Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01335/USCOURTS-ca13-15-01335-0/pdf.json

Parties Involved:
Apotex Corp.
Appellee
Apotex, Inc.
Appellee
AstraZeneca LP
Appellant
Astrazeneca AB
Appellant
Breath Limited
Appellee
Sandoz Inc.
Appellee
Watson Laboratories, Inc.
Appellee

Document Text:

NOTE: This disposition is nonprecedential.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. 

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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 defendantsappellees 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 represented 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 (collectively, “AstraZeneca”) against Breath Limited, Apotex 

Corp., Apotex, Inc., Sandoz Inc., and Watson Laboratories, 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 

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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 obviousness, and therefore we affirm. We also dissolve the injunction 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, pharmaceutically effective budesonide compositions. Representative 

claim 1 (the powder) and claim 50 (the suspension) read 

as follows:

1. A pharmaceutically acceptable, micronized powder composition at least 98.5% by weight of which 

is pure budesonide or an ester, acetal or salt 

thereof, wherein the composition meets the criteria of sterility according to the US Pharmacopoeia 

23/NF18, 1995, pages 1686-1690 and 1963-1975.

50. A pharmaceutically acceptable suspension consisting 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 aqueous solution, wherein the suspension meets the 

criteria of sterility according to the US Pharmacopoeia 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 asthma in children. The Defendants have all filed ANDAs

seeking to market a generic version of Pulmicort

Respules®. 

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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 wellknown sterilization techniques. In addition to making

extensive fact-findings on the prior art, the district court 

thoroughly analyzed and rejected AstraZeneca’s arguments 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 obviousness. 

II

The prior art presented at trial included non-sterile 

budesonide compositions, sterile compositions of corticosteroids other than budesonide, and five well-known 

sterilization techniques: sterile filtration followed by 

aseptic crystallization; moist heat; ethylene oxide; irradiation; 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

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ASTRAZENECA LP v. BREATH LIMITED 5

preparing the claimed compositions with four of the five 

prior art sterilization methods (all but dry heat). Reviewing the voluminous documentary and testimonial evidence of record, the district court determined that, 

although each sterilization method had known disadvantages, 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 multiple 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 compositions 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 product of sufficient purity and pharmaceutical acceptability.” 

Id. at 38. But AstraZeneca mistakes the test for obviousness. 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 obviousness 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 AstraZeneca contends, the known sterilization methods were not 

“operative” to make the claimed product. 

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6 ASTRAZENECA LP v. BREATH LIMITED

Here, AstraZeneca has failed to show any clear error 

underlying the district court’s analysis. While AstraZeneca 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 conclusion.

III

AstraZeneca also challenges the district court’s analysis of the objective indicia of nonobviousness. In particular, 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, AstraZeneca’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 success. 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 

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ASTRAZENECA LP v. BREATH LIMITED 7

concluded, simply, that sterility was not the underlying 

need for, or the crux for success of, AstraZeneca’s Pulmicort Respules® product. Citing the testimony of multiple 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 evidence 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 nonobviousness. As the district court correctly explained: 

Under AstraZeneca’s theory, there would likely always be commercial success when a pharmaceutical 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 skepticism and failures are likewise unavailing. With respect to 

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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 evidence 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 discounted 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 disadvantages 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

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