Bayh Dole Act | Is Your IP at Risk in a New Era of March-in Rights?

The Bayh-Dole Act has long protected innovators while allowing government-funded research to translate into commercial success. But recent political shifts and high-profile reviews may signal a renewed interest in the government’s dormant “march-in rights.” While the likelihood of widespread enforcement is low, IP owners need to understand what this Act allows—and how to proactively protect innovations funded by U.S. federal dollars.

Why Is the Bayh-Dole Act Making Headlines Again?

The Trump administration’s recent remarks could signal a new era of government involvement in intellectual property. With the possibility of march-in rights being invoked, IP owners should revisit the fundamentals of the Bayh-Dole Act and understand how strategic planning can help minimize potential impact.

What Is the Bayh-Dole Act, and Why Does It Matter?

Throughout my life, the United States of America has been an inspiration and world leader in the funding of research and development, including over $800 billion in 2024. But after a recent wave of DOGE cuts and cancelled grants, those critical funds are in much shorter supply. Many, including myself, are beginning to question the long-term impact it will have on the country’s standing as a beacon of innovation.

The focus is often on future research, where life-changing progress is already at risk in fields like medical research, with scientists raising alarm bells.

But what about projects funded under previous administrations? The government has implied that these may also come under review. To understand how, we need to look to the Bayh-Dole Act.

What Rights and Obligations Does Bayh-Dole Define?

A bipartisan piece of legislation sponsored by Senators Birch Bayh (D-IN) and Bob Dole (R-KS) in 1980, the Bayh-Dole Act provides rules and rights around intellectual property created or reduced to practice by research funded wholly or in part by the federal government.

Prior to the Act, the U.S. government would retain ownership of IP developed with public funding. But with limited success in commercializing the IP, this model was largely ineffective. The 1980 Act marked a shift that would allow startups, labs, academic institutions, and non-profits to control the IP, allowing them to build their products and/or go to market faster and/or more efficiently. Hoping to stimulate the economy and innovation, the Act has played a big part in continuing the U.S.’s stretch of global innovative dominance since being enacted over four decades ago.

The Bayh-Dole Act is credited with creating upwards of a trillion dollars in added economic value, stemming from hundreds of new pharmaceuticals and thousands of new companies. It has been a success by almost any measure.

What Should IP Owners Know About the Fine Print?

In exchange for federal support, funding recipients have some obligations, and the government through its agencies maintains certain rights. Most obligations amount to basic transparency, and the funding agency is given a non-exclusive license to the IP. However, there are three notable items in the Act of which IP owners should be aware:

1. Domestic Manufacturing: Any invention intended for use or sale in the U.S. should have reasonable efforts made to manufacture domestically as well.
2. Government Right to Take Title: Failure to comply with the Bayh-Dole Act could result in the government taking over ownership (take title) of the IP and strip the contractor of all IP rights.
3. March-in Rights: This provision allows the government to step in and authorize third-party use of the IP if it's not being made available in a way that meets public needs.

What are March-in Rights—and Have They Ever Been Used?

In simplified terms, march-in rights allow the government to take over the authority of activity related to the IP if it deems it necessary, such as for national interest. For example, if there was a life-saving vaccine patented by a company that refused to produce it or license it to others, the government could authorize another company to manufacture the vaccine in the event of an epidemic or pandemic.

In the 45 years of the Bayh-Dole Act’s existence, the government has never exercised their march-in rights. That precedent, however, may be on shaky ground.

Why Is the Harvard Case Drawing Attention?

Both the first Trump and Biden administrations hinted at the possibility of needing march-in rights due to the COVID-19 crisis but ultimately this proved unnecessary. Now though, in the Trump administration’s second term, the possibility is becoming more real.

Recently, U.S. Secretary of Commerce Howard Lutnick announced that Harvard University would be placed under review for all IP developed from federal research, potentially going back decades. The implication is that the Ivy League school may have failed to comply with Bayh-Dole and that the government could invoke their march-in rights entitling them to take over ownership of some or all of the IP, worth hundreds of millions of dollars.

More controversially, some speculate this could be used to redirect IP control to institutions seen as more aligned with current government priorities. The criteria for exercising march-in rights are broadly defined, and the political maneuverability within that grey area raises concern for many IP professionals.

Should IP Owners Be Worried?

All that being said, while the Harvard situation is notable (and headline grabbing), IP owners need not panic or assume they are next in line. In reality, the Harvard situation is highly unlikely to evolve much past where it is now. But IP strategy is about being prepared for the worst, even when the worst seems far-fetched.

If you have an IP strategy being executed proactively, you can minimize or eliminate the potential impact of risks like Bayh-Dole being asserted. If not, the second-best time to start is today.

How Can You Minimize the Risk?

If you’ve received U.S. federal funding—or acquired IP from someone who has—you should take the following steps:

• Determine whether any of your IP was created wholly or in part by U.S. federal funds. This includes any acquired or licensed IP.
• For licensed IP, seek assurances from the patent owner about their compliance with the Act.
• Keep detailed records about efforts to commercialize the IP, manufacturing plans, and internal documentation..

Once you clear step one you can focus on proactively protecting yourself:

• Start by strengthening your IP governance through clear IP ownership policies, protective licensing agreements, and reporting processes to make ongoing or future compliance easier.
• If you are seeking funding, or are even just considering it, make sure you understand the rights, obligations, and risks involved prior to accepting federal funding.
• If planning to acquire or merge with another company, take all necessary precautions in due diligence to determine whether any incoming IP was tied to U.S. federal funding, and if so to confirm that all obligations under Bayh-Dole have been met.

Don’t let the risks go "Bayh", "Dole" out some proactive measures and protect yourself. (ba-dum-pum-tss)

Final Thoughts: What’s the Real Takeaway?

You're likely not facing an imminent dystopian nightmare where the government seizes your IP. Still, now is the right time to review your IP strategy and compliance posture. Whether or not the Harvard situation escalates, it's a reminder that even long-dormant policies can come back into focus.

If you’re proactive today, you can avoid scrambling tomorrow.

Connect with Stratford’s IP experts to assess your organization’s exposure to Bayh-Dole-related risks and build a proactive IP resilience strategy. We’ll help you understand your obligation, navigate compliance requirements and protect your publicly funded innovations — especially if you’re operating in a cross-border R&D environment.

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