Pharma and Chemical Patent Applications: Meeting Written Description Requirement
Demonstrating Evidence of Possession of the Invention, Navigating the Guidelines, Maintaining Chain of Priority

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Thursday, January 6, 2022
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide patent counsel to ensure chemical and pharmaceutical patent applications meet the written description requirement, outline lessons for counsel from Federal Circuit and PTAB decisions, and offer their perspectives and strategies to avoid challenges.
Faculty

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.

Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the chemical, pharmaceutical, and biotechnology arts. She counsels her clients on a diverse range of patent issues. She assists clients on single-patent issues as well as complex matters involving multiple patents and applications requiring ongoing advice on patent portfolio strategy and development, with an eye towards litigation. She has assisted clients in the early stages of development through due diligence and patent portfolio analysis.

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.

Years of doctoral and industry research on chemical sciences give Dr. Feng a practical understanding of the innovation process, which she applies across the broad range of technologies she works with, including pharmaceutical, biotechnology, medical device, chemical, agriculture, nanotechnology, cosmetic, and metallurgy. She practices patent litigation before U.S. district courts, post-grant proceedings before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), patent prosecution, opinions and counseling, and due diligence. Her technical experience spans a broad range of technologies, including pharmaceutical, biologics, biotechnology, medical device, chemical, agriculture, nanotechnology, cosmetic, and metallurgy.
Description
To satisfy the written description requirement, counsel must ensure that the application "convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the invention, … and demonstrate[s] that by disclosure in the specification of the patent." Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc., 923 F.3d 1368, 1376 (Fed. Cir. 2019), citing Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011) (quoting Carnegie Mellon Univ. (Fed. Cir. 2008))--see also Ariad Pharm. (Fed. Cir. 2010) and Hynix Semiconductor Inc. (Fed. Cir. 2011).
Listen as our authoritative panel of patent attorneys drills down into the changes in case law recent cases interpreting the written description requirement with respect to pharma and chemical patent claims. The panel will outline how to satisfy the requirement in drafting and prosecuting pharmaceutical and chemical patent applications, particularly for future licensing opportunities, AIA post-grant proceedings, and federal district court litigation.
Outline
- Written description requirements
- Recent court treatment
- Best practices for preparing and prosecuting the application: written description
- Describe a representative number of species
- Identify physical or chemical characteristics common to the claimed genus
- Avoid functionally defined genus claims
Benefits
The panel will review these and other key issues:
- Guidelines for the pharmaceutical application's written description support, e.g., a novel drug substance, product, and method(s) of treatments and manufacture
- Preparing non-pharmaceutical, the chemical application's written description in support of a novel compound, composition, and methods of use and compound manufacture
- How a lack of written description support can be used in an AIA post-grant review before PTAB
- How a lack of written description support can be used before PTAB to attack claims by breaking the chain of priority to pre-AIA date benefit in an AIA post-grant proceeding
- PTAB cases analyzing the written description requirement with respect to proposed substitute claims in motions to amend
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