In testimony to the USPTO on March 9, executives from Myriad Genetics and Prometheus Laboratories defended the current legal underpinning of diagnostics tests. They noted that patent protection was essential to recouping the millions of dollars they and other companies have spent to develop new technologies.
Richard Marsh, Myriad evp, general counsel, and secretary, noted that Myriad invested $500 million over 17 years before breaking even on research, development, and commercialization of its tests. “Myriad wouldn’t have been able to make this capital investment without the promise of exclusive patent rights. The risk and reward inherent in the ability to obtain exclusive license rights in the patent system is the driving force behind investment in genetic tests and hence their development and commercialization to the general public.”
Myriad is at the center of Association of Molecular Pathology (AMP) et al. v. US Patent and Trademark Office, a federal patent case the Supreme Court is considering hearing. The company seeks to protect seven patents related to BRCA1 and BRCA2 and its method for analyzing those genes for mutations associated with breast cancer. The U.S. District Court’s Southern District of New York sided with AMP, but the U.S. Court of Appeals for the Federal Circuit overturned most of that decision, finding Myriad’s gene claims patentable as well as its methods of screening for cancer compounds but not the company’s claims for the mutation analysis.
At the hearing hosted by USPTO there was support for Myriad’s view from three speakers, opposition from three others, and another speaker sought a middle ground. Intellectual property attorney Carlos M. Candeloro suggested: “Maybe a Magna Carta or a Bill of Rights for genetic testing consumers and a document put together by government and industry and everyone that will set guidelines.”
Critics of Myriad included Misha Angrist, assistant professor of the practice at Duke Institute for Genomic Sciences & Policy. He faulted Myriad for not making its mutation data open to independent verification and scientific scrutiny, citing its nonparticipation in the international collaborative mutaDATABASE and lack of contribution to the NIH-funded Breast Cancer Information Core since 2004.
“The implication is that if it were not for Myriad there would be no analytically valid, clinically valid, and useful BRCA testing for American women. This contention is simply, excuse my French, bullshit in Babylon,” Angrist testified.
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.
The USPTO hearing was the last of two required by the patent law overhaul enacted in September. The Leahy-Smith America Invents Act (AIA) requires a study of how to ensure availability of confirming genetic diagnostic tests where gene patents and exclusive licensing for such tests exist.
U.S. Rep. Debbie Wasserman Schultz (D-FL), who favors requiring licensing of patents for confirmatory genetic tests, authored the AIA section requiring the study, after trying but failing to amend the patent measure to create safe harbor protection for providers of confirming genetic diagnostic tests from liability for infringement. She withdrew her amendment after the American Civil Liberties Union and medical groups complained the amendment gave test providers too many exemptions.
Gerald J. Flattmann Jr., a partner in the Intellectual Property practice of Paul Hastings, told GEN that compulsory licensing of confirmatory genetic tests would serve as an end-run around the court-upheld practice of genetic patenting. “What’s being proposed by some elements here is, in essence, a compulsory license or worse to allow people free rein to violate the patents on these particular inventions,” Flattmann said, defining the worst case as a licensing without compensation to patent owners.
While acknowledging that compulsory licensing works well in some areas—allowing radio stations to play Bruce Springsteen, for instance—Flattmann said it would not work as well in patent-reliant industries like molecular diagnostics. “Often being forced to give away a compulsory license eviscerates the right because you can make much more money during the patent term on profits than you could ever make on any type of reasonable royalty.”
Assuming the Supreme Court hears an appeal in the AMP vs. USPTO case and assuming the patentability of genes survives high court scrutiny—both reasonable given the importance of the case and the court’s tilt toward business interests—it is unlikely that the federal government will force genetic test developers like Myriad to accept compulsory licensing, no matter how well-intentioned the reason.
All the more reason, then, for USPTO to expand access to genetic testing, especially to underserved patients, by allowing voluntary licenses that offer incentives attractive enough for industry, such as extended patent exclusivity periods or faster reviews of claims, as well as attractive enough to hospitals or universities.