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Protecting Software as a Medical Device: Patents, Design Patents, and Trade Secrets

Recording of a 90-minute premium CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
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Conducted on Tuesday, September 28, 2021

Recorded event now available

or call 1-800-926-7926

This CLE course will guide counsel for companies in the medical device industry on protecting software as a medical device (SaMD). The panel will discuss the FDA rules regulating SaMD and how to leverage IP law to protect SaMD.


SaMD is rapidly growing, ranging from wearable activity tracking devices to smartphone apps that view images obtained from an MRI for diagnostic purposes. Further, the FDA rules delineate the regulatory requirements for SaMD.

With new technologies and products introduced every day, companies and counsel want maximum protection for SaMD. Patent, design patent, trade secrets, and other forms of IP are increasingly crucial to SaMD innovators due to the significant investments needed to withstand FDA scrutiny under the guidelines. However, what is patent eligible in the context of software-related inventions is not always clear.

Listen as our authoritative panel of patent attorneys discusses software as a medical device and the FDA rules regulating SaMD. The panel will examine what IP rights are available for SaMD, outline how to protect SaMD, and offer insights into examining IP rights and limitations applications.



  1. Software-as-a-Medical Device (SaMD) and Software-in-a-Medical Device (SiMD) defined
  2. Examples of SaMD/SiMD FDA regulation 
  3. Protecting SaMD and SiMD inventions
    1. Patent prosecution
      1. Prosecution including patentable subject matter; drafting and prosecution techniques, discussion of recent relevant cases
    2. Patent Enforcement
      1. Enforcement: type of litigation (competitor vs. competitor; NPE)
      2. Pitfalls (e.g., joint infringement issues, early motions based on Alice)
      3. Remedies and settlement
    3. Other Enforcement options
      1. Trade secrets
      2. Design patent (Techniques for protecting products, replacement parts, and user interfaces)
      3. Trade dress: development of trade dress rights, recent cases
      4. Copyright
        1. Role of open source licenses
  4. Joint Development and Collaboration Agreements
    1. Licensing Rights
    2. Protecting ownership
  5. Artificial Intelligence considerations
    1. IP considerations
    2. FDA considerations


The panel will review these and other key issues:

  • Learn about new developments in Artificial Intelligence and considerations by the FDA
  • What are key issues when engaging in joint development activities involving medical device software
  • What are the hurdles for patent counsel to demonstrate a software-related claim is not abstract?
  • What guidance have the courts provided in recent decisions concerning patent eligibility for software-related inventions?
  • What factors should counsel consider when determining what type of IP protection to seek?


Harris, Maia
Maia H. Harris

Troutman Pepper

Ms. Harris focuses her practice on intellectual property litigation, including patent litigation and licensing...  |  Read More

McBride, Scott
Scott P. McBride

McAndrews Held & Malloy

Mr. McBride’s practice focuses primarily on the litigation and trial of patent and complex technology cases in...  |  Read More

Phelan, Ryan
Ryan N. Phelan, J.D., MBA

Marshall Gerstein & Borun

Mr. Phelan is a registered patent attorney who counsels and works with clients in all areas of intellectual property,...  |  Read More

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