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John E. Flaherty 

Jonathan M.H. Short 

Carissa L. Rodrigue 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Counsel for Plaintiffs AstraZeneca AB, 

AstraZeneca LP, KBI-E Inc. and Pozen Inc. 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-5095 

Of Counsel for Plaintiffs AstraZeneca AB and 

AstraZeneca LP 

Stephen M. Hash 

VINSON & ELKINS LLP 

2801 Via Fortuna 

Suite 100 

Austin, TX 78746-7568 

(512) 542-8504 

Of Counsel for Plaintiff Pozen Inc. 

 

Mary W. Bourke 

Kristen Healey Cramer 

CONNOLLY BOVE LODGE & HUTZ LLP 

1007 N. Orange Street 

P.O. Box 2207 

Wilmington, DE 19899 

(302) 658-9141 

R. James Balls 

CONNOLLY BOVE LODGE & HUTZ LLP 

1875 Eye Street, NW 

Suite 1100 

Washington, DC 20006 

(202) 572-0335 

Of Counsel for Plaintiffs AstraZeneca AB,

AstraZeneca LP, and Pozen Inc.

Henry J. Renk 

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas 

New York, NY 10104-3800 

(212) 218-2250 

Of Counsel for Plaintiffs AstraZeneca AB, 

AstraZeneca LP, and KBI-E Inc. 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

ASTRAZENECA AB, ASTRAZENECA LP, 

KBI-E INC., and POZEN INC., 

 

 Plaintiffs, 

 

 v. 

 

DR. REDDY’S LABORATORIES INC. and 

DR. REDDY’S LABORATORIES LTD., 

 

 Defendants. 

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Civil Action No. 11-cv-02317 (JAP)(DEA) 

FIRST AMENDED COMPLAINT 

FOR PATENT INFRINGEMENT

 

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Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E Inc., and Pozen Inc. (collectively, 

“Plaintiffs”), by their attorneys, for their First Amended Complaint against Dr. Reddy’s 

Laboratories Inc. and Dr. Reddy’s Laboratories Ltd. (collectively, “Defendants”), allege as 

follows: 

NATURE OF THE ACTION 

1. This is a civil action for patent infringement arising under the patent laws of the 

United States, 35 U.S.C. § 100 et seq., and in particular under 35 U.S.C. § 271(e). This action 

relates to Abbreviated New Drug Application (“ANDA”) No. 202461 filed by or for the benefit 

of Defendants with the United States Food and Drug Administration (“FDA”) for approval to 

market generic versions of Plaintiffs’ VIMOVO®

 pharmaceutical products that are sold in the 

United States. 

THE PARTIES 

2. Plaintiff AstraZeneca AB (“AZ AB”) is a corporation operating and existing 

under the laws of Sweden, with its principal place of business at S-151 85 Södertälje, Sweden. 

3. Plaintiff AstraZeneca LP (“AZ LP”) is a limited partnership operating and 

existing under the laws of the State of Delaware, with its principal place of business at 1800 

Concord Pike, Wilmington, Delaware 19803. 

4. Plaintiff KBI-E Inc. (“KBI-E”) is a corporation operating and existing under the 

laws of the State of Delaware, with its principal place of business in Wilmington, Delaware. 

5. Plaintiff Pozen Inc. (“Pozen”) is a corporation operating and existing under the 

laws of the State of Delaware, with its principal place of business at 1414 Raleigh Road, Chapel 

Hill, North Carolina 27517. 

6. On information and belief, Defendant Dr. Reddy’s Laboratories Inc. (“Dr. 

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Reddy’s Inc.”) is a corporation operating and existing under the laws of the State of New Jersey, 

with its principal place of business at 200 Somerset Corporate Boulevard, Bridgewater, New 

Jersey 08807 (Somerset County). 

7. On information and belief, Defendant Dr. Reddy’s Laboratories Ltd. (“Dr. 

Reddy’s Ltd.”) is a corporation operating and existing under the laws of India, with its principal 

place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, 500 034, India. 

8. On information and belief, Dr. Reddy’s Inc. is a wholly-owned subsidiary of Dr. 

Reddy’s Ltd. 

BACKGROUND 

The NDA 

9. AZ LP is the holder of New Drug Application (“NDA”) No. 022511 for 

VIMOVO® (naproxen and esomeprazole magnesium) Delayed Release Tablets, in 375 mg 

(naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg (esomeprazole 

magnesium) dosage forms. 

10. VIMOVO® is a prescription drug approved for use to relieve the signs and 

symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the 

risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment 

with non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen and esomeprazole magnesium 

are the active ingredients in VIMOVO®. 

The Patents-In-Suit 

11. United States Patent No. 6,926,907 (“the ’907 patent”), entitled “Pharmaceutical 

Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the 

United States Patent and Trademark Office on August 9, 2005. The claims of the ’907 patent are 

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directed to pharmaceutical compositions that provide for the coordinated release of an acid 

inhibitor and a NSAID (claims 1-21, and 53-55), and a method of treating a patient for pain or 

inflammation comprising administration of the aforementioned compositions (claims 22-52). A 

true and correct copy of the ’907 patent is attached as Exhibit A. 

12. Pozen owns the ’907 patent by assignment. AZ AB is Pozen’s exclusive licensee 

under the ’907 patent. The ’907 patent will expire on February 28, 2023. 

13. United States Patent No. 5,714,504 (“the ’504 patent”), entitled “Compositions,” 

was duly and legally issued by the United States Patent and Trademark Office on February 3, 

1998. The claims of the ’504 patent are directed to pharmaceutical formulations for oral 

administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy2[[4-methoxy-3,5-dimethyl-2-pyridinylmethyl)sulfinyl]-1H-benzimidazole (claims 1-5), and 

methods of inhibiting gastric acid secretion comprising the oral administration of pharmaceutical 

formulations of the alkaline salts of esomeprazole (claims 6, 7 and 10) and esomeprazole (8 and 

9). A true and correct copy of the ’504 patent is attached as Exhibit B. 

14. AZ AB owns the ’504 patent by assignment. KBI-E is AZ AB’s exclusive 

licensee under the ’504 patent. The ’504 patent will expire on February 3, 2015, and pediatric 

exclusivity relating to the ‘504 patent will expire on August 3, 2015. 

15. United States Patent No. 6,875,872 (“the ’872 patent”), entitled “Compounds,” 

was duly and legally issued by the United States Patent and Trademark Office on April 5, 2005. 

The claims of the ’872 patent are directed to magnesium salts of (-)-5-methoxy-2-[[(4-methoxy3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole (claims 1-12). A true and correct 

copy of the ’872 patent is attached as Exhibit C. 

16. AZ AB owns the ’872 patent by assignment. KBI-E is AZ AB’s exclusive 

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licensee under the ’872 patent. The ’872 patent will expire on May 27, 2014, and pediatric 

exclusivity relating to the ’872 patent will expire on November 27, 2014. 

17. United States Patent No. 7,745,466 (“the ’466 patent”), entitled “Form of Someprazole,” was duly and legally issued by the United States Patent and Trademark Office on 

June 29, 2010. The claims of the ’466 patent are directed to pharmaceutical compositions 

comprising a first and second active ingredient and a pharmaceutically acceptable carrier, 

wherein the first active ingredient is a magnesium salt of S-omeprazole trihydrate (claims 1-15), 

and methods for treating gastric acid related conditions comprising administration of the 

aforementioned compositions (claim 16). A true and correct copy of the ’466 patent is attached 

as Exhibit D. 

18. AZ AB owns the ’466 patent by assignment. KBI-E is AZ AB’s exclusive 

licensee under the ’466 patent. The ‘466 patent will expire on October 13, 2018. 

19. United States Patent No. 7,411,070 (“the ’070 patent”), entitled “Form of Someprazole,” was duly and legally issued by the United States Patent and Trademark Office on 

August 12, 2008. The claims of the ’070 patent are directed to magnesium salts of S-omeprazole 

trihydrate (claims 1-2), and processes for the preparation of the aforementioned magnesium salts 

of S-omeprazole trihydrate (claims 3-4). A true and correct copy of the ’070 patent is attached as 

Exhibit E. 

20. AZ AB owns the ’070 patent by assignment. KBI-E is AZ AB’s exclusive 

licensee under the ’070 patent. The ’070 patent will expire on May 25, 2018, and pediatric 

exclusivity relating to the ‘070 patent will expire on November 25, 2018. 

21. United States Patent No. 6,369,085 (“the ’085 patent”), entitled “Form of Somperazole,” was duly and legally issued by the United States Patent and Trademark Office on 

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April 9, 2002. The claims of the ’085 patent are directed to magnesium salts of S-omeprazole 

trihydrate (claims 1-3), processes for the preparation of the aforementioned magnesium salts of 

S-omeprazole trihydrate (claims 4-10), pharmaceutical compositions comprising the 

aforementioned magnesium salts of S-omeprazole trihydrate (claim 11), and methods of treating 

gastric acid related conditions comprising administration of the aforementioned magnesium salts 

of S-omeprazole trihydrate (claim 12). A true and correct copy of the ’085 patent is attached as 

Exhibit F. 

22. AZ AB owns the ’085 patent by assignment. KBI-E is AZ AB’s exclusive 

licensee under the ’085 patent. The ’085 patent will expire on May 25, 2018, and pediatric 

exclusivity relating to the ’085 patent will expire on November 25, 2018. 

The ANDA 

23. On information and belief, Defendants filed ANDA No. 202461 with the FDA 

under 21 U.S.C. § 355(j) to obtain FDA approval for the commercial manufacture, use, import, 

offer for sale, and sale in the United States of naproxen and esomeprazole magnesium delayed 

release tablets containing 375 mg or 500 mg of naproxen and 20.71 mg esomeprazole 

magnesium (“Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets”), 

which are generic versions of Plaintiffs’ VIMOVO® Delayed Release Tablets in 375 mg 

(naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg (esomeprazole 

magnesium) strengths, respectively. 

24. By letters dated March 11, 2011 (the “ANDA Notice Letter dated March 11, 

2011”) and September 19, 2011 (the “ANDA Notice Letter dated September 19, 2011”), 

Defendants notified Plaintiffs that Defendants had filed ANDA No. 202461 seeking approval to 

market Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets, and that 

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Defendants were providing information to Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 

21 C.F.R. § 314.95. 

JURISDICTION AND VENUE 

25. Subject matter jurisdiction over this action is proper pursuant to the provisions of 

Title 28, United States Code, Sections 1331 and 1338(a). 

26. On information and belief, Dr. Reddy’s Inc. is a corporation organized and 

existing under the laws of the State of New Jersey. By virtue of its incorporation in New Jersey, 

this Court has personal jurisdiction over Dr. Reddy’s Inc. 

27. On information and belief, Defendants are in the business of developing, 

formulating, manufacturing, marketing, offering to sell, selling and commercializing 

pharmaceutical products. 

28. On information and belief, Dr. Reddy’s Ltd., either directly or through one or 

more of its wholly owned subsidiaries and/or agents, develops, manufactures, distributes, 

markets, offers to sell, and sells generic drug products for sale and use throughout the United 

States, including within this judicial district. 

29. On information and belief, Dr. Reddy’s Inc., with the assistance and/or at the 

direction of Dr. Reddy’s Ltd., develops, manufactures, distributes, markets, offers to sell, and 

sells generic drug products for sale and use throughout the United States, including within this 

judicial district. 

30. On information and belief, Defendants acted in concert to develop Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets, and to seek approval from 

the FDA to sell Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets 

throughout the United States, including within this judicial district. 

31. On information and belief, both Dr. Reddy’s Ltd. and Dr. Reddy’s Inc. 

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participated in the preparation and/or filing of ANDA No. 202461. 

32. On information and belief and as stated in the ANDA Notice Letters, the FDA 

received ANDA No. 202461 from Dr. Reddy’s Ltd. and Dr. Reddy’s Inc. 

33. In its ANDA Notice Letter dated March 11, 2011, Defendants stated that the 

name and address of its agent in the United States authorized to accept service of process for 

Defendants for purposes of an infringement action based upon its ANDA Notice Letter is Lee 

Banks, Dr. Reddy’s Inc., 200 Somerset Corporate Blvd., Floor 7, Bridgewater, New Jersey 

08807. In its ANDA Notice Letter dated September 19, 2011, Defendants stated that the name 

and address of its agent in the United States authorized to accept service of process for 

Defendants for purposes of an infringement action based upon its ANDA Notice Letter is Alan 

H. Pollack, Esq., Budd Larner, P.C., 150 John F. Kennedy Parkway, Short Hills, NJ 07078 

34. By naming Lee Banks, Dr. Reddy’s Inc., 200 Somerset Corporate Blvd., Floor 7, 

Bridgewater, New Jersey 08807 and Alan H. Pollack, Esq., Budd Larner, P.C., 150 John F. 

Kennedy Parkway, Short Hills, NJ 07078 as their agents in their ANDA Notice Letters, 

Defendants have consented to jurisdiction in the State of New Jersey for this action. 

35. On information and belief, by virtue of, inter alia, Dr. Reddy’s Ltd.’s relationship 

with Dr. Reddy’s Inc. in connection with the preparation and/or filing of ANDA No. 202461; Dr. 

Reddy’s Ltd.’s designation of Lee Banks, Dr. Reddy’s Inc., 200 Somerset Corporate Blvd., Floor 

7, Bridgewater, New Jersey 08807 and Alan H. Pollack, Esq., Budd Larner, P.C., 150 John F. 

Kennedy Parkway, Short Hills, NJ 07078 as its agents for service of process; and the salesrelated activities of Defendants in New Jersey, including but not limited to the substantial, 

continuous, and systematic distribution, marketing, and/or sales of pharmaceutical products to 

residents of New Jersey, this Court has personal jurisdiction over Dr. Reddy’s Ltd. 

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36. On information and belief, Defendants have previously been sued in this district 

and have not challenged personal jurisdiction. See, e.g., Wyeth LLC v. Dr. Reddy’s Labs., Ltd. 

and Dr. Reddy’s Labs., Inc., Civ. Action No. 3:10-cv-04551-FLW-DEA (D.N.J.); Albany 

Molecular Research, Inc. v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc., Civ. Action No. 

2:09-cv-04638-GEB-MCA (D.N.J.); Sepracor, Inc. v. Teva Pharm. USA, Inc., et al., Civ. Action 

No. 2:09-cv-01302-DMC-MF (D.N.J.); Hoffman-La Roche Inc. v. Dr. Reddy’s Labs., Ltd. and 

Dr. Reddy’s Labs., Inc., Civ. Action No. 2:08-cv-04055-SRC-MAS (D.N.J.); and AstraZeneca 

AB et al. v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc., Civil Action No. 3:08-cv-00328-

JAP-TJB (D.N.J.). 

37. On information and belief, both Defendants Dr. Reddy’s Ltd. and Dr. Reddy’s 

Inc. have admitted that each is subject to personal jurisdiction in this district. See, e.g., 

AstraZeneca UK Ltd. and AstraZeneca Pharms. LP v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s 

Labs., Inc., 3:08-cv-03237-MLC-TJB (D.N.J.), Answer to Complaint, ¶ 8 (Jul. 11, 2008). 

38. On information and belief, Defendants have availed themselves of the jurisdiction 

of this court by initiating litigation in this district. See, e.g., Dr. Reddy’s Labs., Ltd. and Dr. 

Reddy’s Labs., Inc. v. Eli Lilly & Co., Civ. Action No. 3:09-0192-GEB-LHG (D.N.J.); and Dr. 

Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc. v. AstraZeneca AB et al., Civil Action No. 3:08-

cv-02496-JAP-TJB (D.N.J.). 

39. On information and belief, by virtue of, inter alia, Defendants’ continuous and 

systematic contacts with New Jersey, including but not limited to the above-described contacts, 

and the actions on behalf of Defendants in connection with ANDA No. 202461, this Court has 

personal jurisdiction over Defendants. These activities satisfy due process and confer personal 

jurisdiction over Defendants consistent with New Jersey law. 

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40. Venue is proper in this District pursuant to the provisions of Title 28, United 

States Code, Sections 1391(c) and (d), and 1400(b). 

COUNT I 

(INFRINGEMENT OF THE ’907 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

41. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

42. By their ANDA Notice Letter dated March 11, 2011, Defendants informed 

Plaintiffs that as part of their ANDA they had filed a certification of the type described in 21 

U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to the ’907 patent. This statutory 

section requires, inter alia, certification by the ANDA applicant that the subject patent, here the 

’907 patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug 

for which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also 

requires a Paragraph IV notice to “include a detailed statement of the factual and legal basis of 

the opinion of the applicant that the patent is not valid or will not be infringed.” The FDA Rules 

and Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must 

include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent 

is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i) 

[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the 

claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or 

unenforceable, a full and detailed explanation of the grounds supporting the allegation.” 

43. On information and belief, at the time the ANDA Notice Letter dated March 11, 

2011 was served, Defendants were aware of the statutory provisions and regulations referred to 

in paragraph 42, above. 

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44. Defendants’ ANDA Notice Letter dated March 11, 2011, which is required by 

statute and regulation to provide a full and detailed explanation regarding non-infringement (see 

paragraph 42 above), does not allege and does not address non-infringement of claims 1, 5, 9-17, 

21-24, 28-29, 32-35, 37, 41-42, 45-48, and 50-55 of the ’907 patent. By not addressing noninfringement of claims 1, 5, 9-17, 21-24, 28-29, 32-35, 37, 41-42, 45-48, and 50-55 of the ’907 

patent, Defendants admit that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed 

Release Tablets meet all limitations in claims 1, 5, 9-17, 21-24, 28-29, 32-35, 37, 41-42, 45-48, 

and 50-55 of the ’907 patent. 

45. Defendants have infringed one or more claims of the ’907 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, prior to the expiration of the ’907 patent. 

46. On information and belief, the commercial manufacture, use, sale, offer for sale, 

or importation into the United States of Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets, if approved by the FDA, will constitute direct infringement of claims 

1, 5, 9-17, and 53-55 of the ’907 patent. 

47. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets, if approved, will be prescribed and administered to human patients to 

relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, 

and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach 

ulcers from treatment with NSAIDs, which uses will constitute direct infringement of claims 22, 

23, 35, 48, and 50-52 of the ’907 patent. On information and belief, these uses will occur with 

Defendants’ specific intent, knowledge and encouragement. On information and belief, 

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Defendants will actively induce, encourage, aid and abet this prescription and administration, 

with knowledge and specific intent that these uses will be in contravention of Plaintiffs’ rights 

under the ’907 patent. 

48. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are especially made or especially adapted to relieve the signs and 

symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the 

risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment 

with NSAIDs by inhibiting gastric acid secretion. On information and belief, Defendants are 

aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets are so 

made or so adapted. On information and belief, Defendants are aware that Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets, if approved, will be used in 

contravention of Plaintiffs’ rights under the ’907 patent. 

49. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law. 

COUNT II 

(INFRINGEMENT OF THE ’504 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

50. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

51. By their ANDA Notice Letter dated September 19, 2011, Defendants informed 

Plaintiffs that as part of their ANDA they had filed a certification of the type described in 21 

U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to the ’504 patent. This statutory 

section requires, inter alia, certification by the ANDA applicant that the subject patent, here the 

’504 patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug 

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for which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also 

requires a Paragraph IV notice to “include a detailed statement of the factual and legal basis of 

the opinion of the applicant that the patent is not valid or will not be infringed.” The FDA Rules 

and Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must 

include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent 

is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i) 

[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the 

claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or 

unenforceable, a full and detailed explanation of the grounds supporting the allegation.” 

52. On information and belief, at the time the ANDA Notice Letter dated September 

19, 2011 was served, Defendants were aware of the statutory provisions and regulations referred 

to in paragraph 51, above. 

53. Defendants’ ANDA Notice Letter dated September 19, 2011, which is required by 

statute and regulation to provide a full and detailed explanation regarding non-infringement (see 

paragraph 51 above), does not allege and does not address non-infringement of claims 1-3, 5-7, 

and 10 of the ’504 patent. By not addressing non-infringement of claims 1-3, 5-7, and 10 of the 

’504 patent, Defendants admit that Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets meet all limitations in claims 1-3, 5-7, and 10 of the ’504 patent. 

54. Defendants have infringed one or more claims of the ’504 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, or the use of which is claimed in this patent, prior to the expiration of the ’504 

patent. 

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55. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets, if approved, will be prescribed and administered to human patients for 

pain in a therapeutically effective amount to inhibit gastric acid secretion, which uses will 

constitute direct infringement of one or more claims of the ‘504 patent. On information and 

belief, these uses will occur at Defendants’ active behest and with their intent, knowledge and 

encouragement. On information and belief, Defendants will actively induce, encourage, aid and 

abet this prescription and administration with knowledge and specific intent that these uses will 

be in contravention of Plaintiffs’ rights under the ’504 patent 

56. On information and belief, Defendants’ Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are especially made or especially adapted to relieve the signs and 

symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the 

risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment 

with NSAIDs by inhibiting gastric acid secretion. On information and belief, Defendants are 

aware that their Naproxen and Esomeprazole Magnesium Delayed Release Tablets are so made 

or so adapted. On information and belief, Defendants are aware that Dr. Reddy’s Naproxen and 

Esomeprazole Magnesium Delayed Release Tablets, if approved, will be used in contravention 

of Plaintiffs’ rights under the ’504 patent. 

57. On information and belief, the manufacture, use and sale of Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe the ’504 patent 

claims. 

58. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law. 

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COUNT III 

(INFRINGEMENT OF THE ’872 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

59. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

60. By their ANDA Notice Letter dated September 19, 2011, Defendants informed 

Plaintiffs that as part of their ANDA they had filed a certification of the type described in 21 

U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to the ’872 patent. This statutory 

section requires, inter alia, certification by the ANDA applicant that the subject patent, here the 

’872 patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug 

for which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also 

requires a Paragraph IV notice to “include a detailed statement of the factual and legal basis of 

the opinion of the applicant that the patent is not valid or will not be infringed.” The FDA Rules 

and Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must 

include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent 

is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i) 

[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the 

claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or 

unenforceable, a full and detailed explanation of the grounds of supporting the allegation.” 

61. On information and belief, at the time the ANDA Notice Letter dated September 

19, 2011 was served, Defendants were aware of the statutory provisions and regulations referred 

to in paragraph 60, above. 

62. Defendants’ ANDA Notice Letter dated September 19, 2011, which is required by 

statute and regulation to provide a full and detailed explanation regarding non-infringement (see 

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paragraph 60 above), does not allege and does not address non-infringement of claims 1-2, 4-5, 

7-8, and 10-11 of the ’872 patent. By not addressing non-infringement of claims 1-2, 4-5, 7-8, 

and 10-11 of the ’872 patent, Defendants admit that Dr. Reddy’s Naproxen and Esomeprazole 

Magnesium Delayed Release Tablets meet all limitations in claims 1-2, 4-5, 7-8, and 10-11 of 

the ’872 patent. 

63. Defendants have infringed one or more claims of the ’872 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, prior to the expiration of the ’872 patent. 

64. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets, if approved, will be prescribed and administered to human patients, 

which uses will constitute direct infringement of one or more claims of the ‘872 patent. On 

information and belief, these uses will occur at Defendants’ active behest and with their intent, 

knowledge and encouragement. On information and belief, Defendants will actively induce, 

encourage, aid and abet this prescription and administration with knowledge and specific intent 

that these uses will be in contravention of Plaintiffs’ rights under the ’872 patent. 

65. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are especially made or especially adapted for treatment of humans. On 

information and belief, Defendants are aware that Dr. Reddy’s Naproxen and Esomeprazole 

Magnesium Delayed Release Tablets are so made or so adapted. On information and belief, 

Defendants are aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed 

Release Tablets, if approved, will be used in contravention of Plaintiffs’ rights under the ’872 

patent. 

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66. On information and belief, the manufacture, use and sale of Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe one or more claims 

of the ’872 patent. 

67. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law. 

COUNT IV 

(INFRINGEMENT OF THE ’466 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

68. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

69. Defendants have infringed one or more claims of the ’466 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, prior to the expiration of the ’466 patent. 

70. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets contain a magnesium salt of esomeprazole trihydrate as claimed by the 

’466 patent. 

71. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are especially made or especially adapted to treat gastric acid related 

conditions via the administration of a therapeutically effective amount of a pharmaceutical 

formulation containing esomeprazole magnesium trihydrate and a non-steroidal antiinflammatory agent. On information and belief, Defendants are aware that its naproxen and 

esomeprazole magnesium delayed release tablets are so made or so adapted. On information and 

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belief, Defendants are aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed 

Release Tablets, if approved, will be used in contravention of Plaintiffs’ rights under the ’466 

patent. 

72. On information and belief, the manufacture, use and sale of Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe the ’466 patent 

claims. 

73. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law. 

COUNT V 

(INFRINGEMENT OF THE ’070 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

74. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

75. By their ANDA Notice Letter dated September 19, 2011, Defendants informed 

Plaintiffs that as part of their ANDA they had filed a certification of the type described in 21 

U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to the ’070 patent. This statutory 

section requires, inter alia, certification by the ANDA applicant that the subject patent, here the 

’070 patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug 

for which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also 

requires a Paragraph IV notice to “include a detailed statement of the factual and legal basis of 

the opinion of the applicant that the patent is not valid or will not be infringed.” The FDA Rules 

and Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must 

include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent 

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is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i) 

[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the 

claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or 

unenforceable, a full and detailed explanation of the grounds of supporting the allegation.” 

76. On information and belief, at the time the ANDA Notice Letter dated September 

19, 2011 was served, Defendants were aware of the statutory provisions and regulations referred 

to in paragraph 75, above. 

77. Defendants’ ANDA Notice Letter dated September 19, 2011, which is required by 

statute and regulation to provide a full and detailed explanation regarding invalidity (see 

paragraph 75 above), does not allege and does not address invalidity of claims 2 and 4 of the 

’070 patent. 

78. Defendants have infringed one or more claims of the ’070 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, prior to the expiration of the ’070 patent. 

79. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets contain a magnesium salt of esomeprazole trihydrate as claimed by the 

’070 patent. 

80. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are manufactured by a process comprised of treating a magnesium salt 

of esomeprazole with water, as claimed by the ’070 patent. 

81. On information and belief, the manufacture, use and sale of Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe the ’070 patent 

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claims. 

82. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law. 

COUNT VI 

(INFRINGEMENT OF THE ’085 PATENT UNDER 35 U.S.C. § 271(e)(2)(A)) 

83. Plaintiffs incorporate by reference paragraphs 1-40 of this Complaint as if fully 

set forth herein. 

84. By their ANDA Notice Letter dated September 19, 2011, Defendants informed 

Plaintiffs that as part of their ANDA they had filed a certification of the type described in 21 

U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) with respect to the ’085 patent. This statutory 

section requires, inter alia, certification by the ANDA applicant that the subject patent, here the 

’085 patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug 

for which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also 

requires a Paragraph IV notice to “include a detailed statement of the factual and legal basis of 

the opinion of the applicant that the patent is not valid or will not be infringed.” The FDA Rules 

and Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must 

include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent 

is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i) 

[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the 

claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or 

unenforceable, a full and detailed explanation of the grounds of supporting the allegation.” 

85. On information and belief, at the time the ANDA Notice Letter dated September 

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19, 2011 was served, Defendants were aware of the statutory provisions and regulations referred 

to in paragraph 84, above. 

86. Defendants’ ANDA Notice Letter dated September 19, 2011, which is required by 

statute and regulation to provide a full and detailed explanation regarding invalidity (see 

paragraph 84 above), does not allege invalidity of any claims of the ’085 patent. 

87. Defendants have infringed one or more claims of the ’085 patent under 35 U.S.C. 

§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking 

approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed 

in this patent, prior to the expiration of the ’085 patent. 

88. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets contain a magnesium salt of esomeprazole trihydrate as claimed by the 

’085 patent. 

89. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets, if approved, will be prescribed and administered to human patients in 

the form of a pharmaceutical formulation and in a therapeutically effective amount to treat 

gastric acid related conditions, which uses will constitute direct infringement of one or more 

claims of the ‘085 patent. On information and belief, these uses will occur at Defendants’ active 

behest and with its intent, knowledge and encouragement. On information and belief, 

Defendants will actively induce, encourage, aid and abet this prescription and administration 

with knowledge and specific intent that these uses will be in contravention of Plaintiffs’ rights 

under the ’085 patent. 

90. On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium 

Delayed Release Tablets are especially made or especially adapted to relieve the signs and 

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symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the 

risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment 

with NSAIDs by inhibiting gastric acid secretion. On information and belief, Defendants are 

aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets are so 

made or so adapted. On information and belief, Defendants are aware that Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets, if approved, will be used in 

contravention of Plaintiffs’ rights under the ’085 patent. 

91. On information and belief, the manufacture, use and sale of Dr. Reddy’s 

Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe the ’085 patent 

claims. 

92. Plaintiffs will be substantially and irreparably harmed by the infringing activities 

described above unless those activities are precluded by this Court. Plaintiffs have no adequate 

remedy at law.

PRAYER FOR RELIEF 

 WHEREFORE, Plaintiffs respectfully request the following relief: 

A. A judgment that the claims of the patents-in-suit are valid and enforceable; 

B. A judgment that the submission of ANDA No. 202461 by Defendants infringes 

one or more claims of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A); 

C. A judgment providing that, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective 

date of any FDA approval of Defendants’ ANDA No. 202461 shall be no earlier than the later of 

the expiration date of the last to expire of the patents-in-suit or any later exclusivity to which 

Plaintiffs are or become entitled; 

D. A judgment pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining 

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Defendants, and all persons acting in concert with any of them, from making, using, selling, 

offering to sell, or importing the naproxen and esomeprazole magnesium product described in 

Defendants’ ANDA No. 202461 no earlier than the later of the expiration date of the last to 

expire of the patents-in-suit or any later exclusivity to which Plaintiffs are or become entitled; 

E. Attorneys’ fees in this action pursuant to 35 U.S.C. § 285; 

F. Costs and expenses in this action; and 

G. Such further and other relief as this Court may deem just and proper. 

Dated: October 28, 2011 

By: 

/s/ John E. Flaherty 

Mary W. Bourke 

Kristen Healey Cramer 

CONNOLLY BOVE LODGE & HUTZ LLP 

1007 N. Orange Street 

P.O. Box 2207 

Wilmington, DE 19899 

(302) 658-9141 

R. James Balls 

CONNOLLY BOVE LODGE & HUTZ LLP 

1875 Eye Street, NW 

Suite 1100 

Washington, DC 20006 

(202) 572-0335 

Of Counsel for Plaintiffs AstraZeneca AB,

AstraZeneca LP, and Pozen Inc.

John E. Flaherty 

Jonathan M.H. Short 

Carissa L. Rodrigue 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Counsel for Plaintiffs AstraZeneca AB, 

AstraZeneca LP, KBI-E Inc., and Pozen Inc. 

Einar Stole 

COVINGON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-5095 

Of Counsel for Plaintiffs AstraZeneca AB and 

AstraZeneca LP 

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Henry J. Renk 

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas 

New York, NY 10104-3800 

Of Counsel for Plaintiffs AstraZeneca AB 

AstraZeneca LP, and KBI-E Inc. 

Stephen M. Hash 

VINSON & ELKINS LLP 

2801 Via Fortuna 

Suite 100 

Austin, TX 78746-7568 

(512) 542-8504 

Of Counsel for Plaintiff Pozen Inc.

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CERTIFICATION PURSUANT TO L. CIV. R. 11.2 

 

 Pursuant to Local Civil Rule 11.2, I hereby certify that the matter in controversy is 

related to the subject matter of ASTRAZENECA AB, ASTRAZENECA LP, KBI-E INC., and 

POZEN INC., v. LUPIN LTD. and LUPIN PHARMACEUTICALS INC., Civil Action No. 3:11-

cv-04275 (JAP)(DEA) (the “VIMOVO® Lupin case”). The VIMOVO® Lupin case involves the 

same patents and the same product as the matter in controversy. Civil Action No. 11-4275 has 

been assigned to Hon. Joel A. Pisano, U.S.D.J. The matter in controversy and the VIMOVO® 

Lupin case have been consolidated for discovery purposes. 

 Furthermore, I certify that the matter in controversy is related to the subject matter of the 

following active cases (the “NEXIUM® cases”) currently pending before Judge Pisano: 

• ASTRAZENECA AB, AKTIEBOLAGET HÄSSLE, ASTRAZENECA LP, KBI INC. and 

KBI-E INC. v. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Civil Action No. 

3:09-cv-05404-JAP-TJB (D.N.J.). 

• ASTRAZENECA AB, AKTIEBOLAGET HÄSSLE, ASTRAZENECA LP, KBI INC. and 

KBI-E INC. v. HANMI USA, INC., HANMI PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD, and HANMI HOLDINGS CO., LTD., Civil Action No. 

3:11-cv-00760-JAP-TJB (D.N.J.).

Dated: October 28, 2011 

By: 

/s/ John E. Flaherty 

Mary W. Bourke 

Kristen Healey Cramer 

CONNOLLY BOVE LODGE & HUTZ LLP 

1007 N. Orange Street 

P.O. Box 2207 

Wilmington, DE 19899 

(302) 658-9141 

John E. Flaherty 

Jonathan M.H. Short 

Carissa L. Rodrigue 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Counsel for Plaintiffs AstraZeneca AB, 

AstraZeneca LP, KBI-E Inc., and Pozen Inc. 

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R. James Balls 

CONNOLLY BOVE LODGE & HUTZ LLP 

1875 Eye Street, NW 

Suite 1100 

Washington, DC 20006 

(202) 572-0335 

Of Counsel for Plaintiffs AstraZeneca AB,

AstraZeneca LP, and Pozen Inc.

Henry J. Renk 

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas 

New York, NY 10104-3800 

Of Counsel for Plaintiffs AstraZeneca AB 

AstraZeneca LP, and KBI-E Inc. 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-5095 

Of Counsel for Plaintiffs AstraZeneca AB and 

AstraZeneca LP 

Stephen M. Hash 

VINSON & ELKINS LLP 

2801 Via Fortuna 

Suite 100 

Austin, TX 78746-7568 

(512) 542-8504 

Of Counsel for Plaintiff Pozen Inc.

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