On June 7, 2024, the Court of Appeals for the DC Circuit in Medical Imaging & Technology Alliance et al. v. Library of Congress et al., No. 23-5067 (D.C. Cir.), vacated an earlier district court decision and held that rules promulgated by the Library of Congress involving copyrights can be challenged under the Administrative Procedure Act (APA). Specifically, the DC Circuit held that the medical device “right to repair”—a copyright regulation exempting medical devices from the Digital Millennium Copyright Act’s (DMCA) anti-circumvention provision—can be challenged under the APA. The significance of the “right to repair” exemption is that medical device companies must make the copyright-protected software code embedded in, and instructions to, their medical devices accessible to third-party operators to enable maintenance and repair services. In the device manufacturers’ view, this third-party access could be unsafe and a violation of manufacturers’ copyrights.

The DMCA, enacted in 1998, was intended in part to address the risks that new technology, including the Internet, posed to copyrighted material. As part of the DMCA, Congress authorized the Librarian of Congress (head of the Library of Congress) to promulgate exceptions every three years to certain DMCA statutory prohibitions, including the prohibition on the circumvention of technological protection measures used to limit access to copyright-protected works. See 17 U.S.C. § 1201(a)(1). Until 2021, the Librarian’s exceptions did not include medical device software code and thus the medical device industry could limit access to the copyrighted software code embedded in medical devices, to privileged device users.

However, in October 2021, on the recommendation of the Register of Copyrights, the Librarian adopted a rule exempting parties accessing “[c]omputer programs that are contained in and control the functioning of a lawfully acquired medical device or system” when circumvention is “a necessary step” for the “diagnosis, maintenance, or repair” of those devices. 37 C.F.R. § 201.40(b)(15). The Register had opined that third-party servicers’ maintenance and repair services were fair uses of the copyrighted software and that the exemption was justified, as the anti-circumvention provision would otherwise have or be likely to have “an adverse impact on the noninfringing diagnosis, repair, and maintenance of medical devices and systems.”

Positing that the exemption could potentially lead to unsafe devices for patients, two medical device trade groups, the Medical Imaging & Technology Alliance and the Advanced Medical Technology Association, challenged the exemption in DC district court in 2022, leading to the DC Circuit’s recent decision. The district court found that sovereign immunity barred plaintiffs’ APA claims because the Library of Congress is part of “the Congress” and therefore not an “agency” within the meaning of the APA’s judicial review provision.

However, on appeal, the DC Circuit assessed the threshold question of whether the medical device repair rule was reviewable under the APA. The court noted that whereas the “parties and the district court analyzed the question of reviewability by focusing on whether the Library [of Congress] was part of Congress,” this framing “fail[ed] to account for the fact that Congress can provide for APA review of the DMCA regulations by statute.” Judge Neomi Rao, joined by Judge Harry T. Edwards, determined that “[i]rrespective of whether the Library is an ‘agency,’ [] Congress has specified that copyright regulations under Title 17 of the U.S. Code are subject to the APA. The Copyright Act of 1976 provides that ‘all actions’ of the Register of Copyrights under Title 17—which includes rules that must be approved by the Librarian—are governed by the APA. And the DMCA authorizes the Register and Librarian to promulgate a new category of rules under Title 17.” Thus, reading the two statutes together, the court concluded that “DMCA rules are subject to the APA . . . [and] the APA therefore provides the necessary waiver of sovereign immunity for the suit.” The DC Circuit vacated the lower court’s decision and remanded the case for “the district court to consider the merits of the APA claims in the first instance.”

The DC Circuit’s decision makes clear that rules promulgated by the Library of Congress—of which the Copyright Office forms a part—can be subject to APA review. Accordingly, the DC district court will address the medical device “right to repair” rule under APA standards.