March in rights are key to bring pharmaceutical costs down—the plan makes that impossible

Harvard Law Today: What is your first impression of the Biden administration’s proposal to use march-in rights to lower drug costs?

Ruth Okediji: I think it is a step in the right direction, by which I mean it is an acknowledgement that we have a system that currently makes many vital drugs, including drugs funded with federal taxpayer money, inaccessible to many Americans. The administration’s proposal to use march-in rights is a move that I certainly welcome, given my scholarly focus on strengthening the government’s role in improving access to medicines generally. The fact is the government is not powerless — there are ethical, moral, and economic justifications for greater involvement nationally and globally. A substantial proportion of drug research and development is funded or subsidized by the federal government, whether you’re talking about COVID-19 vaccines, insulin for diabetes, or other prescription drugs. For much of our history, individual patients have been fighting this problem alone, and often unsuccessfully. Millions of patients in the U.S. have been unable to access essential drugs because they couldn’t afford them, including people of color, single moms, elderly citizens, and the most impoverished Americans in rural communities. The Biden administration is clearly signaling its concern about drug prices, and their impact on the quality of life for American patients and their families. Whether the administration’s draft proposal is in fact implemented and leads to measurable improvements in drug accessibility is a completely different story.

HLT: What are march-in rights?

Okediji: March-in rights originate in the Bayh-Dole Act of 1980. This is a federal law that allowed academic research institutions to take title to patented inventions developed using NIH or other federal funding, and to grant exclusive licenses to private companies to bring the products incorporating those inventions to the market. The Bayh-Dole Act states that if an invention is not being commercialized or is otherwise inaccessible to the public, the government can ‘march in’ and make the patent holder license the invention to other companies. A patent is a quasi-monopoly and march-in rights basically break up that monopoly, meaning that more than one company can produce the patented drug without the patent holder’s permission.