Patent Eligibility and Engineered Natural Products: Overcoming 101 Challenges, Leveraging Options for IP Protection
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Thursday, April 17, 2025
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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This CLE course will guide patent counsel on patent eligibility issues with engineered natural products. The panel will examine the key considerations in determining patentability and review recent case law. The panel will also address alternatives for getting IP protection for engineered natural products.
Ms. Meyers focuses on patent litigation, specifically Abbreviated New Drug Application (ANDA) matters at the district court level and in appeals to the U.S. Court of Appeals for the Federal Circuit, as well as patent prosecution and client counseling. She has experience representing pharmaceutical patent holders in ANDA and 505(b)(2) application litigations arising under the Hatch-Waxman Act. She has technical experience in the biomedical field, including technologies such as prosthetic limbs and orthotic devices.
Mr. Smyth practices intellectual property litigation in a wide variety of areas, with a particular focus on cases involving pharmaceutical and life sciences technologies. He applies a thorough and creative approach to disputes in U.S. district courts, appeals at the U.S. Federal Circuit of Appeals, and arbitration proceedings, which is often where clients’ most important assets are at stake. Mr. Smyth litigates complex disputes involving patents, copyrights, and allegations of trade secret misappropriation in cases involving technologies across fields, including electrical, mechanical, and computer inventions. He is involved in all aspects of U.S. district court litigation, including pre-litigation activity and analysis, written discovery, taking and defending depositions, working with experts, and drafting motions and legal briefs. Mr. Smyth’s trial experience includes participating in jury trials in the Northern District of California, virtual trials in American Arbitration Association arbitrations, and appeals before the Federal Circuit.
Companies are making engineered natural products, often to address health problems. Whether creating synthetic milk or anti-cancer drugs, inventors and their counsel must carefully consider the best way to protect the rights to the product. If an engineered product is not distinguishable from what is naturally occurring, getting patent protection will be more difficult.
Addressing patent eligibility issues early in the process is critical. Patent counsel should carefully describe the product. As the terminology evolves, counsel should ascertain what works with the USPTO. Further, full disclosure of the product and process in the patent application can be crucial.
When seeking patent protection, counsel should weigh the pros and cons of product claims protection and the likelihood of patentability. Counsel should consider other types of claims, such as method claims, product by process claims, and trade secrets, that can protect the invention.
Listen as our authoritative panel examines the key considerations when determining whether an engineered natural product is patentable. The panel will discuss the Myriad decision and other more recent decisions and what they mean for the patentability of engineered natural products. The panel will also address options for getting engineered natural products patented.
- Determining whether a product is patentable: key considerations
- Recent cases and what they mean for patentability of engineered natural products
- Other options for protecting IP rights in engineered natural products
- Method claims
- Product by process claims
- Trade secrets
- Others
The panel will review these and other relevant issues:
- What are the hurdles for patent counsel to demonstrate an engineered natural product is patentable?
- How can patent counsel meet the requirements under Sec. 101 in patent applications for engineered natural products?
- What steps should patent counsel take to minimize the likelihood of Sec. 101 rejections?
- What other IP options are available where Sec. 101 rejections cannot be overcome?
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