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Astrazeneca LP v. Breath Limited

United States District Court, D. New Jersey, Camden Vicinage

June 4, 2014

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.

Ravin R. Patel, Esquire, McCarter & English, LLP, Newark, New Jersey, and Christopher Sipes, Esquire, Stephen P. Anthony, Esquire, Covington & Burling LLP, Washington, DC, and Danielle L. Goldstein, Esquire Covington & Burling LLP, San Francisco, California, and Asher B. Hodes, Esquire, Covington & Burling LLP, Redwood Shores, California, Attorneys for Plaintiffs, Astrazeneca LP and, Astrazeneca AB.

Liza M. Walsh, Esquire Connell Foley LLP, Roseland, New Jersey, and William A. Rakoczy, Esquire, Amy D. Brody, Esquire, Heinz J. Salmen, Esquire, Rakoczy Molino Mazzochi, Siwik LLP, Chicago, Illinois, Attorneys for, Defendant/Counterclaim, Plaintiffs Breath Limited and, Watson Laboratories, Inc.

Eric I. Abraham, Esquire, Hill Wallack LLP, Princeton, New Jersey, and Richard J. Basile, Esquire, David W. Aldrich, Esquire, St. Onge Steward Johnson &, Reens, LLC, Stamford, Connecticut, Attorneys for Defendants/Counterclaim Plaintiffs Apotex, Inc. and Apotex Corp.

Sheila Raftery Wiggins, Esquire, Duane Morris LLP, Newark, New Jersey, and Taras A. Gracey, Esquire, Mark H. Remus, Esquire, Abby Parsons, Esquire, Steptoe & Johnson LLC, Chicago, Illinois, Attorneys for Defendant/Counterclaim-Plaintiff Sandoz, Inc.

REDACTED OPINION

RENÉE MARIE BUMB, District Judge.

Plaintiffs AstraZeneca LP and AstraZeneca AB ("AstraZeneca") bring this consolidated action for patent infringement against the defendants, Breath Limited, Watson Laboratories, Inc. (Collectively, "Breath/Watson"), Sandoz, Inc. ("Sandoz", and together with Breath/Watson, "Defendants"), Apotex Corp., and Apotex, Inc. (collectively, "Apotex"). Because the facts and long history of this case are well-known to the parties, the Court recites them only briefly here.

I. BACKGROUND

This case involves AstraZeneca's invention of a once-daily inhaled corticosteroid under the name PULMICORT RESPULES®. Three patents were initially at issue: U.S. Patent No. 6, 598, 603 (the "'603 Patent"); U.S. Patent No. 6, 899, 099 (the "'099 Patent"); and U.S. Patent No. 7, 524, 834 (the "'834 Patent").[1]

This Court previously found, and was affirmed on appeal, that the '603 Patent was rendered invalid as obvious. AstraZeneca LP v. Breath Ltd., 542 F.Appx. 971, 978-81 (Fed. Cir. 2013). The '099 Patent claims also have been rendered invalid. AstraZeneca LP v. Breath Ltd., No. 08-1512, 2013 WL 2404167 (D.N.J. May 31, 2013). Only the '834 Patent remains for this Court's consideration. AstraZeneca, 542 F.Appx. at 975-78 (reversing this Court's claim construction and finding of non-infringement, and remanding for further proceedings).

The '834 Patent is entitled "STERILE POWDERS AND METHODS FOR PRODUCING THE SAME." Claims 1 and 50, the claims at issue, teach a powder and suspension, respectively, comprising a "micronized powder composition." Specifically, Claim 1 recites:

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 U.S. Pharmacopoeia [sic] 23/NF18, 1995, pages 1686-1690 and 1963-1975.

'834 Patent col.11 ll.48-52 (emphasis added). Claim 50 recites:

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 ...

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