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mri-9s The anti-circumvention provisions of the Digital Millennium Copyright Act (DMCA) exist to deter circumvention of TPMs (technological protection measures) used to protect and prevent access to copyrighted works.

For example, it’s illegal to circumvent a TPM to enable copying of Nintendo Switch games. It’s also illegal to circumvent a TPM to modify a Switch to play pirated games, or indeed anything else.

The same also applies to people who prefer to repair broken electronic devices rather than buy new ones. The moment a work protected by copyright is made accessible after circumventing a TPM, an offense is committed under the DMCA, albeit with limited exceptions.

Exceptions to the Rules

To accommodate instances of circumvention for the promotion of public safety, security, or similarly beneficial activities, the DMCA has some exceptions built-in, applicable to schools, libraries, law enforcement, and encryption researchers, for example.

The Librarian of Congress also engages in a triennial rulemaking process to identify additional exceptions, part of a “fail‐safe mechanism” to protect the right to make non-infringing use of copyrighted works, under the fair use doctrine.

As part of the Eighth Triennial Rulemaking Proceeding (pdf), in October 2021 the Librarian of Congress adopted the ‘Medical Device Exemption.’ An analysis of the statutory factors determined that maintenance and repair of medical devices constituted fair, non-infringing uses, that would be adversely affected by the DMCA’s anti-circumvention provision.

Exemption Challenged by Medical Device Manufacturers

The exemption was subsequently renewed in 2024, despite continued opposition from the trade associations Advanced Medical Technology Association (AdvaMed) and Medical Imaging & Technology Alliance (MITA) whose members manufacture medical devices and rely on TPMs to protect their intellectual property.

From the beginning they argued that the independent service organizations (ISOs) that petitioned in favor of the exemption were primarily commercial and in direct competition with the original manufacturers. Allowing circumvention, they added, would jeopardize both patient safety and privacy.

The associations followed up by filing a lawsuit against the Library of Congress and the Librarian of Congress at a federal district court in Washington, D.C. They argued that the Medical Device Exemption violated the Administrative Procedure Act (APA), describing it as describing it as arbitrary and capricious, and contrary to the APA given the Librarian’s failure to respond to critical comments.

The district court determined that the plaintiffs’ APA claims were barred by sovereign immunity because the Library of Congress was not an “agency” under that statute. On appeal the D.C. Circuit vacated that opinion, finding that the Copyright Act and DMCA provided for APA review of the Library of Congress’s rulemaking.

The case was referred back to the district court, the plaintiffs amended their lawsuit to include three claims under the APA, and both parties cross-moved for summary judgment.

Summary Judgment in Favor of the Defendants

District Judge Beryl A. Howell’s memorandum opinion published last week examines the Librarian’s determination that the exempted uses were non-infringing fair uses under 17 U.S.C. § 107. Judge Howell reviewed the Librarian’s application of the four statutory fair use factors and concluded as follows:

1. Purpose and Character of the Use

The Judge concludes that the diagnosis, maintenance, and repair work of independent service organizations (ISOs) is a transformative use, just as the Librarian observed. By restoring device functionality and not commercializing the protected software itself, that demonstrates a “novel function going beyond the original purpose” of the software.

“Contrary to plaintiffs’ hyperbolic characterization…..the Librarian did acknowledge the commercial nature of the exempted uses but rightly recognized that commercial use is not dispositive,” the Judge notes, adding that the commercial aspect was reasonably outweighed by the transformative use.

2. Nature of the Copyrighted Work

The Librarian’s analysis found that this factor also favors fair use. The plaintiffs had argued that software is “essentially a creative work” but the Librarian took the position that software and data in medical devices are used for their “functional and informational aspects” rather than their expressive qualities. The court agreed.

“The Librarian nonetheless reasonably concluded that in this case, the software code itself and the ancillary materials are informative, factual, and functional rather than expressive in nature, favoring fair use,” Judge Howell writes.

3. Amount and Substantiality of Portions Used

The Librarian concluded that this factor favored fair use but was given little weight. If necessary, entire copyrighted works can be used as long as the use was “reasonable” relative to the purpose of diagnosis, maintenance, or repair.

Judge Howell says the Librarian’s decision was well reasoned, noting that copying even large amounts can favor fair use when “tethered to valid, and transformative, purpose.”

4. Effect on the Market for or Value of Copyrighted Work

The Librarian’s analysis found that diagnosis, maintenance, and repair of devices is unlikely to harm the market for the software embedded inside them, because the software “has no independent value separate from being used with the equipment.”

Judge Howell agrees; third party repairers do not “usurp the market of the original work” or act as a substitute. There is no “chilling effect on innovation” as the plaintiffs insist, since they recoup their costs by selling devices while any other unauthorized uses remain prohibited.

The Judge also cited comment from the FDA which noted that both OEMs and ISOs “provide high quality, safe, and effective medical device servicing” and “that the continued availability of ISOs to service and repair medical devices is critical to the functioning of the healthcare system in the United States.”

Judge Howell’s Conclusion

According to the Judge, the anti-circumvention provision of the DMCA is intended to balance copyright holders’ right to prevent circumvention, with the right to access and use material for non-infringing purposes under the fair use doctrine. Not doing so would risk fair-users of information being “relegated to negotiating access on terms set by the monopoly rights-holders.”

The Exemption for medical devices and systems is consistent with copyright law and the DMCA and supported by the Librarian’s thorough and well-reasoned explanations from the Eighth and Ninth Triennial Rulemaking proceedings. The plaintiffs’ arguments to the contrary, challenging both the substance of the Librarian’s reasoning and her procedural thoroughness, were all unsuccessful.

Consequently, plaintiffs’ motion for summary judgment is denied, and defendants’ cross-motion is granted.

Judge Howell’s Memorandum Opinion is available here (pdf)

From: TF, for the latest news on copyright battles, piracy and more.