Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 Conundrum

April 29, 2019 4:15pm

Andrew Allen
Director, Legal Counsel, IP
Dr. Reddy’s Labs

Bruce M. Wexler
Paul Hastings LLP (New York, NY)

Gerald J. Flattmann Jr.
King & Spalding (New York, NY)

Matthew A. Pearson
Akin Gump Strauss Hauer & Feld LLP (Philadelphia, PA)

Mark E. Waddell
Co-Chair, Life Sciences
Loeb & Loeb LLP (New York, NY)

  • Exploring the §112 and §101 nexus illustrated in recent ANDA cases
    • Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals
  • Understanding how the Federal Circuit’s decision in Affinity Labs of Texas, LLC v., Inc., may impact Paragraph IV litigation
  • Examining the resurgence of 101 applicability in an ANDA setting
  • Drafting claims to avoid §101 roadblocks relative to pharmaceutical patent applications
  • Reviewing court-determined “adequate written descriptions” under § 112
    • AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.
  • Understanding the standard for determining the adequacy of the “written description” of the invention under this recent jurisprudence and how it applies in a Hatch-Waxman setting
    • Reviewing precedent where substantial evidence supports claims of adequate written description
  • Analyzing whether the true test of written description requirement is based on enablement versus possession