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Eli Lilly and Co. v. Los Angeles Biomedical Research Institute at Harbor-Ucla Medical Center

United States Court of Appeals, Federal Circuit

February 28, 2017

ELI LILLY AND COMPANY, Appellant
v.
LOS ANGELES BIOMEDICAL RESEARCH INSTITUTE AT HARBOR-UCLA MEDICAL CENTER, Appellee

         Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2014-00693.

          Mark J. Feldstein, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, argued for appellant. Also represented by Joshua Goldberg, Yieyie Yang; Charles E. Lipsey, Reston, VA; Mark Stewart, Eli Lilly and Company, Indianapolis, IN.

          Ewa M. Davison, Fenwick & West LLP, Seattle, WA, argued for appellee. Also represented by David Keith Tellekson, Elizabeth B. Hagan; Virginia Kay DeMarchi, Amy Hayden, Mountain View, CA.

          Before Newman, Bryson, and Moore, Circuit Judges.

          Bryson, Circuit Judge.

         This appeal is related to the appeal in Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly & Company, No. 2016-1518, decided today. The same patent (U.S. Patent No. 8, 133, 903 ("the '903 patent")) and one of the same prior art references (International Patent Application No. WO 01/80860 (published Nov. 1, 2001) (John S. Whitaker et al., applicants) ("Whitaker")) are at issue in both cases. The background discussion set forth in the Los Angeles Biomedical Research Institute case will not be repeated here, except to the extent required by the differences in the legal issues presented in the two cases.

         I

         At the behest of appellant Eli Lilly and Company ("Lilly"), the Patent Trial and Appeal Board instituted inter partes review of the claims of the '903 patent, owned by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center ("LAB"), for anticipation by Whitaker. Following trial, the Board held that Whitaker did not anticipate the '903 claims because it did not disclose the limitation requiring the administration of a PDE5 inhibitor "at a dosage up to 1.5 mg/kg/day for not less than 45 days."

         Before the Board, Lilly relied heavily on Example 6 of Whitaker. That portion of Whitaker discusses a set of studies on the use of phosphodiesterase 5 ("PDE5") inhibitors to treat erectile dysfunction. The studies included some subjects who took a PDE5 inhibitor "greater than 70% of the time" over the course of either 8 or 12 weeks. Whitaker at 34. The Board, however, found that the disclosure that some of the study subjects took the PDE5 inhibitor more than 70% of the time did not constitute a disclosure of daily dosing.

         The Board also rejected Lilly's argument that Whitaker explicitly disclosed daily dosing for at least 45 days based on Whitaker's title ("Daily Treatment for Erectile Dysfunction Using a PDE5 Inhibitor").

         Finally, the Board concluded that Whitaker's definition of "chronic administration" did not inherently disclose treatment with a PDE5 inhibitor for at least 45 days. Whitaker defines "chronic administration" to mean "regular administration for an extended period, preferably daily for three or more days, and still more preferably daily as long as the patient suffers from erectile dysfunction (in the absence of therapy)." Whitaker at 7. The Board noted that Whitaker discloses that administering daily treatment for as little as three days may effectively treat erectile dysfunction, even if a person of skill in the art would understand that erectile dysfunction can last longer than 45 days in the absence of therapy.

         Based on its analysis of Whitaker, the Board concluded that Lilly had failed to show, by a preponderance of the evidence, that Whitaker anticipates claim 1 of the '903 patent. Because dependent claims 2-5 all incorporate the limitations of claim 1, the Board held that those claims were also not anticipated.

         II

         "To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either expressly or inherently." Rapoport v. Dement, 254 F.3d 1053, 1057 (Fed. Cir. 2001). "In the context of anticipation, the question is not whether a prior art reference 'suggests' the claimed subject matter[;] . . . [r]ather, the dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that ...


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