On May 18, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court determined that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. This panel will discuss the Supreme Court’s decision in Amgen v. Sanofi and the Federal Circuit’s ruling in Juno Therapeutics v. Kite Pharma. What is the future of the disclosure requirements generally, and what specificity is now required to satisfy the enablement and written description requirements?
- 1:00 pm