Eli Lilly v. Zenith Goldline - Case Brief
Eli Lilly & Co. v. Zenith Goldline Pharms., Inc. 471 F.3d 1369 (Fed. Cir. 2006).
Background: Lilly obtained a patent directed to olanzapine (Zyprexa®) and its use for the treatment of schizophrenia. The defendant generic manufacturers filed an ANDA and Lilly responded by filing a complaint in the Southern District of Indiana. After a bench trial, the district court found in favor of Lilly and held that the patent was valid, enforceable, and infringed. The defendants appealed to the Court of Appeals of the Federal Circuit.
Anticipation: To anticipate an invention, a prior art reference “must disclose each and every feature of the claimed invention, either explicitly or inherently.” In both Petering and Schaumann, prior art references that disclosed the family of the claimed compound were found to anticipate the claimed compounds even though the claimed compounds were not specifically identified. Here, the CAFC found that those cases were not applicable because the closest reference to olanzapine did not spell out “a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member in this limited class.”
Obviousness: The CAFC agreed that the prior art references did not suggest the compound. In addition, Lilly provided strong evidence of secondary indicia of nonobviousness including: “(1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results.”
Public Use: Lilly conducted Phase I clinical trials before filing the application. The court found that the trials were well within the experimental use exception:
“In this case, Lilly tailored its tests to their experimental drug safety and efficacy purpose, adequately monitored for results, and maintained confidentiality throughout the duration of the study. The trial court did not err in finding no public use.”