In response to the COVID-19 pandemic, companies, organizations, and individuals have used 3D printing and other measures to address supply chain gaps, producing spare parts and products such as ventilator tube splitters, nasopharyngeal swabs, and face shields. To facilitate similar efforts, the National Institute of Health has created a 3D print exchange to share models and increase production, but it has not generally approved the use of these 3D printed products. Additionally, the FDA has adopted an emergency use authorization that waives manufacturing and labeling requirements for only some protective equipment and medical devices. And, finally, a provision of the 2020 Families First Coronavirus Response Act extended the protection, in the form of liability waivers, provided to some producers and users under the 2005 Public Readiness and Emergency Preparedness Act.
These actions to encourage the 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 products without obtaining governmental agency approvals and without risking private liability. 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. My prior work in this area suggest that the lack of an explicit right of repair is highly problematic. The current pandemic makes an even stronger case for the need to explicitly incorporate a right to repair into our legal system.
Many medical devices and related parts and products are protected by patents or other intellectual property (IP) rights, such as copyrighted software. Unlicensed third-party production and use of those parts and products may constitute unauthorized infringement of IP rights. Under a longstanding legal precedent, products purchased in the marketplace normally may be repaired—but may not be fully reconstructed—using unpatented parts. Further, a recent Supreme Court case held under the “exhaustion” doctrine that patent rights cannot be used to prohibit purchasers from engaging in such repairs. However, the Court left open the possibility of contractually enforcing repair prohibitions against purchasers. And third-party production of patented repair parts also may be prohibited.
The current crisis has led to calls for IP owners to voluntarily pledge not to assert their patents and copyrights, such as the Open COVID Pledge, and for governments to exercise inherent compulsory licensing authorities. This would allow third parties to manufacture and distribute products and parts. But the ability to make repairs in emergencies should not depend on the voluntary choices of specific IP owners to donate their IP rights for public benefit. Nor should it have to await public commitments from such owners or government agency declarations. Changes to IP laws and liability protections are needed to assure the ability to make timely repairs and the continued use of important products in emergencies.
There are, of course, many product purchase contracts that do not restrict repairs. Thus, third-party production and use of unpatented repair parts for needed products is already authorized in a pandemic. At least for public health emergencies when supplies are limited, Congress should clearly preempt contractual restrictions on repair rights and should adopt explicit, limited exceptions to IP rights and liability to enable and encourage third-party production of repair parts. More broadly, Congress should consider adopting limited exceptions to IP rights or should otherwise assure the ability to make repairs. For example, recent European Union “ecodesign” regulations require the continued supply of repair parts and information needed for repairs. Assuring the ability to make repairs is critical to improving our emergency preparedness framework.
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.