• videocam On-Demand Webinar
  • card_travel Patent
  • schedule 90 minutes

Pharma and Chemical Patent Applications: Meeting Written Description Requirement

Demonstrating Evidence of Possession of the Invention, Navigating the Guidelines, Maintaining Chain of Priority

About the Course

Introduction

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.

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.

Presented By

Adriana L. Burgy
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

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.

Li Feng
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

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.

Thomas L. Irving
Senior Partner
Marbury Law Group

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.

Thomas Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP
Amanda K. Murphy, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Ms. Murphy focuses on developing patent filing and prosecution strategies tailored to clients’ worldwide business goals. She works with a wide range of clients, including small biotech startup companies, research foundations, and large publicly traded biotechnology and pharmaceutical companies. Ms. Murphy prepares new patent applications, prosecutes U.S. and foreign applications, and represents appellants in ex parte appeals before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). She has also led clients through numerous reissue applications, inter partes and ex parte reexamination applications, and supplemental examination proceedings. Ms. Murphy’s extensive client counseling practice includes providing patentability, freedom-to-operate, infringement, and validity opinions. In addition, she represents petitioners and patent owners in inter partes review (IPR) and post grant review (PGR) proceedings before the PTAB. She has substantial experience in a wide variety of life sciences technologies, including antibodies and antibody drug conjugates; antiretrovirals and anticancer agents; biologics; blood clotting factors; cell signaling and signal transduction; diagnostic markers and detection assays; drug formulations; gene delivery systems, including AAV; gene editing technologies, including CRISPR; immunooncology; lipid nanoparticles; microbiome analysis and probiotics; nucleic acid modifications; peptide synthesis and protein purification; single-cell and single-molecule analysis; small molecule drugs; and vaccines.

Credit Information
  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

Date + Time

  • event

    Thursday, January 6, 2022

  • schedule

    1:00 p.m. ET./10:00 a.m. PT

  1. Written description requirements
  2. Recent court treatment
  3. Best practices for preparing and prosecuting the application: written description
    1. Describe a representative number of species
    2. Identify physical or chemical characteristics common to the claimed genus
    3. Avoid functionally defined genus claims

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