Don’t Know if Your Child Has Strep? Thank the US Supreme Court

Senator Chris Coons (D-Del.), chair of the Senate Judiciary Subcommittee on Intellectual Property, recently noted that “knowledge about what can be patented … has sunk in the last couple of years.” He’s right.

Even worse, this uncertainty is creating real roadblocks to innovation in critical areas. Congress must restore confidence in America’s patent system, which for many years was considered the global gold standard for IP protection. In no sector is the problem more evident than medical diagnostics.

Confusion over which tests are patent-eligible is chilling potentially life-saving research and investment. Virtually every parent has had the experience of being roused in the middle of the night by a child complaining of a sore throat—a classic symptom of both strep throat and the common cold. The former entails a course of antibiotics. The latter needs rest and, perhaps, some chicken soup.

Today, figuring out which ailment a child has typically requires a trip to urgent care. But it doesn’t have to be this way. The science for rapid at-home strep tests exists. And considering the millions of cases of noninvasive strep every year, one would expect a glut of over-the-counter strep tests on drugstore shelves. But that isn’t the case.

The US has fallen woefully behind other countries in the development of cutting-edge, reliable diagnostic tests for a host of common illnesses. America’s diagnostics development sector isn’t even close to its potential. The blame falls squarely on the increasingly rogue US Supreme Court. More than a decade ago, the court curtailed the patentability of diagnostic tests.

Unsurprisingly, the justices’ decision had an enormous impact on diagnostics innovation and the patients who would benefit from it. The specific case dealt with a company called Prometheus Labs, which invented and patented a diagnostic that could help doctors effectively treat patients with gastrointestinal disease.

Soon after, Mayo Clinic developed a diagnostic test of its own that infringed on Prometheus’s patent. The Supreme Court determined that Mayo Clinic had indeed stolen technology from Prometheus. But in a classic rug pull, the justices decided Prometheus’s test wasn’t patent-eligible to begin with.

Worse yet, the court’s decision in Mayo v. Prometheus wasn’t narrowly limited to one case. It also established a general presumption that diagnostic tests measuring natural processes cannot be patented.

After the Mayo decision, life sciences investors had no choice but to pull their funds from many efforts to develop cutting-edge diagnostics. Venture capital investments in diagnostic technologies dropped by $9.3 billion after the ruling, compared to what they would otherwise have been. Sadly, some lower court judges have used the Mayo decision to nullify the patents behind existing diagnostic tests.

For instance, a few years ago the Court of Appeals for the Federal Circuit upheld a lower court’s ruling that two diagnostic patents owned by Cleveland Clinic were invalid. Scholars agreed that the decision was due, in part, to the Mayo decision.

Meanwhile, other countries have leapfrogged ahead. China is ahead of the US in many aspects of diagnostic innovation, including precision medicine, which uses patients’ genetics to diagnose and treat disease. China has intentionally made its patent rules friendlier to diagnostic innovators.

Europe’s industry is thriving, too. Its diagnostic market will grow to more than double the size of the US’s by 2027. European firms are pushing the limits of diagnostic technology. One firm recently introduced an at-home rapid “triple test” that can detect Covid, Influenza A and B, and respiratory syncytial virus in one fell swoop.

Why isn’t more of this incredible innovation happening here? It’s deeply worrying that America is relying on other countries to develop life-saving diagnostics. Congress can step in where the Supreme Court has fallen short.

Last year, Senator Thom Tillis (R-NC) introduced a bill that would clarify patent eligibility—and effectively reverse the court’s misguided Mayo ruling—and Sen. Chris Coons pledged to co-sponsor it. Once re-introduced, Congress should get it over the finish line quickly. It’s a much-needed reform that would help millions of patients by making it easier to get diagnosed for an illness and seek necessary treatment.

The case is Mayo v. Prometheus, No. 10-1150, US Supreme Court, decided March 20, 2012.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

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Howard Dean is the former chair of the Democratic National Committee and former governor of Vermont.

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