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

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Tuesday, September 28, 2021
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Faculty

Ms. Harris focuses her practice on intellectual property litigation, including patent litigation and licensing disputes; and IP counseling and transactions, including licensing, portfolio management and counseling, and diligence. She is experienced at representing clients in large-scale complex patent and intellectual property litigation, including in international arbitration and federal district courts across the country. Ms. Harris’ client work spans a variety of industries and technologies, including medical device manufacturers, universities and research institutions, semiconductor processing, surgical methods, consumer products, and networking technology. Her work also extends to the unique IP issues facing inventors and companies in start-up and research communities.

Mr. McBride’s practice focuses primarily on the litigation and trial of patent and complex technology cases in federal courts and before the Patent Trial and Appeal Board, and reexamination proceedings before the Patent Office. He has a proven ability to help clients procure or acquire valuable intellectual property to protect their business, reach advantageous arrangements for solving intellectual property disputes where appropriate, and aggressively litigate patents when necessary.

Mr. Phelan is a registered patent attorney who counsels and works with clients in all areas of intellectual property, with a focus on patents. He routinely helps clients with preparing and prosecuting high-quality patent applications, and developing strategic patent portfolios for innovative products and services, including in the U.S. and foreign jurisdictions (e.g., Europe, China, and Japan); preparing legal opinions as to the patentability, non-infringement, validity, and/or freedom-to-operate of innovative products or services; and litigating IP related issues to protect client market share from competitors and defend clients from IP lawsuits against competitors or non-practicing patent entities. As a former technology consultant with Accenture and with a background in computer science and engineering, Mr. Phelan has extensive experience in computer system, hardware, and software design, engineering, development and related technologies. He is also an adjunct professor at Northwestern University’s Pritzker School of Law where he teaches coursework on patenting software inventions.
Description
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.
Outline
- Software-as-a-Medical Device (SaMD) and Software-in-a-Medical Device (SiMD) defined
- Examples of SaMD/SiMD FDA regulation
- Protecting SaMD and SiMD inventions
- Patent prosecution
- Prosecution including patentable subject matter; drafting and prosecution techniques, discussion of recent relevant cases
- Patent Enforcement
- Enforcement: type of litigation (competitor vs. competitor; NPE)
- Pitfalls (e.g., joint infringement issues, early motions based on Alice)
- Remedies and settlement
- Other Enforcement options
- Trade secrets
- Design patent (Techniques for protecting products, replacement parts, and user interfaces)
- Trade dress: development of trade dress rights, recent cases
- Copyright
- Role of open source licenses
- Patent prosecution
- Joint Development and Collaboration Agreements
- Licensing Rights
- Protecting ownership
- Artificial Intelligence considerations
- IP considerations
- FDA considerations
Benefits
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?
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