The Biden Administration recently announced it would use existing laws to ensure that government-funded drugs will remain affordable to most Americans. That may include cancelling a pharmaceutical company’s patent and allowing rival companies manufacture the drug. But can this approach work?
Under the 1980 Bayh Dole Act, the U.S. government retains “residual rights” for inventions—including drugs—that were developed using federal dollars. This includes the right to grant licenses to third parties, if the benefits of the invention, in this case accessibility of certain drugs, are not available to the public on reasonable terms. It’s known as “march-in rights,” and new proposed guidance from the Federal Trade Commission and National Institute of Standards and Technology will now permit price to be among the considerations when agencies assess whether a drug is considered accessible.
