Opinions and Editorials

Oct. 29, 2018

Morning Consult: Supreme Court Patent Decisions Are Stifling Health Care Innovation by David Kappos and Paul Michel

In 2003, after many years of research, scientists at Ohio’s premier health care research institution, the Cleveland Clinic, made a groundbreaking and lifesaving discovery — they determined how to detect an enzyme called myeloperoxidase in the human bloodstream using a new, non-invasive blood sample test. The presence of MPO at elevated levels is an early warning sign for cardiovascular disease. In plain English, the Cleveland Clinic had discovered how to predict heart attacks long before they happen.

Soon after making this discovery, the Cleveland Clinic launched Cleveland HeartLab, a heart disease research lab specializing in commercializing biological markers, or biomarkers, and together they set out to patent this new and important diagnostic tool and bring it to market.

Most people would consider the discovery of a biomarker for heart disease, the leading cause of death for both men and women in the United States, as worthy of patent protection. Patents provide a critical incentive for scientists to bring such medical innovations to market. They also help ensure scientists can raise the capital needed to fund their expensive research. In the Cleveland Clinic’s case, the U.S. Patent and Trademark Office carefully scrutinized the institution’s discovery over a 10-year period and eventually issued patents covering this MPO test.

Yet, for all its promise, the Cleveland Clinic success story devolved into a tragic instance of dysfunctional U.S. patent laws preventing an important medical innovation from reaching patients. In late 2015, an Ohio federal court struck down the patents covering the MPO diagnostic, finding the underlying innovation ineligible for patent protection despite its unquestioned importance. An appellate court affirmed this decision in 2017. And a few months ago, the Supreme Court sealed the MPO diagnostic’s fate by denying the Cleveland Clinic and the Cleveland HeartLab’s appeal to have the patents reinstated.

These outcomes stem from numerous Supreme Court decisions over the past seven years that have found biomarker discoveries and their related diagnostic tests to be ineligible for patent protection. This uncertain patent climate has a chilling effect on innovation in biosciences to the detriment of public health.