What is it about?

• 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