Free Answer to Complaint - District Court of Delaware - Delaware

Case 1:08-cv-00057-GMS

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ENDO PHARMACEUTICALS INC. and PENWEST PHARMACEUTICALS CO., Plaintiffs, v. IMPAX LABORATORIES, INC., Defendant. ) ) ) ) ) ) ) ) ) )

C. A. No. 08-57 (GMS)

PLAINTIFFS' REPLY TO DEFENDANT'S COUNTERCLAIMS Plaintiffs/counterclaim defendants Endo Pharmaceuticals Inc. ("Endo") and Penwest Pharmaceuticals Co. ("Penwest") (collectively, "Plaintiffs"), for their reply to the Answer and Counterclaims filed by defendant/counterclaim plaintiff Impax Laboratories, Inc. ("Impax"), upon knowledge as to their own acts, and upon information and belief as to all other matters, hereby respond and allege as follows: REPLY TO DEFENDANT'S COUNTERCLAIMS 31. Plaintiffs repeat and reallege their allegations with respect to paragraphs 1 to 26

of their Complaint as if set forth at length herein. 32. Admitted in-part and denied in-part. Plaintiffs admit only that a justiciable case

or controversy exists. Plaintiffs, however, deny the remaining allegations and implications of this paragraph. PARTIES 33. 34. 35. Admitted on information and belief. Admitted. Admitted.

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JURISDICTION AND VENUE 36. 37. Admitted. Admitted. BACKGROUND 38. Admitted in-part and denied in-part. Plaintiffs admit only that a justiciable case

or controversy exists. Plaintiffs, however, deny the remaining allegations and implications of this paragraph. 39. Admitted in-part and denied in-part. Plaintiffs admit that they filed a complaint

against Impax relating to the '456 and '933 patents on November 15, 2007, and that they commenced this suit on January 25, 2008. Plaintiffs further admit that the '456 and '933 patents are listed in the Orange Book with respect to OPANA® ER tablets, which are the subject of NDA No. 21-610. Plaintiffs further admit that Impax has requested that Plaintiffs provide it with a perpetual covenant not to sue for infringement of the'456 and '933 patents, and that they refused to do so. Plaintiffs further admit that they issued a joint press release on December 17, 2007, which press release speaks for itself. Plaintiffs deny the remaining allegations and implications of this paragraph. COUNT I 40. Plaintiffs repeat and reallege their allegations with respect to paragraphs 1 to 26

of their Complaint and paragraphs 31-39 of this Reply as if set forth at length herein. 41. 42. Denied. Denied.

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COUNT II 43. Plaintiffs repeat and reallege their allegations with respect to paragraphs 1 to 26

of their Complaint and paragraphs 31-42 of this Reply as if set forth at length herein. 44. 45. Denied. Denied. COUNT III 46. Plaintiffs repeat and reallege their allegations with respect to paragraphs 1 to 26

of their Complaint and paragraphs 31-45 of this Reply as if set forth at length herein. 47. 48. Denied. Denied. COUNT IV 49. Plaintiffs repeat and reallege their allegations with respect to paragraphs 1 to 26

of their Complaint and paragraphs 31-48 of this Reply as if set forth at length herein. 50. 51. Denied. Denied. PRAYER FOR RELIEF WHEREFORE, Plaintiffs respectfully pray that the Court deny all of Impax's requested relief and find in favor of Plaintiffs on all Counts, dismiss Impax's Counterclaim with prejudice, award Plaintiffs the relief they seek in their Complaint, and award Plaintiffs their costs and attorneys fees, as well as such other relief as the Court deems equitable and just.

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MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Julia Heaney (#3052)
Jack B. Blumenfeld (#1014) Mary B. Graham (#2256) Julia Heaney (#3052) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] Attorneys for Plaintiffs Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co.

OF COUNSEL: Martin J. Black George G. Gordon Ann M. Caviani Pease Robert D. Rhoad DECHERT LLP Cira Centre 2929 Arch Street Philadelphia, PA 19104 (215) 994-4000 Attorneys for Plaintiff Endo Pharmaceuticals Inc. Robert J. Gunther, Jr. Lisa J. Pirozzolo James P. Barabas WILMER CUTLER PICKERING HALE AND DORR LLP 399 Park Avenue New York, NY 10022 (212) 230-8800 Attorneys for Plaintiff Penwest Pharmaceuticals Co. March 13, 2008
1942607

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CERTIFICATE OF SERVICE I hereby certify that on March 13, 2008 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to: Richard K. Herrmann Mary B. Mattterer MORRIS JAMES LLP I further certify that I caused to be served copies of the foregoing document on March 13, 2008 upon the following in the manner indicated: BY E-MAIL Richard K. Herrmann Mary B. Matterer MORRIS JAMES LLP 500 Delaware Avenue Suite 1500 Wilmington, DE 19801 Asim Bhansali Klaus H. Hamm KEKER & VAN NEST LLP 710 Sansome Street San Francisco, CA 94111-1704

/s/ Julia Heaney (#3052)
Julia Heaney (#3052)