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

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 (D.C. Cir.), reversed an earlier district court decision and held that the Library of Congress’s copyright regulations can be challenged under the Administrative Procedure Act (APA). Specifically, the D.C. Circuit held that the medical device “right to repair” provision—a copyright provision that exempts medical devices from the anti-circumvention provision of the Digital Millennium Copyright Act (DMCA)—can be challenged under the APA. The significance of the “right to repair” exception is that medical device companies must make available the copyrighted software code embedded in their medical devices and the instructions for those devices to third-party operators to facilitate maintenance and repair services. According to device manufacturers, this third-party access can be dangerous and constitute an infringement of the manufacturers’ copyrights.

The DMCA, enacted in 1998, was intended in part to address the risks that new technologies, including the Internet, posed to copyrighted materials. As part of the DMCA, Congress authorized the Librarian of Congress (the head of the Library of Congress) to promulgate exceptions to some of the statutory prohibitions of the DMCA every three years, including a prohibition against circumventing technological protection measures used to limit access to copyrighted works. See 17 USC § 1201(a)(1). Until 2021, the librarian exception did not cover medical device software code, and thus the medical device industry could limit access to copyrighted software code embedded in medical devices to privileged users of the devices.

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.”

Assuming 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 found that sovereign immunity barred the plaintiffs’ claims under the APA because the Library of Congress is part of “Congress” and thus is not an “agency” within the meaning of the APA’s judicial review provision.

On appeal, however, the D.C. District Court assessed the threshold issue of whether the medical device repair regulation 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 framing “failed to recognize that Congress can provide for APA review of DMCA regulations by statute.” Judge Neomi Rao, joined by Judge Harry T. Edwards, determined that “(i) whether the Library is an ‘agency,’ (Congress) has designated that copyright regulations under Title 17 of the United States Code are subject to the APA. The Copyright Act of 1976 provides that ‘all actions’ of the Register of Copyrights under Title 17—including regulations that must be approved by the Librarian—are subject to the APA. And 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 Rules are subject to the APA . . . (and) the APA thus provides a necessary waiver of sovereign immunity with respect to the lawsuit.” 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.