Are There Patent Infringement Implications of 3D Printing PPE to Help Health Care Workers in the War Against COVID-19? Yes.

As the COVID-19 pandemic unfolds across the country, there have been numerous reports of health care workers facing a shortage of personal protective equipment (PPE) needed to fight the pandemic. Many have suggested 3D printing as a solution for addressing this shortage, whereby companies and even private citizens with 3D printing capability could manufacture PPE such as surgical masks and face shields and provide that equipment to health care workers.

However, such efforts raise significant issues with patent infringement liability for the 3D printing community. Currently, there is no per se immunity from patent infringement liability in cases of national or medical emergencies such as the ongoing COVID-19 pandemic.

An individual can infringe a patent either directly or indirectly. Direct infringement would occur if an individual uses 3D printing to make a patented device. Indirect infringement (i.e., inducement) may occur if an individual knowingly causes another person to 3D print a patented device. Indirect infringement (i.e., contributory infringement) may also occur if an individual knowingly sells an essential “component” of a patented device to another person who then 3D prints the device.

Regarding direct infringement, individuals who undertake 3D printing on a small scale to manufacture PPE should be aware of the possibility of infringement of patent rights, though it would be inefficient for a patent holder to file complaints against 10s, 100s or even 1,000s of such individuals. Currently, there is no effective venue where a patent holder could deal with widespread and decentralized production throughout the United States of a patented device.¹

A more difficult question is whether and to what extent a person who shares a computer-aided design (CAD) file to be 3D printed could be held liable for indirect infringement (inducement or contributory infringement).

One of the unique issues with 3D printing is the difference between the digital version and physical version of a patented device. While an individual who only makes a digital version of the device may not be a direct infringer because he or she is not making the physical device, that individual could still be deemed an indirect infringer by disseminating the digital version to others who then 3D print the physical device. This may give creators of digital files pause prior to public dissemination of a CAD file, especially if they are aware of relevant patent rights. There are, of course, open questions, such as whether a CAD file can be deemed a “component” of a patented device for contributory infringement purposes in the first place.

For large-scale 3D printing operations, and under certain circumstances, some protections may be available on the national or state level for a 3D printing manufacturer. For example, if a company becomes a federal government contractor and the statutory requirements are met, the Defense Production Act in conjunction with 28 U.S.C. § 1498 could provide immunity to the manufacturer. The federal government in that situation would have to compensate the patent owner if necessary. This raises the issue of potential indemnity provisions in government contracts, which should be reviewed and negotiated carefully.

On the state level, state sovereign immunity may apply if the state does the 3D printing of PPE. This obviously would have geographic limits. There also may be an argument that a governor could enlist a private company as an “arm of the state” to cloak it with sovereign immunity to assist with the current shortage of PPE and other medical supplies.

Note that all of the above applies not just to 3D printing of PPE but also to any device that may be useful during the COVID-19 pandemic, such as parts used in ventilators or respirators. Manufacturers who want to assist with the current crisis should consider their overall exposure to risk on a case-by-case basis.

Notes

1. For devices produced abroad and imported into/sold in the United States, however, the US International Trade Commission might provide an effective venue.