Diane C. Ragosa 

AXINN, VELTROP & HARKRIDER LLP 

114 West 47th Street 

New York, NY 10036 

(212) 728-2200 

Attorneys for Defendants 

Natco Pharma Limited and 

Natco Pharma, Inc. 

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

GILEAD SCIENCES, INC., 

HOFFMANN-La ROCHE INC., 

F. HOFFMANN-La ROCHE LTD. 

and GENENTECH, INC., 

 Plaintiffs, 

 v. 

NATCO PHARMA LIMITED 

and NATCO PHARMA INC., 

 Defendants. 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

C.A. No. 1:11-cv-01455-SDW-MCA 

Consolidated with 

C.A. No. 2:11-cv-04969-SDW-MCA 

NATCO PHARMA LIMITED’S AND 

NATCO PHARMA, INC.’S ANSWER AND COUNTERCLAIMS

Defendants Natco Pharma Limited (“Natco Ltd.”) and Natco Pharma Inc. (“Natco Inc.”) 

(collectively “Natco”) hereby respond to the corresponding paragraphs of the Complaint of 

plaintiffs Gilead Sciences, Inc., Hoffman-La Roche Inc., F. Hoffman-La Roche Ltd. and 

Genentech, Inc. (collectively “Plaintiffs”) as follows: 

NATURE OF THE ACTION

1. Denied, except to admit that the Complaint purports to state a cause of action for 

infringement of United States Patent No. 5,763,483 (“the ‘483 Patent”). 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 1 of 15 PageID: 164
2 

PARTIES

2. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 2 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs. 

3. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 3 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs. 

4. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 4 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs. 

5. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 5 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs. 

6. Admitted. 

7. Admitted. 

8. Denied, except to admit that Natco Ltd. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

9. Admitted. 

10. Denied, except to admit that Natco Inc. is a wholly owned subsidiary of Natco 

Ltd. 

11. Admitted. 

12. Denied. 

13. Denied, except to admit that Natco Inc. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

JURISDICTION AND VENUE

14. Admitted. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 2 of 15 PageID: 165
3 

15. Denied, except to admit that Natco has a website at http://www.natcopharma. 

co.in/index.html, which includes the following statement: “NATCO PHARMA was promoted 

by Mr. V.C. Nannapaneni in the year 1981 as a Private Limited Company to be in the business of 

Research, Developing, Manufacturing and Marketing of Pharmaceutical Substances and Finished 

Dosage forms for Indian and International markets.” 

16. Denied, except to admit that Natco Ltd. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

17. Denied, except to admit that Natco Inc. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

18. Denied, except to admit that Natco Inc. is a wholly owned subsidiary of Natco 

Ltd. 

19. Denied, except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA in 

order to obtain approval to engage in the commercial manufacture, use or sale of oseltamivir 

phosphate capsules, 75 mg. 

20. Denied, except to admit that Natco Ltd. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

21. Admitted. 

22. Denied, except to admit that a February 9, 2011 press release on the Alvogen 

website at http://www.alvogen.com/NewsMedia/ViewNews/Alvogenandnatcosecurefirsttofile 

statusongenericversionoftamiflu includes the following statement: “Alvogen, the US-based 

pharmaceutical company, today announced that its India-based partner, Natco Pharma Limited, 

has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug 

Administration (FDA) for the generic version of Tamiflu® (oseltamivir phosphate).” Further 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 3 of 15 PageID: 166
4 

admitted that a February 9, 2011 press release on the Natco website at http://www.natcopharma. 

co.in/tamiflu.html is titled: “NATCO files ANDA for Oseltamivir, (Tamiflu®) ties up with 

Alvogen, gets First to File Status.” 

23. Denied, except to admit that Natco Ltd. does not contest personal jurisdiction 

within this judicial district for the limited purposes of this action with respect to the ‘483 Patent. 

24. Denied, except to admit that Natco Inc. is a wholly owned subsidiary of Natco 

Ltd., and Natco Inc. does not contest personal jurisdiction within this judicial district for the 

limited purposes of this action with respect to the ‘483 Patent. 

25. Denied. 

26. Denied, except to admit that Natco does not contest venue within this judicial 

district for the limited purposes of this action with respect to the ‘483 Patent. 

BACKGROUND

27. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 27 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that Roche is listed in the Orange Book as the Applicant for NDA 21-087 which 

relates, inter alia, to 75 mg capsules of oseltamivir phosphate. 

28. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 28 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that the ‘483 patent on its face is entitled “Carbocyclic Compounds,” and the 

assignee is identified as Gilead Sciences, Inc. Further admitted that the patent issued June 9, 

1998, and that a copy is attached as Exhibit A to the Complaint. 

29. Denied, except to admit that the ‘483 patent claims a compound having the 

following structure: 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 4 of 15 PageID: 167
5 

Further admitted that this compound is the active ingredient in the Tamiflu® product described 

in NDA No. 21-087, and that Tamiflu® is indicated for the treatment of uncomplicated acute 

illness due to influenza infection in patients one year and older who have been symptomatic for 

no more than two days, and for the prophylaxis of influenza in patients one year and older. 

30. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 30 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that the ‘483 patent is listed in the Orange Book for NDA 21-087. Further 

admitted that according to the Orange Book, the ‘483 patent expires December 27, 2016, and that 

the holder of NDA 21-087 obtained a pediatric exclusivity period that expires June 27, 2017. 

31. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 31 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs. 

32. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 32 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA in order to obtain 

approval to engage in the commercial manufacture, use or sale of oseltamivir phosphate 

capsules, 75 mg. 

33. Denied, except to admit that 21 U.S.C. § 355(b)(1) states: “The applicant shall file 

with the application the patent number and the expiration date of any patent which claims the 

drug for which the applicant submitted the application or which claims a method of using such 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 5 of 15 PageID: 168
6 

drug and with respect to which a claim of patent infringement could reasonably be asserted if a 

person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” 

34. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 34 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that Roche is listed in the Orange Book as the Applicant for NDA 21-087 which 

relates, inter alia, to 75 mg capsules of oseltamivir phosphate. Further admitted that the ‘483 

patent is listed in the Orange Book for NDA 21-087. 

35. Denied, except to admit that 21 U.S.C. § 355(j)(2) states: 

(A) An abbreviated application for a new drug shall contain— . . . 

(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with 

respect to each patent which claims the listed drug referred to in clause (i) or which 

claims a use for such listed drug for which the applicant is seeking approval under this 

subsection and for which information is required to be filed under subsection (b) or (c) of 

this section— 

(I) that such patent information has not been filed, 

(II) that such patent has expired, 

(III) of the date on which such patent will expire, or 

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of 

the new drug for which the application is submitted; . . .” 

36. Denied, except to admit that 21 U.S.C. § 355(j)(2) states: 

(A) An abbreviated application for a new drug shall contain— . . . 

(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with 

respect to each patent which claims the listed drug referred to in clause (i) or which 

claims a use for such listed drug for which the applicant is seeking approval under this 

subsection and for which information is required to be filed under subsection (b) or (c) of 

this section— . . . 

(III) of the date on which such patent will expire, or 

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of 

the new drug for which the application is submitted; . . .” 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 6 of 15 PageID: 169
7 

37. Natco is without sufficient knowledge to admit or deny the allegations in 

Paragraph 37 of the Complaint, and therefore denies the same, leaving Plaintiffs to their proofs, 

except to admit that the ‘483 patent is listed in the Orange Book for NDA 21-087. 

38. Denied, except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA 

in order to obtain approval to engage in the commercial manufacture, use or sale of oseltamivir 

phosphate capsules, 75 mg. Further admitted that ANDA No. 202595 included a Paragraph IV 

certification with respect to the ‘483 patent. 

39. Denied, except to admit that Dr. A.K.S. Bhujanga Rao, President-Technical of 

Natco Pharma Limited sent a letter to Hoffman-La Roche, Inc., Genentech and Gilead Sciences, 

Inc. on February 2, 2011, whose subject was “Notification Pursuant to § 505(j)(2)(B)(ii) of the 

Federal Food, Drug and Cosmetic Act for U.S. Patent No. 5,763,483 (NDA No. 021087).” 

40. Denied, except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA in 

order to obtain approval to engage in the commercial manufacture, use or sale of oseltamivir 

phosphate capsules, 75 mg. Further admitted that ANDA No. 202595 included a Paragraph IV 

certification with respect to the ‘483 patent. 

41. Denied because, inter alia, invalid claims cannot be infringed. 

Count 1: Infringement under 35 U.S.C. § 271(e)(2)

42. Defendants repeat and incorporate each of the preceding paragraphs 1-41 of this 

Answer and Counterclaims as if fully set forth herein. 

43. Denied, except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA in 

order to obtain approval to engage in the commercial manufacture, use or sale of oseltamivir 

phosphate capsules, 75 mg. Further admitted that ANDA No. 202595 included a Paragraph IV 

certification with respect to the ‘483 patent. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 7 of 15 PageID: 170
8 

44. Denied because, inter alia, invalid claims cannot be infringed. 

45. Denied. 

Count 2: Infringement under 35 U.S.C. §§ 271(a),(b) and/or(c)

46. Defendants repeat and incorporate each of the preceding paragraphs 1-45 of this 

Answer and Counterclaims as if fully set forth herein. 

47. Denied, except to admit that Natco Ltd. filed ANDA No. 202595 with the FDA in 

order to obtain approval to engage in the commercial manufacture, use or sale of oseltamivir 

phosphate capsules, 75 mg. Further admitted that ANDA No. 202595 included a Paragraph IV 

certification with respect to the ‘483 patent. 

48. The Court lacks subject matter jurisdiction over the allegations of Paragraph 48 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

49. The Court lacks subject matter jurisdiction over the allegations of Paragraph 49 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

50. The Court lacks subject matter jurisdiction over the allegations of Paragraph 50 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

51. The Court lacks subject matter jurisdiction over the allegations of Paragraph 51 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

52. The Court lacks subject matter jurisdiction over the allegations of Paragraph 52 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

53. The Court lacks subject matter jurisdiction over the allegations of Paragraph 53 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

54. The Court lacks subject matter jurisdiction over the allegations of Paragraph 54 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 8 of 15 PageID: 171
9 

55. The Court lacks subject matter jurisdiction over the allegations of Paragraph 55 

under §§ 271(a),(b) and/or (c), and they are therefore denied. 

WHEREFORE, Natco denies that Plaintiffs are entitled to the relief requested in the 

Complaint. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 9 of 15 PageID: 172
10 

AFFIRMATIVE DEFENSES

Without prejudice to the denials set forth in its Answer and to its ability to seek and 

allege any and all defenses not presently known or that are revealed during the course of 

discovery, Natco asserts the following affirmative defenses in response to the Complaint: 

First Affirmative Defense

Natco’s submission of ANDA No. 202595 does not infringe one or more claims of the 

‘483 patent pursuant to 35 U.S.C. § 271(e). 

Second Affirmative Defense

The Court lacks subject matter jurisdiction over allegations relating to 35 U.S.C. §§ 

271(a),(b) and/or (c). 

Third Affirmative Defense

The claims of the ‘483 patent are invalid for failing to comply with one or more 

provisions of Title 35 of the United States Code, including §§ 101, 102, 103, 112, 116 and/or the 

judicial doctrine barring double-patenting. 

Fourth Affirmative Defense

Plaintiffs’ Complaint, in whole or in part, fails to state a claim upon which relief can be 

granted. 

COUNTERCLAIMS

For its counterclaims against Gilead Sciences, Inc., Hoffman-La Roche Inc., F. HoffmanLa Roche Ltd. and Genentech, Inc. (collectively “Counterclaim-Defendants”), Natco Pharma 

Limited and Natco Pharma, Inc. (collectively “Natco”) alleges upon knowledge with respect to 

its own acts, and upon information and belief as to other matters, as follows:

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 10 of 15 PageID: 173
11 

The Parties

1. Natco Pharma Limited is a corporation organized and existing under the laws of 

India and has a principal place of business at Natco House, Road No. 2, Banjara Hills, 

Hyderabad – 500 033, India. 

2. Natco Pharma Inc. is a Delaware Corporation having a principal place of business 

at 297 Mine Bank Road, Wellsville, Pennsylvania 17365-9514. 

3. On information and belief, Gilead Sciences, Inc. is a company organized and 

existing under the laws of the State of Delaware, with its principal place of business at 333 

Lakeside Drive, Foster City, California 94404. 

4. On information and belief, Hoffmann-La Roche Inc. is a company organized and 

existing under the laws of the State of New Jersey, with its principal place of business at 340 

Kingsland Street, Nutley, New Jersey 07110. 

5. On information and belief, F. Hoffmann-La Roche Ltd. is a company organized 

and existing under the laws Switzerland with its principal place of business at CH 4070 Basel, 

Switzerland. 

6. On information and belief, Genentech, Inc. is a company organized and existing 

under the laws of the State of Delaware, with its principal place of business at 1 DNA Way, 

South San Francisco, California 94080-4990. 

Actual and Justiciable Controversy

7. The United States Patent and Trademark Office issued United States Patent No. 

5,763,483 (“the ‘483 Patent”) on June 9, 1998. The face of the ‘483 patent names Gilead 

Sciences, Inc. as the assignee. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 11 of 15 PageID: 174
12 

8. On March 15, 2011, Counterclaim-Defendants filed a Complaint alleging, inter 

alia, infringement of the ‘483 patent by Natco. 

9. In their Complaint, Counterclaim-Defendants allege that Natco’s submission of 

Abbreviated New Drug Application (“ANDA”) No. 202595 to the Food and Drug 

Administration (“FDA”), infringes one or more claims of the ‘483 patent. 

10. Natco’s submission of ANDA No. 202595 does not infringe one or more claims 

of the ‘483 patent. 

11. The claims of the ‘483 patent are invalid for failing to comply with one or more 

provisions of Title 35 of the United States Code, including §§ 101, 102, 103, 112, 116 and/or the 

judicial doctrine barring double-patenting. 

12. Actual and justiciable controversies exist between Natco and CounterclaimDefendants relating to the ‘483 patent. 

Jurisdiction and Venue

13. 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. This Court has 

subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338. 

14. Personal jurisdiction over the Counterclaim-Defendants exists because the 

Counterclaim-Defendants have submitted to the personal jurisdiction of the Court. 

15. Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400 because 

the Counterclaim-Defendants have submitted to the jurisdiction of the Court. 

First Counterclaim (Noninfringement Under 35 U.S.C. § 271(e))

16. Natco repeats and realleges paragraphs 1 – 15 of the counterclaims as if fully set 

forth herein. 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 12 of 15 PageID: 175
13 

17. Natco’s submission of ANDA No. 202595 does not infringe one or more claims 

of the ‘483 patent pursuant to 35 U.S.C. § 271(e). 

Second Counterclaim (Invalidity)

18. Natco repeats and realleges paragraphs 1 – 17 of the counterclaims as if fully set 

forth herein. 

19. The claims of the ‘483 patent are invalid for failing to comply with one or more 

provisions of Title 35 of the United States Code, including §§ 101, 102, 103, 112, 116 and/or the 

judicial doctrine barring double-patenting. 

PRAYER FOR RELIEF

WHEREFORE, Natco respectfully requests this Court to enter judgment for Natco and 

against Counterclaim-Defendants, and decree: 

A. That the Complaint be dismissed with prejudice, and that CounterclaimDefendants take nothing by their Complaint; 

B. That the claims of the ‘483 patent are not infringed by Natco; 

C. That the claims of the ‘483 patent are invalid; 

D. That this is an exceptional case under 35 U.S.C. § 285; 

G. That Natco be awarded its costs and attorneys’ fees pursuant to 35 U.S.C. § 285, 

other statutes or rules, or general power of the Court; 

H. That the Counterclaim-Defendants, their officers, agents, servants, employees, 

attorneys, successors and any person who acts in concert or participation with the counterclaimdefendants, be preliminarily and permanently enjoined from using the ‘483 patent to block, 

hamper, hinder or obstruct FDA approval of the products described in ANDA No. 202595; and 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 13 of 15 PageID: 176
14 

I. That Natco be awarded such other and further relief as the Court deems just and 

proper. 

Dated: September 30, 2011 Respectfully submitted, 

s/ Diane C. Ragosa

Diane C. Ragosa 

AXINN, VELTROP & HARKRIDER LLP 

114 West 47th Street 

New York, NY 10036 

(212) 728-2200 

E-mail: dcr@avhlaw.com 

Attorneys for Defendants 

Natco Pharma Limited 

and Natco Pharma, Inc. 

OF COUNSEL: 

Jonathan A. Harris 

AXINN, VELTROP & HARKRIDER LLP 

90 State House Square 

Hartford, CT 06103-3704 

(860) 275-8100 

E-mail: jah@avhlaw.com

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 14 of 15 PageID: 177
 

CERTIFICATE OF SERVICE 

I hereby certify that on September 30, 2011, I caused a true and correct copy of the 

attached NATCO PHARMA LIMITED’S AND NATCO PHARMA, INC.’S ANSWER 

AND COUNTERCLAIMS to be served via the ECF system on: 

LEORA BEN-AMI 

PATRICIA A. CARSON

KAYE SCHOLER, LLP 

425 Park Avenue 

New York, New York 10022 

(212) 836-8000 

Email: pcarson@kayescholer.com 

 lbenami@kayescholer.com 

RUKHSANAH L. LIGHARI 

LIZA M. WALSH

CONNELL FOLEY LLP 

85 Livingston Ave. 

Roseland, NJ 07068 

(973) 535-0500 

Email: rlighari@connellfoley.com 

 lwalsh@connellfoley.com 

/s/Matthew S. Murphy

Matthew S. Murphy 

Case 2:11-cv-01455-SDW-MCA Document 24 Filed 09/30/11 Page 15 of 15 PageID: 178