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 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.
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:
- 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?
Faculty
Maia H. Harris
Partner
Troutman Pepper
Ms. Harris focuses her practice on intellectual property litigation, including patent litigation and licensing... | Read More
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.
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Scott P. McBride
Shareholder
McAndrews Held & Malloy
Mr. McBride’s practice focuses primarily on the litigation and trial of patent and complex technology cases in... | Read More
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.
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Ryan N. Phelan, J.D., MBA
Partner
Marshall Gerstein & Borun
Mr. Phelan is a registered patent attorney who counsels and works with clients in all areas of intellectual property,... | Read More
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.
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