In March, 2020, two engineers in Brescia, Italy used a desktop 3D printing machine to fabricate needed replacement valves for more than 100 ventilator machines being used to treat coronavirus patients at a local hospital. News reports claim that the ventilator valves fabricated in Italy for a cost of about 1 Euro each were previously sold by the manufacturer for 10,000 Euro each. There is some debate about what happened next, but early news feeds reported that a parts manufacturer threatened to sue the engineers for infringing patents on the replacement valve. While the existence of the threat and the patents remains murky, the incident sparked legal commentary regarding the risk that volunteers fabricating parts for lifesaving devices, and the hospitals that use them, could be liable for patent infringement.
Under U.S. law, the owner of a patented device has the right to repair that device to preserve its useful life. The recognition of this ‘right to repair’ can be traced to the 1850 Supreme Court decision in Wilson v. Simpson, in which the Court “distinguished the right of a purchaser of a patented planing machine to replace the machine’s cutting-knives when they became dull or broken, from the patentee’s sole right to make or renew the entire machine.” The right to repair concept has been recognized in numerous recent cases, including some relating to medical devices (e.g., Kendall Co. v. Progressive Med. Tech., Inc., 85 F.3d 1570 (Fed. Cir. 1996) (permitting replacement of pressure sleeve in a patented medical device as “repair”).
However, the right to repair, as it is currently understood, does not permit the owner of a patented device to ‘reconstruct’ that device in whole or in substantial part. Reconstruction, as opposed to mere repair, represents a “second creation of the patented entity” and thus infringes the exclusive rights of the patent holder (Jazz Photo Corp. v. Int’l Trade Comm’n, 264 F.3d 1094 (Fed. Cir. 2001)). In distinguishing between permitted repair and prohibited reconstruction, courts must consider and weigh “the remaining useful capacity of the article, and the nature and role of the replaced parts in achieving that useful capacity.” Thus, if the owner of a patented device creates new patented parts to extend the life of a device beyond its anticipated lifespan, this would likely constitute impermissible reconstruction, whereas if the owner simply fixes a defect in an existing part, or replaces it with an unpatented part, during the normal lifetime of the device, this would likely constitute permissible repair.
What, then, about 3D printed replacement valves for ventilator devices? Should it matter that a particular ventilator is past the end of its normal useful life, or that the design of the valve in question is covered by the claims of a patent? 3D printing technology gives consumers an inexpensive way to fabricate replacement parts for complex mechanical devices that were previously available only from specialized manufacturers. With the advent of coronavirus and the sudden surge in global demand for ventilators and other medical equipment, this sleepy doctrine is likely to receive renewed attention. This is particularly the case if replacement parts made using 3D printing technology are themselves covered by patent claims (as may have been the case with the Italian ventilator parts discussed above).
In order to permit needed repairs and parts replacements for critical health-related equipment, courts should take a liberal view of the repair doctrine. In particular, reconstruction of patented devices should be permitted to address pressing public health needs, so long as the reconstruction is made by an authorized owner of the original patented article. This would stop short of eliminating patent holders’ rights to enforce their rights against all infringers, but would at least eliminate the threat of infringement during the crisis. Moreover, the immunity from suit afforded by the repair right should be extended not only to the owners of patented equipment, but to their suppliers, parts vendors and maintenance organizations. This step is important as many hospitals, emergency responders and relief organizations may themselves lack the 3D printing equipment and skills necessary to fabricate required parts and devices. These small modifications to existing doctrine could go a long way toward addressing current public health needs.
