Court Opinion

ID: 2799275
Source: CourtListenerOpinion
Date Created: 2015-05-07 16:01:48.858531+00
Date Added: 2024-06-11T12:09:29.109694
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

      ASTRAZENECA LP, ASTRAZENECA AB,
              Plaintiffs-Appellants

                           v.

   BREATH LIMITED, APOTEX CORP., APOTEX,
  INC., SANDOZ INC., WATSON LABORATORIES,
                     INC.,
              Defendants-Appellees
             ______________________

                      2015-1335
                ______________________

    Appeal from the United States District Court for the
District of New Jersey in No. 1:08-cv-01512-RMB-AMD,
Judge Renee Marie Bumb.
                ______________________

                 Decided: May 7, 2015
                ______________________

    CHRISTOPHER NEIL SIPES, Covington & Burling LLP,
Washington, DC, argued for plaintiffs-appellants. Also
represented by KEITH A. TEEL, RODERICK R. MCKELVIE,
STEPHEN PIERCE ANTHONY, JAY I. ALEXANDER, AHMED
MOUSA; DANIELLE LUCE GOLDSTEIN, San Francisco, CA;
JOHN EDMUND FLAHERTY, RAVIN R. PATEL, McCarter &
English, LLP, Newark, NJ.
2                         ASTRAZENECA LP   v. BREATH LIMITED

   WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik
LLP, Chicago, IL, argued for defendants-appellees Breath
Limited, Watson Laboratories, Inc. Also represented by
AMY D. BRODY, NATASHA L. WHITE, HEINZ JOHANN
SALMEN, CONLY S. WYTHERS.

   RICHARD JOSEPH BASILE, St. Onge Steward Johnston
& Reens, LLC, Stamford, CT, argued for defendants-
appellees Apotex Corp., Apotex, Inc. Also represented by
DAVID W. ALDRICH, ALYSON J. DILENA.

    TARAS A. GRACEY, Steptoe & Johnson, LLP, Chicago,
IL, argued for defendant-appellee Sandoz, Inc. Also repre-
sented by THOMAS ARTHUR RAMMER, II; GRETCHEN P.
MILLER, Washington, DC.
                 ______________________

    Before PROST, Chief Judge, BRYSON and LINN, Circuit
                          Judges.
PROST, Chief Judge.
    This Hatch-Waxman case returns to us following our
previous remand to the district court. The suit originates
from a consolidated action for patent infringement
brought by AstraZeneca LP and AstraZeneca AB (collec-
tively, “AstraZeneca”) against Breath Limited, Apotex
Corp., Apotex, Inc., Sandoz Inc., and Watson Laborato-
ries, Inc. (collectively, “Defendants”). In our prior decision
and of relevance here, we reversed and remanded the
district court’s noninfringement findings on AstraZeneca’s
U.S. Patent No. 7,524,834 (“’834 patent”) based on the
district court’s erroneous claim construction. AstraZeneca
LP v. Breath Ltd., 542 F. App’x 971 (2013).
    On remand and following a thirteen-day bench trial,
the district court found the asserted claims of the ’834
patent infringed but invalid under 35 U.S.C. § 103.
AstraZeneca LP v. Breath Ltd., No. 08-1512, 2015 WL
ASTRAZENECA LP   v. BREATH LIMITED                         3

777460 (D.N.J. Feb. 13, 2015). AstraZeneca now appeals
the district court’s obviousness determination to us. We
conclude that, in its very thorough and well-reasoned
opinion, the district court correctly determined that the
asserted claims of the ’834 patent are invalid for obvious-
ness, and therefore we affirm. We also dissolve the in-
junction pending appeal that was entered on March 12,
2015. See ECF No. 46.
                              I
    Because many of the relevant facts are detailed in our
previous decision, we repeat them only briefly here.
    The ’834 patent is directed to sterile, pharmaceutical-
ly effective budesonide compositions.        Representative
claim 1 (the powder) and claim 50 (the suspension) read
as follows:
    1. A pharmaceutically acceptable, micronized pow-
    der composition at least 98.5% by weight of which
    is pure budesonide or an ester, acetal or salt
    thereof, wherein the composition meets the crite-
    ria of sterility according to the US Pharmacopoeia
    23/NF18, 1995, pages 1686-1690 and 1963-1975.
    50. A pharmaceutically acceptable suspension con-
    sisting of a micronized powder composition at least
    98.5% by weight of which is pure budesonide or an
    ester, acetal or salt thereof, suspended in an aque-
    ous solution, wherein the suspension meets the
    criteria of sterility according to the US Pharmaco-
    poeia 23/NF18, 1995, pages 1686-1690 and 1963-
    1975.
’834 patent col. 11 ll. 47–52, col. 13 ll. 55–60. AstraZeneca
markets a product called Pulmicort Respules®, a sterile,
nebulized budesonide suspension used for treating asth-
ma in children. The Defendants have all filed ANDAs
seeking to market a generic version of Pulmicort
Respules®.
4                         ASTRAZENECA LP   v. BREATH LIMITED

    In the decision now on appeal, the district court found
that the asserted claims of the ’834 patent are invalid for
obviousness. In its 166-page opinion, the district court
concluded that a person of ordinary skill in the art, who
the parties agree was motivated to prepare a sterile
budesonide composition, would have had a reasonable
expectation of successfully doing so with four of five well-
known sterilization techniques. In addition to making
extensive fact-findings on the prior art, the district court
thoroughly analyzed and rejected AstraZeneca’s argu-
ments for nonobviousness based on objective indicia.
    On appeal, AstraZeneca argues that the district court
erred in its evaluation of the prior art and in its analysis
of the objective indicia of nonobviousness. We review the
district court’s ultimate legal conclusion of whether a
claimed invention would have been obvious de novo, and
the underlying findings of fact for clear error. Novo
Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346,
1354 (Fed. Cir. 2013). For the reasons explained below,
we agree with the district court’s determination that the
asserted claims of the ’834 patent are invalid for obvious-
ness.
                             II
    The prior art presented at trial included non-sterile
budesonide compositions, sterile compositions of cortico-
steroids other than budesonide, and five well-known
sterilization techniques: sterile filtration followed by
aseptic crystallization; moist heat; ethylene oxide; irradia-
tion; and dry heat. Both parties agreed that a skilled
artisan would have been motivated to prepare sterile
budesonide compositions. Thus, the question before the
district court was whether the claimed sterile budesonide
compositions were obvious in light of the sterilization
methods known in the prior art.
   The district court concluded that a skilled artisan
would have had a reasonable expectation of success in
ASTRAZENECA LP   v. BREATH LIMITED                       5

preparing the claimed compositions with four of the five
prior art sterilization methods (all but dry heat). Review-
ing the voluminous documentary and testimonial evi-
dence of record, the district court determined that,
although each sterilization method had known disad-
vantages, a skilled artisan “had within her toolbox several
methods to address them.”          AstraZeneca, 2015 WL
777460, at *10. The district court’s findings on the prior
art and the reasonable expectation of success span over
ninety pages and include detailed examinations of multi-
ple prior art references and the testimony of numerous
witnesses.
    On appeal, AstraZeneca challenges the district court’s
decision on grounds that the prior art did not disclose
“actual success” in creating sterilized budesonide composi-
tions using the known sterilization methods. Appellant’s
Br. 39. According to AstraZeneca, the district court erred
because none of the references on which it relied “disclose
processes yielding a sterile, micronized budesonide prod-
uct of sufficient purity and pharmaceutical acceptability.”
Id. at 38. But AstraZeneca mistakes the test for obvious-
ness. Obviousness requires a showing that “a skilled
artisan would have perceived a reasonable expectation of
success in making the invention in light of the prior art.”
Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340,
1362 (Fed. Cir. 2009). To meet this standard, “only a
reasonable expectation of success, not a guarantee, is
needed.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
(Fed. Cir. 2007); see also PAR Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1198 (Fed. Cir. 2014) (“The
reasonable expectation of success requirement for obvi-
ousness does not necessitate an absolute certainty for
success.”). In fact, the Defendants used two of the known
sterilization methods in creating sterilized budesonide
compositions, so this is not a case in which, as AstraZene-
ca contends, the known sterilization methods were not
“operative” to make the claimed product.
6                         ASTRAZENECA LP   v. BREATH LIMITED

    Here, AstraZeneca has failed to show any clear error
underlying the district court’s analysis. While AstraZene-
ca cites difficulties in the prior art methods relating to
degradation, toxic residues, and agglomeration, the
district court carefully considered these challenges and
found the evidence insufficient to render the claims
nonobvious. We see no clear error in the district court’s
factual findings, nor any error in its ultimate legal conclu-
sion.
                             III
     AstraZeneca also challenges the district court’s analy-
sis of the objective indicia of nonobviousness. In particu-
lar, AstraZeneca argues that the following factors support
a finding of nonobviousness: commercial success, long-felt
but unmet need, industry skepticism, and the failure of
AstraZeneca and others. The district court rejected these
arguments, and we agree.
    With respect to commercial success and long-felt but
unmet need, AstraZeneca argued that sterility was the
key factor underlying the need for, and success of, its
Pulmicort Respules® product. In particular, AstraZene-
ca’s position was that: nebulized budesonide products for
treating childhood asthma were desperately needed in the
United States; although non-sterile versions of such
products existed abroad, they could not be marketed in
the United States because the FDA required them to be
sterile; AstraZeneca was the first to meet the FDA’s
sterility requirement, thus satisfying the long-felt need
and meeting the nexus requirement of commercial suc-
cess. Now on appeal, AstraZeneca argues that the district
court erred by “refus[ing] to consider” its evidence on
these factors “on the basis that [the] evidence involved an
FDA requirement.” Appellant’s Br. 24.
    AstraZeneca is incorrect. The district court did not
ignore AstraZeneca’s evidence. To the contrary, the
district court thoroughly reviewed the evidence and
ASTRAZENECA LP   v. BREATH LIMITED                         7

concluded, simply, that sterility was not the underlying
need for, or the crux for success of, AstraZeneca’s Pul-
micort Respules® product. Citing the testimony of multi-
ple physicians, the district court found that “the need was
really the nebulized budesonide” and that, “had the FDA
determined that Pulmicort Respules® could be sold in the
United States without being sterile, the unmet need
would have been met.” AstraZeneca, 2015 WL 777460, at
*50–51. Similarly, the district court found that the evi-
dence did not demonstrate a connection between the sales
of Pulmicort Respules® and its characteristic of being
sterile. While recognizing that Pulmicort Respules® has
been very profitable for AstraZeneca in the United States,
the district court found that the success was due to factors
other than that claimed in the ’834 patent—namely,
efficacy, safety of the budesonide molecule, and nebulized
delivery. AstraZeneca has not shown clear error in these
fact-findings, and we reject its invitation for us to reweigh
the evidence. We also reject AstraZeneca’s attempt to
equate regulatory compliance with evidence of nonobvi-
ousness. As the district court correctly explained:
    Under AstraZeneca’s theory, there would likely al-
    ways be commercial success when a pharmaceuti-
    cal product experiences substantial sales because
    the product must comply with FDA requirements
    in order to be sold in the United States. Sterility
    is an FDA requirement; it is not driving demand
    for Pulmicort Respules®. AstraZeneca conflates
    the two. Whether or not there is a nexus between
    the novel features of the patented product and the
    commercial success must be evaluated in terms of
    what is driving sales, not what is allowing the
    product to reach the shelf in the first place.
Id. at *56.
    AstraZeneca’s arguments relating to industry skepti-
cism and failures are likewise unavailing. With respect to
8                        ASTRAZENECA LP   v. BREATH LIMITED

industry skepticism, AstraZeneca argues that the district
court “imposed an inflated standard . . . requiring proof
that the invention was uniformly thought impossible by
all in the scientific community.” Appellant’s Br. 31. With
respect to failures, AstraZeneca argues that the district
court ignored evidence of AstraZeneca’s own failures, and
also “imposed an unreasonable, unsupported standard for
the amount of evidence necessary to show defendants’ and
others’ failures.” Id. at 36.
    We agree with the district court’s analysis of the evi-
dence relating to industry skepticism and failures. The
district court reviewed in detail AstraZeneca’s proffered
evidence and concluded that it was insufficient to show
nonobviousness. In particular, the district court dis-
counted AstraZeneca’s evidence of others’ failures as
insufficient as to the nature and extent of those purported
failures, and further discounted AstraZeneca’s evidence of
its own failures as relating only to potential disad-
vantages and commercial feasibility. The court also
rejected AstraZeneca’s argument that the FDA believed
sterilization to be impossible, finding that the FDA had
merely placed the onus on AstraZeneca to either achieve
sterility or show that it could not be done. We therefore
reject AstraZeneca’s arguments that the district court
erred in analyzing the evidence relating to the objective
indicia of nonobviousness.
                            IV
    For the foregoing reasons, we affirm the district
court’s decision that the asserted claims of the ’834 patent
are invalid for obviousness. We therefore need not reach
the Defendants’ alternative arguments for invalidity and
noninfringement. In view of our opinion, we also dissolve
forthwith the injunction pending appeal that was entered
on March 12, 2015. See ECF No. 46.
                       AFFIRMED