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

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

Conducted on Tuesday, April 9, 2019

Recorded event now available

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Program Materials

This CLE webinar 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 to ensure 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 the 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 applications of IP rights and limitations.



  1. SaMD defined
  2. FDA rules regulating SaMD
  3. Examples of recent FDA approved SaMDs
  4. Protecting SaMDs
    1. Patent prosecution and enforcement
      1. Differences between life science and tech
      2. Prosecution including patentable subject matter; drafting and prosecution techniques, discussion of recent relevant cases, portfolio management
      3. Licensing: Including patent pools
      4. Enforcement: Type of litigation (competitor vs. competitor; NPE), remedies and settlement
    2. Trade secrets
    3. Design patent
      1. Techniques for protecting products, replacement parts and user interfaces
    4. Trade dress: Development of trade dress rights, recent cases
    5. Copyright
    6. Role of open source licenses
  5. The interplay of timing for FDA approval and applying for IP rights
  6. Case studies


The panel will review these and other key issues:

  • What are the hurdles for patent counsel to demonstrate a software-related claim is not abstract?
  • What factors should counsel consider when determining what type of IP protection to seek?
  • What guidance have the courts provided in recent decisions concerning patent eligibility for software-related inventions?


Bell, Cory
Cory C. Bell

Finnegan Henderson Farabow Garrett & Dunner

Mr. Bell focuses on patent prosecution management, client counseling, post-grant practice, and litigation, with an...  |  Read More

Ferrill. Elizabeth
Elizabeth D. Ferrill

Finnegan Henderson Farabow Garrett & Dunner

Ms. Ferrill focuses her practice on all aspects of design patents, including prosecution, counseling, and litigation....  |  Read More

Tull, Susan
Susan Y. Tull

Finnegan Henderson Farabow Garrett & Dunner

Ms. Tull focuses her practice on patent litigation and client counseling in the mechanical, industrial, electrical, and...  |  Read More

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