Scientists have responded to COVID-19 with unprecedented speed. Just months after the outbreak of the novel coronavirus, clinical trials are already underway for nearly 200 vaccines and therapies.
But while the pace of COVID-19 innovation may be extraordinary, the research infrastructure allowing this remarkable work is hardly new. In fact, it was cemented into place nearly two generations ago when Congress passed the Bayh-Dole Act of 1980.
That reform laid the groundwork for a system of partnerships between publicly funded universities and private companies that has produced some of the world’s greatest drug breakthrough innovations. The Economist Technology Quarterly called the Bayh-Dole Act, “possibly the most inspired piece of legislation to be enacted in America over the past half century.”
This uniquely American research model is the foundation for much of the COVID-19 research taking place today.
Public-private partnerships are hardly unique to biotech innovation. Run a Google search for “Honeycrisp apple” and you’ll find it had its origins in a lab at the University of Minnesota. It was patented in 1988.
Oh, and that Google search engine you just used? Co-founder Sergei Brin had a National Science Foundation Fellowship for graduate students at Stanford University as he was developing it.
Breakthroughs like these often build upon very basic research inquiries, funded, in part, by the federal government. But historically, any resulting discoveries were owned by the government — not the inventor. As a result, the discoveries would often lay dormant. Before Bayh-Dole became law, the federal government licensed less than 5 percent of the patented inventions it retained.
Recognizing that thousands of scientific breakthroughs were gathering dust — and that taxpayers weren’t benefiting from the research they helped fund — Senators Birch Bayh and Bob Dole stepped in to accelerate public-private collaboration.
Their legislation, the Bayh-Dole Act, enabled universities to retain ownership of patented inventions developed with federal funding — and then license those patents to private companies, who take on enormous risks and spend millions, or even billions, of dollars to research and develop new medicines. The universities don’t create the products — but they come up with the ideas that clever companies can develop into useful products.
In the biomedical field, risk of failure is very high. Most potential drugs never recoup their development costs. Fewer than 12 percent of candidates that enter Phase I clinical trials eventually make it to the market. And a single clinical trial program can cost hundreds of millions of dollars — and still fail!
Universities are ill-suited for drug development. Public research dollars are best spent on what universities are really good at — making basic discoveries and pushing the boundaries of science — while private capital underwrites the high-risk trial-and-error work of turning these discoveries into real-world medicines.
Bayh-Dole ignited an explosion of U.S. innovation by bringing the two together and providing incentives to work together for the betterment of America, creating hundreds of thousands of jobs since then. Bayh-Dole has proven so successful that countries like Japan, Brazil, Singapore, China, and Malaysia have all implemented some version of it.
It’s no surprise, then, that America’s model of biomedical innovation has been indispensable to the current COVID-19 response.
For instance, the Massachusetts-based biotech firm Moderna — a company spun out of MIT — identified a leading vaccine candidate for the novel coronavirus in just 42 days and is already in phase II human trials. The revolutionary mRNA technology used to develop the candidate stems, in part, from research done at the University of Pennsylvania and Harvard.
Compare this model of innovation with the one that delivered the vaccine for polio, at a time when the government owned the intellectual property. Fifty-nine years passed between the initial outbreak of polio in the United States and the first vaccine. Vaccine research was driven by a single entity, the National Foundation for Infantile Paralysis — better known as the March of Dimes. Seventeen years passed from its founding in 1938 until the approval of the vaccines developed by Jonas Salk and Alfred Sabin. It worked, but much more slowly.
Clear ownership of property rights has always been a mainstay of the American system. As President Lincoln once said, “The patent system . . . secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.”
With the Bayh-Dole Act, the United States found a way to foster collaboration between universities, government agencies, and private companies to turn laboratory science into lifesaving inventions. This model has worked astoundingly well for years. In this time of crisis, it’s more valuable than ever and also stands ready to address future challenges.
John Fraser is a past president of AUTM, the global association of academic technology transfer professionals.