Background
The Digital Millennium Copyright Act generally prohibits circumvention of technological measures that control access to copyrighted works. Every three years, however, the Librarian of Congress may create limited exemptions for users who are or are likely to be adversely affected in making noninfringing uses of particular classes of copyrighted works.
In 2021, the Librarian adopted an exemption permitting circumvention of access controls on computer programs and related data files in lawfully acquired medical devices when necessary for diagnosis, maintenance, or repair. The Librarian renewed the exemption in 2024. Two medical-technology trade associations challenged both actions under the Administrative Procedure Act, but the district court granted summary judgment to the Librarian and the Library of Congress.
The Court’s Holding
The D.C. Circuit affirmed. Reviewing the agency action under the APA, the court held that the Librarian reasonably concluded that the repair-related uses were likely to be noninfringing fair uses. The administrative record supported treating the copyrighted material as clinical-operation software used for a distinct repair purpose, and the challengers had not established a separate body or standalone market of repair software that the Librarian irrationally overlooked.
The court upheld the Librarian’s analysis of all four fair-use factors. Using operational software to restore a nonfunctional device served a transformative purpose; the software was functional rather than primarily expressive; temporary access to the necessary material was reasonably tied to repair; and the record did not show harm to the market for the devices or their embedded software. Competition in the separate repair-services market was not itself cognizable market harm to the copyrighted work.
Key Takeaways
- The court upheld the 2021 adoption and 2024 renewal of the DMCA exemption for diagnosis, maintenance, and repair of lawfully acquired medical devices and systems.
- Commercial repair work can favor fair use when the transaction centers on technicians’ labor and expertise rather than commercialization of copied software.
- Under APA review, unsupported assertions about a distinct repair-software market did not make the Librarian’s record-based conclusions arbitrary or capricious.
Why It Matters
The decision preserves an important federal right-to-repair measure for medical equipment and permits independent service organizations to bypass access controls when necessary to diagnose, maintain, or repair covered devices, subject to the exemption’s limits.
It also distinguishes harm to a copyrighted-software market from increased competition in an aftermarket for repair services. For future DMCA rulemakings, challengers will need administrative-record evidence connecting an exemption to harm in the market for the protected work or its derivatives.