About the Course
Introduction
This CLE webinar will guide patent counsel on the Federal Circuit decision in Teva Pharms Int’l GMBH v. Eli Lilly & Co. The panel will discuss how the decision will impact best practices for written description and enablement. The panel will also address the implications for freedom to operate analyses, patent health checks, and due diligence.
Description
Teva's patents for a headache drug have been given new life with the Federal Circuit's reversal of a JMOL. On Apr. 16, 2026, the Federal Circuit Court of Appeals differentiated between new antibody genus claims and method claims using those antibodies. Reviewing written description, the Federal Circuit leaned into CCPA decisions. The court noted that the "headache patents make clear that their claimed invention is the use of anti-CGRP antagonist antibodies, or humanized versions thereof, to treat headache—not such antibodies themselves." The Federal Circuit noted that written description is specific to the context. The level of detail that must be in the written description depends on the invention.
On enablement, the court distinguished these claims from the claims in Amgen and Baxalta "because they do not claim humanized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache." The court concluded Teva's claims were enabled.
The decision provides lessons for patent drafting, including clearly defining what the invention is and what it is not, establishing the genus is known if the claims rely on a broad genus, and considering old CCPA precedent.
Listen as our authoritative panel of patent attorneys examines the lessons from the recent Federal Circuit decision and discusses how those lessons impact best practices for written description and enablement for method claims, as well as lessons for freedom to operate analyses, for patent health checks, and due diligence analyses.
Presented By
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. Mr. Irving has served as lead counsel in many patent interferences.
Ms. O’Brien has more than 25 years of experience representing both domestic and foreign clients of all sizes in the areas of patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of Ms. O’Brien’s technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products including new chemical entities and formulations, as well as novel solid forms including polymorphs, cocrystals, and amorphous forms of compounds. Ms. O’Brien’s expertise includes all aspects of preparing and prosecuting U.S. and foreign patent applications, such as patent drafting and prosecution, as well as more complex matters such as reissue and reexamination proceedings, appeals hearings, Post-Grant Reviews (PGR), and Inter Partes Reviews (IPR) before the Patent Trial and Appeal Board (PTAB). Her litigation expertise focuses on patent infringement cases including, for example, Hatch-Waxman litigation involving Abbreviated New Drug Applications, and includes all stages from pre-discovery through trial.
Ms. Weatherhead has 19 years of experience as a patent practitioner, with a PhD and PostDoc 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.
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
-
Date + Time
- event
Wednesday, May 27, 2026
- schedule
1:00 PM ET/10:00 AM PT
I. Teva Pharms Int’l GMBH v. Eli Lilly & Co., No. 24-1094 (Fed. Cir. Apr. 16, 2026)
II. Implications for written descriptions
III. Implications for enablement
IV. Best practices for claim drafting, freedom to operate analyses, patent health checks, and due diligence analyses
The panel will review these and other key issues:
- What lessons can patentees apply to meet the written description and enablement requirements?
- What steps can fix written description problems?
- What proactive steps should patent counsel take going forward to avoid repeating past mistakes?
- What lessons can be applied in freedom to operate analyses?
- What lessons can be applied to patent health checks?
- What lessons can be applied during due diligence analyses?
Related Courses
Teva v. Lilly: Best Practices for Written Description and Enablement for Method Claims
Wednesday, May 27, 2026
1:00 PM ET/10:00 AM PT
International Patent Licensing: Key Considerations
Available On-Demand
