SCOTUS exceptions undermine DNA research generally

2. Myriad Caused Multiple Genetic Diagnostics to Be Abandoned

Another major concern following Myriad was that it would stifle the development of medical diagnostics and treatments. Although some believed that Myriad would lead to decreased costs for consumers due to greater competition in the marketplace for gene-based medicines,205 others feared that the decision could lead to an overall decrease in the research that made these diagnostics and treatments possible.206

Case studies of specific instances of research abandoned post-Myriad abound. In Is the Sky Really Falling?: Myriad and Its Impact on Therapeutic Development, Taylor Beardall details the story of Mambalgin-1, a snake toxin with potential application as a painkiller that could serve as an opioid alternative in development at the time of Myriad. 207 Following Myriad, the researchers attempting to develop Mambalgin-1 were unable to patent their discoveries and, in the absence of patent protection, were unable to secure investments necessary to continue their work.208 The team ultimately determined Mambalgin-1 was commercially unviable and abandoned the project.209

Many similar stories exist. Retired Judge Paul Michel, former Director of the USPTO David Kappos, and others detail a number of these, including: patents for genes that could predict flare-ups of Lupus that were invalidated and abandoned post-Myriad; a patent for the diagnosis of Noonan syndrome—a rare genetic disorder in infants that causes developmental abnormalities and heart defects—that was held invalid post-Myriad and led to the patent holders abandoning efforts to improve testing; and a gene-based Schizophrenia diagnostic that was so limited in scope by Mayo and Myriad that it failed to attract investment.210 Likewise, in a 2017 study, Kevin Madigan and Professor Adam Mossoff found that of 1,310 patent applications rejected by the USPTO since 2014 but approved by either the EPO or Chinese Patent Office, nearly half related to the diagnostics of diseases such as cancer, Alzheimer’s, and diabetes.211 Although largely anecdotal, these stories demonstrate that biotechs were compelled to abandon their research into disease diagnostics and treatments in the wake of Myriad for fear of an inability to procure the funding needed to see their work through to completion.

On the other side of this issue, Professor Jorge Contreras argues that Myriad helped to significantly reduce the costs of gene-based diagnostics like Myriad’s BRCA testing.212 Although Myriad’s BRCA testing could cost upwards of $3,000 when Myriad was the exclusive provider, modern consumers can test their BRCA genes for around $100.213 Organizations such as the ACLU have likewise suggested that Myriad led to a decrease in healthcare costs.214 However, it should be noted that the cost of sequencing a human genome has dropped dramatically in the past two decades, largely due to advances in sequencing technologies.215 Thus, the extent to which Myriad and the invalidation of gene patents were responsible for this drop in gene-based diagnostic healthcare costs is unclear.

Collectively, these examples suggest that although Myriad might have contributed to the reduction in DNA sequencing costs for existing genetic diagnostics, it also stymied the introduction of new diagnostics into the marketplace.