No Good Deed Goes Unpunished: How 3D Printing Medical Supplies During Global Pandemic Could Lead to Patent Infringement
As the rapid spread of COVID-19 overloads healthcare systems around the world, medical personnel on the frontline face increasing shortages of personal protective equipment (“PPE”) and life-saving devices.[1] In response to this shortage, some individuals and businesses have taken to 3D printing much-needed medical supplies.[2] These 3D printing volunteers are manufacturing various equipments for medical facilities, including face shields, ventilator and respirator parts, hands-free door openers, and nasal test swabs.[3] Several manufacturers of 3D printers, including Stratasys and HP, are encouraging their customers to participate by posting free design files and assembly instructions for face shields, ventilation bags, and more.[4]
However, these well-meaning individuals and businesses may be exposing themselves to liabilities in their efforts to provide resources during the pandemic. Patent owners of certain medical technologies likely have infringement claims against those who 3D print a patented device, as well as those who use the device.[5] Under U.S. law, patent owners have a legal claim for direct infringement where a party “makes, uses, offers to sell, or sells” a patented device without permission.[6] Therefore, anyone who 3D prints a patented device commits direct infringement by “making” the device.[7] Likewise, anyone who “uses” the patented device—including medical personnel and hospitals—could be liable for direct infringement.[8] Patent owners also have a legal claim for indirect infringement, which could create liability for those who “actively induce infringement” by providing 3D printing instructions for patented devices.[9]
Despite the multiple ways that 3D printing volunteers could infringe a patent, there are some assurances that they will remain safe from liability. For one thing, it would be impractical for a patent owner to sue every individual infringing on their patent, especially considering the large number of 3D printing hobbyists operating out of their homes.[10] For another, the optics of enforcing patent rights during a time of crisis could dissuade litigation on its own.[11] Isinnova, a 3D printing startup in Italy, did not let the risk of liability stop them from printing life-saving ventilator valves.[12] Even when the patent owner refused to release the design files, Isinnova accepted the risk of bypassing the patent, and reverse-engineered the valves to provide the printed devices to local hospitals.[13]
Unfortunately, the nature of these 3D-printed medical devices could present an additional incentive for patent owners to stop infringers, and that is products liability.[14] There is no guarantee that 3D-printed face shields will provide the same level of protection or that 3D-printed ventilator valves can withstand daily use.[15] If a 3D-printed product is defective, it will be difficult to determine whether the flaw was in the original design, the printing process, or elsewhere.[16] Such safety concerns may be enough to compel companies to sue for infringement to prevent potentially dangerous manufacturing of medical supplies.[17]
Ultimately, 3D printing volunteers are moving forward into uncharted territory. For many, the risk of liability is not a concern when compared to the benefit of saving lives. Although one can hope that patent owners would not put money above mankind during a pandemic, 3D printing volunteers should be aware of the potential risks.[18]
Footnotes
