By Robert J. Kerwin

Last week the U.S. District Court for the District of Columbia dismissed MITA and AdvaMed’s lawsuit challenging the 2021 decision by the Librarian of Congress granting an exemption from the digital piracy law, the Digital Millennium Copyright Act, (“DMCA”) for circumvention of technology protection measures (“TPMs”) controlling access to software for service and repair of medical devices or systems.

Every three years under the DMCA, the Librarian considers petitions for exemptions after the Copyright Office makes recommendations to the Librarian.

The Librarian is the final decision maker and accordingly in 2021 issued, in connection with two petitions of independent medical device servicing organizations, a rule permitting a medical device repair exemption. Specifically, the petitions had sought an exemption to circumvention of TPMs controlling access to “software programs and data files that are contained in and control the functioning of a computer-controlled medical device for the purpose of diagnosis, maintenance, or repair of such a device.”

MITA and AdvaMed claimed that the Librarian’s decision to allow the exemption was manifestly unlawful, unconstitutional and did not comply with, among other things, the Administrative Procedures Act.

In the 32-page decision, U.S. District Court found that the challenged exemption was properly adopted by the Librarian. This followed a sixteen-month rule-making process conducted by the U.S. Copyright Office. This process involved formal notices, submission and consideration of proposals, comments (including MITA’s and AdvaMed’s comments) and a hearing.

In its decision dismissing the 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.

Chief Judge Beryl A. Howell summed up the situation as “[a]t most, the Librarian and Plaintiffs just have differing views on the outcome of a fair use analysis here.” 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," Howell said.

The "repair" exemption may be found at 37.C.F.R. §201.40(b)(15).

It is not presently known whether MITA and AdvaMed will appeal the decision issued by the U.S. District Court. As of publication, no Notice of Appeal was filed.

Disclaimer: The information provided in this article does not, and is not intended to, constitute legal advice. Readers should contact their attorney to obtain advice with respect to seeking to avail themselves of the DMCA exemption. They are strongly encouraged to discuss with counsel their specific situation as the court noted in its decision, the Copyright Office’s position that if an ISO or service provider were to reproduce and retain additional copies of any 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. Only your individual attorney can provide assurances that the information contained herein and the interpretation of it is applicable and appropriate to your situation.

About the author: 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.

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