from the United States Patent and Trademark Office, Patent
Trial and Appeal Board in No. IPR2014-00693.
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,
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.
Newman, Bryson, and Moore, Circuit Judges.
Bryson, Circuit Judge.
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.
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."
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
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").
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.
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
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 ...