MITA, AdvaMed Appeal Dismissal of Copyright Lawsuit

On March 31, 2023, MITA and AdvaMed appealed dismissal of their lawsuit challenging the 2021 decision by the Librarian of Congress granting a temporary exemption from the digital piracy law, Digital Millennium Copyright Act (“DMCA”) for circumvention of certain technology protection measures (“TPMs”) which otherwise prevented access to electronic manuals and servicing materials to repair, diagnose and conduct maintenance. Given that a final determination of the appeal could well be issued around the time for renewal of the Exemption, it is important to understand the implications and benefits to the industry. As Diana Upton, president of IAMERS observed the situation: “hospitals should have this option to have medical devices repaired by the servicers they choose. This is another indication of the growing recognition of the benefits to ‘Right to Repair.’ You know the independent servicers are competent and reliable because manufacturers frequently use them.”

Some observers have expressed surprise as to how and why the Librarian of Congress has the authority to render a decision pertaining to electronic manuals given the protections of the U.S. Copyright laws for “original works of authorship.” Yet these same copyright laws also permit certain limited uses under the “fair use doctrine.” Under the DMCA, the Librarian is directed to consider every three years petitions for exemptions, because, if granted, they are deemed for all intents and purposes “fair uses.” As the U.S. District Court noted in its 32- page decision dismissing the case, Congress long ago recognized that changing marketplace realities and ever-evolving digital technologies might make some of the DMCA powers actually harmful to non-infringing uses of copyright materials. To provide flexibility in accommodating the various interests, Congress empowered the Librarian of Congress to promulgate exemptions from the DMCA protections.

At the time of the Librarian’s public rulemaking determination in 2021, there were more than 10 previously approved DMCA exemptions, albeit none pertaining to medical devices. The Librarian issued, in connection with the petitions of independent medical device servicing organizations, a final rule that exempts parties accessing copyrighted software for the purpose of diagnosis, maintenance and repair of medical devices from the DMCA proscriptions barring the circumvention of TPMs.

In the U.S. District Court lawsuit that followed the Librarian’s granting of an Exemption, MITA and AdvaMed sought to have the Exemption for repair of medical devices set aside and declared to be unlawful and void. Specifically, they claimed that the Librarian’s decision to allow the exemption was unlawful, unconstitutional and did not comply with, among other things, the Administrative Procedures Act. The U.S. District Court found that the challenged exemption was properly adopted by the Librarian. This followed a lengthy rulemaking process conducted by the U.S. Copyright Office. This process involved formal notices, submission and consideration of proposals, comments (including MITA and AdvaMed’s comments) and a hearing. Opponents of the exemption had claimed, among other things, that the granting of the exemption would harm the market for medical devices and systems, was unnecessary because of adequate repair services and that the granting would undermine patient safety. Notwithstanding, the Copyright Office recommended to the Librarian to grant the exemption as 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.” 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. In an observation following the Court decision, Dave Band, CEO of Advanced Imaging Group aptly summed up the situation: “we need to put patient safety first and this is a step in the right direction.”

In the decision dismissing the MITA/AdvaMed lawsuit, the Court characterized the underlying process and the Copyright Office’s explanation for the exemption as fulsome. The Court held that the repair exemption was indeed lawful, did not exceed the Librarian’s authority and was constitutional. Importantly, the Court recognized the dilemma the ISOs frequently faced: “[to] provide maintenance services for these medical devices, ISOs must circumvent TPMs to access OEM software.” The Court further noted, ‘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 magnified by the current COVID-19 pandemic.”

Chief Judge Howell further summed up the situation in the decision as “[a]t most, the Librarian and Plaintiffs just have differing views on the outcome of a fair use analysis here.” Judge Howell was frank in her assessment that the Librarian did not exceed her power: “In short, Plaintiffs have fallen well short of completing their ‘Hail Mary pass’ of an ultra vires claim … because they have not come close to showing that the Librarian has plainly acted in excess of [her] delegated powers.” Judge Howell also acknowledged that the allowance of the exemption has limitations. If an ISO or service provider were to reproduce and retain additional copies of copyrighted material for use with other devices or enable permanent access to subscription only services, these activities would remain prohibited under the DMCA because they fall outside of the scope of the exemption. The “repair” exemption may be found at 37.C.F.R. §201.40(b)(15). https://www.copyright.gov/title37/201/37cfr201-40.html.

– Robert J. Kerwin is General Counsel to IAMERS and participated on behalf of IAMERS in the April 2021 hearing held before the United States Copyright Office. He notes that the information provided in this article does not, and is not intended to, constitute legal advice. Readers who may have questions concerning the scope of their lawful access rights should consult their attorney as individual situations may differ. Comments on this article may be emailed to rkerwin@iamers.org.