Schizophrenia Drug Patent Held to Be Valid and Infringed

Case: Eli Lilly & Co. v. Zenith Goldline Pharms., Inc. (12/26/06 - Fed. Cir. No. 05-1396, 05-1429, 05-1430)

The One Sentence Summary: A drug patent was not anticipated, obvious or subject to a public use bar and the applicant did not commit inequitable conduct.


What They Were Fighting About: Plaintiff Eli Lilly had a patent for using olanzapine to treat schizophrenia. Plaintiff sold the drug under the trademark Zyprexa. Defendants filed an ANDA to market a generic. After a trial, the district court found the patent valid and infringed.

Federal Circuit Holdings:

• The district court correctly found that the claimed invention was not anticipated by a prior art article that disclosed millions of potential compounds.
• The prior art did not make the substitution of a hydrogen atom for a halogen obvious where the prior art taught away from non-halogens. The structural similarity of substituting hydrogen for fluorine was not sufficient for obviousness where the properties of the halogen were thought to be important in the prior art.
• Plaintiff established secondary considerations of non-obviousness of long-felt need, commercial success, awards for the invention, and unexpected results.
• The clinical trials by plaintiff were not a public use establishing a section 102(b) bar. Plaintiff restricted access to the trials, and had security. Visitors to the volunteers did not make the trials public. Moreover, even public experimentation with an invention does not create a 102(b) bar.
• The district court did not err in finding no inequitable conduct by patentee.