AstraZeneca LP v. Breath Ltd., Civil Action No. 08–1512 RMB/AMD.

• Court: United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
• Writing for the Court: BUMB, District Judge.
• Citation: 88 F.Supp.3d 326
• Parties: ASTRAZENECA LP and AstraZeneca AB, Plaintiffs, v. BREATH LIMITED, Defendant. AstraZeneca LP and AstraZeneca AB, Plaintiffs, v. Apotex, Inc. and Apotex Corp., Defendants. AstraZeneca LP and AstraZeneca AB, Plaintiffs, v. Sandoz, Inc., Defendant. AstraZeneca LP and AstraZeneca AB, Plaintiffs, v. Watson Laboratories, Inc., Defendant.
• Docket Number: Civil Action No. 08–1512 RMB/AMD.
• Decision Date: 13 February 2015

88 F.Supp.3d 326

ASTRAZENECA LP and AstraZeneca AB, Plaintiffs
v.
BREATH LIMITED, Defendant.

AstraZeneca LP and AstraZeneca AB, Plaintiffs
v.
Apotex, Inc. and Apotex Corp., Defendants.

AstraZeneca LP and AstraZeneca AB, Plaintiffs
v.
Sandoz, Inc., Defendant.

AstraZeneca LP and AstraZeneca AB, Plaintiffs
v.
Watson Laboratories, Inc., Defendant.

Civil Action No. 08–1512 RMB/AMD.

United States District Court, D. New Jersey.

Signed Feb. 13, 2015.

88 F.Supp.3d 331

John E. Flaherty, Esq., Ravin R. Patel, Esq., McCarter & English LLP, Four Gateway Center, Newark, NJ, Jay I. Alexander, Esq., Stephen P. Anthony, Esq., Christopher Sipes, Esq., Keith A. Teel, Esq., Covington & Burling LLP, Washington, DC, Danielle L. Goldstein, Esq., Covington & Burling LLP, San Francisco, CA, for Plaintiffs AstraZeneca LP and AstraZeneca AB.

Eleonore Ofosu–Antwi, Esq., Liza M. Walsh, Esq., Connell Foley, LLP, Roseland, NJ, William A. Rakoczy, Esq.,

88 F.Supp.3d 332

Amy D. Brody, Esq., Heinz J. Salmen, Esq., Natasha White, Esq., Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for Defendant/Counterclaim Plaintiffs Breath Limited and Watson Laboratories, Inc.

Eric I. Abraham, Esq., Christina L. Saveriano, Esq., Hill Wallack, LLP, Princeton, NJ, Richard J. Basile, Esq., David W. Aldrich, Esq., St. Onge Steward Johnson & Reens, LLC, Stamford, CT, for Defendants/Counterclaim Plaintiffs Apotex, Inc. and Apotex Corp.

Sheila R. Wiggins, Esq., Duane Morris, LLP, Newark, NJ, Eric D. Frank, Esq., Duane Morris LLP, Cherry Hill, NJ, Gretchen P. Miller, Esq., Steptoe & Johnson, Washington, DC, Taras A. Gracey, Esq., Thomas A. Rammer, II, Esq., Steptoe & Johnson, Chicago, IL, for Defendant/Counterclaim Plaintiff Sandoz, Inc.

REDACTED OPINION (PUBLIC)

BUMB, District Judge.

Table of Contents

I.	INTRODUCTION	333
II.	BACKGROUND	334

A.	The Asserted Claims of the '834 Patent	334
B.	Markman Hearing	334
C.	Federal Circuit Decision	334
D.	Remand Proceedings	334
E.	Defendants' Sterilization Processes	335

III. LEGAL ANALYSIS 335

A.	Asserted Claims on Remand	335
B.	Infringement	335
C.	Invalidity Defenses	336

1.	Reduction to Practice of the Invention	336
2.	Obviousness	339

a.	Motivation	340
b.	Prior Art Sterilization Techniques	343

i. Sterile filtration/crystallization 344

a)	1994 FDA Inspection Guide	344
b)	Lachman: The Theory and Practice of Industrial Pharmacy (1986)	347
c)	Ansel: Pharmaceutical Dosage Forms and Drug Delivery Systems (1995)	348
d)	Remington: The Science and Pharmacy (1995)	349
e)	Harris: U.S. Patent No. 6,187,765 (1997)	350
f)	Conclusion	361

ii. Moist Heat Sterilization 361

a)	Sodium Chloride Saturation	363
b)	Surfactant	367
c)	Sonication	368
d)	Milling	369
e)	Rotary Sterilization	370
f)	Conclusion	371

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