The overwhelming majority of genetic testing occurs in the United States – the industry is competitive now

3. Some critics of PERA claim that restoring patent eligibility to gene-based technologies and diagnostics will impede scientific research, innovation, and access to diagnostics. But Europe has and continues to allow patents on all of these things, without any of these negative impacts. In fact, academic research in these areas thrives in Europe, and the diagnostics industry there now outcompetes the U.S. If eligibility for these technologies hasn’t led to any negative outcomes in Europe, why do you think it would lead to these outcomes here under PERA?

Invitae questions the assertion that Europe outcompetes the U.S. in clinical genetic diagnostics industry. For example, Invitae suggests that the subcommittee consider the data available in the NIH’s Genetic Testing Registry1, which is a global repository for the listing of genetic tests by providers from around the world. An analysis of the availability of genetic tests listed in the Genetic Testing Registry for the period from 2012 to 2022 showed that fully 49% of all of the listed clinical genetic tests in the world were associated with U.S. laboratories.2 Since the U.S. is less than 5% of the world population and accounts for about 15% of global GDP, this represents a disproportionate share of the global clinical genetic testing availability and counters the suggestion that Europe is outcompeting the U.S. Notably, the period under study matches very closely the post-Myriad.

In my supplemental written testimony, I described the NIH’s ClinVar database which is the world’s leading, authoritative database for clinically interpreted variants (aka genetic biomarkers). Invitae alone has contributed about 40% of the determinations of clinical relevance of variants in the database and U.S. sources collectively comprise well over half of all such contributors. The U.S. continues to lead the world in the clinical genetic testing space and PERA would imperil that reality.

As I stated in my written and oral testimony, I believe that PERA would lead to negative outcomes in the United States, because we witnessed the consequences of such an approach to the law related to genetic testing in the pre-Myriad period and then the benefits of the current caselaw since then. Even the CEO of Myriad Genetics said the Supreme Court got it right on the 10th anniversary of the decision. 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.