Medical Imaging & Technology Alliance v. Library of CongressMedical Imaging & Technology Alliance v. Library of Congress
I.
Both this court and the district court have fully recounted the background events giving rise to this litigation in several opinions. See Med. Imaging & Tech. All. v. Libr. of Cong. (MITA I), No. 22-499, 2023 WL 2387760 (D.D.C. Mar. 7, 2023); Med. Imaging & Tech. All. v. Libr. of Cong. (MITA II), 103 F.4th 830 (D.C. Cir. 2024); Advanced Med. Tech. Ass‘n v. Libr. of Cong. (MITA III), No. 22-499, 2025 WL 2029804 (D.D.C. July 21, 2025). We restate here only the information relevant to this appeal.
1.
The Constitution grants Congress the power to provide copyright protection. See
A fair use determination requires a case-by-case inquiry. Harper & Row, 471 U.S. at 549. Courts traditionally consider four non-exhaustive statutory factors in evaluating fair use:
(1) the purpose and character of the use, including whether [the] use is of a commercial nature or is for nonprofit educational purposes; (2) the nature of the copyrighted work; (3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and (4) the effect of the use upon the potential market for or value of the copyrighted work.
In response to “the ease with which pirates could copy and distribute a copyrightable work in digital form,” Congress again utilized its copyright powers and passed the DMCA in 1998, which “backed with legal sanctions the efforts of copyright owners to protect their works from piracy behind digital walls such as encryption codes or password protections.” Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 458 (2007) (citation modified). “Those walls, also called [TPMs], limit access to and use of copyrighted work.” Green v. U.S. Dep‘t of Just., 111 F.4th 81, 89 (D.C. Cir. 2024). To protect TPMs, the DMCA contains an anticircumvention provision prohibiting a “person” from circumventing or overcoming a TPM which “effectively controls access to a” copyright-protected work.
However, “[t]he anticircumvention provision is subject to statutory and regulatory exemptions.” Green, 111 F.4th at 89. Critically, the DMCA authorizes the Librarian to issue limited three-year exemptions from the Act‘s anticircumvention provision for persons “who are or are likely to be ‘adversely affected’ . . . in their ability to make noninfringing uses of copyrighted materials.” Id. at 90; see also
The Librarian grants exemptions by conducting triennial rulemakings and acting “upon the recommendation of the Register of Copyrights,” after the Register has “consult[ed]
B.
The United States Copyright Office launched the eighth triennial rulemaking on June 22, 2020, and issued its notice of proposed rulemaking approximately four months later. See Exemptions to Permit Circumvention of Access Controls on Copyrighted Works, 85 Fed. Reg. 65,293, 65,293 (Oct. 15, 2020). The Copyright Office received many proposals for new exemptions to the DMCA‘s anticircumvention provision from independent service organizations (ISOs). Because they “derive a ‘commercial benefit’ from medical equipment repair services,” JA627, these ISOs petitioned for (1) an exemption to circumvent “TPMs on software-enabled medical devices and systems for purposes of diagnosis, maintenance, and repair” and (2) “access to related data files stored on medical devices and systems, including manuals and servicing materials.” 86 Fed. Reg. at 59,635.
On October 19, 2021, the Register recommended that the Librarian grant “a new exemption allowing circumvention of TPMs restricting access to firmware and servicing materials on medical devices and systems for the purposes of diagnosis, maintenance, and repair.” JA651. In support of the recommendation for adopting the medical device repair exemption, the Register explained that the agency had “previously concluded that diagnosis and repair are likely to be transformative uses,” thus, “the first factor favors fair use.”
The Librarian accepted the Register‘s recommendation, 86 Fed. Reg. at 59,637, and adopted the regulation in a final rule, id. at 59,627. The medical device repair exemption—which permits circumvention with respect to “[c]omputer programs that are contained in and control the functioning of a lawfully acquired medical device or system, and related data files, when circumvention is a necessary step to allow the diagnosis, maintenance, or repair of such a device or system“—was codified at
C.
Appellants are trade associations representing manufacturers of various kinds of medical and digital devices. In February 2022, Appellants sued Appellees alleging that the Librarian violated the Administrative Procedure Act (APA), exceeded statutory authority, and exercised
Before we ruled in MITA II, the Copyright Office launched the ninth triennial rulemaking on June 8, 2023, and issued its notice of proposed rulemaking on October 19, 2023. Exemptions to Permit Circumvention of Access Controls on Copyrighted Works, 88 Fed. Reg. 72,013 (Oct. 19, 2023). Numerous entities petitioned for renewal of the medical device repair exemption. Appellants and others submitted opposition comments to the renewal. Of note, the opponents of the exemption argued that the United States Supreme Court‘s decision in Andy Warhol Foundation for the Visual Arts v. Goldsmith undermined the Librarian‘s rationale for adopting the medical device repair exemption. See JA1510; JA1514–17; JA1550–54; JA1559–60; JA1563–64. One opponent specified that in Warhol, the Court clarified that the use of a copyrighted work “for the same or highly similar purpose” as it was created “is non-transformative,” an infringing use, “and not fair use under the Copyright Act.” JA1510. A second one agreed opining that the medical device repair exemption failed
On October 18, 2024, the Register recommended that the Librarian renew the medical device repair exemption. The Register considered the exemption opponents’ arguments regarding the applicability of other regulatory schemes and the Warhol decision. See JA810–12. Those arguments did not persuade the Register that “the Office‘s analysis from the 2021 cycle” was now unsound. JA811. The Librarian accepted the Register‘s renewal recommendation regarding the medical device repair exemption, Exemption to Prohibition on Circumvention of Copyright Protection Systems for Access Control Technologies, 89 Fed. Reg. 85,437, 85,445 (Oct. 28, 2024), and it was codified at
On remand after MITA II, Appellants amended their complaint to allege only APA violations, adding allegations about the Librarian‘s renewal of the medical device repair exemption in the ninth triennial rulemaking. Subsequently, both parties moved for summary judgment. The district court granted summary judgment in favor of Appellees and denied Appellants’ motion. Specifically, the district court found that the Librarian‘s assessment of the medical device repair exemption was well reasoned and consistent with modern copyright law, particularly the fair-use doctrine. The district court rejected Appellants’ contention that the Librarian‘s conclusions regarding the transformative nature of the ISOs’ use of copyrighted works was arbitrary or capricious. The district court further ruled that the Librarian‘s analysis was consistent with the text and purpose of the DMCA and the 2021
II.
Because the district court‘s order “ended the litigation on the merits,” we have jurisdiction under
III.
Appellants’ main argument on appeal is that the Librarian misapplied the statutory fair-use factors in adopting and renewing the medical device repair exemption. But this is not a copyright infringement case. Appellants bring claims for a violation of the APA, and that is how we must resolve this appeal. In that regard, Appellants assert that the record so poorly supports the Librarian‘s conclusion that the medical device repair exemption permits noninfringing use that the decision was “arbitrary, capricious, and not in accordance with law.” Reply Br. 2. As such, the burden rests on Appellants to demonstrate that the Librarian‘s decision violates the Copyright Act or “entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Motor Vehicle Mfrs. Ass‘n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).
After consideration of the Librarian‘s determination as to each of the four factors of the fair use analysis, we affirm the district court‘s determination that the Librarian‘s adoption of the medical device repair exemption was lawful, reasonable, and supported by “thorough and well-reasoned explanations from the Eighth and Ninth Triennial Rulemaking procedures.” See JA1715.
Appellants argue that the primary purpose of the copyrighted software is repair and maintenance, and the Librarian erred in determining that the software is primarily for
A.
We begin by assessing the Librarian‘s determination under the first fair-use factor, which concerns “the purpose and character of the use, including whether the use is of a commercial nature or is for nonprofit educational purposes.”
Appellants claim that ISOs use manufacturer-created repair software and data files in a commercially substitutive manner, thereby infringing Appellants’ copyrights. They further contend that, because the software‘s purpose is to repair the machines and the ISOs’ purpose is also to repair them, the ISOs’ work is not transformative and is commercially substitutive of Appellants’ work. They state that “[a]ll third-party servicers do is put the works at issue to their intended uses in a commercial application,” Reply Br. 11, and claim that ISOs profit from the fees for the labor they perform in the same manner a licensed operator would.
Appellants’ challenge to the Librarian‘s determination of transformativeness is rooted in their argument about the scope of the medical device repair exemption. Again, Appellants’ challenge relies on their argument that the copyrighted works at issue are separately licensed and created for the primary purpose of repair, and that the Librarian did not adequately assess that distinction in making its determination.
That argument is misplaced. The Librarian reasonably determined that the purpose and character of the secondary repair use favored fair use. In adopting the Register‘s 2021 recommendation, the Librarian understood that ISOs requested an exemption for “medical equipment computer programs and
To be sure, the Librarian did not address the proposed distinction between operating works and repair works. But that is because Appellants did not demonstrate before the agency the existence of this distinction that it now presses. At most, comments before the agency discuss the possible distinction only in vague terms and provide no supporting evidence. See, e.g., JA1356, JA1361. In fact, in the Ninth Rulemaking, one of Appellants argued that both the original and secondary uses of the work were the same: “operating a medical device or system.” JA1563. The other argued that both uses “share the exact same purpose—to enable the device[s] to function.” JA1552. So the record amply supported the Librarian‘s finding in the Ninth Rulemaking that “the original purpose of the software is to operate a device that functions as designed“—not to repair devices. JA812.
Moreover, Appellants were fully aware that the medical device repair exemption‘s “proponents were clear that they sought [the] exemption for diagnostic software and data files” and this repair use is distinct from the general operational software. Appellants’ Br. 30 (citation modified).
As for transformativeness, ISOs put clinical operation software to a new use when it is used as a tool for repairing medical devices, transforming the machines from nonfunctional to functional devices—a use that is markedly different from the original, manufacturer-intended purpose. Since the primary use of the clinical operation software by ISOs was fundamentally different from the primary purpose of Appellants, the Librarian found that the ISOs’ use is not a substitutive use, but transformative.
Appellants’ focus on the money exchanged for the repair service is not dispositive. In the 2021 recommendation during the eighth triennial rulemaking, the Register directly addressed this concern observing that Appellants “overstate[d] the significance of the commercial purpose element to the fair use analysis.” JA628. In that same analysis, the Register also supported the distinction in purpose by citing earlier analogous exemptions and comments on the initial proposals and replies. Id. In short, calling the Register‘s analysis, which the Librarian adopted, an “illogical ipse dixit,” Appellants’ Br. 33, is simply a claim unsupported by the record. Appellants’
Accordingly, on this record, the Librarian‘s conclusion that the ISOs’ use of clinical operation software is fundamentally transformative in nature and weighs in favor of a finding of fair use did not violate the APA.
B.
Next, we turn to the Librarian‘s assessment under the second statutory fair-use factor, “the nature of the copyrighted work.”
Here, both parties acknowledge that the computer programs at issue are functional works which serve to “enable users to control and understand the operation of the equipment.” JA629; see also Appellants’ Br. 52; Appellees’ Br. 36. Both the clinical operation software and the repair software are inherently utilitarian rather than artistic and thus beyond the “core of intended copyright.” Campbell, 510 U.S. at 586. Furthermore, the clinical operation software is not used for its “expressive qualities, but rather for its functional and informational aspects that enable users to control and understand the operation of the equipment.” JA629. The Librarian adopted the Register‘s finding that the specific works
Appellants, however, contend that the commercial purpose of the software, and their arguments regarding a lack of transformativeness, should turn the second factor against fair use. See Appellants’ Br. 54. Yet this contention incorrectly assumes that the commerciality of the use defeats the possibility that the use may be transformative due to its effects on the market for maintenance and repair services. We know that the commerciality of a use is not dispositive of its purpose. See Andy Warhol Found., 598 U.S. at 531. Additionally, we have already concluded that the Librarian did not err in determining that the use was transformative based on the record before the agency. See supra Section III. Similarly, in this rulemaking context, the Librarian did not err by following the general proposition that the software is functional and therefore favors fair use.
C.
Appellants’ challenge to the Librarian‘s assessment under the third statutory factor likewise fails. This fair-use factor asks whether “the amount and substantiality of the portion used in relation to the copyrighted work as a whole,”
Appellants argue that the third factor turns against fair use because the copy uses the entire work. See Appellants’ Br. 55. But even the copying of the entirety of a work can be justified if the amount and portion copied is “central to a copier‘s valid purpose.” Google, 593 U.S. at 33. Appellants make no developed argument in their briefing that the amount copied by the ISOs is too much relative to the purpose of repair. Appellants’ argument instead once again rests on mischaracterizing the scope of the medical device repair exemption. As stated previously, the Librarian did not err in finding that the copyrighted material at issue is clinical operation software and the exemption is confined to temporary access needed to repair those systems. See supra Section III. Because Appellants’ arguments presume that the exemption references a distinct and independent body of purely repair software, Appellants have offered no argument or analysis of the third factor in the context of clinical operation software that the Librarian, the Register, and the administrative record addressed. Additionally, the Register and Librarian accorded “little weight” to this factor. JA630; 86 Fed. Reg. at 59,637. Given the lack of meaningful alternative arguments, and the little weight accorded to this factor in the Librarian‘s decision, the Appellants have not demonstrated that the Librarian erred in finding that the third factor favors fair use.
D.
As to the Librarian‘s assessment of the fourth fair-use factor, we look to “the effect of the use upon the potential
The Librarian adopted the Register‘s view that the medical device repair exemption was “unlikely to harm the market for the embedded software,” JA631, 86 Fed. Reg. at 59,637, because “medical device and system software and data files are sold with the equipment and have no independent value separate from the devices,” JA630.
Appellants disagree, claiming market harm based upon loss of revenue from copiers, healthcare providers, and higher-cost manufacturer-affiliated technicians. But Appellants did not introduce evidence into the administrative record to prove their claims. In fact, one of the Appellants told the agency that “there is no independent market for the medical imaging device software beyond the devices themselves.” JA646 n.1261.
Here, the harm alleged by Appellants is the type that typically falls outside the realm of copyright protection because the secondary use cannot usurp or replace the market for the original. Recall that, per the Register‘s 2021 recommendation, ISOs neither retain copies nor create competing works using those copies because, even with the medical device repair exemption, users would be prohibited from “reproduc[ing] and retain[ing] additional copies of any copyrighted materials for use with other devices.” JA631. The ISOs’ purpose is to “restore a medical device or system‘s functionality, not to
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In sum, we uphold the Librarian‘s medical device repair exemption as consistent with the law, reasoned, and supported by the record. Accordingly, we affirm the district court‘s grant of summary judgment to the Librarian and Library of Congress.
So ordered.
Notes
Section 1201(a)(1)(C) provides:
During the 2-year period described in subparagraph (A), and during each succeeding 3-year period, the Librarian of Congress, upon the recommendation of the Register of Copyrights, who shall consult with the Assistant Secretary for Communications and Information of the Department of Commerce and report and comment on his or her views in making such recommendation, shall make the determination in a rulemaking proceeding for purposes of subparagraph (B) of whether persons who are users of a copyrighted work are, or are likely to be in the succeeding 3-year period, adversely affected by the prohibition under subparagraph (A) in their ability to make noninfringing uses under this title of a particular class of copyrighted works. In conducting such rulemaking, the Librarian shall examine—(i) the availability for use of copyrighted works; (ii) the availability for use of works for nonprofit archival, preservation, and educational purposes; (iii) the impact that the prohibition on the circumvention of technological measures applied to copyrighted works has on criticism, comment, news reporting, teaching, scholarship, or research; (iv) the effect of circumvention of technological measures on the market for or value of copyrighted works; and (v) such other factors as the Librarian considers appropriate.