Eli Lilly v. Los Angeles Biomedical (2016-1547), February 28, 2017. Before Judges Newman, Bryson, and Moore.

Takeaway:

  • In order to anticipate claims directed toward a daily treatment regime, a reference must do more than merely suggest the claimed subject matter.

Procedural Posture:

Los Angeles Biomedical filed a patent infringement suit against Eli Lilly and Company alleging infringement of U.S. Patent No. 8,133,903 (“the ‘903 Patent”). Eli Lilly filed multiple inter partes review petitions challenging the validity of the ‘903 Patent. This is an appeal from the PTAB’s decision finding that a single prior art reference did not anticipate the claims of the ‘903 Patent. The CAFC affirmed the PTAB’s decision.

Synopsis:

  • Anticipation: The PTAB found that the prior art reference Whitaker did not disclose the limitation recited in independent claim 1 of administering a class of drugs “at a dosage up to 1.5 mg/kg/day for not less than 45 days.” Whitaker discussed a set of studies in which subjects were treated with a PDE5 inhibitor “greater than 70% of the time” over the course of either 8 or 12 weeks, but the CAFC found that taking a drug “more than 70% of the time” does not disclose daily dosing. The CAFC found that Whitaker also disclosed “chronic administration,” but this was in reference to daily administration for at least three days, and longer if the erectile dysfunction persists. The CAFC found that this description does not disclose treatment for 45 days, “particularly in light of the fact that the only daily dosing done in Whitaker lasted for at most three weeks.” Eli Lilly & Co. v. Los Angeles Biomedical Research Inst. at Harbor–UCLA Med. Ctr., 2016-1547, 2017 WL 765829, at *2 (Fed. Cir. Feb. 28, 2017). The CAFC affirmed the PTAB’s decision, and held that substantial evidence supported the PTAB’s finding that Whitaker did not anticipate the claims of the ‘903 Patent.