American scientists helped shepherd three COVID-19 vaccines from lab to jab in just under a year. More could soon win approval.
In many ways, our victory in the global race to develop pandemic-ending inoculations was predestined. For decades, our country has been the innovation capital of the world, producing about two in three new medicines.
But the United States now has a major potential competitor. China has designated biopharmaceuticals as one of its key sectors for innovation as part of its “Made in China 2025” initiative.
The United States needs to maintain its competitive edge in innovation. Sen. Ron Wyden is leading a bipartisan effort to craft legislation to deal with the China challenge across the entire U.S. economy. A central element must be a crackdown on the propensity of Chinese businesses and government to help themselves to U.S. technological innovations. We must protect our intellectual property from theft from abroad.
American innovation is no accident. It’s the direct result of strong intellectual property protections woven deeply into the fabric of the U.S. economy.
The idea behind such protection is that those who innovate should be able to reap a reward from doing so. A patent is an exclusive claim to take an innovation to market or to license others to develop it. It’s designed to prevent others from copying the product and selling the result as their own. The ability to reap a reward is what drives innovation.
The United States has recognized the importance of IP since our founding. The U.S. Constitution itself recognized patents as necessary “to promote the progress of science and useful arts” — and empowered Congress to write the rules governing such rights. During my time in the House of Representatives, I fought hard to ensure those protections remained strong.
In the case of medical innovation of the kind that produced Covid-19 vaccines in record time, the key moment came in 1980, when Congress recognized that a flaw in intellectual property protection was holding back innovation.
Before that time, the U.S. government essentially retained all the patent rights resulting from basic research done in government-funded labs. But there is a huge amount of additional research and development that must take place before such basic discoveries turn into new treatments for patients.
Developing a single new drug costs an average of $2.6 billion, taking into account the research lines that don’t pan out. With the government owning the intellectual property, however, no one had an incentive to fund that additional work. So discoveries languished in government-funded labs, their potential locked up tight.
In 1980, Congress passed legislation that granted those making the actual discoveries the patent rights, allowing them to license their innovations to private companies willing to invest in the research and development efforts required to bring a potential new treatment through the federal approval process to patients. The Bayh-Dole Act opened a floodgate of innovation. More than 4,000 medicines are currently in clinical development in the United States.
That, in turn, is what made our research pharmaceutical companies ready for COVID-19. We have an abundance of labs with state-of-the-art equipment supporting some of the best scientists in the world. The COVID-19 vaccines from Moderna and Pfizer are based on breakthrough messenger RNA (mRNA) technology they have been developing for years.
In 2018 alone, the biopharmaceutical industry spent nearly $100 billion on U.S. research and development ventures. Without IP protections, that figure would plummet. The pipeline of new medicines would soon dry up. Even worse, our laboratory infrastructure would collapse, leaving us helpless when the next public health emergency arises. it
China, meanwhile, has been doing whatever it deems necessary to undermine intellectual property protection, from copying U.S. discoveries without permission to supporting an effort at the World Trade Organization to void American companies’ IP protections for COVID-19 vaccine-related discoveries.
The new challenge is global. It’s time for Congress to step up again — by rejecting any effort to weaken incentives for innovation at home and by cracking down on those seeking to undermine them abroad.
Ileana Ros-Lehtinen, a Distinguished Presidential Fellow at the University of Miami, represented Florida’s 27th congressional district in Congress from 1989 to 2019. She is a senior advisor at Akin Gump Strauss Hauer & Feld LLP, a law firm and lobbying firm in Washington, D.C. She does not do any lobbying and does not work with clients in the pharmaceutical industry.