 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 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,” says 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.”