New Bill Requires License to Export Digital DNA Sequences to “Countries of Concern”

The Biological Intellectual Property Protection Act of 2025 is setting up a whole new system to control how advanced genetic information leaves the country. Essentially, this bill creates a mandatory license requirement for sharing specific digital files—the blueprints for synthetic DNA or RNA—with entities linked to countries the U.S. government deems a national security risk.

The Security Firewall for Genetic Blueprints

This legislation is laser-focused on synthetic biology, which is the cutting edge of biotech. The core of the bill is Section 3, which mandates that the Secretary of Commerce establish a licensing system within one year. If you or your company wants to export, reexport, or transfer a “digital sequence” of synthetic DNA or RNA to a “foreign entity of concern,” you’ll need government sign-off first. Think of a “digital sequence” as the binary file containing the precise instructions for building a new, human-designed genetic molecule. Congress explicitly states this is necessary because foreign adversaries, particularly the People’s Republic of China, are using systematic efforts to steal U.S. intellectual property (IP) and use it to advance their military and security forces.

Who Gets the Red Tape and Why?

This isn't about stopping the shipment of actual physical samples; it’s about controlling the flow of high-value data. The bill targets “foreign entities of concern,” a broad term that includes government bodies, foreign persons subject to the laws of a “foreign country of concern,” or any foreign person owned or controlled by such an entity. This definition is important because it could capture not just state-run labs, but also ostensibly private academic or commercial institutions if they are deemed under the control or direction of a foreign government. If you’re a U.S. researcher collaborating on a novel drug sequence with a university in a designated country, your data sharing just got a lot more complicated and will require a license.

The Real-World Friction

For the biotech sector—from large pharmaceutical companies to small academic labs—this bill introduces a significant new regulatory hurdle into the research pipeline. While the goal is protecting U.S. IP, the practical effect is slowing down international scientific collaboration. The bill does include an exception for information already considered publicly available or certain educational data (referencing Section 734.3(b) of existing export regulations), but the lines between what is “public” and what is a controlled “digital sequence” can be blurry in fast-moving fields like synthetic biology.

This isn't just a concern for big corporations; it affects the post-doc researcher trying to publish their latest findings or the small startup trying to license their technology abroad. The Secretary of Commerce now holds significant new authority over what is essentially the free flow of scientific data in a critical industry. While protecting sensitive genetic IP is a clear national security benefit, the broad definitions and new licensing requirements mean that anyone working in this space needs to pay close attention to where their digital research files are going, or risk running afoul of federal export controls.