Patent eligibility increases health care costs

If PERA were enacted, it would create a patent environment similar to the time before the Myriad and Mayo decisions and as such, biomarkers (including human genes) and their association with health status would once again be patent eligible. The answer to your question is not hypothetical in that we have a real world test case of what this would mean for consumers and patients, as we saw the consequences pre-2013 and the benefits since then. Specifically, prior to 2013, patient access to genetic testing was greatly limited due to testing monopolies stemming from patents on human genes. I refer you back to my written testimony beginning on page 6 in which I describe at length multiple examples of these consequences for patients.

To summarize my written testimony, consumers and the broader healthcare system should expect dramatic increases in the cost of testing and concomitant reduced access due to reduced competition. PERA would return us to a pre-Myriad environment with genetic testing monopolists charging high prices for partial results and no provider able to offer comprehensive testing as is offered by multiple genomic testing companies today. These consequences will be particularly felt by lower income patients if they live in states with Medicaid programs that do not cover the only test available due to a monopoly. Further, patients will not have access to tests reflecting the latest scientific advances because just as was the case during the pre-Myriad period, providers having a patent on a specific necessary test will lack an adequate business incentive for them to update their tests. Most concerning of all, patients in the United States may find themselves with no access at all to critical, lifesaving genetic information if a patent holder opts not to commercialize a test nor license it, which was the case of long QT syndrome pre-2013.

For example, if PERA were enacted, a clinician seeking to understand a patient’s hereditary cancer risk may need to order genetic tests from multiple laboratories depending on the patent holder of each gene in order to obtain a complete and comprehensive evaluation of genetic risk for each of their patients. This would not only potentially increase the financial costs to patients and payers including Medicare, but also increase the administrative burden on clinicians, delay clinical care as patients wait for multiple test results, contribute to poor patient outcomes, and create unnecessary liability and malpractice risk for clinicians if they fail to order or review all necessary tests. Clearly, if PERA is enacted into law, the broader healthcare system should expect increasingly impaired access to genetic testing, higher costs, and poorer quality of healthcare.

PERA would also shut down variant sharing data, pivotal to advancing our understanding and interpretation of genomic testing results. After the hearing, I submitted additional written testimony for the record that specifically focused on the federal investment in genomic data sharing, its importance and what the elimination of this would mean for patients. PERA would disincentivize such data sharing which has been a key driver in rapid advancement and broadening of the benefits of genetic testing post-Myriad.