"I don't like to be alarmist," says Vern Norveil, a partner at Wilson Sonsini Goodrich & Rosati, "but this case could be a disaster for the industry if the [Supreme Court] goes too far." The industry is diagnostics—and specifically the burgeoning world of diagnostic start-ups. The case—due to be heard in March—goes to the very heart of the new biomarker-based diagnostics industry: whether a patent on the correlation between natural biological markers, like proteins or genes, and a disease is valid.
The story's beginnings didn't appear portentous. A predecessor company of Competitive Technologies Inc. , a firm which buys and manages patents, mostly for universities, owned a 1986 patent on the correlation of elevated levels of homocysteine and vitamin B deficiency made by researchers at the University of Colorado and Columbia University . CTI licensed the patent to a lab run by the Colorado researchers, Metabolite Laboratories Inc., which then sublicensed the test to a Laboratory Corp. of America Holdings predecessor