Copyrights in Medical Device Technology

  • Gerald B. Halt
  • John C. Donch
  • Amber R. Stiles
  • Lisa Jenkins VanLuvanee
  • Brandon R. Theiss
  • Dana L. Blue


Copyrights protect original works of authorship fixed in a tangible medium of expression. Copyrighted works include literary, dramatic, and musical compositions, movies, pictures, paintings, sculptures, computer programs, etc. Copyright protects the expression of an idea, but not the idea itself. Copyright protection is created the moment that a work is fixed in a tangible media. In effect, obtaining a copyright is essentially “free” since registration of the copyright is not required, but is highly recommended. Registration of a copyright is a prerequisite to litigating a copyright claim and is desirable to preserve the remedies for attorney’s fees and statutory damages. Copyright protection is often used by medical device companies to protect a number of important works, such as software code associated with a medical device, user manuals, operating protocols, and marketing materials.


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    Software as a Medical Device (SAMD): Clinical Evaluation, Guidance for Industry and Food and Drug Administration Staff, U.S. Department of Human Services, Food and Drug Administration, Center for Devices and Radiological Health, issued December 8, 2017, available online at (accessed Aug. 21, 2018).
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    Situation Management Systems v. ASP Consulting LLC, 90 USPQ 2d 1095 (1st Cir. 2009).Google Scholar
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    17 U.S.C. § 201(a).Google Scholar
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    17 U.S.C. § 203.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Gerald B. Halt
    • 1
  • John C. Donch
    • 2
  • Amber R. Stiles
    • 3
  • Lisa Jenkins VanLuvanee
    • 4
  • Brandon R. Theiss
    • 5
  • Dana L. Blue
    • 4
  1. 1.United PlazaVolpe and Koenig, P.C. United PlazaPhiladelphiaUSA
  2. 2.Volpe and Koenig, P.C.PhiladelphiaUSA
  3. 3.Miramar BeachUSA
  4. 4.Facet Life Sciences, Inc.WayneUSA
  5. 5.Volpe and Koenig, PCPhiladelphiaUSA

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