AuthorMitri, Joslyeen H.
  1. Introduction

    The COVID-19 pandemic generated uncertainty around the globe, much of which was attributed to the supply-demand war in the healthcare field. (1) As the virus swept across the United States, healthcare professionals painstakingly searched for the most resilient and advanced solutions to save our shrinking population. (2) Three dimensional ("3D") printing quickly emerged as an effective solution to meet the growing demand. (3) The digital versatility and swift prototyping of 3D printing empowers a rapid response to severe disruptions in supply chain operations. (4) Although 3D printed medical devices could potentially solve the world's supply-demand crisis with just the push of a button, 3D printing also poses an unusual patent infringement dilemma. (5) "Patent infringement issues associated with 3D printing are often a result of the difference between the digital and physical versions of the patented device." (6)

    Patent law enables multiple parties to utilize the same invention while protecting the inventors' interests. (7) Patents allow the holder to bring suit for patent infringement against those who violate the patent. (8) in times of desperation, patent infringement regulations negatively impact society by preventing medical device manufacturers from swiftly producing life-saving patented devices, such as personal protective equipment. (9)

    This issue came to the forefront in the past year due to the COVID-19 pandemic, when personal protective equipment was desperately needed, yet unattainable. Medical manufacturers have put their profits above society's welfare during the COVID-19 pandemic by refusing to limit their interest in patents. When facing this devastating challenge of a global pandemic, many countries granted temporary government immunity, protecting manufacturers of medical equipment from patent infringement repercussions. As 3D printing technology becomes more readily available, patent infringement regulation must follow at an equivalent rate in order to effectively integrate the technology into society and provide manufacturers with clear guidelines.

  2. History

    Ambiguities in relation to patent law and 3D printing have presented multiple issues that have been exacerbated by COVID-19. (10)

    Patents protect an invention by giving legal rights to its owner to prevent others from manufacturing, using, selling, or importing the claimed invention. (11) Understanding what aspects of 3D printed devices are protected under patent law and to what extent they are protected can be challenging. (12) If a piece of equipment is patented, then making a 3D printed replica of that invention or using it without the patent owner's permission may constitute patent infringement. (13)

    An analysis of patent law and the implications associated with 3D printing are critical to understanding the potential direct and indirect forms of infringement. (14) As the growing world of 3D printing blurs the line between digital and physical patents, it has become crucial to develop appropriate regulations and reform existing ones. (15)

    1. A Brief Overview of Patent Law and Infringement Lawsuits

      1. An Overview of Patent Law

        The United States Constitution grants Congress the power to secure, for a limited amount of time, certain rights for inventors to their respective inventions. (16) The purpose of patent protection is to protect the public, accordingly rights are given to the inventor when the public expects to benefit and denied where the public would suffer long-term. (17) Patent law protects the rights of the inventor for a period of time, upon which the invention falls into the public domain. (18) Patent protection provides exclusive rights to the holder of the patent to incentive innovation, which benefits society by providing new and useful technologies. (19) After determining that a patent is the appropriate type of intellectual property protection needed for an invention, the inventor files a patent application with the United States Patent and Trademark Office ("USPTO"). (20) With the fast-paced nature of today's digital era, inventors are struggling to manage the growing number of patent infringers, often with no recourse available due to minimal regulation. (21)

        A patent examiner reviews the application to ensure that the patent has not been previously claimed, that it meets the requirements outlined by Congress, and that it fulfills the required patent subject matter inquiry. (22) The patent must meet two criteria to satisfy the subject matter eligibility requirement. (23) The first criteria is that the claimed invention must fall into one of the four statutory categories defined in 35 U.S.C. [section] 101, including: process, machine, manufacture, or composition of matter. (24) The first of the four statutory categories defines an "action" while the other three categories define "things" or "products". (25) The second criteria is that the claimed invention must qualify as patent-eligible subject matter, or the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. (26) This criteria is aimed at preventing the monopolization of abstract ideas, laws of nature, and natural phenomenon, which the Supreme Court was concerned would impede innovation rather than promote it. (27)

      2. An Overview of the Procedure and Law Surrounding Patent Infringement

        By owning a patent, holders may prohibit others from making, using, or selling the protected invention without permission. (28)

        Accordingly, if the patent holder discovers that a product is infringing on their patent, they can claim monetary damages and, in some cases, get an injunction to stop the infringing behavior. (29) Under current United States law, patent infringement can be direct or indirect, and these categories are further broken down to active inducement of infringement and contributory infringement. (30)

        In order to prove patent infringement in general, the patent holder must first satisfy three criteria. (31) First, the patent owner must prove that they own a valid patent, which is typically proven through a written assignment. (32) Second, the owner must prove that the alleged infringer engaged in an act of infringement, often shown through sales data, Securities Exchange Commission ("SEC") filings, or product demonstrations. (33) Third, the owner must prove that the infringing product or process incorporates all of the distinguishing features of at least one independent claim. (34) It is the duty of the patent owner to enforce their patent by keeping a close eye on the market to ensure nobody is using their protected work without permission. (35)

      3. Why Patent Infringement is an Issue for 3D Printed Medical Devices

        After years of innovation, 3D printing has revolutionized research and development of the medical device world. (36) Comparable to the traditional manufacturing of medical devices, the 3D printing of medical devices requires several different steps. (37) First, the device must be designed and then digitally converted into a file suitable for printing the device. (38) Next, the medical device must be printed and processed further through cleaning, polishing, and sterilization. (39) Then, the device is verified and tested to ensure that it meets all specifications. (40) Lastly, the device specifications are sent to the Food and Drug Administration ("FDA") for review to determine whether the 3D-printed device is safe and effective. (41) So long as those steps can be followed in a timely manner, patent law does not infringe upon the 3D printing of medical devices, however this process was uprooted after COVID-19 swept through the nation. (42)

        Prosecuting patent infringement brought on by such a widespread or decentralized production of patent medical devices is exceptionally challenging for patent holders. (43) One of the unique features of 3D printing is the difference between the digital and physical version of a patented device. (44) While an individual who makes a digital version of a medical device may not be a direct infringer, that individual could still be an indirect infringer by distributing the digital version to others who then 3D print the physical device. (45) In other industries, the lack of 3D printing regulation may be overlooked, but for the medical field, the lack of guidance is particularly fatal to the welfare of society. (46)

    2. 3D Printed Medical Devices & the Race Against COVID-19

      Companies of all sizes, including Ford and Volkswagen, are fighting the COVID-19 pandemic by placing their usual operations on hold, and using their equipment in never-before-seen ways. (47) "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. (48) COVID-19 has not changed the FDA's 2017 guidance for the 3D printing of medical devices, although, the FDA has recognized that 3D printing has been useful in combatting medical shortages during the COVID-19 pandemic. (49) Without the proper FDA regulations, several medical device companies are risking the future of their operations by expressly waiving their patent rights for ventilators, PPE, and other medical devices. (50) On March 17, 2020, the secretary of the Department of Health and Human Services ("HHS") issued a declaration protecting entities that took steps to combat the coronavirus crisis from claims for "any type of loss". (51) In another attempt to remedy the scarcity of materials, former President Donald Trump issued an executive order on March 18, 2020, that categorized "personal protective equipment and ventilators" as "scarce and critical material essential" to the national defense under the Defense Production Act of 1950. (52)

      The HHS Declaration and Defense Production...

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