Court Opinion

ID: 4223006
Source: CourtListenerOpinion
Date Created: 2017-11-22 16:00:46.261353+00
Date Added: 2024-06-11T13:26:26.324221
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

 ELI LILLY AND COMPANY, ELI LILLY EXPORT
          S.A., ACRUX DDS PTY LTD.,
                Plaintiffs-Appellants

                           v.

     PERRIGO COMPANY, PERRIGO ISRAEL
      PHARMACEUTICALS LTD., ACTAVIS
     LABORATORIES UT, INC., FKA WATSON
         LABORATORIES INC., LUPIN
     PHARMACEUTICALS, INC., LUPIN LTD.,
             Defendants-Appellees

       AMNEAL PHARMACEUTICALS LLC,
           Defendant-Cross-Appellant
            ______________________

                 2016-2555, 2016-2614
                ______________________

   Appeals from the United States District Court for the
Southern District of Indiana in Nos. 1:13-cv-00851-SEB-
DKL, 1:13-cv-01799-JMS-DKL, 1:14-cv-02025-SEB-TAB,
Judge Jane Magnus-Stinson, Judge Sarah Evans Barker.
                ______________________

              Decided: November 22, 2017
                ______________________
2               ELI LILLY AND COMPANY   v. PERRIGO COMPANY

   CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, Reston, VA, argued for plaintiffs-
appellants.     Also represented by LAWRENCE SCOTT
BURWELL; HOWARD WARREN LEVINE, LAURA POLLARD
MASUROVSKY, Washington, DC; ALISSA KEELY LIPTON,
Boston, MA; JENNIFER SWAN, Palo Alto, CA; MANISHA A.
DESAI, Eli Lilly and Company, Indianapolis, IN.

    WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik
LLP, Chicago, IL, argued for defendants-appellees Perrigo
Company, Perrigo Israel Pharmaceuticals Ltd.         Also
represented by GREGORY DUFF, LAUREN MARIE LESKO,
ALICE L. RIECHERS, CHRISTINE SIWIK.

    MICHAEL KEENAN NUTTER, Winston & Strawn LLP,
Chicago, IL, argued for defendants-appellees Actavis
Laboratories UT, Inc., Lupin Ltd., Lupin Pharmaceuti-
cals, Inc. Defendant-appellee Actavis Laboratories UT,
Inc. also represented by DAN HOANG, KURT A. MATHAS;
GEOFFREY P. EATON, Washington, DC.

   JOHN T. BATTAGLIA, Fisch Sigler, LLP, Washington,
DC, argued for defendant-cross-appellant Amneal Phar-
maceuticals LLC. Also represented by JOSEPH FRANKLIN
EDELL, ROY WILLIAM SIGLER; CAROLYN ALENCI, VINCENT
CAPUANO, ANTHONY JAMES FITZPATRICK, CHRISTOPHER S.
KROON, Duane Morris LLP, Boston, MA.

    KEITH DAVID PARR, Locke Lord LLP, Chicago, IL, for
defendants-appellees Lupin Pharmaceuticals, Inc., Lupin
Ltd. Also represented by DAVID BRIAN ABRAMOWITZ,
HUGH S. BALSAM, CAROLYN ANNE BLESSING, NINA
VACHHANI.
                ______________________

     Before CHEN, PLAGER, and HUGHES, Circuit Judges.
CHEN, Circuit Judge.
ELI LILLY AND COMPANY    v. PERRIGO COMPANY                3

                         INTRODUCTION
    This litigation relates to Abbreviated New Drug Ap-
plications filed by the defendants for generic equivalents
of Eli Lilly’s Axiron® testosterone applicator. Eli Lilly, in
turn, sued the defendants for patent infringement. After
a nine-day bench trial, the district court issued a thor-
ough, well-considered opinion over 200 pages long. Eli
Lilly appeals the district court’s opinion that claim 20 of
U.S. Patent No. 8,435,944 (the ’944 patent) is invalid for
obviousness under 35 U.S.C. § 103. Amneal cross-appeals
the district court’s opinion that claims 9 and 10 of U.S.
Patent No. 8,807,861 (the ’861 patent) are (1) not invalid;
and (2) infringed by Amneal’s applicator. Because we find
no fault in the district court’s opinion, we affirm on all
grounds.
                           ANALYSIS
                    I.    The ’944 Patent
    Claim 20 of the ’944 patent recites a transdermal de-
livery method of applying testosterone to the axilla of a
patient. We agree with the district court that the prior
art (e.g. the Aschkenasy ’268 publication and the Cutter
2000 and 2001 references) teach and suggest that apply-
ing testosterone to the axilla will increase a patient’s
testosterone level with a reasonable expectation of suc-
cess. See J.A. 165–69. Eli Lilly’s arguments against those
references lack merit and/or are based on a misreading of
the lower court’s opinion. Lilly’s primary challenge is that
the district court improperly reached a “prima facie”
decision of obviousness and improperly treated its sec-
ondary considerations as an afterthought. We disagree
with Lilly’s argument for a few reasons. As an initial
matter, it is premised on Lilly having provided weighty
objective indicia of non-obviousness. We agree with the
district court, however, that Lilly’s proffered objective
indicia lacked probative weight. See J.A. 170–79. In
Lilly’s briefing below, it advanced two primary bases of
4                ELI LILLY AND COMPANY   v. PERRIGO COMPANY

secondary considerations: (1) the prior art teaches away
from applying testosterone to the axilla due to concerns
over causing an undesired elevated level of dihydrotestos-
terone (DHT); and (2) the claimed method yielded unex-
pected results. Id. Lilly’s expert, however, did not point
to any teaching in the prior art that suggested avoiding
the axilla as a location for applying and delivering testos-
terone.
    As the district court noted, Eli Lilly’s teaching away
theory rested on a position that the scrotal skin and the
axilla have comparably high 5-alpha reductase activity,
which can result in an elevated DHT level. But Lilly’s
reference to support that assertion, Takayasu, did not
include measurements from the scrotal area in its study.
See J.A. 22797–801. 1 Thus, even if the prior art sought to
avoid areas that had the same level of 5-alpha reductase
activity as scrotal skin (and we agree with the district
court that, at the time of the invention, this was less than
clear), Lilly did not present any evidence that the axilla
and scrotal skin have comparably high activity. 2 Thus,
the district court correctly found, on this record, that the

    1    Takayasu’s measurements of high 5-alpha reduc-
tase in the axillary skin were also limited exclusively to
samples taken from women and thus may be less proba-
tive in the context of testosterone administration to men.
See J.A. 22800.
    2    Lilly contended in its briefing below, J.A. 7118–
19, and at oral argument that Takayasu itself recognized
that the level of 5-alpha reductase was comparably high
in the scrotum and axilla by stating that “the activity is
high in genital and axillary skin.” J.A. 22798 (citations
omitted). But, as the district court recognized, J.A. 75–77,
Takayasu only states that the levels are high in both
areas—it does not state that levels in the axilla are as
high or higher than in the scrotum.
ELI LILLY AND COMPANY   v. PERRIGO COMPANY                  5

only teaching relating to DHT levels in the axilla was by
Cutter, which reported a normal DHT level after applica-
tion of testosterone to the axilla.
    On unexpected results, Eli Lilly makes no meaningful
argument contesting the district court’s rejection of Lilly’s
theory of unexpected results. On review, we see no error
in the district court’s explanation that Lilly’s asserted
‘seven-fold increase’ in skin permeability was based on a
flawed extrapolation of data reported in a prior art refer-
ence. In sum, the lower court correctly found that Lilly’s
objective indicia lacked weight. The district court thus
could not have committed any reversible legal error in the
order of how it considered the evidence, given that Lilly’s
proffered evidence was unhelpful.
    Eli Lilly notes the district court’s admitted use of the
phrase “prima facie” in several places in the course of the
court’s discussion of obviousness, and considers that
reversible error. But even if Eli Lilly’s secondary consid-
eration/objective indicia evidence carried probative
weight, there is nothing to indicate that the court reached
the ultimate conclusion of obviousness prematurely, or
without fully considering all the evidence before it, includ-
ing the evidence of objective indicia. For that reason we
do not see the insertion of that particular phrase as
reversible error in this case, since it does not accurately
reflect what the district court actually did. See, e.g., In re
Cyclobenzaprine Hydrochloride Extended-Release Capsule
Patent Litig., 676 F.3d 1063, 1076–77 (Fed. Cir. 2012).
Rather, we are satisfied that the district court thoroughly
considered all the arguments and evidence presented
before reaching its decision that the defendants had met
their burden of proof that claim 20 of the ’944 patent is
invalid for obviousness.
                    II. The ’861 Patent
   Claims 9 and 10 of the ’861 patent are directed to an
applicator with a “resiliently deformable wall” used to
6                ELI LILLY AND COMPANY   v. PERRIGO COMPANY

administer a testosterone solution to the axilla. We
detect no error in the district court’s conclusions that the
claims, as construed, are not invalid over the asserted
prior art (e.g. Gueret ’187 and Gueret ’986) and were
infringed by Amneal’s applicator. On appeal, Amneal
argues that (1) these claims are anticipated or obvious
over some combination of Gueret ’187 and Gueret ’986;
(2) the district court improperly disregarded other theo-
ries of invalidity advanced by other defendants and joined
by Amneal; and (3) Amneal’s applicator does not infringe
because it does not deform “in a blade-like manner.”
    As to the Gueret references, we are unconvinced by
Amneal’s arguments that Gueret ’187 discloses the double
wall required by the claims as construed. As the district
court correctly recognized, annular rib 201/202 contains a
number of features that are materially different from the
double wall of the claims. Amneal does not challenge the
district court’s finding that annular rib 201/202 does not
meet the double wall limitation, and instead contends
that annular rib 201/202 and annular rib 204, taken
together, form a double wall as required by the claims.
We decline to consider this argument because it was not
raised below. See HTC Corp. v. IPCom GmbH & Co., KG,
667 F.3d 1270, 1281 (Fed. Cir. 2012). Amneal’s expert
testimony was exclusively directed to an invalidity theory
of removing annular rib 204 to form a double wall struc-
ture from only annular rib 201/202. See J.A. 2071–76. 3
Amneal offers a plethora of record citations as proof that
it had raised below its newly-minted argument. We have
carefully reviewed every single one of Amneal’s citations

    3   Amneal contends that a slide from its expert’s
demonstrative, J.A. 31906, supports this theory. But that
slide plainly does not focus on annular rib 204 in conjunc-
tion with annular rib 201/202, let alone suggest that those
elements, taken together, represent a double wall.
ELI LILLY AND COMPANY   v. PERRIGO COMPANY                 7

and did not find any testimony or briefing showing it
argued that annular rib 204 together with annular rib
201/202 form a double-wall structure. The district court
accordingly never addressed this theory. 4 At bottom, we
detect no reversible error in the district court’s conclusion
that Amneal failed to meet its burden of proving the
asserted ’861 patent claims invalid. 5
     Amneal also argues that the district court improperly
failed to consider arguments that (1) the ’861 claims were
obvious over the DiPietro reference in combination with
the Gueret references; (2) the claims were anticipated by
Gueret ’986 under a theory that its single wall could fold
over to form a double wall; and (3) the claims were invalid
for lack of written description if the claims were construed
to cover an embodiment in which a single wall of an

    4   Amneal contends that the district court in fact
addressed and rejected this theory. But the record shows
that the district court considered annular rib 201/202 and
annular rib 204 separately, not in conjunction with one
another. J.A. 129.
    5   Amneal contends that the district court erred by
placing a higher burden of proof on Amneal by noting that
the asserted prior art references had appeared before the
examiner during prosecution of the ’861 patent. J.A. 211.
We disagree. Despite its imprecise use of the word “bur-
den,” we read the district court’s opinion as merely stat-
ing, as has the Supreme Court, that “new evidence
supporting an invalidity defense may ‘carry more weight’
in an infringement action than evidence previously con-
sidered by the PTO.” Microsoft Corp. v. i4i Ltd. P’ship,
564 U.S. 91, 110 (2011) (quoting Am. Hoist & Derrick Co.
v. Sowa & Sons, Inc., 725 F.2d 1350, 1360 (Fed. Cir.
1984)).
8                ELI LILLY AND COMPANY   v. PERRIGO COMPANY

applicator could fold over to form a double wall. 6 None of
these arguments help Amneal’s cause.
    The defendants below relied on DiPietro only for the
teaching of applying testosterone to the axilla, not for any
particular design of an applicator. See J.A. 6768–69. And
DiPietro itself does not disclose any particular applicator.
See J.A. 24778–95. Because we hold that none of the
Gueret references disclose a double wall, even if the
DiPietro reference were considered, the outcome would
not differ. It was thus not reversible error for the court to
decline to consider theories depending in part on the
DiPietro reference. With regard to Amneal’s invalidity
theories which were contingent upon the district court
adopting a construction of the claims that would cover a
single wall that could fold over to create a double wall,
this wall-folding theory was explicitly rejected by the
district court. See J.A. 193 n.30. Thus, theories which
depend on the rejected wall-folding theory are moot under
the district court’s claim construction, and it was not error
for the district court to not consider these alternative
theories.
    As to Amneal’s argument that its applicator does not
infringe because it does not deform in a “blade-like man-
ner,” the phrase “blade-like manner” appears nowhere in
the claims and appears only in the context of a specific
embodiment in the specification. Thus, we agree with the
district court that the claims require only that the appli-
cator wall be “resiliently deformable” and do not require a
specific mode of resilient deformation. Amneal also
argues that the district court itself recognized that the
claims require that the applicator deform in a “blade-like
manner.” We read the district court’s statements in the

    6    Amneal also mentioned, but did not appeal, the
district court’s lack of consideration of an indefiniteness
theory.
ELI LILLY AND COMPANY   v. PERRIGO COMPANY                9

record as simple explications of the ’861 patent and the
expert testimony in the case. See J.A. 124 (summarizing
expert testimony), 139 (describing the specific embodi-
ment of the patent). Thus, we do not find those isolated
statements to conflict with the court’s own correct holding
that the claims do not require a specific mode of defor-
mation. E.g. J.A. 125, 199–200.
                        CONCLUSION
    We have considered all of the appellant’s and cross-
appellant’s other arguments and find them unpersuasive.
For the foregoing reasons, the opinion of the district court
is
                        AFFIRMED
                           COSTS
   No costs.