The Supreme Court has handed down momentous decisions over the past two decades on a variety of hot-button issues — from reproductive rights and affirmative action to campaign finance and the Affordable Care Act.
But some of the most consequential rulings — for our physical well-being, our economic vitality, and even our national security — have flown under the radar.
For years, the justices have steadily chipped away at long-standing intellectual property rights. By doing so, they’ve unintentionally stymied investment into critical industries, from medical diagnostics to artificial intelligence, that will determine our health, wealth, and security for much of the 21st century.
Take, for instance, Mayo Collaborative Services v. Prometheus Laboratories. Prometheus Labs had sued the Mayo Clinic for violating a patent on a diagnostic test for gastrointestinal disease. The Supreme Court ruled in 2012 that the Mayo Clinic had, in fact, infringed Prometheus’ patent — but also ruled that the Prometheus technology was ineligible for patenting because it measured a naturally occurring process, even though the test itself was clearly novel.
Mayo caused investors to reduce their funding for U.S. medical diagnostics companies by billions of dollars in the years following the Court’s ruling. That drop helps explain why European biotech companies were producing and cheaply distributing reliable at-home COVID tests during the first year of the pandemic, while Americans were stuck waiting for days for PCR tests that had to be sent to centralized labs. In Europe, diagnostic tests remain patentable.
And when the world experienced a hard season of flu and respiratory illness in 2021 and 2022, European firms launched convenient, three-in-one tests for the flu, COVID, and RSV. Americans were left gaping at the newfangled tests and wondering why they weren’t coming out of U.S. labs.
Other decisions, such as Bilski v. Kappos (2010), Association for Molecular Pathology v. Myriad Genetics (2013), and Alice Corp. v. CLS Bank International (2014), have raised similar uncertainty around patents. Inventors wondered: Are our creations patent-eligible, and if they are, will the patent count for anything?
And their investors asked: Why pour money into new technologies if we can neither patent what’s invented nor protect what’s been patented? A wave of doubt crept into fields like biotechnology, artificial intelligence, 5G, and blockchain, among others.
When inventors cannot capitalize on their inventions, they cannot recruit investors, and transformative ideas cease coming to market. That’s especially true in the life sciences industry.
It can take billions of dollars and many years to produce medical breakthroughs — breakthroughs protected by patents that can be licensed or sold. Yet absent robust patent protection, potential life sciences investors can’t expect a return, and in that case, they take their investment dollars elsewhere.
Fortunately, Congress seems to recognize the damage these Supreme Court rulings have wrought — and lawmakers are now poised to correct the justices’ mistakes.
To restore strength to America’s patent system and promote innovation, Congress is contemplating reforms to Section 101 of U.S. patent law, which governs what sort of products and processes are eligible for patent protection. The proposed legislation, spearheaded by Senators Chris Coons (D-DE) and Thom Tillis (R-NC), eliminates the uncertainty created by the Supreme Court decisions. The bill replaces Mayo and other rulings with new and clearer guidelines. The new, predictable intellectual property framework will provide inventors and investors with confidence their creations will be protected.
Crucially, the bill also aligns the U.S. patent system with international standards, enabling American inventors to compete on a level playing field. In a world where the competition for innovative technologies is ever-increasing, the United States can’t afford to fall farther behind.
The bill also levels the playing field for inventors and small businesses, enabling them to compete with larger corporations that have more resources to navigate and manipulate the current patent system.
Americans’ health, economic prosperity, and even national security depend on regaining an edge over rival nations in critical fields. Supreme Court rulings have derailed our technological leadership. Senators Coons’ and Tillis’ legislation will help put us back on track.
Howard Dean is the former chair of the Democratic National Committee and former governor of Vermont.