Access for Patients and Researchers
Since the test was developed, Myriad’s Marsh said, some 40,000 healthcare providers have ordered BRCA testing accessible to 95% of patients via private and public insurance. Marsh added that the firm performed free tests for “over 4,000 low income and underinsured patients.”
Several speakers said they were not aware of this program, including Kimberly Irish, program manager with patient advocacy group Breast Cancer Action, a plaintiff against Myriad in the AMP v. USPTO case. Irish testified that Myriad’s BRACAnalysis test costs about $3,500, with the supplemental BRACAnalysis Large Rearrangement Test in High Risk Patients test (BART) costing an additional $700. Not all insurers cover the cost of the main or supplemental tests, she noted, and an estimated 17 million women ages 18–64 lack health insurance.
“For some high-risk women, in particular women of Latin American and Hispanic ancestry, about 10% of the mutations (called large rearrangements) are missed by the standard BRACAnalysis test,” said Irish, adding that as many as 10% of people tested had an indeterminate test result, a disproportionate number of whom were women of color.
“What are women supposed to do when the results are unclear? Should they have prophylactic surgeries? Will their insurance cover increased screenings?” Irish asked, adding, “Limits that inhibit other labs from doing tests and research that could save the lives of our mothers, sisters, friends, daughters, wives, and partners are simply not acceptable.”
Bernard Greenspan, director, intellectual property for Prometheus Laboratories, said it would be hard for labs to conduct confirming tests without infringing on the patents of primary test developers. Current patent law, he noted, places the burden of stopping infringement squarely on the shoulders of the patent holder. Monitoring and distinguishing both noninfringing and infringing actions “will only add costs and redirect resources from new developments.”
“The chilling effect on research and development of new and innovative tests created by a carve-out to a nonlicensed party to avoid infringement will be far-reaching,” Greenspan said. “Established companies, university technology transfer offices, and job creation by startup ventures will be faced with the proposition that they will lose proprietary benefits of patents. Any steps taken to weaken those rights, while having a presupposed short-term gain in access to current technology, will result in long-term reduction of investments needed to commercialize future innovations thus creating a decrease in access to future technologies.”
Prometheus has spent the past nearly eight years defending two diagnostic method patents it owns against Mayo Collaborative Services (doing business as Mayo Medical Laboratories) and Mayo Clinic Rochester. In 2010, the Court of Appeals for the Federal Circuit decided Prometheus Laboratories, Inc. v. Mayo Collaborative Services et. al, by upholding the patents, which cover the methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases.
Mayo contended that Prometheus’ patents are invalid and unenforceable because the claims were based on subject matter that is unpatentable as they impermissibly claimed natural phenomena—the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity—and that the claims wholly preempt use of the natural phenomena. The Federal Circuit ruled that Prometheus’ patent claims recited specific treatment steps, not just correlations themselves, and involved a specific application of natural correlationism—namely the treatment of a specific disease by administering specific drugs and measuring specific metabolites.