Copyright Developments: A Challenge to the Medical Device “Right to Repair” Permitted Under the APA

On June 7, 2024, the Court of Appeals for the District of Columbia in Medical Imaging & Technology Alliance et al. v. Library of Congress et al., No. 23-5067 (DC Cir.), reversed the district court’s earlier decision and held that the Library of Congress’s copyright policy could be challenged under the Administrative Procedure Act (APA). Specifically, the D.C. Circuit held that a medical device “right to repair” – a copyright regulation that exempts medical devices from the anti-circumvention provision of the Digital Millennium Copyright Act (DMCA) – could be challenged under the APA. The importance of the “right to repair” exemption is that medical device manufacturers must make the copyrighted software code and instructions for their medical devices available to third-party operators to enable maintenance and repair services to be provided. According to device manufacturers, such access by third parties may be dangerous and constitute a violation of the manufacturers’ copyrights.

The DMCA, passed in 1998, was intended, in part, to address the risks that new technologies, including the Internet, posed to copyrighted material. Under the DMCA, Congress authorized the Librarian of Congress (the head of the Library of Congress) to promulgate exceptions to certain DMCA statutory prohibitions every three years, including prohibitions against circumvention of technological protection measures used to restrict access to copyrighted works. See 17 USC § 1201(a)(1). Until 2021, the Librarian’s exemption did not cover medical device software code, allowing the medical device industry to limit access to 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 who access “the (computer) that is contained in and controls the operation of a legally acquired medical device or system” when circumvention is a “necessary step” in “diagnosis, maintenance, or repair” of those devices. 37 CFR § 201.40(b)(15). The Register opined that maintenance and repair services provided by third-party service providers constitute fair use of copyrighted software and that the exemption is justified because the anti-coverage provision would otherwise have or would be likely to have “an adverse effect on the noninfringing diagnosis, repair, and maintenance of medical devices and systems.”

On the premise 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 D.C. District Court in 2022, leading to the recent D.C. Circuit decision. The district court held that sovereign immunity barred plaintiffs’ claims under the APA because the Library of Congress is part of “Congress” and therefore not an “agency” within the meaning of the APA’s judicial review provision.

On appeal, however, the D.C. Circuit assessed the threshold issue of whether the medical device repair rule was reviewable under the APA. The court noted that while “the parties and the district court analyzed the issue of reviewability by focusing on whether the Library (of Congress) was a part of Congress,” that language “failed to recognize that Congress may provide for APA review of DMCA rules under the Act.” Judge Neomi Rao, joined by Judge Harry T. Edwards, determined that “(i) whether the Library is an ‘agency,’ (Congress) has designated copyright regulation under Title 17 of the United States Code as subject to the APA. The Copyright Act of 1976 provides that ‘all actions’ of the Register of Copyrights under Title 17—which includes rules requiring approval by the Librarian—are subject to the APA. The DMCA authorizes the Register and the Librarian to promulgate a new category of regulations under Title 17.” Thus, reading both statutes together, the court concluded that “the DMCA is subject to the APA. . . . (i) the APA thus provides a necessary waiver of sovereign immunity from suit.” The D.C. Circuit vacated the lower court’s decision and remanded the case “to the district court to consider the merits of the APA’s claims in the first instance.”

The D.C. Circuit’s decision makes clear that regulations promulgated by the Library of Congress—of which the Copyright Office is a part—may be subject to APA review. As such, the D.C. Circuit Court will address the “right to repair” rule for medical devices under APA standards.