By: Joslyeen Mitri
A new world where we can rectify a global health pandemic by the push of a button is on the horizon, but not without legal repercussions. During the COVID-19 pandemic, an Italian company held a patent on a valve used in respirator machines that were critical for coronavirus patients. Due to surging demands, the company was unable to fill all orders but refused to share the design file with engineers seeking to help. On the same day that the orders could not be filled, two engineers from Northern Italy were able to create a digital version of the valve and produced over 100 copies. The unique nature of patent infringement with 3D printing is due to the difference between the digital and physical versions of the patented device. Typically, patents only cover the tangible object, not its corresponding digital blueprint. Patent owners also have a legal claim against indirect infringement. The U.S. Code states that whoever actively induces infringement of a patent shall be liable as the infringer. By creating a 3D printable file of the valves, the Italian engineers did not engage in an act of direct infringement.
Three-dimensional (“3D”) printing or additive manufacturing is the process of creating a physical model from a digital file. The additive process is accomplished through laying down successive layers of material as thinly sliced horizontal cross-sections, to create the physical object. Contrary to popular belief, one of the top five industries where 3D printing has marked its territory is in medicine. North America is anticipated to hold the largest share in the global market due to increased financial support by the government for 3D printing applications in the healthcare industry. Other countries are struggling to keep up due to the high cost of 3D printing systems and a lack of skilled professionals. The first 3D printed medical devices to catch the public’s attention were hearing-aid devices and Invisalign braces. The United States Food and Drug Administration has increased their approval of 3D printed implants under the 510k pre-approval system, which permits the use of 3D printed devices in routine and complex surgical procedures. Now, there have been drastic medical advancements including 3D printed implants, models for surgical practice, bone replacement, and even human tissues.
As the COVID-19 outbreak swept the globe, makers of 3D printers including Stratasys and HP, put their equipment to work in ways like never before. “The strengths of 3D printing – be anywhere, print virtually anything, adapt on the fly – make it a capability for helping address shortages of parts related to shields, masks, and ventilators, among other things,” said Stratasys CEO, Yoav Zeif. HP utilized all of their research and development centers across the world to 3D print components of face masks, face shields, nasal swabs, respirator marks and short-term emergency ventilators. Large corporations including Ford, Volkswagen, and SmileDirectClub put their routine manufacturing on hold in order to use their 3D printing factories to produce personal protective equipment. “Reports of medical supply shortages are very concerning and we have the production capacity to help in the printing of plastic materials,” said SmileDirectClub CEO, David Katzman.
Although large corporations have put their businesses at risk to save lives during the pandemic, they have exposed themselves to potential legal consequences. Under the U.S. Code, anyone without authority who manufactures, uses, sells, or makes an offer to sell an invention that is protected under a patent is infringing on that patent. COVID-19 has not changed the FDA’s 2017 guidance for the 3D printing of medical devices. However, the FDA has recognized that 3D printing may be useful to combat shortages during the COVID-19 pandemic.
Proving the sentiment of the FDA’s statement, several medical device companies expressly waived their patent rights for ventilators, PPE, and other medical devices. On March 17, the secretary of the Department of Health and Human Services (“HHS”) issued a declaration protecting entities that have taken steps to combat the coronavirus crisis from claims for “any type of loss.” Additionally, on March 18, President Donald Trump issued an executive order that categorized personal protective equipment and ventilators as scarce and critical material essential to the national defense under the Defense Production Act of 1950.
Although the HHS Declaration and Defense Production Act limit the liability for claims of antitrust and breaches of contract, there have not been any protections against patent infringement liability for manufacturers of medical devices. Without explicit government immunity, patent infringement liability is a risk to any manufacturer of medical equipment. Other governments around the world including those in Germany, the United Kingdom, Canada, and Israel have all taken measures to completely bypass medical device patents. Society would hope that medical manufacturers put their patents on hold to assist during a global pandemic— unfortunately, this has not been the case. The risk of patent infringement is heavily outweighed by incredible strides in the world of medical technology, with a real ability to save lives. At the time of a global pandemic, temporary government immunity, like that given by other governments around the world, would have been critical to protecting any manufacturers of medical equipment from patent infringements.
As 3D printing technology continues to advance, the law must follow at an equivalent rate in order to effectively integrate the technology into society and provide producers with clear guidelines. At a time of global pandemic, one would hope engineers optimize all available resources in order to save lives—without worrying about the legal repercussions of their life-saving actions.
Student Bio: Joslyeen Mitri is a second-year law student at Suffolk University Law School and a Staff Member of the Journal of High Technology Law. Prior to law school, Joslyeen received a Bachelor of Science Degree in Corporate Finance and Accounting from Bentley University.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.
