It’s hard to turn on the TV without hearing analysts talk about the threat of executive branch overreach in 2025, regardless of who wins the presidential election. 

Yet, little mention is made of how the current administration has targeted the biopharmaceutical industry and its employees for the last four years. Certainly, there has been no note of the regulatory proposal that would make old-style central planners cheer. This effort — largely invisible to the general public, is aptly-called the “march-in rights” authority — and it allows the federal government to confiscate the intellectual property of innovators.

Let’s take a few steps back for context. The American people say they care most about the economy, inflation, the border, crime and abortion. Healthcare? It’s not usually a top-three issue, but we do know people care deeply about their healthcare: access to care, the latest drugs and innovations, and availability to flexible and reasonably priced insurance.

If you listen, you can hear one side of the aisle bragging about their efforts to combat inflation by controlling the prices of drugs and “beating pharma.” Making healthcare a political issue is nothing new, and beating up on the private sector for high healthcare costs is also nothing new.

Candidates, of course, run their campaigns with the goal of improving healthcare. President George W. Bush ran on reforming Medicare to add prescription drug coverage. The new Part D drug coverage became a top domestic policy goal for his first term.

Donald Trump highlighted the high cost of healthcare in his 2016 campaign.  Once elected, his secretary of Health and Human Services, Alex Azar, unveiled a blueprint to reverse the perverse incentives that incentivize high prescription drug prices with the help of insurance middlemen called pharmacy benefit managers.

With inflation raging in 2022, President Biden decided to include price controls masked as “negotiation” in the Inflation Reduction Act. While the passage of the IRA received much attention, what didn’t was a lesser-known effort: an assault on intellectual property rights. That attack was framed as an effort “to pursue a whole-of-government approach to review its march-in authority as laid out in the Bayh-Dole Act.”

While Biden claimed the Bayh-Dole Act empowers them to confiscate biopharmaceutical innovations based on pricing, scores of experts disagreed. To the contrary, they argued, the act was designed to allow the private sector to commercialize products that were developed using federal funds.

A little background might be helpful. Under Bayh-Dole, the government is allowed under rare circumstances to “March In” on patented products derived from federally funded research and relicense them to a third party for release into the marketplace. These rare circumstances are limited to situations in which a patent holder is not trying to make the product available to the public.

According to Biden, if a product is not “reasonably priced,” that alone means the patent holder is not trying to make the product available in the marketplace. That goes against the letter and spirit of the Bayh-Dole Act since senators Evan Bayh and Bob Dole cautioned against what the administration is trying to do.

Interestingly, as a U.S. senator, Joe Biden opposed what is now his administration’s policy. As Dana Colarulli wrote earlier this year in RealClearHealth, “As a senator in the 1990s, Biden resisted efforts to undermine the effectiveness of the Bayh-Dole Act. He rejected a bill that granted government agencies “reasonable pricing” authority over federally funded products. It passed anyway, but so severely eroded new research alliances that the National Institutes of Health eliminated the harmful provisions. Senator Biden also resisted other legislative efforts to let the government use pricing as a pretext to weaken patent rights.”

Fast-forward to today, and Biden is using Bayh-Dole as a stealthy way to impose price controls. In the process, he is engaging in an assault on life-sciences innovation that comes in the form of collaboration and partnership between private-sector manufacturers, investors and academic institutions.

The consequences are many if this moves forward, leading to a loss of faith in patent protections and affecting innovators. Seventy percent of all academic licenses go to small companies that already have a hard time raising funds.

This action will deliver a blow to American competitiveness on a global level and also to national security. Under this scheme, March-In petitions could be filed by hostile foreign companies or governments. Biden and Harris are handing them a way to undermine U.S. intellectual property on a silver platter.

The administration has set its sights on lowering drug prices. In truth, if this precedent were set, any product developed under Bayh-Dole could be confiscated by the government.

As entrepreneurs, small businesses and academic researchers have learned about this “interagency guidance framework” and the opposition is growing. As a reaction, the Business Alliance to Stop Innovation Confiscation was formed by the U.S. Chamber of Commerce and partner organizations to represent innovators, build alliances, and speak out against this controversial property confiscation effort. 

Even Howard Dean, the former chair of the Democratic National Committee, has spoken out in opposition: “(President Biden) would be wise to abandon this backdoor attempt at drug price controls. Destroying the private sector’s confidence in patent protections would do far more harm than good.”

The administration needs to reverse course. Individuals and groups need to take a stand to protect our constitutionally guaranteed freedoms. If it starts with one set of innovators, don’t expect it to stop there.