Free Redacted Document - District Court of Delaware - Delaware

Case 1:04-cv-00940-JJF Document 113 Filed 02/20/2008 Page 1 of 2
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FREDERICK lm C¤t'FRELL» lll WILMINGTON, DELAWARE isaac: |;;C;5gAT_7;;E;R
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February E2, 2008
BY ELECTRONIC FILING AND HAND DELIVERY
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United States District Court VERSION
for the District of`Delaware
844 Nt King Street
Wilmington, Delaware 19801
Re: The Procter & Gamble Compcmy v. Teva P/rozrnioceuticols USA, Inc ;
Civil Action No 04—940—.lJF
Dear Judge Farnan:
I write to alert the Court to the probability that plaintiff The Procter & Gamble Co
("P&G”) will be tiling a motion for a preliminary injunction in the a`oove—referlenced action in
the very near future.
As the Court is aware, P&G is the owner by assignment of United States Patent No.
5,583,122 (the “’122 patent") entitled "Pharrnaceuticai Compositions Containing Geminal
Diphosphonatesf which issued on December 10, 1996 and expires on December I0, 2013.
Among other compounds, the ‘122 patent covers the commercial formulation of the compound
risedronate sodium, which is manufactured and sold 'oy P&G under the trade name Actonel®
P&G initiated this action on August 13, 2004 as a result of the tiling by Defendant Teva
Pharmaceuticals USA, inc. ("Teva”) of an Abbreviatecl New Drug Application (“ANDA”’) No
77-l32 with the Food and Drug Administration (“iiDA"), seeking approval to market a generic
version of`Actonei® in the United States. The parties tried the case to this Court from November
6-8, 2006, with briefing thereafter. A decision in the case is currently pending.
Pursuant to 21 USC. § 355 (j)(5)(B)(iii), P&G°s tiling of this action triggered a 30—~
month statutory stay on FDA approval of Ieva’s ANDA No 77-132, That stay expired on
January 2, 2007. See 21 US C. § 355(j)(5)(B)(iii).
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Case 1 :04-cv-00940-JJF Document 113 Filed 02/20/2008 Page 2 of 2
The Honorable Joseph J. Farnan, Jr.
February 12, 2008
Page 2
REDACTED
P&Ci is available to discuss this matter telephonically or in person should the Court have
any questions or concerns.
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Frederick L. Cottrell, HI (#2555)
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cc: Josy W. Ingersoll, Esq. (by electronic filing and hand delivery)
David B,. Bassett, Esq. (by facsimile)
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