Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 Conundrum
Andrew Allen
Director, Legal Counsel, IP
Dr. Reddy’s Labs
Bruce M. Wexler
Partner
Paul Hastings LLP (New York, NY)
Gerald J. Flattmann Jr.
Partner
King & Spalding (New York, NY)
Matthew A. Pearson
Partner
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. Amazon.com, 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
