Manufacturers of medical and digital devices, represented by two trade associations, challenged a regulation enacted by the Librarian of Congress under the Digital Millennium Copyright Act (DMCA). The regulation, known as the medical device repair exemption, allows certain third parties to circumvent technological protection measures on medical equipment software for the purpose of diagnosis, maintenance, or repair. The associations contended that this exemption threatened their copyrights by enabling independent service organizations to access and use software that, they argued, was primarily intended for repair and maintenance.

The United States District Court for the District of Columbia initially dismissed some of the associations’ claims, including those under the Administrative Procedure Act (APA), on sovereign immunity grounds and found the rulemaking was within the Librarian’s authority and not unconstitutional. On appeal, the United States Court of Appeals for the District of Columbia Circuit reversed in part, directing the district court to evaluate the APA claims. After further rulemaking and additional arguments, including discussion of Supreme Court precedent and the renewal of the exemption, the district court granted summary judgment for the Librarian and Library of Congress. The court concluded that the exemption was consistent with the DMCA, the fair use doctrine, and was supported by the administrative record.

On further appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. It held that the Librarian’s adoption and renewal of the medical device repair exemption were not arbitrary or capricious under the APA. The court found the Librarian’s application of the statutory fair use factors reasonable, including determinations that the use was transformative, the software was primarily functional, the amount of use was justified, and the exemption did not harm the market for the original works. The judgment for the Librarian and Library of Congress was affirmed. View “Medical Imaging & Technology Alliance v. Library of Congress” on Justia Law