"Private companies, universities, and governmental entities are working to develop a vaccine for
coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the
Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New
vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they
can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in
human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling
that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with
other information, to prepare a biologics license application (BLA) to submit to FDA. FDA
approves the BLA if it determines that the vaccine is safe, potent, and pure.
Because the development and review process can be lengthy, the FD&C Act provides several
avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious
diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for
products that are intended to fill an unmet need or improve existing therapies. Both designations entitle the sponsor to
increased communication with FDA and rolling review of the BLA. Products may also qualify for accelerated approval based
on intermediate or surrogate endpoints likely to predict a clinical benefit. FDA may also designate products for priority
review. Finally, in certain emergency situations, FDA may temporarily authorize the use of unapproved products or approved
products for unapproved uses through an emergency use authorization (EUA). For FDA to issue an EUA, the Secretary of
Health and Human Services (HHS) must determine that a qualifying emergency exists due to a biological, chemical, or
nuclear agent that can cause a serious or life-threatening disease. The Secretary must also determine that it is reasonable to
believe that the authorized product may treat or prevent the disease caused by the agent; the known and potential benefits
outweigh the known and potential risks; and there are no approved, adequate, and available alternatives. Products authorized
by an EUA may be marketed and used for the authorized use while the emergency persists unless FDA revokes the EUA.
FDA may also modify or waive good manufacturing practice and prescription requirements in an EUA.
FDA approval of a vaccine allows for its marketing, but does not guarantee that the vaccine will be widely available or
affordable. Because patents grant inventors a temporary monopoly on a patented invention, patents may influence access to
and the affordability of a COVID-19 vaccine. Federal agencies and funding support many of the COVID-19 vaccine
candidates in development, which may affect the allocation and scope of patent rights, depending on the form of federal
support and the terms of a vaccine developer’s contracts with the federal government. Under certain circumstances, the
federal government can also exercise several legal authorities if patent rights limit the affordability of or access to a COVID19 vaccine. For vaccines developed with federal support, the government may secure upfront guarantees on pricing or
distribution via funding or purchasing contracts with vaccine developers. For vaccines protected by patents subject to the
Bayh-Dole Act, the funding agency could invoke “march-in rights” to enable other producers to manufacture the vaccine. For
any U.S. patent, the federal government could use its “eminent domain” powers under 28 U.S.C. § 1498, which allows the
government to make and use patented inventions without license, if reasonable compensation is provided to the patent holder..."
COVID-19 legal issues
