Medical Imaging & Technology Alliance v. Library of Congress
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Opinion
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
MEDICAL IMAGING & TECHNOLOGY ALLIANCE, et al., Civil Action No. 22-499 (BAH) Plaintiffs, Chief Judge Beryl A. Howell v.
LIBRARY OF CONGRESS, et al.
Defendants.
MEMORANDUM OPINION
Nearly twenty-five years ago, Congress passed the Digital Millennium Copyright Act of
1998 (“DMCA”), 17 U.S.C. § 1201 et seq., to address the risks that the internet and new digital
technology posed to copyrighted works. At the same time, Congress also recognized that changing
marketplace realities and ever-evolving digital technologies might make some of the DMCA’s
tools to combat digital piracy harmful to innovation and non-infringing uses of copyrighted
materials. To provide flexibility in accommodating those varied policy interests, Congress
authorized the Librarian of Congress (“Librarian”) to promulgate exceptions every three years to
certain statutory proscriptions, including the DMCA’s prohibition on circumvention of
technological protection measures used by copyright owners to prevent access to their copyrighted
works (“TPMs”). This authority is at issue in this case.
On October 28, 2021, pursuant to her triennial rulemaking authority under the DMCA, the
Librarian adopted a final rule, effective the same date, that exempts parties accessing copyrighted
software for the purpose of diagnosis, maintenance, and repair of medical devices from the
statute’s proscription barring the circumvention of TPMs. Final Rule, Exemption to Prohibition
1 on Circumvention of Copyright Protection Systems for Access Control Technologies, 86 Fed. Reg.
59,627, 59,628 (Oct. 28, 2021) (“Exemption”), codified at 37 C.F.R. § 201.40. Four months after
the Final Rule went into effect, plaintiffs—the Medical Imaging & Technology Alliance and the
Advanced Medical technology Association, which are membership-based trade associations for
manufacturers of medical imaging equipment manufacturers, see Compl. ¶¶ 16-17, ECF No. 1—
initiated this lawsuit against defendants, the Library of Congress (“Library”) and the Librarian to
challenge the Exemption. Specifically, plaintiffs seek to have the Exemption for repair of medical
devices set aside and declared to be unlawful and void, and any enforcement by defendants
enjoined, pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq., the
Declaratory Judgment Act, 28 U.S.C. § 2201, and this Court’s inherent equitable powers. Id. ¶ 24,
Prayer for Relief. 1
Now pending are the parties cross-motions for summary judgment. See Pls.’ Mot. Summ.
J. (“Pls.’ Mot.”), ECF No. 10; Defs.’ Cross-Mot. Dismiss, ECF No. 16; Defs.’ Mem. Supp. Cross-
Mot. Dismiss (“Defs.’ Cross-Mem.”), ECF No. 16-1. For the reasons explained below,
defendants’ motion to dismiss is granted, and plaintiffs’ motion for summary judgment is denied.
I. BACKGROUND
The relevant statutory and regulatory scheme is described below, followed by a summary
of the factual and procedural background to this case.
A. Statutory and Regulatory Scheme
1 The Administrative Record (“AR”) in this case is voluminous and, in accordance with the local rules, the parties filed a Joint Appendix, containing portions of the AR cited or otherwise relied upon for the pending motions. See D.D.C. LCVR 7(n); Joint App’x at 1, ECF No. 24. The 9,410-page Joint Appendix is docketed in six separate attachments, see ECF Nos. 24-1–24-6. For clarity, “AR” citations herein are to those documents from the administrative record found in the Joint Appendix.
2 The Copyright Act of 1976, 17 U.S.C. § 101 et seq., proscribes the unauthorized
reproduction of “original works of authorship fixed in any tangible medium of expression.” Id.
§ 102(a). “Works of authorship” covered by the Copyright Act include “literary work[s],” which
themselves include “computer program[s].” Id. §§ 101, 102(a)(1), 109(b)(1)(A). While the
purpose of the Copyright Act is “to encourage the production of works” that, without copyright
protection, could be “reproduce[d] more cheaply” by others, this protection is intended to
encourage the production of new creative works, not “stand in the way of others exercising their
own creative powers.” Google LLC v. Oracle America, 141 S. Ct. 1183, 1195 (2021). To this
end, the Copyright Act codifies the fair use doctrine, which limits copyright protections as
necessary to encourage “criticism, comment, news reporting, teaching . . . scholarship, [and]
research.” 17 U.S.C. § 107.
Anticipating the changing digital landscape, Congress passed the DMCA in 1998 to
facilitate electronic commerce, communications, development, and education while
simultaneously addressing the threats that the internet and new digital technology posed to
copyrighted works. S. Rep. No. 105-190, at 1–2 (1998); see also Egilman v. Keller & Heckman,
LLP, 401 F. Supp. 2d 105, 112 (D.D.C. 2005) (quoting Universal City Studios, Inc. v. Corley, 273
F.3d 429, 435 (2d Cir. 2001)) (“Congress enacted the DMCA in 1998 ‘to strengthen copyright
protection in the digital age.’”). Observing that “copyright owners will hesitate to make their
works readily available on the Internet without reasonable assurance that they will be protected
against massive piracy[,]” S. Rep. No. 105-190, at 8, the Senate Committee Report on the DMCA
explained that “the law must adapt in order to make digital networks safe places to disseminate
and exploit copyrighted materials.” Id. at 2. The DMCA accordingly “create[d] the legal platform
for launching the global digital on-line marketplace for copyrighted works.” Id. at 8.
3 To combat digital privacy, the DMCA prohibits, inter alia, “circumvent[ing] a
technological measure that effectively controls access to a work protected under” the Copyright
Act. 17 U.S.C. § 1201(a)(1)(A) (“the anti-circumvention provision”). As defined in the anti-
circumvention provision, to “circumvent a technological measure” means “to descramble a
scrambled work, to decrypt an encrypted work, or otherwise to avoid, bypass, remove, deactivate,
or impair a technological measure, without the authority of the copyright owner.” Id.
§ 1201(a)(3)(A). Exceptions to the anti-circumvention provision are provided to allow
circumvention of a TPM (or another form of access control to a copyrighted work) in the following
instances: (1) in order for a school or library to determine whether to acquire a copyrighted product;
(2) for law enforcement purposes; (3) to identify and analyze elements necessary to achieve
interoperability of computer programs; (4) to engage in encryption research; (5) as necessary to
limit the Internet access of minors; (6) as necessary to protect personally identifying information;
Free access — add to your briefcase to read the full text and ask questions with AI
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
MEDICAL IMAGING & TECHNOLOGY ALLIANCE, et al., Civil Action No. 22-499 (BAH) Plaintiffs, Chief Judge Beryl A. Howell v.
LIBRARY OF CONGRESS, et al.
Defendants.
MEMORANDUM OPINION
Nearly twenty-five years ago, Congress passed the Digital Millennium Copyright Act of
1998 (“DMCA”), 17 U.S.C. § 1201 et seq., to address the risks that the internet and new digital
technology posed to copyrighted works. At the same time, Congress also recognized that changing
marketplace realities and ever-evolving digital technologies might make some of the DMCA’s
tools to combat digital piracy harmful to innovation and non-infringing uses of copyrighted
materials. To provide flexibility in accommodating those varied policy interests, Congress
authorized the Librarian of Congress (“Librarian”) to promulgate exceptions every three years to
certain statutory proscriptions, including the DMCA’s prohibition on circumvention of
technological protection measures used by copyright owners to prevent access to their copyrighted
works (“TPMs”). This authority is at issue in this case.
On October 28, 2021, pursuant to her triennial rulemaking authority under the DMCA, the
Librarian adopted a final rule, effective the same date, that exempts parties accessing copyrighted
software for the purpose of diagnosis, maintenance, and repair of medical devices from the
statute’s proscription barring the circumvention of TPMs. Final Rule, Exemption to Prohibition
1 on Circumvention of Copyright Protection Systems for Access Control Technologies, 86 Fed. Reg.
59,627, 59,628 (Oct. 28, 2021) (“Exemption”), codified at 37 C.F.R. § 201.40. Four months after
the Final Rule went into effect, plaintiffs—the Medical Imaging & Technology Alliance and the
Advanced Medical technology Association, which are membership-based trade associations for
manufacturers of medical imaging equipment manufacturers, see Compl. ¶¶ 16-17, ECF No. 1—
initiated this lawsuit against defendants, the Library of Congress (“Library”) and the Librarian to
challenge the Exemption. Specifically, plaintiffs seek to have the Exemption for repair of medical
devices set aside and declared to be unlawful and void, and any enforcement by defendants
enjoined, pursuant to the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq., the
Declaratory Judgment Act, 28 U.S.C. § 2201, and this Court’s inherent equitable powers. Id. ¶ 24,
Prayer for Relief. 1
Now pending are the parties cross-motions for summary judgment. See Pls.’ Mot. Summ.
J. (“Pls.’ Mot.”), ECF No. 10; Defs.’ Cross-Mot. Dismiss, ECF No. 16; Defs.’ Mem. Supp. Cross-
Mot. Dismiss (“Defs.’ Cross-Mem.”), ECF No. 16-1. For the reasons explained below,
defendants’ motion to dismiss is granted, and plaintiffs’ motion for summary judgment is denied.
I. BACKGROUND
The relevant statutory and regulatory scheme is described below, followed by a summary
of the factual and procedural background to this case.
A. Statutory and Regulatory Scheme
1 The Administrative Record (“AR”) in this case is voluminous and, in accordance with the local rules, the parties filed a Joint Appendix, containing portions of the AR cited or otherwise relied upon for the pending motions. See D.D.C. LCVR 7(n); Joint App’x at 1, ECF No. 24. The 9,410-page Joint Appendix is docketed in six separate attachments, see ECF Nos. 24-1–24-6. For clarity, “AR” citations herein are to those documents from the administrative record found in the Joint Appendix.
2 The Copyright Act of 1976, 17 U.S.C. § 101 et seq., proscribes the unauthorized
reproduction of “original works of authorship fixed in any tangible medium of expression.” Id.
§ 102(a). “Works of authorship” covered by the Copyright Act include “literary work[s],” which
themselves include “computer program[s].” Id. §§ 101, 102(a)(1), 109(b)(1)(A). While the
purpose of the Copyright Act is “to encourage the production of works” that, without copyright
protection, could be “reproduce[d] more cheaply” by others, this protection is intended to
encourage the production of new creative works, not “stand in the way of others exercising their
own creative powers.” Google LLC v. Oracle America, 141 S. Ct. 1183, 1195 (2021). To this
end, the Copyright Act codifies the fair use doctrine, which limits copyright protections as
necessary to encourage “criticism, comment, news reporting, teaching . . . scholarship, [and]
research.” 17 U.S.C. § 107.
Anticipating the changing digital landscape, Congress passed the DMCA in 1998 to
facilitate electronic commerce, communications, development, and education while
simultaneously addressing the threats that the internet and new digital technology posed to
copyrighted works. S. Rep. No. 105-190, at 1–2 (1998); see also Egilman v. Keller & Heckman,
LLP, 401 F. Supp. 2d 105, 112 (D.D.C. 2005) (quoting Universal City Studios, Inc. v. Corley, 273
F.3d 429, 435 (2d Cir. 2001)) (“Congress enacted the DMCA in 1998 ‘to strengthen copyright
protection in the digital age.’”). Observing that “copyright owners will hesitate to make their
works readily available on the Internet without reasonable assurance that they will be protected
against massive piracy[,]” S. Rep. No. 105-190, at 8, the Senate Committee Report on the DMCA
explained that “the law must adapt in order to make digital networks safe places to disseminate
and exploit copyrighted materials.” Id. at 2. The DMCA accordingly “create[d] the legal platform
for launching the global digital on-line marketplace for copyrighted works.” Id. at 8.
3 To combat digital privacy, the DMCA prohibits, inter alia, “circumvent[ing] a
technological measure that effectively controls access to a work protected under” the Copyright
Act. 17 U.S.C. § 1201(a)(1)(A) (“the anti-circumvention provision”). As defined in the anti-
circumvention provision, to “circumvent a technological measure” means “to descramble a
scrambled work, to decrypt an encrypted work, or otherwise to avoid, bypass, remove, deactivate,
or impair a technological measure, without the authority of the copyright owner.” Id.
§ 1201(a)(3)(A). Exceptions to the anti-circumvention provision are provided to allow
circumvention of a TPM (or another form of access control to a copyrighted work) in the following
instances: (1) in order for a school or library to determine whether to acquire a copyrighted product;
(2) for law enforcement purposes; (3) to identify and analyze elements necessary to achieve
interoperability of computer programs; (4) to engage in encryption research; (5) as necessary to
limit the Internet access of minors; (6) as necessary to protect personally identifying information;
or (7) to engage in security testing of a computer, computer system, or computer network. See 17
U.S.C. § 1201(d)–(j).
In addition to these statutory exceptions, the DMCA directs the Librarian to determine,
through triennial rulemaking proceedings, any categories of copyrighted materials that should be
exempted from the anti-circumvention provision for the next three-year period because the
restriction adversely prevents users of copyrighted works from making noninfringing use of
copyrighted material. See id. § 1201(a)(1)(C). As explained in the House Committee Report on
the DMCA, Congress was concerned that evolving “marketplace realities” might make access to
copyrighted materials unjustifiably difficult, so the triennial rulemaking requirement created a
“‘fail-safe’ mechanism” that allowed the Library to “monitor developments in the marketplace for
copyrighted materials,” and “selectively waive[]” the anti-circumvention provision for a particular
4 category of materials for “limited time periods, [as] necessary to prevent a diminution in the
availability to individual users of [that] particular category of copyrighted materials.” H.R. Rep.
No. 105-551(II), at 36 (1998).
When engaging in the statutorily authorized triennial rulemaking authority, the Librarian
must comply with several requirements. First, the DMCA obligates the Librarian to make her
rulemaking determinations “upon the recommendation of the Register of Copyrights,” who in turn
must “consult with the Assistant Secretary for Communications and Information of the Department
of Commerce.” 17 U.S.C. § 1201(a)(1)(C). Second, the DMCA provides that exemptions to the
anticircumvention rule are authorized only if users are “adversely affected by” the rule “in their
ability to make noninfringing uses.” Id. In making this assessment during rulemaking, the
Librarian must examine the following enumerated factors: “(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 [access controls]
has on criticism, comment, news reporting, teaching, scholarship, or research; (iv) the effect of
circumvention of [access controls] on the market for or value of copyrighted works; and (v) such
other factors as the Librarian considers appropriate.” Id. The Librarian must also “assess whether
the implementation of access controls impairs the ability of individuals to make noninfringing uses
of copyrighted works within the meaning of section 1201(a)(1).” Exemption, 86 Fed. Reg. 59,627,
59,628.
The Librarian is the final decisionmaker, but the Register is tasked with conducting the
rulemaking process and making recommendations on exemptions to the Librarian. The House
Committee Report explains that, “in recognition of the expertise of the Copyright Office, the
Register of Copyrights will conduct the rulemaking, including providing notice of the rulemaking,
5 seeking comments from the public, consulting with the Assistant Secretary for Communications
and Information of the Department of Commerce and any other agencies that are deemed
appropriate.” H.R. Rep. No. 105-796, at 64. “To aid in this process, the Register develops a
comprehensive administrative record using information submitted by interested members of the
public, and makes recommendations to the Librarian concerning whether exemptions are
warranted based on that record.” 86 Fed. Reg. at 59,628. Proponents seeking an exception must
demonstrate “(1) that uses affected by the prohibition on circumvention are or are likely to be
noninfringing; and (2) that as a result of [a TPM], the prohibition is causing, or in the next three
years is likely to cause, an adverse impact on those uses.” Id. “The Register will recommend
granting an exemption only ‘when the preponderance of the evidence in the record shows that the
conditions for granting an exemption have been met.’” Id. Upon receiving these recommendations
from the Register, the Librarian then issues a Final Rule promulgating the temporary exemptions
for the next three-year period. See Exemption, 86 Fed. Reg. 59,627. 2
B. Exemption Adopted During Eighth Triennial Rulemaking Proceeding
The challenged exemption was adopted by the Librarian following a sixteen-month
rulemaking process involving formal notices, submission and consideration of proposals,
comments, a hearing, and a fulsome explanation by the Register regarding application of the
requisite statutory factors, as summarized below.
1. Notice of Proposed Rulemaking, Petitions and Comments
2 During the three-year period beginning October 28, 2021, the Librarian adopted twenty-six exemptions for classes of copyrighted works. See 86 Fed. Reg 59,627. Examples of classes of copyrighted works for which the Librarian has granted an exemption include “computer programs that control motorized land vehicles” and “computer programs that control smartphones, home appliances, or home systems” for diagnosis, maintenance, or repair, id. at 59,631, excerpts of audiovisual works for criticism and comment, id. at 59,632, and literary works for use with assistive technologies for disabled individuals, id. at 59,633, 59,634.
6 The eighth triennial rulemaking proceeding began on June 22, 2020, when the U.S.
Copyright Office (“the Office”) submitted a Notice of Inquiry, published in the Federal Register,
U.S. Copyright Office, seeking petitions for renewals of existing exemptions and proposals for
new exemptions. Notice of Inquiry, Exemptions to Permit Circumvention of Access Controls on
Copyrighted Works, 85 Fed. Reg. 37,399 (June 22, 2020) (“Notice”), AR at 45–49. Upon receipt
of twenty-seven petitions for new or expanded exemptions in response to the Notice, the Office
organized the petitions into seventeen proposed classes for exceptions, and then requested
comment. Notice of Proposed Rulemaking, Exceptions to Permit Circumvention of Access
Controls on Copyrighted Works, 85 Fed. Reg., 65,293, 65,302 (Oct. 15, 2020) (“NPRM”), AR at
50–67.
Two of the petitions noticed for comment were submitted by two so-called independent
service organizations (“ISOs”), which are non-manufacturer companies hired by hospitals and
other medical professionals to repair and maintain complex, computer-controlled medical
equipment. These ISOs petitioned for an exemption to allow TPMs in computer-controlled
medical equipment to be circumvented “for the purpose of diagnosis, maintenance, or repair of
such a device.” Summit Imaging, Inc.’s Petition for New Exemption under 17 U.S.C. § 1201, AR
at 2357 (“Summit Petition”); accord Transtate Equipment Company’s Petition for New Exemption
under 17 U.S.C. § 1201, AR at 2362 (“Transtate Petition”). The principal justification for the
exemption sought by these two ISOs was the strong public health interest in “maintain[ing] and
repair[ing] lifesaving equipment,” a need that “has been magnified by the current COVID-19
pandemic.” Summit Petition at 2, AR at 2357; see also Transtate Petition at 4, AR at 2365 (“The
ability to diagnose, maintain, and repair medical equipment is a public health priority, particularly
in the midst of a global health crisis. . . .).
7 Plaintiffs’ members are “original equipment manufacturers” (“OEMs”), which develop and
manufacture medical devices, such as MRI machines, CT scanners, and defibrillators. Compl.
¶ 37. To allow the medical devices “to deliver their advanced capabilities safely and effectively,”
OEMs “design and write software embedded within the machines,” which software is comprised
of computer code that “is original copyrighted work created by the OEM” and protected by the
Copyright Act. Id. ¶¶ 37-38; see also 17 U.S.C. §§ 101, 102(a). These devices also store and relay
confidential patient data to providers connected to the network. Compl. ¶ 37. To safeguard their
copyrighted material and patient data, OEMs use a wide variety of TPMs to guard against
unauthorized access to their copyrighted material. Id. ¶¶ 37, 41, 45. According to plaintiffs, OEMs
rely on copyright protections to recoup their substantial investments and facilitate further
innovations to their medical devices, and absent such protections, they will not be able to continue
developing more effective and efficient devices. Id. ¶¶ 53-55. Due to the potential risks to patients
and providers posed by unauthorized access or release of sensitive patient information, the Food
and Drug Administration (“FDA”) strictly regulates OEMs and the medical devices they
manufacture. Id. ¶ 46.
ISOs provide third-party maintenance and repair services for these medical devices, though
these services are not necessarily authorized by OEMs. Id. ¶¶ 42-43, 47-50. To provide
maintenance services for these medical devices, ISOs must circumvent TPMs to access OEM
software. As Summit explained, “Unless hospitals or other owners of medical devices purchase
expensive service contracts from the manufacturer, they may be unable to repair their own
equipment (or have it repaired by an independent service provider) without risking a lawsuit
against them or their service provider for allegedly violating the anti-circumvention provisions of
the [DMCA].” Summit Petition at 2, AR at 2357; Transtate Petition, AR at 2363 (“This exemption
8 is sought to allow for timely critical servicing activities required for medical systems and devices
. . . used by hospitals and other medical service providers to care for individuals in need of medica
attention.”). Plaintiffs counter that the primary reason ISOs circumvent TPMs is to “benefit [their]
commercial interests, resulting in greater market share and more profits.” Compl. ¶ 49.3
In soliciting comments regarding the submitted petitions, the Office combined several
petitions relating to repair of software-enabled devices, including the Summit and Transtate
petitions, into a single proposed class, noting that current exemptions already include repair-related
exemptions to access computer programs in automobiles, smartphones, and home systems and
appliances for repair-related purposes. 85 Fed. Reg. at 65,306, 65,307, AR at 63–64. The Office
scheduled three rounds of comments from: (1) proponents of petitions or neutral parties; (2)
opponents of petitions; and (3) proponents or neutral parties replying to arguments or facts raised
in other comments. Id. at 65,302, AR at 59. Transtate and Summit both submitted comments in
support of their petitions, AR at 2909–16; AR at 2917–53, while plaintiffs filed opposing
comments, AR at 4010–24; AR at 4095–30; AR at 4131–56. Transtate also submitted reply
comments. AR at 4507–12.
Plaintiffs criticized the Transtate and Summit exemption petitions as violating the basic
purposes of copyright law and damaging the market while providing only commercial gain to the
ISOs. As support, plaintiffs explained, first, that the proposed exemptions would only facilitate
competing maintenance and repair services, with nothing transformative about the ISOs’ intended
uses. See Compl., Ex. B, Medical Imaging & Technology Alliance Comments (“MITA
Comments”) at 8–9, ECF No. 1-2; Compl., Ex. C, Advanced Medical Technology Association
Comments (“AdvaMed Comments”) at 7–8, ECF No. 1-3; see also Compl., Ex. D, Philips North
3 Many OEMs, nonetheless, “provide service specifications to ISOs to enable them to perform maintenance and repair services.” Id. ¶ 51.
9 America, LLC Comments (“Phillips Comments”) at 7–8 & n.24, ECF No. 1-4. Second, plaintiffs
complained that, because the software at issue is innovative and required substantial investment of
time and labor made in anticipation of financial return, the proposed exemption would allow ISOs
to free-ride off the work of OEMs and discourage the production of further similar work. MITA
Comments 9; AdvaMed Comments 8–9. Third, plaintiffs asserted that the proposed exemption
would decrease the value of the copyrighted software and the medical devices that require the
software to function by making circumvention of TPMs protecting these devices more likely,
exacerbating cybersecurity risks and putting patient data and OEMs intellectual property at risk of
exposure. MITA Comments 9-10; AdvaMed Comments 8–11; see also Phillips Comments 9–10.
Finally, according to plaintiffs, by increasing TPM circumvention, the requested exemption could
damage the devices themselves and introduce dangers such as electrical shock, mechanical failure,
improper dosing, and burns. AdvaMed Comments 3, 11-15; MITA Comments 3-5; see also
Philips Comments 17-19.
2. Hearing
Following the close of the comment period, the Office held a hearing, after notice, on April
20, 2021, regarding the proposed exemption for repairing computer software. See Notice of Public
Hearings, Exemptions to Permit Circumvention of Access Controls on Copyrighted Works, 86
Fed. Reg. 8560, 8561 (Feb. 8, 2021), AR at 68–69. A representative from Transtate and a
representative from the International Association of Medical Equipment Remarketers and
Servicers testified. AR at 5627–5763. Plaintiffs did not participate. See id.
3. Register’s Recommendation
Based upon the evidence gathered and submitted during the rulemaking process, the
Register submitted her recommendation to the Librarian in October 2021. See Section 1201
10 Rulemaking: Eighth Triennial Proceeding to Determine Exemptions to the Prohibition on
Circumvention: Recommendation of the Register of Copyrights (Oct. 2021), AR at 1571–1926.
The Recommendation concluded that “the prohibition on circumvention of TPMs is causing, or is
likely to cause, an adverse impact on the noninfringing diagnosis, repair, and maintenance of
medical devices and systems.” AR at 1802.
In explaining this recommendation, the Register considered four statutory factors guiding
the analysis of whether diagnosis, maintenance, and repair was likely to be a noninfringing use of
the copyrighted software under the fair use doctrine. AR at 1781–85.4 As to the first factor—“the
purpose and character of the use”— the Register concluded that, although device repair can be
commercialized, ISOs’ repair activities were intended to “restore” a device’s “functionality, not to
commercialize the embedded copyrighted software.” AR at 1782. Referencing her prior
conclusions that diagnosis, maintenance, and repair of other software-enabled devices “are likely
to be transformative uses,” the Register determined that the first factor weighed in favor of fair
use. Id.
The Register also found that the second factor—the nature of the copyrighted work—
favored a finding of fair use because ISOs and hospitals did not seek to use the copyrighted
software for its “expressive qualities,” but rather for the “functional and informational” purposes
of allowing them to operate the medical equipment. AR at 1783. As to the third factor—the
amount and substantiality of the copyrighted work used—the Register determined that it also
weighed in favor of finding fair use because the ISOs’ desired use is “necessary to accomplish the
4 The Copyright Act provides that “fair use of a copyrighted work” is “not an infringement of copyright,” 17 U.S.C. § 107, and outlines four factors “to be considered” in making a fair use determination: (1) “the purpose and character of the use, including whether such 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.” Id.
11 transformative purpose[] of diagnosis, maintenance, and repair,” which the Register believed was
“reasonable” under the circumstances. AR at 1784.
Finally, the Register evaluated the fourth factor—the effect of the use on the market value
of the copyrighted work—and found that it also weighed in favor of finding fair use since
diagnosis, repair, and maintenance of software-enabled medical devices and systems would
minimally “effect [ ] the market for or value of the copyrighted works because medical device and
system software and data files are sold with the equipment and have no independent value separate
from the devices[.]” Id. The Register observed, however, that if an ISO or provider were to
“reproduce and retain additional copies of any copyrighted materials for use with other devices, or
enable permanent access to subscription-only services, those activities would remain prohibited
because they fall outside the scope of the proposed exemption.” AR at 1785.
Upon finding that the proffered uses by ISOs of the OEMs’ copyrighted software were
likely noninfringing, the Register next found that the prohibition against circumvention here was
“adversely affecting” the repair of the at-issue medical devices, pursuant to the statutory criteria
for an exception outlined in 17 U.S.C. § 1201(a)(1)(C). AR at 1802. With respect to the first
statutory factor—the availability for use of copyrighted works—the Register concluded that the
prohibition on circumvention for these types of medical devices “makes medical equipment
software and manuals less available for use in noninfringing diagnosis, maintenance, and repair,”
rejecting the plaintiffs’ comments that the medical device software is otherwise broadly licensed
and available. AR at 1799. As to the second and third statutory factors—the availability for use
of works for nonprofit purposes and the impact that anti-circumvention provision has on criticism,
comment, news reporting, teaching, scholarship, or research—the Register did not find “these
factors [ ] especially relevant to the determination.” AR at 1800–01. The Register accordingly
12 sidestepped an OEM argument that the ISOs’ interest here is purely commercial-oriented,
observing instead that “repair of medical devices and systems that are no longer supported by
OEMs arguably preserves the availability for use of the equipment’s software and servicing
materials.” Id. As to the fourth statutory factor, the Register discounted plaintiffs’ concerns of
harms to the market, concluding that the narrow scope of the exemption and proposed ISO uses
“limit[s] any potential market harm” because repair of medical equipment “support[s] rather than
displace[s] the embedded computer programs,” and the device software has “no independent value
separate from the equipment [it] operate[s] or explain[s].” AR at 1800. Finally, as to the fifth
statutory factor—granting the Librarian discretion to consider additional factors as she deems
appropriate—the Register found relevant that the exemption could help address competitive
concerns related to OEMs dominating the repair market and the FDA’s determination that the
exemption did not pose a substantial safety or security concern. AR at 1801–02. The Register
accordingly recommended that the Librarian grant the requested exemption. Id. at 1804–06.
4. Librarian’s Final Rule Adopting Exemption
After considering the Register’s recommendation, the Librarian adopted the Exemption in
a final rule on October 28, 2021. Exemption, 86 Fed. Reg. 59,627, AR at 70–84. In relevant part,
the final rule exempts “computer 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” from the
anti-circumvention provision. 37 C.F.R. § 201.40(b)(15), AR at 83. The Exemption defines
“maintenance” as the “servicing of the device or system in order to make it work in accordance
with its original specifications and any changes to those specifications authorized for that device
or system,” id. at § 201.40(b)(15)(i), AR at 83, and defines “repair” as “the restoring of the device
13 or system to the state of working in accordance with its original specifications and any changes to
those specifications authorized for that device or system.” Id. at § 201.40(b)(15)(ii), AR at 83. By
its terms then, the Exemption is solely limited to repair, diagnosis, and maintenance, and does not
exempt ISOs or other users from liability under other provisions of the DMCA. See id.
§ 201.40(b)(15), AR at 83.
C. Procedural History
On February 25, 2022, plaintiffs filed their Complaint for declaratory and injunctive relief,
alleging that the Librarian’s adoption in the Final Rule of the Exemption for repair of medical
devices violates the APA, as arbitrary and capricious and not in accordance with the law, Compl.
¶¶ 78–85, and contrary to the APA’s procedural requirements because the Librarian failed to
respond to critical comments, id. ¶¶ 86–91. Alternatively, plaintiffs claim that, if the APA is
inapplicable to the Library of Congress, the Librarian’s action should be deemed ultra vires as
outside the scope of her statutory authority and in violation of the constitutional separation of
powers. Id. ¶¶ 92–101 (citing Larson v. Domestic and Foreign Com. Corp., 337 U.S. 682 (1949)).
About one month after instituting this lawsuit, plaintiffs filed their motion for summary
judgment, Pls.’ Mot., to which defendants have responded by moving to dismiss, under Federal
Rule of Civil Procedure 12(b)(6), plaintiffs’ ultra vires and constitutional claims for failure to state
plausible claims, or in the alternative, cross-motion for summary judgment, under Federal Rules
of Civil Procedure 12(b)(1), 12(b)(6), and 56, because plaintiffs’ APA claims are barred under the
doctrine of sovereign immunity. See generally, Defs.’ Cross-Mem.; Defs.’ Opp’n Pls.’ Mot.
Summ. J., ECF No. 17. With the parties having filed their respective oppositions and replies, Pls.’
Consolidated Reply Supp. Mot. Summ J. & Opp’n Govt’s Mot. Dismiss, ECF No. 18; Defs.’ Reply
14 Supp. Mot. Dismiss, ECF No. 20, and the joint appendix, Joint App’x, ECF No. 24, the parties’
cross-motions are ripe for resolution.
II. LEGAL STANDARD
“Article III of the Constitution prescribes that ‘[f]ederal courts are courts of limited subject-
matter jurisdiction’ and ‘ha[ve] the power to decide only those cases over which Congress grants
jurisdiction.’” Bronner ex rel. Am. Stud. Ass’n v. Duggan, 962 F.3d 596, 602 (D.C. Cir. 2020)
(alterations in original) (quoting Al-Zahrani v. Rodriguez, 669 F.3d 315, 317 (D.C. Cir. 2012));
see also Gunn v. Minton, 568 U.S. 251, 256 (2013) (“‘Federal courts are courts of limited
jurisdiction,’ possessing ‘only that power authorized by Constitution and statute.’” (quoting
Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994))). Absent subject-matter
jurisdiction over a case, the court must dismiss it. See Arbaugh v. Y & H Corp., 546 U.S. 500,
506–07 (2006) (citing Kontrick v. Ryan, 540 U.S. 443, 455 (2004)); FED. R. CIV. P. 12(h)(3).
To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), the plaintiff
bears the burden of demonstrating the court’s subject-matter jurisdiction over the claim at issue.
Arpaio v. Obama, 797 F.3d 11, 19 (D.C. Cir. 2015). When considering a motion to dismiss under
Rule 12(b)(1), the court must determine jurisdictional questions by accepting as true all
uncontroverted material factual allegations contained in the complaint and “‘constru[ing] the
complaint liberally, granting plaintiff[s] the benefit of all inferences that can be derived from the
facts alleged.’” Hemp Indus. Ass’n v. DEA, 36 F.4th 278, 281 (D.C. Cir. 2022) (second alteration
in original) (quoting Am. Nat’l Ins. Co. v. FDIC, 642 F.3d 1137, 1139 (D.C. Cir. 2011)). The court
need not accept inferences drawn by the plaintiff, however, if those inferences are unsupported by
facts alleged in the complaint or amount merely to legal conclusions. Id. at 288 (alteration in
original) (quotation marks omitted) (making clear that liberally construing complaint in plaintiff’s
15 favor “does not entail accept[ing] inferences unsupported by facts or legal conclusions cast in the
form of factual allegations”).
To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), “[a]
plaintiff need not make ‘detailed factual allegations,’” but the “complaint must contain sufficient
factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” VoteVets
Action Fund v. McDonough, 992 F.3d 1097, 1104 (D.C. Cir. 2021) (quoting Ashcroft v. Iqbal, 556
U.S. 662, 678 (2009)). A facially plausible claim pleads facts that are not “‘merely consistent
with’ a defendant's liability” but that “allow[ ] the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (quoting Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 556 (2007)); accord Atchley, v. AstraZeneca UK Limited, et al., 22 F.4th
204, 214 (D.C. Cir. 2022). In deciding a motion under Rule 12(b)(6), the court must consider the
whole complaint, accepting all factual allegations as true, “even if doubtful in fact.” Twombly,
550 U.S. at 555. Courts do not, however, “assume the truth of legal conclusions . . . nor . . . accept
inferences that are unsupported by the facts set out in the complaint.” Arpaio, 797 F.3d at 19
(internal citation omitted).
III. DISCUSSION
Defendants’ motion to dismiss all four of plaintiffs’ claims is predicated on a
straightforward three-pronged argument. First, they argue that Congress exempted itself and the
Library of Congress from APA review and thus sovereign immunity bars plaintiffs’ procedural
and substantive APA claims, in Counts I and II, under Rule 12(b)(1). Defs.’ Cross-Mem. at 16–
23. Second, plaintiffs have failed to plead, in Count III, a plausible statutory ultra vires claim
because they have not alleged the Librarian violated a specific prohibition in the DMCA that is
clear and mandatory. Id. at 37–40. Finally, defendants contend that the DMCA rulemaking
16 scheme, challenged in Count IV, does not violate the constitutional separation of powers because
the Librarian is appointed by the President in accord with the Appointments Clause, so the
regulatory scheme does not place unconstitutional power in Congress to legislate without proper
bicameralism and presentment. Id. at 41–44.
Defendants are right on all counts. First, plaintiffs’ APA claims are barred by sovereign
immunity because the Librarian’s decisions are not subject to APA review. Second, plaintiffs’
ultra vires claim fails because the Librarian’s promulgation of the Exemption does not amount to
the type of extreme statutory error required to state a plausible claim. Third, plaintiffs’
constitutional challenge is meritless because members of Congress do not participate in the
challenged rulemaking, and the Librarian of Congress and the Register of Copyrights are subject
to the control of the Chief Executive in carrying out these responsibilities.
A. Plaintiffs’ APA Claims Are Barred By Sovereign Immunity
The parties do not dispute that the United States is immune from suit absent express consent
to be sued. See United States v. Sherwood, 312 U.S. 584, 586 (1941). As noted, defendants
contend that the APA does not waive sovereign immunity for the Library, even when the Library
is engaging in rulemaking proceedings, requiring dismissal of plaintiffs’ APA challenges for lack
of jurisdiction. Defs.’ Cross-Mem. at 16–23.
This inquiry begins, as it must, with the statute’s text. The APA contains an express waiver
of sovereign immunity for “[a]n action . . . seeking relief other than money damages and stating a
claim that an agency or an officer or employee thereof acted or failed to act in an official capacity
or under color of legal authority shall not be dismissed . . . on the ground that it is against the
United States or that the United States is an indispensable party.” 5 U.S.C. § 702. The APA
defines “agency” as “each authority of the Government of the United States, whether or not it is
17 within or subject to review by another agency, but does not include—(A) the Congress . . . .” 5
U.S.C. §§ 701(b)(1), 551(1). The Library of Congress is indisputably part of Congress, see Pls.’
Mot. at 28–29; Defs.’ Cross-Mem. at 16–17, and, accordingly, pursuant to the plain text of Section
701(b)(1), the Library is excluded from the definition of an “agency.” See Kissinger v Reps.
Comm’n for the Freedom of the Press, 445 U.S. 136, 145 (1979) (holding that the Library “is not
an ‘agency’” within the meaning of the term used in the Freedom of Information Act (“FOIA”),
which uses the same definition of “agency” as the APA); see also Intel Corp. Inv. Pol’y Comm. v.
Sulyma, 140 S. Ct 768, 776 (2020) (“We must enforce plain and unambiguous statutory language
. . . according to its terms.”) (quotation marks omitted). The result is that the Library does not
qualify as an “agency” subject to the APA.
If the plain text were not enough, Congress’s decision to make the Copyright Office, which
is a component of the Library, subject to the APA—but not the Library of Congress as a whole—
confirms that Congress intended to exclude the Library from the APA. Specifically, after the APA
was passed, Congress amended U.S. copyright law to make the Copyright Office subject to the
APA. See 17 U.S.C. § 701(e) (“Except as provided by section 706(b) and the regulations issued
thereunder, all actions taken by the Register of Copyrights under this title are subject to the
provisions of the [APA.]”); H.R. Rep. No. 94-1476 at 171 (1976), reprinted in 1976 U.S.C.C.A.N.
5659 (“Under an amendment to section 701 adopted by the Committee, the Copyright Office is
made fully subject to the [APA] . . . .”). If the APA already provided a statutory authorization for
review of the Librarian’s rulemaking decisions under the Copyright Act or the DMCA, section
706(b)’s addition would have been superfluous. See Hohn v. United States, 524 U.S. 236, 249
(1998) (“We are reluctant to adopt a construction making another statutory provision
superfluous.”). Instead, this precise congressional action making the Copyright Office subject to
18 the APA, but not the Library, reflects a specific choice to decline waiving sovereign immunity
under the APA as to the latter.
To put matters to rest, binding D.C. Circuit precedent makes crystal clear that the Library
is not an “agency,” as that term is defined in the APA and therefore not subject to the APA. See
Clark v. Libr. of Cong., 750 F.2d 89, 102-03 (D.C. Cir. 1984) (citing 5 U.S.C. § 701(b)(1)(A)
(“[T]he Library of Congress is not an ‘agency’ as defined under the [APA].”); Ethnic Employees
of Libr. of Cong. v. Boorstin, 751 F.2d 1405,1416 n.15 (D.C. Cir. 1985) (observing “that the
Library is not an agency under the Administrative Procedure Act”); Wash. Legal Found. v. U.S.
Sent’g Comm., 17 F.3d 1446, 1449 (D.C. Cir. 1994) (noting that “the Library of Congress . . . is
exempt from the APA because its provisions do not apply to ‘the Congress’—that is, the legislative
branch”).
Notwithstanding this clear textual evidence and binding precedent, plaintiffs assert that the
Library of Congress should only be exempt from the APA when acting in a “legislative” capacity,
in contrast to its role in the triennial rulemaking process under the DMCA. Pls.’ Mot. at 28–34.
Citing to dicta in several court decisions analyzing the Library of Congress’ structure under the
Appointments Clause, U.S. CONST., art. II, § 2, cl., 2, plaintiffs maintain that when exercising
functions similar to those of Executive Branch agencies, the Library should be treated like an
agency subject to the APA. Id. (citing Intercollegiate Broad. Sys., Inc. v. Copyright Royalty Bd.,
684 F.3d 1332 (D.C. Cir. 2012); Live365, Inc. v. Copyright Royalty Bd., 698 F. Supp. 2d 25
(D.D.C. 2010); Eltra Corp. v. Ringer, 579 F.2d 294 (4th Cir. 1978)). Plaintiffs also attempt to
distinguish Clark v. Library of Congress by describing the Library as acting in a legislative
capacity in that case, whereas when engaging in triennial rulemaking under the DMCA, the Library
should qualify as an “agency” for purposes of the APA. Pls.’ Reply at 10 (second and third
19 alterations in original) (“[T]o determine the capacity in which the Library is acting, courts
‘consider each [of its] function[s] . . . separately and . . . determine the character of each, whether
legislative or executive.’ Eltra, 579 F.2d at 301. That explains the outcome in Clark.”).
Plaintiffs’ wishful reading of these cases does not withstand scrutiny. For starters, the issue
addressed in the cases plaintiffs cite concerned the validity of the Library’s structure under the
Appointments Clause, without touching on whether the Library should be treated as an “agency”
for the purposes of the APA when engaging in agency-like activities. See, e.g., Intercollegiate
Broad. Sys., 684 F.3d at 1342 (“We too hold that the Librarian is a Head of Department. . . .”);
Live365, 698 F. Supp. 2d at 43 (“[E]ven though the Library is codified under Title II and is a free
standing entity that operates independently from the Executive Branch in conducting its daily
operations, the Librarian appears to nonetheless qualify as a Head of Department. . . .”); Eltra
Corp., 579 F.2d at 301 (holding that Library “operat[es] in conformity with the Appointments
Clause”). To be sure, the Library does perform both executive and legislative functions. Eltra
Corp., 579 F.2d at 301 (“The Librarian performs certain functions which may be regarded as
legislative (i.e., Congressional Research Service) and other functions (such as the Copyright
Office) which are executive or administrative. Because of its hybrid character, it could have been
grouped code-wise under either the legislative or executive department.”).
Critically, however, none of these cases condition their holdings on whether the challenged
activity in question was legislative or executive in nature. Indeed, in Clark, the D.C. Circuit never
held that the Library is exempt from the APA based on the specific facts of that case, as plaintiffs
mistakenly argue. See Pls.’ Reply at 10 (“Thus, given the particular facts at issue in Clark, the
court held that the Library of Congress [was] not an ‘agency’ as defined under the Administrative
Procedure Act.” 750 F.2d at 102.”). Instead, the Court held that Congress did not waive sovereign
20 immunity with respect to the Library because it is not an “agency” as defined under the APA.
Clark, 750 F.2d at 102. 5
In a last gasp effort, plaintiffs urge that the D.C. Circuit implicitly overturned or modified
decades of precedent in Clark, Boorstin, and Washington Legal Foundation in Intercollegiate
Broadcasting Systems v. Copyright Royalty Board, when the D.C. Circuit held that the
appointment of Copyright Royalty Judges by the Librarian violated the Appointments Clause and
severed “the restrictions on the Librarian[‘s] . . . ability to remove the” judges to remedy that
violation. 684 F.3d at 1334. Yet, Intercollegiate never articulated this “hybrid” framework for
evaluating APA challenges to the Librarian’s actions as plaintiffs theorize. See Pls.’ Mot. at 28.
This is far too flimsy a basis to sustain the “substantial burden on a party advocating the
abandonment of an established precedent,” Saad v. Sec. & Exch. Comm’n, 980 F.3d 103, 107 (D.C.
Cir. 2020) (quotation marks omitted), and, consequently, plaintiffs’ invitation to recast decades of
D.C. Circuit precedent exempting the Library from APA review is declined. See Green v. U.S.
Dep’t of Justice, 392 F. Supp. 3d 68, 99 (D.D.C. 2019) (likewise rejecting argument that
Intercollegiate changed whether the Library was subject to APA review because plaintiffs
“pointed to nothing in the text of the APA, its legislative history, or legal precedent that suggests
that Congress did not intend to include the Library of Congress when engaging in Executive
Branch functions . . . [when Congress] exempted [itself] from the APA’s definition of ‘agency’”).
For the foregoing reasons, the Library is not subject to the APA since Congress explicitly
declined to waive sovereign immunity for APA challenges to the Library’s actions. 6 Accordingly,
5 For the same reason, the fact that “the Library publishes all relevant documents in connection with its DMCA rulemakings in the Federal Register and promulgates its final exemptions in the Code of Federal Regulations,” Pls.’ Mot. at 38, is immaterial, since such activity alters neither the statutory definition of an “agency,” under 5 U.S.C. § 701(b)(1), nor the scope of any APA waiver of sovereign immunity. 6 Plaintiffs make two additional textual arguments in support of their foreclosed reading of the definition of “agency,” under 5 U.S.C. § 701(b)(1), but neither is persuasive and cannot override binding D.C. Circuit precedent to
21 the Court lacks jurisdiction to address the merits of plaintiffs’ substantive and procedural APA
challenges in Count I and II, which must be dismissed.
B. Plaintiffs Fail to Plead Plausible Ultra Vires and Constitutional Claims
Aside from asserting APA challenges, plaintiffs raise an ultra vires statutory challenge to
the Exemption and a constitutional challenge to the Library’s rulemaking authority under the
DMCA, in Counts III and IV, respectively. Given that the Library of Congress is part of the federal
government, however, these claims “must satisfy all the requirements for actions commenced
against the United States.” FDIC v. Meyer, 510 U.S. 471, 475 (1994) (“Absent a waiver, sovereign
immunity shields the Federal government and its agencies from suit.”). “‘In any suit in which the
United States is a defendant, there must be a cause of action, subject matter jurisdiction, and a
waiver of sovereign immunity.’” United Am., Inc. v. N.B.C.-U.S.A. Hous., Inc. Twenty Seven, 400
F. Supp. 2d 59, 61 (D.D.C. 2005) (quoting Presidential Gardens Assocs. v. United States, 175 F.3d
132, 139 (2d Cir. 1999)); see also First Vir. Bank v. Randolph, 110 F.3d 75, 77–78 (D.C. Cir.
1997) (outlining these three requirements). To be sure, plaintiffs have properly asserted that their
claims challenging the Librarian’s actions raise issues under the DMCA and the U.S. Constitution,
and thus are brought pursuant to the court’s federal question jurisdiction, 28 U.S.C. § 1331. See
Compl. ¶ 25. That begs the other critical questions, however, whether the United States has waived
the contrary. First, plaintiffs point to the strong presumption of judicial review of administrative action as militating in favor of finding that the Library’s DMCA rulemaking actions are subject to APA review. Pls.’ Mot. at 31–32 (citing Mach Mining, LLC v. EEOC, 575 U.S. 480 (2015)). This argument fails to grapple with the overwhelming weight of textual evidence favoring reading “the Congress” to include the Library. See Knapp Med. Ctr. v. Hargan, 875 F.3d 1125, 1128 (D.C. Cir. 2017) (cleaned up) (explaining that the presumption for judicial review of agency action, “like all presumptions used in interpreting statutes, may be overcome by specific language that is a reliable indicator of congressional intent”). Moreover, judicial review of the Librarian’s actions remains available under the Larson-Dugan doctrine, Clark, 750 F.2d at 102 (“It is well-established that sovereign immunity does not bar suits for specific relief against government officials where the challenged actions of the officials are alleged to be unconstitutional or beyond statutory authority.”), which plaintiffs concede, Pls.’ Mot. at 36. Second, plaintiffs argue that the canon of constitutional avoidance requires reading “agency” to include the Library because otherwise “tremendous separation of powers problems” are raised, id. at 32–35, but this variation on their constitutional attack on the Librarian’s DMCA rulemaking authority is meritless, as explained, infra in Part III.B.2.
22 sovereign immunity to permit the claims, and, if so, whether plaintiffs have adequately plead their
separate causes of action.
Plaintiffs maintain that sovereign immunity does not bar suit here under the Larson-Dugan
doctrine. In Larson v. Domestic & Foreign Commerce Corporation, the plaintiff sued the head of
the War Assets Administration, not for money damages, but for specific performance of the
delivery of surplus coal in accordance with plaintiff's contract with the government. 337 U.S. at
684–85. Finding that the Administrator’s action in refusing the coal shipment to the plaintiff was
not unconstitutional or ultra vires conduct outside the scope of the Administrator’s authority, nor
contrary to statute or order, id. at 703, the Supreme Court concluded that the Administrator’s
action “was, therefore, inescapably the action of the United States and the effort to enjoin it must
fail as an effort to enjoin the United States,” id.; see also id. at 688 (noting suit would be barred
“not because it is a suit against an officer of the Government, but because it is, in substance, a suit
against the Government over which the court, in the absence of consent, has no jurisdiction”). The
Court thus articulated, and made explicit in Dugan v. Rank, an exception to sovereign immunity
in actions seeking specific relief for “(1) action by [government] officers beyond their statutory
powers [or] (2) even though within the scope of their authority, the powers themselves or the
manner in which they are exercised are constitutionally void.” 372 U.S. 609, 621–22 (1963). “In
either of such cases the officer’s action ‘can be made the basis of a suit for specific relief against
the officer as an individual.’” Id. at 622 (quoting Malone v. Bowdoin, 369 U.S. 643, 647
(1962)); see also Dalton v. Specter, 511 U.S. 462, 472 (1994) (quoting Larson, 337 U.S. at 691
n.11) (emphasis in original) (summarizing Larson as holding “that sovereign immunity would not
shield an executive officer from suit if the officer acted either ‘unconstitutionally or beyond his
statutory powers’”); Pollack v. Hogan, 703 F.3d 117, 120 (D.C. Cir. 2012) (quoting Larson, 337
23 U.S. at 689, 693) (“Under [the Larson-Dugan] exception, ‘suits for specific relief against officers
of the sovereign’ allegedly acting ‘beyond statutory authority or unconstitutionally’ are not barred
by sovereign immunity.”).
Here, plaintiffs allege both types of Larson-Dugan violations. First, they say that the
Librarian acted beyond the express limits authorized by the DMCA by promulgating the
Exemption. Pls.’ Mot. at 38–39. Second, they argue that the Exemption’s promulgation was
unconstitutional because, in so doing, the Librarian either “unconstitutionally exercise[d]
executive authority (running afoul of separation-of-powers principles) or [ ] unconstitutionally
exercise[d] legislative authority (running afoul Article I’s bicameralism and presentment
requirements).” Pls. Mot. at 39. Resolving whether Larson-Dugan ultimately applies, however,
requires an assessment of the merits of plaintiffs’ underlying statutory and constitutional claims
and thus “the question of jurisdiction merges with the question on the merits.” Wash. Legal Found.
v. U.S. Sent’g Comm’n, 89 F.3d 897, 901 (D.C. Cir. 1996); see also Swan v. Clinton, 100 F.3d
973, 981 (D.C. Cir. 1996) (determining whether “the Larson-Dugan exception would be triggered
and hence no waiver of sovereign immunity is required” rested on “discussion of the central merits
question in the case, namely whether” challenged government action violated statute); Mashiri v.
Dep't of Educ., 724 F.3d 1028, 1032 (9th Cir. 2013) (quoting Wash. Legal Found., 89 F.3d at
901) (alterations in original) (following D.C. Circuit’s practice when finding that “the question of
‘[w]hether the Larson-Dugan exception’ applied ‘merge[d] with the question on the merits,’” and
therefore turning “to address the substantive merits of the mandamus claim before it’”). Each
claim is evaluated in turn.
24 1. The Librarian Did Not Exceed Her Statutory Authority Under the DMCA.
Plaintiffs argue that the Librarian’s enactment of the Exemption was “well in excess of her
delegated authority and contrary to the specific requirements of the DMCA . . . for the same basic
reasons that the Exemption is substantively unlawful under the APA.” Pls.’ Mot. at 38. In other
words, plaintiffs’ theory underlying this claim is that the DMCA authorizes the Librarian to
promulgate exemptions only for “noninfringing uses . . . of a particular class of copyrighted
works,” 17 U.S.C. § 1201(a)(1)(C), but the Exemption authorizes uses purportedly failing to meet
this requirement because the sole purpose of the Exemption is to allow ISOs to engage in
commercial behavior. Pls.’ Mot. 16–20. Plaintiffs’ recycled APA argument falls well short of
pleading a plausible ultra vires claim.
At the outset, “[j]udicial review for ultra vires agency action rests on the longstanding
principle that if an agency action is unauthorized by the statute under which the agency assumes
to act, the agency has violated the law and the courts generally have jurisdiction to grant relief.”
Fed. Express Corp. v. U.S. Dep't of Com., 39 F.4th 756, 763 (D.C. Cir. 2022) (cleaned up); see
also Leedom v. Kyne, 358 U.S. 184, 188 (1958) (upon finding that the National Labor Relations
Board directly contravened a provision in the National Labor Relations Act, thereby making its
action unlawful “in excess of its delegated powers and contrary to a specific prohibition in the
Act,” holding that the district court had jurisdiction to set aside the unlawful agency action).
Pleading a plausible ultra vires claim is no simple task and has been described as “essentially a
Hail Mary pass—and in court as in football, the attempt rarely succeeds.” See Nyunt v. Chairman,
Broad. Bd. of Governors, 589 F.3d 445, 449 (D.C. Cir. 2009); accord N. Am. Butterfly Ass’n v.
Wolf, 977 F.3d 1244, 1262 (D.C. Cir. 2020) (quotation marks omitted) (“Ultra vires review is
intended to be of extremely limited scope, and it represents a more difficult course than would
25 review under the [APA].”). With respect to claims, as here, that a government official’s action
was contrary or in excess of statutory authority, “such a ‘Kyne exception’ applies only when three
requirements are met: ‘(i) the statutory preclusion of review is implied rather than express; (ii)
there is no alternative procedure for review of the statutory claim; and (iii) the agency plainly acts
in excess of its delegated powers and contrary to a specific prohibition in the statute that is clear
and mandatory.’” DCH Reg’l Med. Ctr. v. Azar, 925 F.3d 503, 509 (D.C. Cir. 2019) (quoting
Nyunt, 589 F.3d at 449); see also Fed. Express Corp. v. U.S. Dep't of Com., 39 F.4th 756, 763
(D.C. Cir. 2022) (same). Here, given that, absent the availability of review under the APA, no
federal statute specifically precludes judicial review, and there is no alternative procedure for
review, the critical question—both to state a plausible claim and for the exercise of jurisdiction—
is whether the Librarian “plainly act[ed]” outside the scope of her delegated powers in
promulgating the Exemption.
Plaintiffs’ claim fails to satisfy the third “Kyne exception” requirement. “The third
requirement covers only extreme agency error, not merely garden-variety errors of law or fact.”
DCH Reg’l Med. Ctr., 925 F.3d at 509 (cleaned up); see also Doehla Greeting Cards v.
Summerfield, 227 F.2d 44, 47 (D.C. Cir. 1955) (quoting Larson, 337 U.S. at 703) (“Erroneous
action taken in the exercise of an admittedly validly delegated power is ‘inescapably the action of
the United States and the effort to enjoin it must fail as an effort to enjoin the United States.’”).
Ultra vires claims are accordingly “confined to extreme agency error where the agency has stepped
so plainly beyond the bounds of its statutory authority, or acted so clearly in defiance of it, as to
warrant the immediate intervention of an equity court.” Fed. Express Corp., 39 F.4th at 764
(cleaned up). “Only error that is patently a misconstruction of the [statute], that disregards a
26 specific and unambiguous statutory directive, or that violates some specific command of a statute
will support relief.” Id. (cleaned up).
Plaintiffs merely restate that the Librarian erred in her fair use analysis, which, even if true,
would amount to nothing more than a textbook error in statutory interpretation. The D.C. Circuit
has given clear instruction that an ultra vires claim “must show more than the type of routine error
in statutory interpretation or challenged findings of fact that would apply if Congress had allowed
APA review.” Fed. Express Corp., 39 F.4th at 765 (quotation marks omitted). Moreover,
plaintiffs’ claim appears even weaker when considering that a fair-use analysis is a highly fact-
specific determination involving consideration of four different factors. See Am. Soc’y for Testing
& Materials, et al. v. Public.Resource.Org, Inc., 896 F.3d 437, 448 (D.C. Cir. 2018) (explaining
that “each case raising the question” concerning “whether a particular use is fair . . . must be
decided on its own facts”) (quoting Harper & Row Publishers, Inc. v. Nation Enterprises, 471 U.S.
539, 560 (1985)); see also supra n.4. The Librarian’s determination that diagnosis, maintenance,
and repair was likely to be a noninfringing use of the copyrighted software could not have been
“patent[] [ ] misconstruction of the” DMCA, Fed. Express Corp., 39 F.4th at 764, for this exact
reason: it was premised on a detailed balancing of the fair use factors to determine that the ISOs’
proffered uses of the OEMs’ copyrighted software were likely noninfringing, see AR at 1780–
1785. Even if plaintiffs believe that the Librarian’s reasoning was “terse and incomplete[,]” Pls.’
Mot. at 25, they have not demonstrated how that the Librarian has patently “disregard[ed] a
specific and unambiguous statutory directive” or “violate[d] some specific command of a statute.”
Fed. Express Corp., 39 F.4th at 764. At most, the Librarian and plaintiffs just have differing views
on the outcome of a fair use analysis here.
27 In short, plaintiffs have fallen well short of completing their “Hail Mary pass” of an ultra
vires claim, see Nyunt, 589 F.3d at 449, because they have not come close to showing that the
Librarian has plainly acted “in excess of [her] delegated powers and contrary to a specific
prohibition in the statute that is clear and mandatory.” Fed. Express Corp., 39 F.4th at 763
(quotation marks omitted).
2. The Librarian’s Rulemaking Authority Does Dot Violate the Separation of Powers.
Finally, in Count IV, plaintiffs challenge the Librarian’s DMCA rulemaking authority as
an unconstitutional violation of the separation of powers. The doctrine of separation of powers
emanates from the Framers’ decision to separate “powers of the [ ] Federal Government into three
defined categories, legislative, executive, and judicial, to assure, as nearly as possible, that each
Branch of government would confine itself to its assigned responsibility.” INS v. Chadha, 462
U.S. 919, 951 (1983); see also U.S. CONST. art. I, § 1 (“All legislative Powers herein granted shall
be vested in a Congress of the United States”); U.S. CONST. art. II, § 1 (“The executive Power shall
be vested in a President of the United States[.]”); U.S. CONST. art. III, § 1 (“The judicial Power of
the United States, shall be vested in one supreme Court, and in such inferior Courts as the Congress
may from time to time ordain and establish[.]”). As relevant here, when exercising legislative
authority, Congress must follow the procedures outlined in Article I, section 7 of the Constitution:
passage by both Houses of Congress and presentment to the President. Chadha, 462 U.S. at 951.
Moreover, Congress cannot “reserve for itself the power of removal of an [executive branch]
officer” because “[t]o permit the execution of the laws to be vested in an officer answerable only
to Congress would, in practical terms, reserve in Congress control over the execution of the laws.”
Bowsher v. Synar, 478 U.S. 714, 726 (1986). Such wielding of executive power is unconstitutional
and, conversely, Congress also “may not transfer to another branch ‘powers which are strictly and
28 exclusively legislative.’” Gundy v. United States, 139 S. Ct. 2116, 2123 (2019) (quoting Wayman
v. Southard, 23 U.S. 1, 42–43 (1825)).
At the same time, “the separation-of-powers principle, and the nondelegation doctrine in
particular, do not prevent Congress from obtaining the assistance of its coordinate Branches.”
Mistretta v. United States, 488 U.S. 361, 372 (1989). Thus, Congress “may confer substantial
discretion on executive agencies to implement and enforce the laws,” Gundy, 139 S. Ct. at 2123,
so long as it “lay[s] down by legislative act an intelligible principle to which the person or body
authorized to [act] is directed to conform,” Whitman v. Am. Trucking Associations, 531 U.S. 457,
472 (2001) (alteration in original) (quoting J.W. Hampton, Jr., & Co. v. United States, 276 U.S.
394, 409 (1928)). Accordingly, assuming Congress “has supplied an intelligible principle to guide
the [agency’s] use of discretion,” Gundy, 139 S. Ct. at 2123, the agency’s lawful exercise of that
authority is an exercise of executive power. City of Arlington v. FCC, 569 U.S. 290, 304 n.4
(2013); see also Collins v. Yellen, 141 S. Ct. 1761, 1785 (2021) (cleaned up) (quoting Bowsher,
478 U.S. at 733) (“‘[I]nterpreting a law enacted by Congress to implement the legislative mandate
is the very essence of execution of the law.’”).
Plaintiffs’ argument is not that Congress unconstitutionally delegated to the Librarian
legislative power by giving her rulemaking authority under Section 1201 of the DMCA, but rather
that the Library faces a different Catch-22: “[I]f the Library functions as a component of the
legislative branch rather than the executive branch in the course of its DMCA rulemakings, either
it is unconstitutionally exercising executive authority (running afoul of separation-of-powers
principles) or it is unconstitutionally exercising legislative authority (running afoul [of] Article I’s
bicameralism and presentment requirements).” Pls.’ Mot. at 39. “Either way,” plaintiffs assert,
“the rulemaking is constitutionally ultra vires.” Id. Plaintiffs’ “either-or” reasoning is flawed.
29 The Library serves both executive and legislative functions and does not run afoul of
separation of powers principles so long as both executive and legislative power are not
simultaneously wielded when conducting those functions. Considering that the Librarian is
appointed and subject to removal by the President, and that plaintiffs do not challenge the
Librarian’s DMCA rulemaking authority as an unconstitutional delegation of legislative power,
the Librarian accordingly lawfully engages in executive power under Article II when promulgating
rules under the DMCA.
The Fourth Circuit’s decision in Eltra Corporation v. Ringer is instructive on this issue.
When faced with the argument that “the Office of the Register of Copyrights is . . . violative of
the Appointments Clause[,]” the Fourth Circuit concluded that the Clause was not violated because
“[t]he Register is appointed by the Librarian of Congress, who in turn is appointed by the President
with the advice and consent of the Senate,” and the “Librarian is an ‘Officer of the United States’”
within the meaning of the Clause, Eltra, 579 F.2d at 300; see also Intercollegiate, 684 F.3d at 1342
(holding that the “Librarian is a Head of Department” within the meaning of the Appointments
Clause). The court deemed “irrelevant that the Office of the Librarian of Congress is codified
under the legislative branch or that it receives its appropriation as a part of the legislative
appropriation” because the “Librarian performs certain functions which may be regarded as
legislative (i.e., Congressional Research Service) and other functions (such as the Copyright
Office) which are executive or administrative.” 579 F.2d at 301; accord Intercollegiate, 684 F.3d
at 416 (acknowledging that the Library of Congress “performs a range of different functions,
including some, such as the Congressional Research Service, that are exercised primarily for
legislative purposes”). “Because of its hybrid character,” the court continued, “it could have been
grouped code-wise under either the legislative or executive department.” 579 F.2d at 301. The
30 court concluded, however, that “such code-grouping cannot determine whether a given function is
executive or legislative.” Id. 7
Just as the Eltra plaintiff, plaintiffs have created a false dichotomy here because, even
though the Library performs some legislative functions, it also performs executive functions for
the purposes of the Constitution when promulgating regulations under the DMCA. Eltra correctly
concluded that the Librarian can perform both executive and legislative functions while still not
raising separation-of-powers problems because of its “hybrid” character. When promulgating
regulations under the DMCA and exercising executive functions, the Library thus need not comply
with Article I, section 7’s bicameralism and presentment requirements.
As defendants aptly point out, Defs.’Cross-Mem at 43, the critical flaw in plaintiffs’
argument is that Congress’s decision to categorize the Library as part of “the Congress” rather than
make this entity subject to APA review, either directly (as with the Copyright Office) or through
the definition of “agency” in 5 U.S.C. § 701(b)(1), has no bearing on whether the exercise of
authority in triennial rulemaking is either legislative or executive in function. Congress’s decision
simply reflects its choice to exempt the Librarian’s administrative actions from APA review, a
choice that Congress could revisit at any time by amending the APA’s definition of “agency.”
7 Defendants are correct, see Defs.’ Cross-Mem. at 42–43, that administrative bodies invalidated on separation- of-powers grounds had direct participation by Congress or Members of Congress in the exercise of executive actions. See, e.g., Metro. Wash. Airports Auth. v. Citizens for the Abatement of Aircraft Noise, Inc., 501 U.S. 252, 276–77 (1991) (invalidating a review board partly composed of members of Congress); Bowsher, 478 U.S. at 733–34 (invalidating investment of executive powers in an officer removable by Congress); Buckley v. Valeo, 424 U.S. 1, 140–41 (1976) (per curiam) (holding that Congress could not vest administrative powers in a commission for which members were not appointed pursuant to the Appointments Clause, U.S. Const. art. II, § 2, cl. 2). No such constitutional infirmity is present for the Library of Congress.
31 III. CONCLUSION
For the foregoing reasons, defendants’ motion to dismiss is granted, and plaintiffs’ motion
for summary judgment is denied. An Order consistent with this Memorandum Opinion will be
entered contemporaneously.
Date: March 7, 2023
_________________________
BERYL A. HOWELL Chief Judge
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Cite This Page — Counsel Stack
Medical Imaging & Technology Alliance v. Library of Congress, Counsel Stack Legal Research, https://law.counselstack.com/opinion/medical-imaging-technology-alliance-v-library-of-congress-dcd-2023.