Source: https://www.scribd.com/document/189725122/Astrazeneca-Ab-et-al-v-Kremers-Urban-Pharmaceuticals-et-al
Timestamp: 2017-03-29 04:29:40
Document Index: 795105195

Matched Legal Cases: ['§ 100', '§ 271', '§ 355', '§ 355', '§ 314', '§ 355', '§ 355', '§ 271', '§ 355', '§ 355', '§ 271', '§ 282', '§ 355', '§ 355', '§ 271', '§ 282', '§ 355', '§ 355', '§ 271', '§ 282', '§ 271', '§ 285', 'art0', 'art02']

Astrazeneca Ab et. al. v. Kremers Urban Pharmaceuticals et. al. | Patent | Food And Drug Administration
BrowseInterestsStay InformedCareerPersonal GrowthFiction & BiographiesHealth & FitnessLifestyleCultureBrowse byBooksAudiobooksNews & MagazinesSheet MusicBrowse allUploadSign inJoinJohn E. Flaherty Jonathan M.H.Short McCARTER & ENGLISH LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 (973) 622-4444 Counsel for Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc., and KBI-E Inc. Einar Stole Ed Rippey COVINGTON & BURLING LLP 1201 Pennsylvania Ave., NW Washington, DC 20004 (202) 662-6000 Of Counsel for Plaintiffs
ASTRAZENECA AB, AKTIEBOLAGET HASSLE, ASTRAZENECA LP, KBI INC., and KBI-E INC., Plaintiffs, v. KREMERS URBAN PHARMACEUTICALS, KREMERS URBAN DEVELOPMENT CO., and KREMERS URBAN LLC, Defendants. Civil Action No. COMPLAINT FOR PATENT INFRINGEMENT AND CERTIFICATION PURSUANT TO LOCAL CIVIL RULE 11.2
Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc., and KBI-E Inc. (collectively, “Plaintiffs”), by their attorneys, for their Complaint against Kremers Urban Pharmaceuticals, Kremers Urban Development Co., and Kremers Urban LLC (collectively, “Defendants” or “Kremers”), 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. 205563 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’ NEXIUM® pharmaceutical products that are sold in the United States. THE PARTIES 2. Plaintiff AstraZeneca AB (“AZ AB”) is a corporation operating and existing
place of business at Wilmington, Delaware. KBI-E has exclusive rights in the United States to market and sell products covered by United States Patent Nos. 5,714,504, 6,369,085,7,411,070, and 8,466,175. 7. On information and belief, Defendant Kremers Urban Pharmaceuticals (“Kremers
Pharma”) is a corporation operating and existing under the laws of the State of Indiana with its principal place of business at 902 Carnegie Center, Suite 360, Princeton, New Jersey 08540. 8. On information and belief, Defendant Kremers Urban Development Co.
(“Kremers Development”) is a corporation operating and existing under the laws of the State of Delaware with its principal place of business at 6140 West Executive Drive, Mequon, Wisconsin 53092. 9. On information and belief, Defendant Kremers Urban LLC (“Kremers LLC”) is a
corporation operating and existing under the laws of the State of Delaware with its principal place of business at 902 Carnegie Center, Suite 360, Princeton, New Jersey 08540. BACKGROUND The NDA 10. AZ LP is the holder of New Drug Application (“NDA”) No. 21153 for
patent will expire on May 25, 2018, and pediatric exclusivity relating to the ’175 patent expires on November 25, 2018. The ANDA 19. On information and belief, Kremers Pharma filed ANDA No. 205563 with the
FDA under 21 U.S.C. § 355(j) to obtain FDA approval for the commercial manufacture, use, importation, offer for sale, and sale in the United States of esomeprazole magnesium delayedrelease tablets, 20 mg and 40 mg (“Kremers’s Esomeprazole Magnesium Delayed-Release Tablets”), which are generic versions of Plaintiffs’ NEXIUM® Esomeprazole Magnesium Delayed-Release Tablets, in 20 mg and 40 mg dosage forms.
By letter dated October 24, 2013 (the “ANDA Notice Letter”), Kremers Pharma
notified Plaintiffs that Kremers Pharma had filed ANDA No. 205563 seeking approval to market Kremers’s Esomeprazole Magnesium Delayed-Release Tablets and that Kremers Pharma was providing information to Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95. 21. On information and belief, Kremers Pharma sells products manufactured by
Kremers Development and Kremers LLC in New Jersey and throughout the United States. JURISDICTION AND VENUE 22. Subject matter jurisdiction over this action is proper pursuant to the provisions of
Title 28, United States Code, Sections 1331 and 1338(a). 23. On information and belief, Defendant Kremers Pharma is a corporation operating
and existing under the laws of the State of Indiana with its principal place of business at 902 Carnegie Center, Suite 360, Princeton, New Jersey 08540. 24. On information and belief, Kremers Pharma, 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 the judicial district. 25. On information and belief, Kremers Development, with the assistance and/or at
the direction of Kremers Pharma, develops, manufactures, distributes, markets, offers to sell, and sells generic drug products for sale and use throughout the United States, including within the judicial district. 26. On information and belief, Defendants are in the business of developing,
formulating, manufacturing, marketing, offering to sell, selling, and commercializing pharmaceutical products.
On information and belief, Kremers LLC, with the assistance and/or at the
direction of Kremers Pharma, develops, manufactures, distributes, markets, offers to sell, and sells generic drug products for sale and use throughout the United States, including within the judicial district. 28. On information an belief, Defendants acted in concert to develop Kremers’s
Esomeprazole Magnesium Delayed-Release Tablets and to seek approval from the FDA to sell Kremers’s Esomeprazole Magnesium Delayed-Release Tablets throughout the United States, including within this judicial district. 29. On information and belief and as stated in the ANDA Notice Letter, Kremers
Pharma prepared and filed ANDA No. 205563. 30. On information and belief and as stated in the ANDA Notice Letter, the FDA
received ANDA No. 205563 from Kremers Pharma. 31. On information and belief by virtue of, inter alia, Kremers Development’s
relationship with Kremers Pharma in connection with the preparation and/or filing of ANDA No. 205563 and the sales-related 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 Kremers Development. 32. On information and belief by virtue of, inter alia, Kremers LLC’s relationship
with Kremers Pharma in connection with the preparation and/or filing of ANDA No. 205563 and the sales-related 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 Kremers LLC.
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. 205563, this Court has personal jurisdiction over Defendants. These activities satisfy due process and confer personal jurisdiction over Defendants consistent with New Jersey law. 34. Venue is proper in this District pursuant to the provisions of Title 28, United
set forth herein. 36. On information and belief, Defendants submitted ANDA No. 205563 to the FDA
under 21 U.S.C. § 355(j) in order to obtain approval to market Kremers’s Esomeprazole Magnesium Delayed-Release Tablets in the United States before the expiration of the ’504 patent. 37. By their ANDA Notice Letter, Defendants informed Plaintiffs that they had
submitted to the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a certification alleging that the ’504 patent is invalid, unenforceable, or will not be infringed by the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets. 38. Under 35 U.S.C. § 271(e)(2)(A), the submission by Defendants to the FDA of
ANDA No. 205563 to obtain approval for the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release
Tablets before the expiration of the ’504 patent constitutes infringement of one or more claims of the ’504 patent, either literally or under the doctrine of equivalents. 39. On information and belief, Kremers’s Esomeprazole Magnesium Delayed-Release
Tablets, if approved by the FDA, will be prescribed and administered to human patients in a therapeutically effective amount to inhibit gastric acid secretion and for the treatment of gastrointestinal inflammatory disease. On information and belief, this administration will occur at Defendants’ active behest and with their intent, knowledge, and encouragement. On information and belief, Defendants will actively encourage, aid and abet this administration with knowledge that it is in contravention of Plaintiffs’ rights under the ’504 patent. 40. The ANDA Notice Letter, which is required by statute and regulation to provide a
full and detailed explanation regarding all defenses, does not allege non-infringement of any claims of the ’504 patent. By not alleging non-infringement, Defendants admit that Kremers’s Esomeprazole Magnesium Delayed-Release Tablets meet each limitation of each claim of the ’504 patent. 41. Plaintiffs will be substantially and irreparably harmed by the infringing activities
set forth herein. 43. On information and belief, Defendants submitted ANDA No. 205563 to the FDA
under 21 U.S.C. § 355(j) in order to obtain approval to market Kremers’s Esomeprazole
Magnesium Delayed-Release Tablets in the United States before the expiration of the ’085 patent. 44. By their ANDA Notice Letter, Defendants informed Plaintiffs that they had
submitted to the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a certification alleging that the ’085 patent is invalid, unenforceable, or will not be infringed by the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets. 45. Under 35 U.S.C. § 271(e)(2)(A), the submission by Defendants to the FDA of
ANDA No. 205563 to obtain approval for the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets before the expiration of the ’085 patent constitutes infringement of one or more claims of the ’085 patent, either literally or under the doctrine of equivalents. 46. On information and belief, Kremers’s Esomeprazole Magnesium Delayed-Release
Tablets, if approved by the FDA, will be prescribed and administered to human patients in a therapeutically effective amount to inhibit gastric acid secretion and for the treatment of gastrointestinal inflammatory disease. On information and belief, this administration will occur at Defendants’ active behest and with their intent, knowledge, and encouragement. On information and belief, Defendants will actively encourage, aid and abet this administration with knowledge that it is in contravention of Plaintiffs’ rights under the ’085 patent. 47. The ANDA Notice Letter, which is required by statute and regulation to provide a
full and detailed explanation regarding all defenses, does not allege invalidity of any claims of the ’085 patent. By not alleging invalidity, Kremers effectively accepts the statutory presumption that the ’085 patent is valid. 35 U.S.C. § 282.
described above unless those activities are precluded by this Court. Plaintiffs have no adequate remedy at law. COUNT 3: INFRINGEMENT OF THE ’070 PATENT 49. Plaintiffs incorporate by reference paragraphs 1-34 of this Complaint as if fully
set forth herein. 50. On information and belief, Defendants submitted ANDA No. 205563 to the FDA
under 21 U.S.C. § 355(j) in order to obtain approval to market Kremers’s Esomeprazole Magnesium Delayed-Release Tablets in the United States before the expiration of the ’070 patent. 51. By their ANDA Notice Letter, Defendants informed Plaintiffs that they had
submitted to the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a certification alleging that the ’070 patent is invalid, unenforceable, or will not be infringed by the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets. 52. Under 35 U.S.C. § 271(e)(2)(A), the submission by Defendants to the FDA of
ANDA No. 205563 to obtain approval for the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets before the expiration of the ’070 patent constitutes infringement of one or more claims of the ’070 patent, either literally or under the doctrine of equivalents. 53. On information and belief, Kremers’s Esomeprazole Magnesium Delayed-Release
Tablets, if approved by the FDA, will be prescribed and administered to human patients in a therapeutically effective amount to inhibit gastric acid secretion and for the treatment of
gastrointestinal inflammatory disease. On information and belief, this administration will occur at Defendants’ active behest and with their intent, knowledge, and encouragement. On information and belief, Defendants will actively encourage, aid and abet this administration with knowledge that it is in contravention of Plaintiffs’ rights under the ’070 patent. 54. The ANDA Notice Letter, which is required by statute and regulation to provide a
full and detailed explanation regarding all defenses, does not allege invalidity of any claims of the ’070 patent. By not alleging invalidity, Kremers effectively accepts the statutory presumption that the ’070 patent is valid. 35 U.S.C. § 282. 55. 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 4: INFRINGEMENT OF THE ’175 PATENT 56. Plaintiffs incorporate by reference paragraphs 1-34 of this Complaint as if fully
set forth herein. 57. On information and belief, Defendants submitted ANDA No. 205563 to the FDA
under 21 U.S.C. § 355(j) in order to obtain approval to market Kremers’s Esomeprazole Magnesium Delayed-Release Tablets in the United States before the expiration of the ’175 patent. 58. By their ANDA Notice Letter, Defendants informed Plaintiffs that they had
submitted to the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a certification alleging that the ’175 patent is invalid, unenforceable, or will not be infringed by the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets.
Under 35 U.S.C. § 271(e)(2)(A), the submission by Defendants to the FDA of
ANDA No. 205563 to obtain approval for the commercial manufacture, use, sale, offer for sale, or importation into the United States of Kremers’s Esomeprazole Magnesium Delayed-Release Tablets before the expiration of the ’175 patent constitutes infringement of one or more claims of the ’175 patent, either literally or under the doctrine of equivalents. 60. On information and belief, Kremers’s Esomeprazole Magnesium Delayed-Release
Tablets, if approved by the FDA, will be prescribed and administered to human patients in a therapeutically effective amount to inhibit gastric acid secretion and for the treatment of gastrointestinal inflammatory disease, including Heliobacter infection. On information and belief, this administration will occur at Defendants’ active behest and with their intent, knowledge, and encouragement. On information and belief, Defendants will actively encourage, aid and abet this administration with knowledge that it is in contravention of Plaintiffs’ rights under the ’175 patent. 61. The ANDA Notice Letter, which is required by statute and regulation to provide a
full and detailed explanation regarding all defenses, does not allege invalidity of any claims of the ’175 patent. By not alleging invalidity, Kremers effectively accepts the statutory presumption that the ’175 patent is valid. 35 U.S.C. § 282. 62. Plaintiffs will be substantially and irreparably harmed by the infringing activities
PRAYER FOR RELIEF WHEREFORE, Plaintiffs respectfully request the following relief: A. enforceable; B. A judgment that the submission of ANDA No. 205563 by Defendants infringes A judgment that the claims of the ’504, ’085, ’070, and ’175 patents are valid and
date of any FDA approval of Defendants’ ANDA No. 205563 shall be no earlier than the latest expiration date of the patents-in-suit and any additional periods of exclusivity; D. A judgment pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining
Defendants, and all persons acting in concert with any of them, from making, using, selling, offering to sell, or importing the esomeprazole magnesium product described in Defendants’ ANDA No. 205563 prior to the latest expiration of the patents-in-suit and any additional periods of exclusivity; E. F. G. Attorneys’ fees in this action pursuant to 35 U.S.C. § 285; Costs and expenses in this action; and Such further and other relief as this Court may deem just and proper.
Respectfully submitted, s/ John E. Flaherty John E. Flaherty Jonathan M.H. Short McCARTER & ENGLISH LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 (973) 622-4444 Counsel for Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc., and KBI-E Inc. Einar Stole Ed Rippey COVINGTON & BURLING LLP 1201 Pennsylvania Ave., NW Washington, DC 20004 (202) 662-6000 Of Counsel for Plaintiffs
Sign up to vote on this titleUsefulNot usefulAstrazeneca Ab et. al. v. Kremers Urban Pharmaceuticals et. al. by PriorSmart0.0 (0)EmbedDownloadDescriptionOfficial Complaint for Patent Infringement in Civil Action No. 3:13-cv-07299-JAP-TJB: Astrazeneca Ab et. al. v. Kremers Urban Pharmaceuticals, Inc. et. al. Filed in U.S. District Court for the Dist...Official Complaint for Patent Infringement in Civil Action No. 3:13-cv-07299-JAP-TJB: Astrazeneca Ab et. al. v. Kremers Urban Pharmaceuticals, Inc. et. al. Filed in U.S. District Court for the District of New Jersey, the Hon. Joel A. Pisano presiding. See http://news.priorsmart.com/-l9Bx for more info.Interests: Types, Business/Law, Court FilingsRead on Scribd mobile: iPhone, iPad and Android.Copyright: Public DomainDownload as PDF, TXT or read online from ScribdFlag for inappropriate contentShow moreShow less
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