Investment in U.S. biotechnology could be about to plummet, with major implications for future innovation. It all depends on the outcome of a February meeting of the World Trade Organization, and what the Biden administration decides to do there.
The WTO is considering a TRIPS proposal that would waive global patent protections on Covid-19 tests and treatments. Since the WTO makes decisions by consensus, the proposal can only become policy if the United States gives it a green light. The White House is still playing its cards close to its chest, but if the policy goes ahead, the impact of lost investment in medical discovery could be devastating.
Patents and other intellectual property protections give inventors the exclusive right to make and sell their creations for a set period of time. For investors, these rights provide certainty that after the financially risky process of product development, companies will have a shot at earning a return.
Developing a new drug from initial discovery into an approved, marketable medicine costs, on average, more than $2 billion. It can take more than a decade. And the vast majority of candidate drugs wash out along the way.
The proposed patent waiver would allow foreign companies to freely use American IP to produce copycat products -- without consent, compensation, or even safety supervision. It's bad enough that the rightful IP owners would lose access to global markets. Even worse, those copycat dugs could end up smuggled back into the U.S. market, undercutting our own companies at home and jeopardizing patient safety.
The consequences of setting such a precedent for Covid-19 treatments and tests would quickly ripple well beyond Covid-19. Without reliable IP rights, startup founders with novel technologies cannot guarantee a fair return for investors, and will find it harder to secure initial capital. Fundraising among demanding venture investors is already challenging. It will become even tougher if the patent rights at the heart of the process can be arbitrarily overturned.
Biotech startups have already faced tough times over the past few years. Financing for biotech fell by almost 50% between 2021 and 2022. In 2023, the industry saw widespread layoffs as investment capital dried up. Waiving IP protections would cause even more instability.
This is all happening at a time when we need every possible resource at our disposal to deal with emerging public health threats. Viruses continue to mutate. Rising antimicrobial resistance threatens millions of lives around the world, and calls for the development of new antibiotics. And it's only a matter of time before another pandemic hits the globe.
The sad irony of the proposal before the WTO is that its supporters pitch it as a way to speed up pandemic response. In fact, it attacks the very IP system that allowed companies to respond rapidly to Covid-19.
Proponents of the waiver argue that forfeiting patent rights could help increase access to medicine in developing nations. But the evidence shows otherwise: During Covid-19, barriers to vaccine access arose primarily from supply chain issues and lack of infrastructure -- not IP law. And now, even though the World Health Organization declared an end to the Covid-19 public health emergency in May 2023, some continue to press for the waiver, a solution in search of a problem.
If the Biden administration succumbs to pressure and allows the waiver, it will sabotage American leadership in innovation -- while doing nothing to help patients in developing countries. The only tangible impact would be its deleterious effect on the American firms willing and able to put in the time and money to develop new treatments.
The Biden administration should be leading an effort to build up global healthcare infrastructure to address the very real obstacles to access in the developing world. IP protection is no such obstacle. On the contrary, without IP, there would be no new treatments to distribute. That's not a world anyone wants to live in.
The White House needs to reject the proposed WTO patent waiver, not just for the benefit of the U.S. biotech industry, but for the sake of public health worldwide.
Lindsay Androski is Chair of the Board of Directors for Incubate, an organization of life-science investors that works to educate policymakers on the role of venture capital in bringing promising treatments to patients in need. She previously served as an Assistant U.S. Attorney, where she prosecuted prescription drug smuggling cases.
