Best Practices for Enablement and Written Description After Amgen v. Sanofi *

Best Practices for Enablement and Written Description After Amgen v. Sanofi *

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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.

Meanwhile, although not granted cert. by the Supreme Court, the Federal Circuit in Juno Therapeutics v. Kite Pharma said that patent applicants must convey both “known and unknown” aspects of the invention to satisfy the written description requirement. But how can an anyone describe something that is unknown?

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? More specifically, the panel will address: (1) best practices for patent application drafting in light of these recent 112 decisions; (2) best practices for saving already filed patent applications and issued patents not written with an eye toward these recent decisions; and (3) best practices for challenging patents and making 112 attacks.

Materials

SCOTUS Ushers in New Era of Enablement in Amgen v. Sanofi

Exploring the CAFC’s Ridiculous Written Description Standard for Life Sciences Patents

Best Practices for Conquering the Enablement Requirement After Amgen