Court decisions are causing a rapid increase in diagnostics and precision medicine

Now that the Supreme Court decisions have helped to make a genetic diagnosis more affordable and accessible, we’ve also seen a corresponding boom in precision therapeutics with the availability of gene-linked therapies at an all-time high. They are bringing hope to patients battling diseases like cystic fibrosis, non-small cell lung cancer, and even hepatitis C. The number of both applications and approvals for orphan drugs with the Food and Drug Administration accelerated significantly after 201315 and in 2018 when drug approvals reached an all-time high, orphan drugs for rare, often genetic, disorders accounted for more than half of all approvals.16 The broad availability and low-cost of genetic sequencing is a core driver of this success because genetic screening is so often necessary to identify the patient population receptive to such drugs.

It is clear that after the Supreme Court decisions giving rise to the current patent eligibility jurisprudence, investment and innovation in diagnostics and precision medicine has increased dramatically. The benefit of these advancements lies not just in maintaining American leadership in the field, but also in the improved standard of care allowing many more patients to obtain an earlier diagnosis, prevent disease altogether, or receive a tailored more effective treatment. We hope that after reviewing the data presented that you will recognize that the current patent eligibility jurisprudence has greatly benefited and accelerated both clinical availability and continuing innovation in precision medicine which is rooted in an evolving understanding of the human genome and other biomarkers. And as such, that you will proceed cautiously with any legislative efforts to modify patent eligibility that would allow patents on laws and products of nature.

For all of the reasons discussed above, we believe that PERA is both unnecessary and harmful to the genetic testing industry, patient access to self-knowledge regarding the significance of their genetic characteristics, and the evolution and delivery of precision medicine. Invitae would urge the subcommittee to consider instead the codification of existing Supreme Court jurisprudence on patent subject matter eligibility. Invitae stands ready to offer any assistance the subcommittee may request in order to approach patent law reform while preserving the vitality of the genetic testing industry and the promise of precision medicine and 21st century healthcare.