Court Opinion

ID: 4148816
Source: CourtListenerOpinion
Date Created: 2017-02-28 16:01:12.913474+00
Date Added: 2024-06-11T14:37:46.801670
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
               ______________________

            ELI LILLY AND COMPANY,
                    Appellant

                          v.

    LOS ANGELES BIOMEDICAL RESEARCH
    INSTITUTE AT HARBOR-UCLA MEDICAL
                  CENTER,
                   Appellee
            ______________________

                     2016-1547
               ______________________

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

             Decided: February 28, 2017
              ______________________

    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.
2         ELI LILLY AND COMPANY   v. LOS ANGELES BIOMEDICAL

                 ______________________

    Before NEWMAN, BRYSON, and MOORE, Circuit Judges.
BRYSON, Circuit Judge.
    This appeal is related to the appeal in Los Angeles Bi-
omedical 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., appli-
cants) (“Whitaker”)) are at issue in both cases. The
background discussion set forth in the Los Angeles Bio-
medical 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 Whita-
ker. 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”) inhibi-
tors 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
ELI LILLY AND COMPANY   v. LOS ANGELES BIOMEDICAL         3

inhibitor more than 70% of the time did not constitute a
disclosure of daily dosing.
    The Board also rejected Lilly’s argument that Whita-
ker 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 defini-
tion of “chronic administration” did not inherently dis-
close 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 dysfunc-
tion (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 conclud-
ed 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 dis-
close 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 anticipa-
tion, 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
4         ELI LILLY AND COMPANY   v. LOS ANGELES BIOMEDICAL

disclosed in that reference.” AstraZeneca LP v. Apotex,
Inc., 633 F.3d 1042, 1055 (Fed. Cir. 2010) (internal brack-
ets and quotation marks omitted).
    Lilly’s argument boils down to saying that Whitaker’s
definition of “chronic administration” anticipates daily
administration for 45 days or more because a person of
skill would understand that erectile dysfunction (in the
absence of therapy) can last longer than 45 days. As the
Board stated, however, that, “at best, is an obviousness
argument.” Whitaker’s definition of “chronic administra-
tion,” which is “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),” does not
expressly teach daily treatment for at least 45 days.
    The understanding of a person of skill at that time re-
garding how long a patient would suffer from erectile
dysfunction in the absence of therapy says nothing about
how long erectile dysfunction would last with the therapy
at issue in Whitaker that had not before been pre-
scribed—i.e., chronic daily treatment with PDE5 inhibi-
tors, rather than on-demand use. For that reason, Lilly’s
expert testimony, which was addressed to the former
question, does not answer the latter. 1

    1    ClearValue, Inc. v. Pearl River Polymers, Inc., 668
F.3d 1340 (Fed. Cir. 2012), on which Lilly relies, does not
help Lilly. The prior art reference at issue in that case
met every limitation but disclosed a broader range than
was recited in the claim. The reference disclosed a pro-
cess for “clarification” of water with alkalinity of 150 ppm
or less, while the claim at issue recited a process for
clarification of water with alkalinity of 50 ppm or less. Id.
at 1344. The court held that the reference anticipated the
claim because the patent did not distinguish its narrower
ELI LILLY AND COMPANY   v. LOS ANGELES BIOMEDICAL          5

    A fair reading of Whitaker’s definition of “chronic ad-
ministration” is that it refers to daily administration for
at least three days, and more if the erectile dysfunction
persists. That does not disclose the treatment of penile
fibrosis for at least 45 days, particularly in light of the
fact that the only daily dosing done in Whitaker lasted for
at most three weeks. Whitaker at 37 (Example 7).
    The reference to a dosing period of 8 or 12 weeks in
Whitaker’s Example 6 does not provide the necessary
disclosure of dosing every day for at least 45 days. In fact,
the “daily” dosing referred to in Example 6 included
dosing on fewer than 30% of the days. Thus, even in light
of the embodiments discussed by Whitaker, the definition
of “chronic administration” does not provide the clear
disclosure required to prove anticipation. 2
    In AstraZeneca LP v. Apotex, Inc., this Court affirmed
the district court’s determination that the method claims
for once-daily dosing would likely survive an anticipation
challenge by a prior advertisement that disclosed twice-
daily dosing. 633 F.3d at 1055. The advertisement did
not explicitly disclose once-daily dosing, nor did it inher-

range as “critical.” Id. at 1344-45. In this case, Whitaker
does not disclose a broader range than the “not less than
45 days” treatment period while meeting every other
limitation, because it does not disclose a daily treatment
regimen that necessarily extends for more than 45 days.

    2   The results reported in Example 6 of Whitaker do
not support a conclusion that a strict regimen of daily
dosing is superior to dosing on more than half the days.
See Whitaker at 36-37 (Tables 2-4 report better results for
those taking the 10mg dose 50%-70% of the time than for
those taking the 10mg dose greater than 70% of the time).
6         ELI LILLY AND COMPANY   v. LOS ANGELES BIOMEDICAL

ently do so because, as the expert testified, persons of skill
in the art at that time did not have “any information or
historical perspective that once a day therapy worked for
anyone.” Id. at 1054.
    This case is similar. Whitaker may “suggest” long-
term daily treatment by noting the beneficial effects of
daily treatment (better erectile response and decreased
side effects) in light of Example 6, but that is not enough.
To anticipate, a reference must do more than “suggest”
the claimed subject matter. AstraZeneca, 633 F.3d at
1055. Thus, we hold that substantial evidence supports
the Board’s finding that Whitaker does not disclose the
claimed treatment regimen with sufficient clarity to
satisfy the demanding standard for anticipation. 3
                        AFFIRMED

    3    Lilly also argues that LAB’s infringement conten-
tions in the related district court proceeding, Los Angeles
Biomed. Research Inst. v. Eli Lilly & Co., No. 2:13-cv-
08567-JAK-JCG (C.D. Cal.), “confirm anticipation by
Whitaker.” LAB objects to the court’s consideration of
those materials in this case. As noted in the related
appeal decided today, Los Angeles Biomedical Research
Institute at Harbor-UCLA Medical Center v. Eli Lilly &
Co., No. 2016-1518, at 19 n.6, we can properly take judi-
cial notice of the records of related district court proceed-
ings, and we therefore deny LAB’s motion to strike from
the joint appendix the materials filed in the district court
action and disregard Lilly’s argument. On the merits, as
explained in the related appeal, No. 2016-1518, at 19-20,
we disagree with Lilly that LAB asserted in the district
court proceeding that the ’903 patent is infringed regard-
less of treatment duration.