BarbriSFCourseDetails

Course Details

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

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

  1. Written description requirements
  2. Recent court treatment
  3. 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