- videocam Live Webinar with Live Q&A
- calendar_month February 12, 2026 @ 1:00 PM E.T.
- signal_cellular_alt Intermediate
- card_travel Patent
- schedule 90 minutes
Written Description: Lessons From Duke v. Sandoz and Seagen v. Daiichi Sankyo
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About the Course
Introduction
This CLE course will guide patent counsel on leveraging recent Federal Circuit decisions regarding applying Section 112 written description requirements in patent cases. The panel will examine lessons from these decisions and discuss how these lessons impact best practices.
Description
Patent practitioners in every technology face §112 issues all the time, in examiner rejections during prosecution, patentability challenges in post-grant reviews before the PTAB, and validity challenges before the courts. The Federal Circuit has seemingly been raising the bar for meeting the written description and enablement requirements in recent years.
On Nov. 18, 2025, the Federal Circuit Court of Appeal continued its application of §112 stringent standards, finding invalidity for lack of adequate written description and reversing a $39 million damages award in Duke University v. Sandoz Inc. The court determined "no reasonable juror could find anything other than clear and convincing evidence that the ’270 patent fails to describe either (i) a representative number of species of claim 30's subgenus or (ii) structural features common to all members of that subgenus."
On Dec. 2, 2025, the Federal Circuit followed its decision in Duke v. Sandoz with a precedential decision in Seagen Inc. v. Daiichi Sankyo Co., providing additional clarification on how much disclosure must be included in a patent application to uphold claims covering a generic scope of chemical structures.
These decisions emphasize the strict application of the written description requirement to claims and higher disclosure standards. Patentability and enforceability are expected to be impacted by these decisions.
Listen as our panel of authoritative patent attorneys examines the lessons from recent Federal Circuit decisions and discusses how those lessons impact best practices.
Presented By
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization. Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Mr. Irving has more than 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of her technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products, including new chemical entities and formulations and novel solid forms, including polymorphs, cocrystals, and amorphous forms of compounds.
Ms. Weatherhead is Vice President, Intellectual Property and Legal, for Ventus Therapeutics. With a PhD and Post-doc in synthetic organic chemistry, her areas of expertise include patent prosecution of biologics (antibodies and ADCs), small molecules (including Orange Book listed products), polymers, polymorphs, organometallics, synthetic organic processes, methods of treatment, and formulations, as well as trademark prosecution of pharma and digital health products.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Live Online
On Demand
Date + Time
- event
Thursday, February 12, 2026
- schedule
1:00 PM E.T.
I. Duke v. Sandoz (Fed. Cir. Nov. 18, 2025)
II. Seagen v. Daiichi (Fed. Cir. Dec. 2, 2025)
III. Implications for written descriptions and §112 enforcement
IV. Best practices
The panel will review these and other key issues:
- What lessons can patentees apply to meet the written description requirements and withstand invalidity/unpatentability challenges based on written description?
- What steps can fix written description problems?
- What proactive steps should patent counsel take going forward to avoid repeating past mistakes?
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Written Description: Lessons From Duke v. Sandoz and Seagen v. Daiichi Sankyo
Thursday, February 12, 2026
1:00 PM E.T.