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.
Travesties such as the Cleveland Clinic MPO diagnostic cancellation have become commonplace, and investors are less interested in funding costly new biomarker diagnostic research. As a result, diseases will go undiagnosed, and patients will suffer the consequences.
From an economic perspective, these patent cancellations also undermine U.S. global competitiveness. A 2017 study of almost 18,000 patent applications rejected as ineligible for patent protection in the United States found that counterpart applications were routinely granted in the European Union or China, or both.
So while the United States dithers and sows confusion about what is and is not patent eligible, our competitors are providing patent protection and certainty to inventors and their investors. The disparity has been particularly clear for high-tech and biotech innovations, suggesting that China and the EU are well-positioned to leapfrog the United States as the frontrunners for innovation in those sectors.
Data released earlier this year by the U.S. Chamber of Commerce confirms that the United States is falling behind on patent protection. After years of occupying the top spot, the United States has fallen to 12th place in the Chamber’s international ranking of patent system strength, owing in large measure to uncertainty over patent eligibility standards in our country.
Ensuring the continued development of new health care diagnostics should be a high priority for policymakers. Investment in diagnostics goes to the core of containing spiraling health care costs, improving patient outcomes and treating illnesses before they become debilitating to suffering Americans. Undermining past investments and discouraging future ones is a huge mistake and lost opportunity.
Our patent system has been the engine driving American innovation for more than 200 years. It incentivizes research and development in the risky and expensive field of health care diagnostics. But that engine is stalling. And the recent Supreme Court decisions are now discouraging research at the Cleveland Clinic and similar institutions across the country.
Congress needs to act by passing legislation that redefines patent eligibility standards to overrule the Supreme Court’s decisions that deviate from Congress’s original intent. Such action is needed to clarify the law and restore patent protection for health care diagnostics. Otherwise, diseases that could be diagnosed and treated will continue to ravage Americans and the world, and our nation’s economic strength and competitiveness will continue to suffer.
David J. Kappos served as under secretary of commerce and director of the United States Patent and Trademark Office from 2009-2013. Paul R. Michel served as the chief judge for the U.S. Court of Appeals for the Federal Circuit from 2004-2010.
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