New IP Law Requires Licenses to Export Digital DNA/RNA Sequences to Adversarial Nations

The Biological Intellectual Property Protection Act of 2025 is a new piece of legislation aimed squarely at protecting U.S. advancements in synthetic biology—basically, the high-tech design and engineering of DNA and RNA. The bill’s core action is simple: it mandates that the Secretary of Commerce establish a new licensing requirement for exporting, reexporting, or transferring the digital code of synthetic DNA or RNA to a “foreign entity of concern.” This requirement must be set up within one year of the law’s enactment.

The Security Premise: Digital Biology as a National Asset

This bill doesn't pull any punches about why it exists. The Sense of Congress section (Sec. 2) explicitly names the People's Republic of China, stating that their systematic campaign to exploit U.S. data and intellectual property poses a grave threat to national security. The argument is that exporting novel synthetic DNA and RNA sequences—the digital blueprints for creating new biological tools or organisms—gives foreign adversaries insight into cutting-edge U.S. biotech research, enabling IP theft and supporting military modernization.

Think of it this way: a biotech company spends years and millions developing a groundbreaking new genetic sequence for a drug. That sequence is stored as a digital file—a “digital sequence.” This law treats that digital file like a piece of sensitive military hardware when it’s being sent to certain countries. The bill defines a “digital sequence” as a binary file or other digital representation showing the identity and order of a DNA or RNA molecule.

Who Needs a License, and for What?

The new license requirement (Sec. 3) specifically targets the transfer of these digital sequences to a “foreign entity of concern.” This term is defined broadly, encompassing government entities, foreign persons subject to the jurisdiction of, or even foreign persons controlled by, a “foreign country of concern.” While the bill points the finger at China in its findings, the actual list of “countries of concern” is pulled from an existing law (42 U.S.C. 19221(a)), which currently includes China, Russia, Iran, and North Korea.

If you work in a lab, a biotech startup, or a university and need to digitally send a newly designed DNA sequence to a collaborating researcher in one of those countries, you’ll likely need a license first. This applies whether the sequence was designed by a human researcher or an AI system. For the busy scientist, this means new administrative hurdles and potential delays in international research collaboration, a process that is often essential for advancing science quickly. The Commerce Department has a year to figure out the exact rules for this licensing system, which will determine how much friction this adds to the process.

The Real-World Friction

For the U.S. biotech industry, the protection of intellectual property is a clear win, potentially safeguarding billions in research investment. However, the regulatory burden falls heavily on the researchers and companies that deal in this data. Imagine a small U.S. startup that uses a cloud server or a foreign contractor to process large amounts of synthetic biology data. If that contractor or server is located in a country of concern, or owned by an entity from one, this new law could complicate or halt those operations.

Furthermore, while the intent is to stop adversarial governments, the broad definitions could inadvertently sweep up legitimate academic research and data sharing. The bill’s effect will depend heavily on how the Secretary of Commerce defines the specifics of the licensing process. Will it be a quick rubber stamp for non-sensitive academic transfers, or a lengthy bureaucratic slog? For those in the field, this uncertainty means waiting to see if their international research pipelines get slowed down by red tape, even if they aren't working on anything remotely military-related.