Free Answer to Counterclaim - District Court of Delaware - Delaware

Case 1:07-cv-00818-GMS-LPS

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SCIELE PHARMA, INC. and SCIELE PHARMA CAYMAN LTD., Plaintiffs, v. MYLAN PHARMACEUTICALS, INC. and JURY TRIAL DEMANDED MYLAN LABORATORIES, INC., Defendants. C.A. No. 07-818-GMS

PLAINTIFFS' REPLY TO DEFENDANTS' COUNTERCLAIMS Plaintiffs Sciele Pharma, Inc. and Sciele Pharma Cayman Ltd. (collectively, "Sciele" or "Plaintiffs"), by their attorneys, Fish & Richardson P.C., reply to the Counterclaims of Defendants Mylan Pharmaceuticals, Inc. and Mylan Laboratories, Inc. (collectively, "Mylan" or "Defendants"). Except as expressly admitted below, Plaintiffs deny each and every allegation in Defendants' Counterclaims. Specifically, Plaintiffs reply as follows: The Parties 1. Mylan Pharms is a corporation organized under the laws of the State of West

Virginia, having an office and place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. REPLY: Admitted. 2. Mylan Laboratories, Inc. (now known as Mylan Inc.) is a corporation organized

under the laws of the State of Pennsylvania, having an office and place of business at 1500 Corporate Drive, Canonsburg, Pennsylvania 15317.

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REPLY: Admitted. 3. Plaintiff Sciele Pharma, Inc. purports to be a corporation organized and existing

under the laws of the State of Delaware, with a principal place of business at 5 Concourse Parkway, Suite 1800, Atlanta, Georgia 30328. REPLY: Plaintiff Sciele Pharma, Inc. admits that it is a corporation organized and existing under the laws of the State of Delaware, with a principal place of business at 5 Concourse Parkway, Suite 1800, Atlanta, Georgia 30328. 4. Plaintiff Sciele Pharma Cayman Ltd. purports to be a corporation organized and

existing under the laws of the Cayman Islands with a principal place of business at Ugland House, South Church Street, Georgetown, Grand Cayman, Cayman Islands. REPLY: Plaintiff Sciele Pharma Cayman Ltd. admits that it is a corporation organized and existing under the laws of the Cayman Islands with a principal place of business at Ugland House, South Church Street, Georgetown, Grand Cayman, Cayman Islands. Jurisdiction and Venue 5. This Counterclaim 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. REPLY: Sciele admits that Mylan's counterclaim arises under 35 U.S.C. § 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, but denies that Mylan is entitled to any relief under these statutes.

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6.

In the event and to the extent this Court has subject matter jurisdiction over

Sciele's action, this Court also has original jurisdiction over the subject matter of this Counterclaim under 28 U.S.C. §§ 1331 and 1338(a). REPLY: Sciele admits that the Court has subject matter jurisdiction over both Sciele's action and Mylan's counterclaim under 28 U.S.C. §§ 1331 and 1338(a). 7. This Court has personal jurisdiction over Plaintiffs because Plaintiffs have availed

themselves of the rights and privileges, and subjected themselves to the jurisdiction, of this forum by suing Mylan in this District, and/or because Plaintiffs conduct substantial business in this District. REPLY: Sciele admits that the Court has personal jurisdiction over it. Sciele denies any remaining allegations of paragraph 7. 8. Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b).

REPLY: Admitted. Patent-in-Suit 9. On or about January 9, 1990, the U.S. Patent and Trademark Office (" PTO" )

issued U.S. Patent No. 4,892,741 (" the '741 patent" ), entitled " Press Coated DHP Tablets," to Andreas Ohm, Helmut Luchtenberg, Shinji Maegata and Wolfgang Opitz. REPLY: Admitted.

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10.

On or about October 22, 2007, Plaintiffs sued Mylan in this District in Sciele

Pharma, Inc. and Sciele Pharma Cayman Ltd. v. Mylan Pharmaceuticals, Inc. and Mylan Laboratories, Inc., No. 07-664-GMS (D.Del.), alleging infringement of the ' 741 patent under 35 U.S.C. § 271(e)(2)(A) with respect to the 40 mg product. REPLY: Admitted. 11. On or about December 14, 2007, Plaintiffs sued Mylan again in this District

alleging infringement of the ' 741 patent under 35 U.S.C. § 271(e)(2)(A) with respect to the 20 mg and 30 mg products. REPLY: Admitted. Count I (Declaratory Judgment of Non-Infringement of the '741 Patent) 12. forth herein. REPLY: Sciele re-asserts and re-alleges its replies to each of the foregoing paragraphs as though fully set forth herein. 13. The manufacture, use, sale, offer for sale, or importation of the nisoldipine tablets Mylan re-asserts and re-alleges each of the forgoing paragraphs as if fully set

that are the subject of Mylan Pharms' ANDA have not infringed, do not infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the ' 741 patent.

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REPLY: Sciele incorporates its claim of infringement set forth in its Complaint. Sciele also denies that Mylan is entitled to any judgment of invalidity or unenforceability of the ' 741 patent. 14. Mylan is entitled to a judicial declaration that the manufacture, use, sale, offer for

sale, and/or importation of the nisoldipine tablets that are the subject of Mylan Pharms' ANDA have not infringed, do not infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the ' 741 patent. REPLY: Sciele incorporates its claim of infringement set forth in its Complaint. Sciele also denies that Mylan is entitled to any judgment of invalidity or unenforceability of the ' 741 patent. Demand for Jury Trial Plaintiffs demand a trial by jury on all issues appropriately tried to a jury.

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Dated: January 28, 2008

FISH & RICHARDSON P.C.

By: /s/ William J. Marsden, Jr. William J. Marsden, Jr. (#2247) Susan M. Coletti (#4690) 919 N. Market Street, Suite 1100 P.O. Box 1114 Wilmington, DE 19899-1114 Telephone: (302) 652-5070 Facsimile: (302) 652-0607 Email: [email protected]; [email protected] Jonathan E. Singer Deanna J. Reichel 3300 Dain Rauscher Plaza 60 South Sixth Street Minneapolis, MN 55402 Telephone: (612) 335-5070 Facsimile: (612) 288-9696 Nagendra Setty 1180 Peachtree Street, N.E., 21st Floor Atlanta, GA 30309 Telephone: (404) 892-5005 Facsimile: (404) 892-5002 John D. Garretson Citigroup Center - 52nd Floor 153 East 53rd Street New York, NY 10022-4611 Telephone: (212) 765-5070 Facsimile: (212) 258-2291 Attorneys for Plaintiffs SCIELE PHARMA, INC., and SCIELE PHARMA CAYMAN LTD.

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CERTIFICATE OF SERVICE I hereby certify that on January 28, 2008, I electronically filed with the Clerk of Court PLAINTIFFS' REPLY TO DEFENDANTS' COUNTERCLAIMS using CM/ECF which will send electronic notification of such filing(s) to the following Delaware counsel. In addition, the filing will also be sent via hand delivery: Richard K. Herrmann Esquire Mary B. Matterer, Esquire Morris James LLP 500 Delaware Ave., Ste. 1500 P.O. Box 2306 Wilmington, DE 19899 Attorneys for Defendants Mylan Pharmaceuticals, Inc. and Mylan Laboratories, Inc.

I also certify that on January 28, 2008, I have sent by electronic mail and U.S. First Class Mail, the document(s) to the following non-registered participants:

William A. Rakoczy, Esquire Rakoczy Molino Mazzochi Siwik LLP 6 West Hubbard Street, Suite 500 Chicago, IL 60610

Attorneys for Defendants Mylan Pharmaceuticals, Inc. and Mylan Laboratories, Inc.

60478929.doc

/s/ William J. Marsden, Jr. William J. Marsden, Jr.