IP Law Daily, COPYRIGHT—D.D.C.: DMCA exemption for accessing medical device software upheld on fair use grounds, (Jul 25, 2025)

By Thomas Long, J.D.

Librarian of Congress reasonably decided that use of operational software and related documents for repair of medical devices was “transformative” and supported a fair use determination warranting a DMCA exemption.

Accessing copyrighted software and related materials in order to make repairs to medical devices, such as MRI machines, was reasonably deemed by the Librarian of Congress to be a “fair use” justifying the issuance of an exemption to the “anti-circumvention” provisions of the Digital Millennium Copyright Act (DMCA), the federal district court in Washington, D.C. has decided. The Librarian’s rulemaking did not violate the Administrative Procedure Act (APA) because the determination that the exempted uses were likely noninfringing was consistent with the Copyright Act and justified by reasoned analysis. The court particularly noted that repair and maintenance of a medical device had a “different character” from the original purpose of the underlying software, the court said, supporting a fair use finding. Also key to the court’s decision was its agreement with the Librarian that the software and materials at issue had no independent market value separate from sales of the medical devices themselves, further supporting a finding that the exempted repair and maintenance activities were fair use. The court granted the Librarian’s motion for summary judgment against APA claims by two medical device industry associations (Advanced Medical Technology Association v. Library of Congress, No. 1:22-cv-00499-BAH (D.D.C. July 21, 2025)).

Section 1201 of the DMCA, 17 U.S.C. § 1201, created a private right of action against anyone who circumvents a technological measure that effectively controls access to a work protected under federal copyright law. The DMCA contains several exemptions to the anticircumvention provision, and also provides for a triennial rulemaking process through which the Librarian of Congress is authorized to identify additional exemptions. This case concerned an exemption issued in 2021 and renewed in 2024, known as the Medical Device Exemption. In those proceedings, the Librarian determined that the use of embedded computer programs and related data files for diagnosis, maintenance, and repair of medical devices was noninfringing under 17 U.S.C. § 107, the fair use provision of the Copyright Act. The Librarian also concluded that users would be adversely affected by the anticircumvention provision, warranting the issuance of an exception.

The plaintiffs, Medical Imaging & Technology Alliance and Advanced Medical Technology Association (“the associations”), filed suit against the Library and Librarian of Congress challenging the Medical Device Exemption under the APA. The district court dismissed the lawsuit, finding that the APA did not apply, and that the Librarian’s exercise of her power was not unconstitutional. The U.S. Court of Appeals for the D.C. Circuit—in a split decision—rejected the district court’s conclusion that sovereign immunity barred the lawsuit and held that the associations could challenge the rulemaking under the APA.

Shortly after the D.C. Circuit issued its mandate, the Librarian renewed the exemption in the 2024 triennial rulemaking. The associations filed an amended complaint, asserting three claims under the APA: that the Medical Device Exemption was contrary to statute, arbitrary and capricious, and procedurally flawed. Both parties subsequently cross-moved for summary judgment.

The district court rejected the APA claims. “The Librarian applied the law to the evidence in the record in a fair and principled way in adopting the Exemption and fully addressed all key points raised by opponents in the rulemaking process,” said the court. “While plaintiffs may perceive competitive harms resulting from the Exemption, they identify no violation of the APA to justify granting their desired relief.”

Fair use. The associations contended that the exemption was contrary to law because it permitted uses that were not “fair uses” under Section 107. It challenged the Librarian’s analysis of the four fair-use factors. However, the court decided that the Librarian’s determination that accessing copyrighted works in order to repair medical devices was likely noninfringing was consistent with the Copyright Act and justified by reasoned analysis. In reviewing the Librarian’s analysis, the court noted that some deference was to be given to the Librarian’s factual findings to the extent those findings were supported by substantial evidence. Therefore, the exemption was to be upheld as long as it was reasonable and reasonably explained. After discussing the Librarian’s analysis of the fair use factors, the court held that the standard was met.

Purpose and character of use. Although the diagnostic, maintenance, and repair activities at issue were commercial in nature, the Librarian concluded that the transformativeness of the uses outweighed their commerciality. In the court’s view, the Librarian put forth a fairly reasoned argument those uses served “a different function” from the original code, by expanding its usefulness rather than replacing it. According to the court, the original embedded programs and files made the medical devices run; when an ISO referenced the computer programs to conduct diagnosis, maintenance, or repair, it did so to protect or fix the devices and did not reproduce the code for purposes of run other devices. To be “transformative,” the uses did not have to alter or modify the computer code, they only had to have a distinct purpose from the software’s original purpose, the court explained. “While copying part of a code to repair a device may be ‘derivative’ of its use to operate that device, its purpose is sufficiently distinct to qualify as a fair use,” it said.

Similarly, the use of ancillary copyrighted materials, such as electronic manuals, machine specifications, and error logs, could be deemed transformative because “their immediate original purpose was to help operate the device or to provide information about the general operation of the device.” Use of those materials to carry out repairs (a secondary purpose) required users to employ their own knowledge, creative and analytical thinking, and mechanical skills. “That secondary function transforms the basic knowledge conveyed in the copyrighted materials into a distinct and meaningful output, which is considered transformative,” the court said.

Nature of copyrighted work. Although the software at issue was copyrighted, the Librarian determined that it was informative, factual, and functional in nature rather than “expressive,” which supported fair use. The court agreed that the proper question was how “close” the software was “to the core of intended copyright protection.” The Librarian did not act improperly in deeming that the software was not as close to the core purpose of copyright as such works as fictional short stories and movies, the court decided.

Amount and substantiality of portions used. The Librarian had reasoned that the amount of copyrighted material used under the Medical Device Exemption was “reasonable relative to the purpose.” Sometimes repairs would require only a portion of the copyrighted works, and when reference to the entire versions was necessary, this was justified “to achieve a transformative purpose.” The court did not disturb this determination, noting that the copying of a large amount of material is “not inherently problematic.” In the court’s view, the Librarian’s determination was well-reasoned and consistent with the law. “Sometimes diagnosis, repair, and maintenance will require copying large portions of the software code or other materials in their entirety, but because its purpose is transformative, this factor does not weigh against fair use,” the court explained. The exemption only authorized copying to the extent it was necessary to carry out repairs.

Effect on market for or value of copyrighted work. The Librarian concluded that diagnosis, maintenance, and repair of medical devices and systems was unlikely to harm the market for the embedded software. According to the Librarian, most software and data files related to medical devices had no independent value. Therefore, replication of those copyrighted works for purposes of repairing the medical device did not harm their value, which depended on purchases of the actual device.

The associations argued that the Librarian failed to consider three adverse market effects: (1) harm to the service-and-repair market; (2) reduced incentive for derivative innovations; and (3) increased potential for device malfunction and cybersecurity attacks. “To the contrary, the Librarian considered all relevant facts, including these three considerations referenced by plaintiffs, and came to a conclusion consistent with those facts and the law,” the court said. The analysis of market effects was tied to the analysis of the purpose and character of the use. The proper inquiry was whether the market for the operating software and related materials will be harmed by copying those materials for diagnosis, maintenance, and repairs. The court was persuaded by the Librarian’s finding that the software and data files had no distinct value of their own, noting that they could not be used to operate other equipment or installed on a computer to perform other functions. In the court’s view, the value of a secondary market for repair services did not depend on the value of the software and data, but on the application of labor, creative analytics, and expertise by the service providers. “That process does not compete with or replace the use of the copyrighted materials as they were originally provided in the initial sale,” the court said. The court also rejected the argument that recouping costs through ongoing licensing or repairs was essential to protect the incentive to innovate.

Finally, with respect to the potential for technical vulnerabilities, the court noted that the Librarian had sought the input of the Food and Drug Administration, which took the position that the evidence was insufficient to justify a conclusion that there was a widespread health concern related to medical device servicing. “The Librarian’s consideration of input from the FDA demonstrates a careful and logic-driven, rather than biased or arbitrary, approach to all of the concerns raised during the rulemaking process,” the court said.

Consistency with DMCA’s text and purpose. The court went on to determine that the text of the DMCA and the policies behind it provided more support for upholding the exemption. According to the court, the drafters of Section 1201(a)(1)(C) sought to balance copyright-holders’ right to prevent circumvention, on one hand, with protections for the public’s access to carry certain noninfringing uses. “Accordingly, courts have warned against an overbroad reading of the DMCA’s anticircumvention provision and suggested a robust role for the Librarian’s creation of exemptions,” the court said. Additionally, the court pointed to other provisions of the DMCA that indicated an intention by Congress to ensure that maintenance and repairs were not monopolized by copyright owners of computer programs. The Medical Device Exemption was consistent with this intent. Accordingly, the associations were not entitled to any relief from the rulemaking on any substantive ground claimed under the APA.

Procedural validity. The court rejected the associations’ contention that the Librarian failed to employ valid procedure, rendering the rulemaking arbitrary and capricious. The Librarian explicitly addressed topics of concern raised by the associations, including comments requesting a device-specific analysis of the fair-use doctrine, comments addressing the commercial nature of the exemption uses, and comments about the purported chilling effect on innovation. “The Librarian’s 2021 and 2024 Rulemakings were thorough and procedurally sound, addressing all significant comments in a substantive and principled way,” the court said. Therefore, the court denied the associations’ motion for summary judgment and granted the Librarian’s motion.

The case is No. 1:22-cv-00499-BAH.

Judge: Howell, B.

Attorneys: Alex Christopher Boota (McDermott Will & Emery) for Advanced Medical Technology Association. Allyson Scher (Democracy Forward Foundation) for Library of Congress.

Companies: Advanced Medical Technology Association; Library of Congress

MainStory: TopStory Copyright TechnologyInternet DistrictofColumbiaNews GCNNews