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.
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.,
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 |
