The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and ventilators abound, making 3D printing particularly interesting with regard to fighting COVID-19. The FDA even issued some guidance on 3D printing of medical devices, accessories, components and parts during the COVID-19 pandemic. But potential exposure to patent infringement liability remains a risk.
FDA Guidance Addressing 3D Printing
The FDA began addressing the 3D printing of medical devices years ago. For example, in October 2014, the FDA held a public workshop, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Then, in December 2017, the FDA issued “Technical Considerations for Additive Manufactured Medical Devices Guidance for Industry,” which addressed the 3D printing of medical devices. According to the FDA, “Additive manufacturing is a process that builds an object by sequentially building 2-dimensional layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative designs without the need for retooling and to create complex devices built as a single piece.” Additive manufacturing is the process of 3D printing. In the guidance, the FDA discusses design and manufacturing process considerations, device testing considerations, and labeling for the emerging technology of 3D printing medical devices.
Like any other medical device, medical devices made using 3D printing technology are subject to FDA regulatory requirements. The specific requirements depend on the classification of the medical device – Class I, II or III – with increasing regulatory requirements as the class increases.
Also, like traditional manufacturing of medical devices, 3D printing of medical devices involves multiple steps. First, the device must be designed. Then, the device design must be digitally converted into a buildable file and sent to a printer. Third, the appropriate materials must be selected and loaded into the printer. Next, the medical device must be printed. Some devices are then processed further to clean, cool, drill, cut, polish or sterilize them. After the device is finished, most devices must be validated and verified. That is, certain functions may be tested to ensure they meet specifications. Alternatively, “process validation ensures that a manufacturing process will produce product that is within defined specifications, as long as specified processing parameters are monitored and controlled.” (FDA, “Process of 3D Printing Medical Devices.”) Last, device test results are sent to the FDA for review to determine whether the 3D-printed device is safe and effective.
Considerations for 3D Printing During the COVID-19 Pandemic
COVID-19 has not changed the FDA’s general recommendations for 3D printing of medical devices from those found in the 2017 guidance. The FDA, however, has recognized that 3D printing of medical devices may be useful to help combat shortages during the COVID-19 pandemic. For example, 3D printing may be used to produce PPE that provides a physical barrier. That said, the FDA notes that challenges remain for 3D printing of PPE that provides a fluid barrier or air filtration.
Likewise, 3D printing may be particularly useful for manufacturing components, parts and accessories for medical devices. As acknowledged by the FDA, 3D printing could make items such as tubing connectors for multiplexing ventilator use, which are the topic of an emergency use authorization for ventilators, ventilator tubing connectors and ventilator accessories.
3D printing may provide a benefit in the fight against COVID-19, but as with any emerging technology, the FDA must ensure patient safety. Because the FDA realizes that 3D printing may increase availability of medical devices, the FDA is willing to discuss potential applications and concerns of 3D printing with manufacturers and facilities.
3D Printing During the COVID-19 Pandemic and Patent Infringement Risks
There are an estimated 100,000 patents relevant to 3D printing.
During the COVID-19 pandemic, many medical device companies have expressly agreed to waive their patent rights for ventilators and PPE, and some have even made their product proprietary specifications available online. Even the National Institute of Health (NIH), the FDA, the Veterans Health Administration and America Makes created an NIH-hosted website that provides a collection of designs for 3D-printed PPE. Nevertheless, currently there is no immunity from patent infringement liability for individuals and manufacturers that make medical equipment to help with the ongoing pandemic.
On March 17, the secretary of the Department of Health & Human Services (HHS) issued “Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.” The declaration applies to entities that have taken steps (i.e., “covered countermeasures”) to combat the current crisis and immunizes them against claims for “any type of loss.”
On March 18, President Donald Trump issued an executive order, “Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19,” which explicitly found “personal protective equipment and ventilators” are “scarce and critical material essential to the national defense” under the Defense Production Act of 1950 (DPA).
Then on March 27, Trump issued another executive order, “Delegating Additional Authority Under the DPA with Respect to Health and Medical Resources to Respond to the Spread of COVID-19,” which tasks the HHS secretary with increasing the “domestic industrial base capabilities to produce” health and medical resources.
While the HHS declaration and the DPA expressly limit liability for certain claims such as product liability, antitrust and breach of contract, neither expressly absolves a manufacturer from patent infringement liability. And though Trump publicly has asked companies to retool production lines to start producing ventilators and PPE, his administration has yet to take affirmative steps that would protect companies from patent infringement lawsuits.
Other governments around the world – including those in Germany, the U.K., Canada, Israel, Ecuador and Chile – have taken measures to bypass medical device patents altogether. And many scientists and lawmakers are urging the World Health Organization to set up a voluntary system for companies to “pool” patents and to create compulsory government use licenses that override a company’s patent rights.
Absent government immunity, patent infringement liability remains a risk. But one would hope that a patent owner would consider this global pandemic a reason to forgo enforcement of its rights.