In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.
In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.
For example, the NIH has developed a 3D print exchange to facilitate distributed production, but has not generally approved the use of such products. The FDA has adopted an emergency use authorization that waives manufacturing and labeling requirements for only some protective equipment and medical devices. A declaration under the 2005 Public Readiness and Emergency Preparedness (PREP) Act has provided liability waivers for some producers and users, and a provision of the 2020 Families First Coronavirus Response Act extended that protection.
These actions to encourage third-party production, distribution, and use of replacement parts and entire medical devices during a pandemic shed renewed light on the need to adopt a more robust legal right to repair needed products and to produce them in emergencies.
Many medical devices, parts, and products are protected by patents or other intellectual property (IP) rights, such as copyrighted software. Production and use of those parts and products may constitute unauthorized infringement of IP rights. As a result, there have been calls for voluntary pledging by IP owners not to assert their rights against third-party production and uses to address the pandemic (such as the Open COVID Pledge) and for governments to exercise inherent compulsory licensing authorities.
The current public health crisis makes clear the need for explicit legal rights to repair and supply needed medical products, given the problems with inadequate supplies and supply chains, and the inability to adequately scale up licensed production in an emergency.
Under a longstanding patent law precedent, products purchased in the marketplace normally may be repaired – but may not be fully reconstructed or newly made – using unpatented parts, without requiring authorization of the patentee (usually the original equipment manufacturer, or OEM). Further, a recent Supreme Court case held under the “exhaustion” doctrine that patents cannot be used to prohibit purchasers from engaging in such repairs.
As the Court stated, “[t]he business works because the [repair] shop can rest assured that, so long as those bringing in the cars own them, the shop is free to repair and resell those vehicles. That smooth flow of commerce would sputter if companies that make the thousands of parts that go into a vehicle could keep their patent rights after the first sale.” Although the Court focused on the need to keep third-party automobile repair service providers free from patent rights, the point is even more cogent for the direct purchasers of needed medical equipment, such as hospitals or health departments.
Nevertheless, the Supreme Court left open the possibility of OEMs enforcing no-repair prohibitions contractually against direct purchasers of medical products. Further, the Court did not address the need for third-parties to produce repair parts when OEM parts are not readily available or are provided only at excessive prices. Unlicensed, third-party production may be prohibited if the parts themselves are separately patented. Recent “ecodesign” regulations relating to consumer appliances from the European Union thus require OEMs to assure that different kinds of repair parts are available to third-party service providers for at least seven or ten years, as well as to assure access to repair and maintenance information. But even then, the requirements are limited to OEM-provided parts and only for specific time-frames. A similar approach for needed medical equipment thus would be inadequate whenever OEM supplies of patented repair parts prove insufficient or unaffordable.
As noted above, many legislative measures have been adopted to restrict tort liability so as to promote third-party production of needed medical products and repair parts during this pandemic.
The PREP Act provides broad immunity from federal and state law claims for “covered countermeasures” within the scope of the Health and Human Services Department’s declaration, while protecting the public against intentional malfeasance. PREP Act immunity from liability for production and use also may extend to intellectual property claims, such as patent infringement. Additional state-law liability protections that would apply to production and use are being adopted in the form of “good Samaritan” laws. But these liability protections typically arrive well after the need for supplies has been recognized and often have uncertain application.
The ability to make legitimate repairs to needed products and to produce additional products to address public health emergencies should not have to depend on the voluntary choices of specific IP owners to donate their IP rights for public benefit. Nor should it have to await either binding public commitments by IP owners, as under the Open COVID Pledge, or government agency declarations and clarifications providing liability protections, as under the PREP Act.
Given the inevitability of supply shortages in medical emergencies, we need to assure in advance the ability to make repairs and to expand needed medical part and product supplies through unlicensed third-party production. Such legislative measures are critical to improving our emergency preparedness framework.
To address legal barriers to making repairs and shortfalls of repair parts, Congress should adopt automatic, limited exceptions to IP rights and tort liability triggered by defined public health emergencies, including, but not limited to, pandemics. Such exceptions should explicitly authorize legitimate repairs to needed medical products, as well as unlicensed third-party production of patented parts and reproduction of copyrighted software needed for such repairs. Congress also should explicitly preempt contractual prohibitions on making repairs in those circumstances. Finally, Congress should consider expressly authorizing and providing liability protection for unlicensed third-party production of medical products needed in such emergencies.
Joshua D. Sarnoff is a Professor of Law at DePaul University College of Law. He has testified before Congress on patent law issues and has been a Thomas A. Edison Distinguished Scholar at the U.S. Patent and Trademark Office.