Medical Device Makers Sue Library Of Congress For Allowing People To Fix Their Own Medical Devices

Copyright

from the so-much-nonsense dept

For many years we’ve discussed the sheer ridiculousness of the “triennial review” process of Section 1201 of the DMCA. If you’re lucky, and don’t spend that much time deep in the weeds of semi-obscure copyright law, Section 1201 of the DMCA is the “anti-circumvention” part of the law, that was initially designed to outlaw breaking digital rights management (DRM) tools. Of course, 1201 was written broadly, saying that basically any attempt to “circumvent a technological measure” (even just talking about ways to circumvent a technological measure) would itself be considered copyright infringement even if the underlying purpose for which you were circumventing the technological measure had nothing whatsoever to do with copyright.

This was a bizarrely structured law for so many reasons, and even the drafters of it at the time realized that this would likely lead to all sorts of perfectly reasonable and normal activity being declared “infringing” of copyrights. Indeed, lots of companies almost immediately moved to take advantage of this in order to block people from using “unauthorized” ink cartridges in printers, or unauthorized garage door openers, among other things.

So, the drafters of the DMCA added in this ridiculously weird safety valve: every three years, people could apply to the Librarian of Congress to “exempt” certain classes of items from the law for a three year period. The process itself is ridiculous. People need to apply for the exemption, then there’s a public comment period, followed by recommendations from the director of the Copyright Office, before the Librarian of Congress comes down from the mountain and blesses certain types of circumvention as non-infringing for the next three years.

No sane system would ever do things this way. A reasonable legislature would realize that if you have to apply for exemptions every three years, perhaps the underlying law itself is problematic. But, no, every three years we go through this ridiculous song and dance. Sometimes it leads to truly wacky outcomes, like the time, a decade ago, when the Librarian of Congress refused to renew the phone unlocking exemption, forcing Congress to grandstand about how they should fix things (something that never actually happened).

Anyway… last year was the latest three year cycle, and it’s gotten to the point that it’s barely even worth reporting on the results, which the Librarian of Congress adopted last fall. One of them was an expansion of an earlier exemption (from six years prior) exempting the circumvention of technological protection measures (TPMs) on medical devices in order to access the data on those devices. For the 2021 round, petitioners sought to expand that exemption somewhat, getting rid of the part of the original exemption that limited it to “wholly or partially implanted” devices, arguing that it should apply to any type of medical device.

The Copyright Office recommended allowing this broader exemption and the Librarian of Congress agreed:

For the reasons detailed in the Register’s Recommendation, the Register concluded that accessing medical data outputs likely qualifies as a fair use and that expanding the exemption to include non-implanted medical devices and non-passive monitoring would not alter the fair use analysis. Additionally, the Register concluded that proponents set forth sufficient evidence that the ‘‘wholly or partially implanted’’ language and the passive monitoring limitation are causing, or are likely to cause, adverse effects on these noninfringing uses. The Register also recommended expanding the exemption to permit circumvention ‘‘by or on behalf of a patient.’’ After consultation with the U.S. Food and Drug Administration, the Register recommended removing the language requiring compliance with other laws, and replacing it with a statement that eligibility for the exemption does not preclude liability from other applicable laws.

Basically, in the midst of a pandemic, where locked down medical devices had represented a real problem, the Copyright Office and the Librarian of Congress reasonably decided that both users of medical devices, and their medical care professionals, ought to be able to circumvent various technological protection measures in order to access their own data.

All of this should be relatively uncontroversial. But… that’s not how any of this works. Earlier this year, some medical device company trade associations decided to sue the Librarian of Congress over this exemption. They’re using the standard administrative law argument that the exemption was “arbitrary and capricious.” The complaint has a lot of overwrought language:

The Exemption is manifestly unlawful. By issuing a rule that enables unregulated, for-profit service providers to piggyback off the creative efforts and intellectual property of medical device manufacturers, it not only thwarts the purpose of the Copyright Act, but also puts patient safety, device integrity, and device cybersecurity at risk. What is more, the process by which the Exemption was adopted was infected with major procedural errors, including a failure to address many of the significant legal concerns raised by plaintiffs and other opponents.

In the course of the rulemaking at issue here, moreover, the Library of Congress was acting as an executive agency and is therefore subject to the strictures of, and judicial review under, the Administrative Procedure Act (APA). Because the Exemption is not in accordance with law and was adopted without observance of required procedures, it should be set aside. Alternatively, if the Library of Congress did not assume the character of an executive agency within the meaning of the APA, the Exemption violates separation-of-power principles twice over. Either way, it should be vacated.

Then, before the government was able to respond to the lawsuit, the medical device makers moved for summary judgment. A big part of their argument is that because this exemption might will allow third party companies to service medical devices (at a cheaper rate than the manufacturers themselves) that it serves a purpose unrelated to copyright and thus is not allowed as an exemption:

But the exemption is for a manifestly infringing use. It was granted at the behest—and solely for the commercial benefit—of two so-called independent service operators, or ISOs, which are unregulated third-party service providers who freeride on the creative labors of device manufacturers. And the Librarian readily admitted the true reason for her decision: Allowing ISO circumvention would reduce the cost of machine servicing contracts and thus serve a separate executive-branch policy. But the DMCA does not grant the Librarian free-ranging policymaking authority untethered to copyright law. In approving the exemption, moreover, the Library failed to address numerous substantial comments that called into question the underlying fair-use analysis. The exemption is thus unlawful many times over: It is contrary to the statutory text, it is arbitrary and capricious, and it was promulgated without observance of procedure required by law

So, to some extent, I find this absolutely hilarious. Because the reason medical device manufacturers lock down these devices with TPMs and then rely on the DMCA to block competitive service providers is also wholly unrelated to copyright law. So, they are actually the ones abusing copyright law to lock out competition — and then when they’re effectively called on it by the Librarian of Congress, they whine that the Librarian of Congress can’t use the triennial review process to exempt their abuse of copyright law, because… it goes beyond the intention of copyright law!

The government has responded, asking for a chance to actually file a motion to dismiss before it has to deal with the summary judgment demand and noting the somewhat bizarre rush by the medical device manufacturers for summary judgment when they waited many months before filing the lawsuit in the first place.

Either way, this really appears to be little more than an extremely cynical move by the device manufacturers. Hopefully the court sees through it, but should it succeed, I imagine we’ll see many other similar lawsuits filed on behalf of other industries where exemptions were granted, potentially taking us back to an even worse world, in which companies can abuse the 1201 anti-circumvention rules to block out all sorts of competition.

Filed Under: carla hayden, competition, copyright, copyright office, dmca 1201, librarian of congress, library of congress, medical devices, triennial review
Companies: advamed, medical imaging technology alliance, mita