Editor’s Note: Tom Quaadman is executive vice president of the US Chamber of Commerce. The opinions expressed in this commentary are his own.
The speed at which vaccines for Covid-19 have been developed and their effectiveness at stemming the pandemic are nothing short of a modern miracle. While society will marvel at the science behind these vaccines for years to come, policymakers should not overlook two important factors that together have made vaccine development possible: intellectual property (IP) protections that encourage private sector research and development and access to investor capital.
These incentives are under threat today as activists are calling on the World Trade Organization to temporarily suspend its rules on intellectual property. Specifically, WTO members are currently considering a resolution that would unwind many of the IP safeguards that have helped underwrite the mRNA vaccines, claiming it will hasten the worldwide deployment of vaccines.
We believe this is the wrong approach and will undermine the ability to accelerate global production of vaccines and may jeopardize public confidence in their safety.
Pharmaceutical innovations are protected by a range of IP protections. While patents protect the innovation itself — like mRNA vaccines — trade secrets protect the proprietary information or the “secret sauce” needed to produce that innovation.
While global trading rules permit countries to override specific patents in a public health emergency such as the pandemic, activists have instead focused their efforts on delegitimizing the intellectual property system through a temporary waiver of the WTO international treaty rules on intellectual property. These efforts are devoid of sufficient evidence to support their claim that waiving IP protections will somehow expand access to vaccines and future innovation.
Moderna and BioNTech became household names after developing Covid-19 vaccines using innovative mRNA technologies, and are great examples of the close connection between strong equity markets and robust innovation. When these companies went public, Moderna in 2018 and BioNTech in 2019, the companies’ leadership could not have known they would soon be essential to bringing an end to a global pandemic. They did, however, know that an initial public offering was necessary to fully support their mRNA research efforts.
Before Moderna went public, it spent a little over $400 million annually in research and development. That increased to $496 million by the end of 2019 and to $1.37 billion by the end of 2020. The company’s workforce has also nearly doubled and it continues efforts to expand the possible uses of its mRNA technologies. As Moderna has explained: “Our speed in developing the Moderna Covid-19 vaccine was ultimately a product of our many years of research and investment in mRNA vaccines.”
Meanwhile, BioNTech’s R&D budget expanded significantly after its IPO and continues to increase as a result of the pandemic. As BioNTech explained in one of its filings with the Securities and Exchange Commission (SEC), “Our commercial success depends in part on our ability to obtain, maintain, protect, defend, and enforce patent and other intellectual property, including trade secret and know-how.”
Not surprisingly, the stock of both companies has performed incredibly well, providing outsized returns for investors. IP protections were fundamental to attract the investors that enabled applied research in mRNA and other technologies. Without IP protections, businesses could be unwilling to take the risks, and equity investors could be unwilling to commit the funds necessary to conduct such proprietary research and bring products to market.
The failure rate in drug development has been said to be higher than 96% — and that includes a 90% failure rate during clinical development. Companies like Moderna and BioNTech make these multi-million, or even multi-billion-dollar upfront investments to develop new technologies without any guarantee that key products will succeed, or that they will be able to recoup their sunk costs, let alone make a profit someday. If the broadly written WTO rules waiver is approved, Moderna and BioNTech could not only lose rights to their vaccine-related inventions, they could be coerced by governments to give up a broad range of the proprietary knowledge that makes up the essential value of these companies and enables them to attract investors.
In 2012, Congress passed the Jumpstart our Business Startups (JOBS) Act, an overwhelmingly bipartisan effort that made it easier for businesses to raise capital and eventually complete an initial public offering (IPO). Importantly, the JOBS Act relieved small public companies, like US-based Moderna, from several key regulatory burdens that did not protect investors. This allowed them to devote capital and resources to more productive uses, such as hiring new employees and expanding important research and development projects.
The JOBS Act was particularly beneficial for the biotechnology industry. Biotech companies like Moderna and BioNTech are unique because they often have little or no revenue in their early years as they focus solely on the development of drugs, vaccines or therapeutics. Often, the only way for a biotech company to secure the type of long-term financing it needs to turn its research into life-saving products is through an IPO. Since passage of the JOBS Act, many biotech companies have gone public under the law’s provisions.
The historic development of Covid-19 vaccines is a prime example of how smart regulation can help connect businesses with investors, grow jobs and bring products to market that advance the quality of human life. Policymakers should implement further reforms that allow more businesses to go public and ensure that IP protections in the United States are not weakened in the face of misguided activism.
American ingenuity proved its mettle during the Covid-19 pandemic. It’s now up to Congress and regulators to defend America’s leading role in the world by fostering a regulatory environment that allows emerging and existing companies to develop the next life-changing technology through reliable IP and streamlined access to our capital markets.
