- videocam Live Online with Live Q&A
- calendar_month January 13, 2026 @ 1:00 p.m. ET./10:00 a.m. PT
- signal_cellular_alt Intermediate
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- schedule 90 minutes
Patent Validity and Entresto: Lessons From the Ongoing Dispute
Written Description, Stipulations and Admissions, Adverse Inferences, Means Plus Function, and More
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Description
In January 2025, the Federal Circuit Court of Appeals reversed a district court decision, holding that a patent is not invalid for lack of written description for failing to describe what infringes. Patent validity is determined based on what is claimed.
The dispute between pharmaceutical companies Novartis and Torrent, Alembic, and MSN centers around the pharmaceutical combination known as Entresto. Novartis' new drug application was approved in 2015. In 2019, MSN and other manufacturers filed abbreviated new drug applications (ANDA). Novartis sued, alleging the generics would infringe its patent. In May 2025, the Federal Circuit ruled in Novartis' favor, finding Novartis possessed pediatric exclusivity until July 15, which meant MSN could not launch until that date and its ANDA approval could not be before that date. In July 2025, the district court found MSN did not infringe Novartis' patent, which may result in competition from generics. Novartis has appealed.
And in a fast-moving set of events, FDA says they will not delay the date of approval for generic Entresto. But as Entresto is said to be Novartis’ number one selling drug, it may be unlikely that generics will launch at risk and rather, may wait until a final decision is reached on the validity of Novartis’ relevant patent.
This litigation teaches lessons on patent validity, written description, the wisdom of stipulating to infringement, making any admissions, arguing against adverse inferences, means plus function claims in pharma, and more.
Listen as our panel of experienced patent attorneys examines the Federal Circuit's opinion and the guidance it provides for written description, as well as how the situation of how validity looks in the present appeal lodged by Novartis in September 2025. The panel will offer best practices for both patentees and challengers on stipulations, admissions, adverse inferences, and more.
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 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. Tully works at Genentech as Director and Assistant General Counsel, Neuroscience and Ophthalmology IP Lead. In her role, she works on IP policy issues with a particular focus on the biopharmaceutical industry. Prior to joining Genentech, Ms. Tully did a judicial clerkship with the Honorable Judge Raymond T. Chen at the United States Court of Appeals for the Federal Circuit. Before her clerkship, she worked as an associate at Haley Guiliano and Cooley and as a patent agent at Ropes & Gray. Ms. Tully holds a J.D. from Stanford Law School, a Ph.D. in chemistry from California Institute of Technology and a Bachelor of Arts in Biochemistry from Barnard College, Columbia University.
Ms. Wang is a first-chair trial lawyer who represents biotech, pharmaceutical, and technology companies in complex and high stakes intellectual property and commercial disputes across the country. She is a go-to resource for clients in the life sciences industry, including for “bet-the-company” patent litigation (including Hatch-Waxman and biosimilar litigation), post-grant review (PGR) and inter partes review (IPR) proceedings before the United States Patent Trial and Appeal Board (PTAB), trade secrets litigation, and contract, licensing, and other commercial disputes. Ms. Wang also routinely advises clients on the management of their US and global patent and litigation strategies, including regularly consulting with counsel before the EPO and in the UK, Germany, and other foreign jurisdictions.
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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
Tuesday, January 13, 2026
- schedule
1:00 p.m. ET./10:00 a.m. PT
Outline
I. Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc.
A. Federal Circuit opinion (Jan. 10, 2025)
B. Federal Circuit ruling (May 23, 2025)
C. District court ruling (July 11, 2025)
II. Written description
III. Best practices
IV. The saga continues… Novartis appeal to the Federal Circuit (Sept. 2025)
V. Is it likely that a generic will launch at risk until the Sept. 2025 appeal results in a final decision?
Benefits
The panel will review these and other important issues:
- What lessons can patentees apply to meet the written description requirements and withstand invalidity/unpatentability challenges based on written description?
- How broadly can the applicant claim? How much support does a filing need to have?
- What are best practices for patent counsel to avoid patent validity issues?
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