Opinions and Editorials

Feb. 7, 2022

STAT News: The Supreme Court is Partly to Blame for the Covid-19 Test Kit Shortage by Judge Michel

Many pharmacies across the nation are sold out of Covid-19 rapid diagnostic tests, making it exceedingly difficult for Americans to contain the spread of the Omicron variant of SARS-CoV-2, the virus that causes Covid-19. Similar shortages and backlogs hampered efforts to control earlier surges, too.

The lack of diagnostic tests has been blamed on everything from slow FDA approval of rapid tests to manufacturers deliberately restricting supplies to keep prices high. But there’s another culprit — the U.S. Supreme Court.

In a 2012 case known as Mayo v. Prometheus, the court effectively blocked patent protections for diagnostic tests and procedures. Its decision was a legal bombshell that upended the prior law on patent eligibility. And it has had disastrous real-world consequences for Americans.