Free Answer to Counterclaim - District Court of Delaware - Delaware

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 1 of 7

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) ) ) ) ) ) ) )

CANCER RESEARCH TECHNOLOGY LIMITED and SCHERING CORPORATION, Plaintiffs, v. BARR LABORATORIES, INC., and BARR PHARMACEUTICALS, INC., Defendants.

C.A. No. 07-457-SLR

PLAINTIFFS' REPLY TO DEFENDANTS' RESTATED COUNTERCLAIMS Plaintiffs Cancer Research Technology Limited and Schering Corporation (collectively "Plaintiffs") reply to defendants Barr Laboratories, Inc.'s and Barr Pharmaceuticals, Inc.'s (collectively "Barr") Restated Counterclaims as follows: 1. Plaintiffs admit, upon information and belief, the allegations contained in

Paragraph 1 of the Counterclaims. 2. Plaintiffs admit that Cancer Research Technology Limited is a limited

liability company organized and existing under the laws of the United Kingdom, having its principal place of business at Sardinia House, Sardinia Street, London, WC2A 3NL, England. Plaintiffs deny the remaining allegations in Paragraph 2 of the Counterclaims. 3. Counterclaims. 4. States of America. Plaintiffs admit that this action arises under the patent laws of the United Plaintiffs further admit that Barr purports to state Counterclaims for Plaintiffs admit the allegations contained in Paragraph 3 of the

declaratory judgment arising under 28 U.S.C. §§ 2201 and 2202, and that subject matter

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 2 of 7

jurisdiction exists under 28 U.S.C. §§ 1331 and 1338(a) with respect to claims 1-3, 5-7, 11-13 and 27 of U.S. Patent No. 5,260,291 ("the `291 patent"). allegations in Paragraph 4 of the Counterclaims. 5. Plaintiffs admit that venue is proper in this Court under 28 U.S.C. Plaintiffs deny the remaining

§§ 1391(b), 1391(c) and 1400(b). 6. Plaintiffs admit that Schering is the holder of approved New Drug

Application ("NDA") No. 21-029, for the manufacture and sale of temozolomide, which it markets under the trade name TEMODAR® (temozolomide) Capsules ("TEMODAR "), in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg dosage forms. Plaintiffs deny the remaining allegations in Paragraph 6 of the Counterclaims. 7. Plaintiffs state that the allegations set forth in Paragraph 7 of the
®

Counterclaims are legal conclusions to which no responsive pleading is required. Plaintiffs further state that the FDCA and regulations that govern approval of generic drugs speak for themselves with respect to the matters stated therein. 8. Plaintiffs state that the allegations set forth in Paragraph 8 of the

Counterclaims are legal conclusions to which no responsive pleading is required. Plaintiffs further state that the FDCA and regulations that govern approval of generic drugs and listing of patents in the Orange Book speak for themselves with respect to the matters stated therein. 9. Plaintiffs state that the allegations set forth in Paragraph 9 of the

Counterclaims are legal conclusions to which no responsive pleading is required. Plaintiffs further state that the FDCA and regulations that govern approval of generic drugs and listing of patents in the Orange Book speak for themselves with respect to the matters stated therein. 10. Plaintiffs state that the allegations set forth in Paragraph 10 of the

Counterclaims are legal conclusions to which no responsive pleading is required. Plaintiffs

2

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 3 of 7

further state that the FDCA and regulations that govern approval of generic drugs and listing of patents in the Orange Book speak for themselves with respect to the matters stated therein. 11. Plaintiffs admit that the FDA Orange Book lists the `291 patent as a
®

reference patent in NDA No. 21-029 for TEMODAR , 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg. 12. Plaintiffs admit on information and belief that Barr filed with the FDA an

ANDA, which the FDA assigned No. 78-879, seeking to market a generic version of the 5 mg, 20 mg, 100 mg and 250 mg dosage forms of TEMODAR . Plaintiffs lack information sufficient to form a belief as to the remaining allegations in Paragraph 12 of the Counterclaims and, therefore, deny them. 13. Plaintiffs admit that Schering received a letter from Barr on June 13, 2007
®

pursuant to 21 U.S.C. § 355(j)(5)(C), purporting to contain the factual and legal bases for Barr's contentions concerning the validity, enforceability and infringement of the `291 patent. Plaintiffs further admit that Barr's letter included an "Offer of Confidential Access" to certain information from ANDA No. 78-879, and that plaintiffs subsequently requested portions of Barr's ANDA. Plaintiffs admit that CRT received a copy of that letter on July 27, 2007. Plaintiffs deny the remaining allegations of Paragraph 13 of the Counterclaims. 14. Plaintiffs admit that they filed their Complaint in this action on July 20,

2007, and that the Complaint alleges that Barr's manufacture, use, sale, offer for sale and/or importation of temozolomide capsules, 5 mg, 20 mg, 100 mg and 250 mg, will infringe, contribute to the infringement of, and/or induce the infringement of claims 1-3, 5-7, 11-13 and 27 of the `291 patent. Plaintiffs further admit that Barr purports to deny those allegations. Plaintiffs further admit that on April 15, 2008, they filed a stipulation seeking leave to file an amended complaint, and that the Court granted permission on April 18, 2008. Plaintiffs further 3

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 4 of 7

admit that they filed their Amended Complaint in this action on April 18, 2008, and that the Amended Complaint alleges that Barr's manufacture, use, sale, offer for sale and/or importation of temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, will infringe, contribute to the infringement of, and/or induce the infringement of claims 1-3, 5-7, 11-13 and 27 of the `291 patent. Plaintiffs further admit that Barr purports to deny those allegations. Plaintiffs deny the remaining allegations contained in Paragraph 14 of the Counterclaims. Reply To Counterclaim I 15. Plaintiffs repeat and incorporate by reference their replies to

Paragraphs 1­14 of the Counterclaims. 16. the United States. Plaintiffs admit that Barr's Counterclaim I arises under the Patent Laws of Plaintiffs further admit that Barr purports to state a Counterclaim for

declaratory judgment arising under 28 U.S.C. §§ 2201 and 2202. Plaintiffs deny that there is a case or controversy as to claims 4, 8-10, 14-26, and 27-33 of the `291 patent and, therefore, deny that there is subject matter jurisdiction as to those patent claims. Plaintiffs deny the remaining allegations in Paragraph 16 of the Counterclaims. 17. Plaintiffs admit that their Amended Complaint in this action alleges that

Barr's manufacture, use, sale, offer for sale and/or importation of temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, will infringe, contribute to the infringement of, and/or induce the infringement of claims 1-3, 5-7, 11-13 and 27 of the `291 patent, and that Barr purports to deny those allegations. Paragraph 17 of the Counterclaims. 18. Plaintiffs admit that a justiciable controversy exists as to the validity of Plaintiffs deny the remaining allegations contained in

claims 1-3, 5-7, 11-13 and 27 of the `291 patent. Plaintiffs deny the remaining allegations contained in Paragraph 18 of the Counterclaims. 4

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 5 of 7

19. Counterclaims.

Plaintiffs deny the allegations contained in Paragraph 19 of the

Reply To Counterclaim II 20. Plaintiffs repeat and incorporate by reference their replies to

Paragraphs 1­19 of the Counterclaims. 21. Plaintiffs admit that Barr's Counterclaim II arises under the Patent Laws

of the United States. Plaintiffs further admit that Barr purports to state a Counterclaim for declaratory judgment arising under 28 U.S.C. §§ 2201 and 2202. Plaintiffs deny that there is a case or controversy as to claims 4, 8-10, 14-26, and 27-33 of the `291 patent and, therefore, deny that there is subject matter jurisdiction as to those patent claims. Plaintiffs deny the remaining allegations in Paragraph 21 of the Counterclaims. 22. unenforceable. Counterclaims. 23. Counterclaims. 24. Plaintiffs admit that a justiciable controversy exists as to the enforceability Plaintiffs deny the allegations contained in Paragraph 23 of the Plaintiffs admit that Barr purports to allege that the `291 patent is

Plaintiffs deny the remaining allegations contained in Paragraph 22 of the

of claims 1-3, 5-7, 11-13 and 27 of the `291 patent. Plaintiffs deny the remaining allegations contained in Paragraph 24 of the Counterclaims. 25. Counterclaims. 26. Counterclaims. Plaintiffs deny the allegations contained in Paragraph 26 of the Plaintiffs deny the allegations contained in Paragraph 25 of the

5

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 6 of 7

REPLY TO PRAYER FOR RELIEF 27. Plaintiffs deny that Barr is entitled to the judgment it seeks in

Paragraphs 1-6 of its Prayer For Relief. AFFIRMATIVE DEFENSES TO COUNTERCLAIMS 28. Plaintiffs repeat and incorporate by reference herein the assertions set

forth in its Complaint in this action and in Paragraphs 1 through 27 herein. 29. Claims 1-3, 5-7, 11-13 and 27 of the `291 patent are valid and enforceable.

There is no case or controversy and, therefore, no subject matter jurisdiction with respect to claims 4, 8-10, 14-26, and 27-33 of the `291 patent. MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Rodger D. Smith II
_________________________________________ Jack B. Blumenfeld (#1014) Rodger D. Smith II (#3778) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] Attorneys for Plaintiffs Cancer Research Technology Limited and Schering Corporation OF COUNSEL: Jesse J. Jenner Denise L. Loring Christopher J. Harnett ROPES & GRAY LLP 1211 Avenue of the Americas New York, NY 10036 (212) 596-9000 May 13, 2008
2326451

6

Case 1:07-cv-00457-SLR

Document 57

Filed 05/13/2008

Page 7 of 7

CERTIFICATE OF SERVICE I hereby certify that on May 13, 2008, I caused the foregoing to be electronically filed with the Clerk of the Court using CM/ECF, which will send notification of such filing to: John C. Phillips, Jr., Esquire Brian E. Farnan, Esquire PHILLIPS, GOLDMAN & SPENCE, P.A. I further certify that I caused copies of the foregoing document to be served on May 13, 2008, upon the following in the manner indicated: John C. Phillips, Jr., Esquire Brian E. Farnan, Esquire PHILLIPS, GOLDMAN & SPENCE, P.A. 1200 North Broom Street Wilmington, DE 19806 George C. Lombardi, Esquire Taras A. Gracey, Esquire Stephanie S. McCallum, Esquire WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, IL 60601 VIA ELECTRONIC MAIL and HAND DELIVERY

VIA ELECTRONIC MAIL And FIRST CLASS MAIL

/s/ Rodger D. Smith II
Rodger D. Smith II (#3778)