Federal Circuit Weighs In on Enablement Law with Contrasting Decisions
The Federal Circuit has issued two decisions that highlight the complexities of enablement law in patent cases. In Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, the court reinstated a $176.5 million verdict for patent infringement. Three months later, in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, the same court affirmed a judgment as a matter of law that invalidated a $107.5 million verdict on similar grounds.
The two cases involved broad method-of-treatment claims tested against the enablement standard set by the Supreme Court in Amgen Inc. v. Sanofi. The decisions offer lessons on the current state of enablement law, particularly when it comes to functional claiming and the disclosure requirements for patent holders.
In Teva, the claimed genus of anti-CGRP antibodies was well-understood and routine to produce in the art, allowing a single representative species and established protocols to enable the full scope of the claims. In contrast, the Wyeth decision emphasized that when a method claim requires daily administration to a human patient, in vitro cell-killing data alone is insufficient unless the patent provides a reliable dose translation mechanism or working human dosing models.