Free Answer to Counterclaim - District Court of Delaware - Delaware

Case 1:07-cv-00679-SLR

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Filed 01/11/2008

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) C.A. No. 07-679-SLR ) ) ) ) ) )

ELAN CORPORATION, PLC and ELAN PHARMA INTERNATIONAL LTD., Plaintiffs, v. ACTAVIS SOUTH ATLANTIC LLC, Defendant.

PLAINTIFFS' REPLY TO DEFENDANT ACTAVIS SOUTH ATLANTIC LLC'S COUNTERCLAIMS Plaintiffs Elan Corporation, plc and Elan Pharma International Ltd. (collectively "Elan"), for their Reply to the numbered paragraphs of the Counterclaims of Defendant Actavis South Atlantic LLC ("Actavis"), hereby state as follows: THE PARTIES 1. 2. Admitted, upon information and belief. Plaintiffs are without knowledge or information sufficient to form a belief

as to the allegations of Paragraph 2. 3. 4. 5. Admitted. Admitted. Admitted. FIRST COUNT 6. Plaintiffs repeat and incorporate their reply to Paragraphs 1-5.

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7.

Admitted that Actavis purports to state a declaratory judgment

counterclaim that arises under the Patent Laws of the United States, 35 U.S.C. § 1 et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and that this Court has jurisdiction over this counterclaim under 28 U.S.C. §§ 1331 and 1338(a), but denied that there is any factual or legal basis for this counterclaim. 8. Admitted, upon information and belief, that Actavis seeks approval

through abbreviated new drug application ("ANDA") No. 79-108 to manufacture and sell dexmethylphenidate hydrochloride capsules in the 5, 10, 15 and 20 mg strengths ("Actavis' Proposed Products") prior to the expiration of United States Patent Nos. 6,228,398 ("the `398 patent") and 6,730,325 ("the `325 patent"). Admitted that Plaintiffs have asserted that Actavis has infringed the `398 and `325 patents by submission of ANDA No. 79-108 to the Food and Drug Administration under 21 U.S.C. § 355(j). Except as expressly admitted, Plaintiffs deny the averments of Paragraph 8. 9. Admitted that Plaintiffs assert that Actavis' Proposed Products infringe the Except as expressly admitted, Plaintiffs deny the averments of

`398 and `325 patents. Paragraph 9. 10. 11.

Denied. The allegations contained in Paragraph 11 of Actavis' Counterclaims are

legal conclusions to which no response is required. 12. Denied. SECOND COUNT 13. Plaintiffs repeat and incorporate their reply to Paragraphs 1-5.

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14.

Admitted that Actavis purports to state a declaratory judgment

counterclaim that arises under the Patent Laws of the United States, 35 U.S.C. § 1 et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and that this Court has jurisdiction over this counterclaim under 28 U.S.C. §§ 1331 and 1338(a), but denied that there is any factual or legal basis for this counterclaim. 15. 16. Denied. The allegations contained in Paragraph 16 of Actavis' Counterclaims are

legal conclusions to which no response is required. 17. Denied. REPLY TO DEFENDANTS' PRAYER FOR RELIEF WHEREFORE, Plaintiffs deny that Actavis is entitled to any relief, either as prayed for in its Counterclaims or otherwise. Plaintiffs further deny each allegation in Defendants' Counterclaims that was not specifically admitted, denied, or otherwise responded to in this Reply to Defendant Actavis South Atlantic LLC's Counterclaims. MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) Richard J. Bauer (#4828) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 Attorneys for Plaintiffs Elan Corporation, plc and Elan Pharma International Ltd. January 11, 2008
1352374

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CERTIFICATE OF SERVICE I hereby certify that on January 11, 2008 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to:. David J. Margules, Esquire BOUCHARD MARGULES & FRIEDLANDER, P.A. I further certify that I caused to be served copies of the foregoing document on January 11, 2008 upon the following in the manner indicated: David J. Margules, Esquire BOUCHARD MARGULES & FRIEDLANDER, P.A. 222 Delaware Avenue Suite 1400 Wilmington, DE 19801 Francis H. Morrison, III, Esquire Jonathan A. Harris, Esquire Matthew J. Becker, Esquire James Mahanna, Esquire AXINN, VELTROP & HARKRIDER LLP 90 State House Square Hartford, CT 06103-3702 VIA ELECTRONIC MAIL and HAND DELIVERY

VIA ELECTRONIC MAIL and FIRST CLASS MAIL

/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014)