throbber
Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 1 of 17 PageID: 2800
`
`Stephen M. Hash
`Stephen C. Stout
`Deirdre Dorval
`Shannon M. Kidd
`VINSON & ELKINS LLP
`2801 Via Fortuna, Suite 100
`Austin, TX 78746-7568
`(512) 542-8400
`
`Of Counsel for Plaintiff Pozen Inc.
`
`
`
`
`
`John E. Flaherty
`Jonathan M.H. Short
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Horizon Pharma, Inc.
`and Pozen Inc.
`
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5000
`
`Of Counsel for Plaintiff Horizon Pharma, Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`
`
`
`
`Civil Action No. 3:13-cv-00091-JAP-
`DEA
`
`(consolidated for discovery purposes
`with Civ. A. Nos. 3:11-cv-02317-JAP-
`DEA and 3:11-cv-04275-JAP-DEA
`and 3:11-cv-06348-JAP-DEA)
`
`
`
`HORIZON PHARMA, INC. and POZEN INC.,
`
`Plaintiffs,
`
`v.
`
`
`DR. REDDY'S LABORATORIES INC. and
`DR. REDDY'S LABORATORIES LTD.,
`
`
`Defendants.
`
`FIRST AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`
`
`
`
`
`
`
`
`
`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 2 of 17 PageID: 2801
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`
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`Plaintiffs Horizon Pharma, 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. 204206 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 Horizon Pharma, Inc. (“Horizon”) is a corporation operating and existing
`
`under the laws of the State of Delaware, with its principal place of business at 520 Lake Cook
`
`Road, Suite 520, Deerfield, Illinois 60015.
`
`3.
`
`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.
`
`4.
`
`On information and belief, Defendant Dr. Reddy’s Laboratories, Inc. (“Dr.
`
`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).
`
`5.
`
`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
`
`
`
`1
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 3 of 17 PageID: 2802
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`
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`place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, 500 034, India.
`
`6.
`
`On information and belief, Dr. Reddy’s Inc. is a wholly-owned subsidiary of Dr.
`
`Reddy’s Ltd.
`
`BACKGROUND
`
`The NDA
`
`7.
`
`Horizon 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.
`
`8.
`
`VIMOVO® Delayed-Release Tablets are prescription drugs 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® Delayed-Release Tablets.
`
`The Patents-In-Suit
`
`9.
`
`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
`
`directed to pharmaceutical compositions that provide for the coordinated release of an acid
`
`inhibitor and an 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.
`
`10.
`
`Pozen owns the ’907 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`
`
`2
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 4 of 17 PageID: 2803
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`
`
`under the ’907 patent. The ’907 patent will expire on February 28, 2023.
`
`11.
`
`United States Patent No. 8,557,285 (“the ’285 patent”), entitled “Pharmaceutical
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`
`United States Patent and Trademark Office on October 15, 2013. The claims of the ’285 patent
`
`are directed to pharmaceutical compositions in unit dosage form comprising esomeprazole and
`
`naproxen. A true and correct copy of the ’285 patent is attached as Exhibit B.
`
`12.
`
`Pozen owns the ’285 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’285 patent. The ’285 patent will expire on May 31, 2022.
`
`The ANDA
`
`13.
`
`On information and belief, Defendants filed ANDA No. 204206 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.
`
`14.
`
`By letter dated November 20, 2012 (the “ANDA Notice Letter”), Defendants
`
`notified Plaintiffs that Defendants had filed ANDA No. 204206 seeking approval to market Dr.
`
`Reddy’s Naproxen and Esomeprazole Magnesium Delayed-Release Tablets and that Defendants
`
`were providing information to Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R.
`
`§ 314.95.
`
`
`
`
`
`3
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`

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`
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`JURISDICTION AND VENUE
`
`15.
`
`Subject matter jurisdiction over this action is proper pursuant to the provisions of
`
`Title 28, United States Code, Sections 1331 and 1338(a).
`
`16.
`
`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.
`
`17.
`
`On information and belief, Defendants are in the business of developing,
`
`formulating, manufacturing, marketing, offering to sell, selling and commercializing
`
`pharmaceutical products.
`
`18.
`
`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.
`
`19.
`
`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.
`
`20.
`
`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.
`
`21.
`
`On information and belief, both Dr. Reddy’s Ltd. and Dr. Reddy’s Inc.
`
`participated in the preparation and/or filing of ANDA No. 204206.
`
`
`
`4
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`
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`22.
`
`On information and belief and as stated in the ANDA Notice Letter, the FDA
`
`received ANDA No. 204206 from Dr. Reddy’s Ltd. and Dr. Reddy’s Inc.
`
`23.
`
`In their ANDA Notice Letter, Defendants stated that the name and address of their
`
`agent in the United States authorized to accept service of process for Defendants for purposes of
`
`an infringement action based upon their ANDA Notice Letter is Lee Banks, Dr. Reddy’s
`
`Laboratories Inc., 200 Somerset Corporate Blvd., Floor 7, Bridgewater, New Jersey 08807.
`
`24.
`
`By naming Lee Banks, Dr. Reddy’s Laboratories Inc., 200 Somerset Corporate
`
`Blvd., Floor 7, Bridgewater, New Jersey 08807 as their agent, Defendants have consented to
`
`jurisdiction in the State of New Jersey for this action.
`
`25.
`
`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. 204206; Dr.
`
`Reddy’s Ltd.’s designation of Lee Banks, Dr. Reddy’s Laboratories Inc., 200 Somerset
`
`Corporate Blvd., Floor 7, Bridgewater, New Jersey 08807 as its agent for service of process; 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 Dr. Reddy’s Ltd.
`
`26.
`
`On information and belief, Defendants have previously been sued in this district
`
`and have not challenged personal jurisdiction. See, e.g., AstraZeneca AB et al. v. Dr. Reddy’s
`
`Laboratories, Inc. et al., Civ. Action No. 3:11-cv-02317-JAP-DEA (D.N.J); 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.
`
`
`
`5
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 7 of 17 PageID: 2806
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`
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`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.).
`
`27.
`
`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 (July 11, 2008).
`
`28.
`
`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.).
`
`29.
`
`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. 204206, this Court has
`
`personal jurisdiction over Defendants. These activities satisfy due process and confer personal
`
`jurisdiction over Defendants consistent with New Jersey law.
`
`30.
`
`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))
`
`Plaintiffs incorporate by reference paragraphs 1–30 of this Complaint as if fully
`
`31.
`
`set forth herein.
`
`
`
`6
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`
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`32.
`
`By their ANDA Notice Letter, 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.”
`
`33.
`
`On information and belief, at the time the ANDA Notice Letter, Defendants were
`
`aware of the statutory provisions and regulations referred to in paragraph 32, above.
`
`34.
`
`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.
`
`35.
`
`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
`
`
`
`7
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`

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`
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`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.
`
`36.
`
`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,
`
`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.
`
`37.
`
`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.
`
`
`
`8
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 10 of 17 PageID: 2809
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`
`
`38.
`
`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 ’285 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`39.
`
`Plaintiffs incorporate by reference paragraphs 1–30 of this Complaint as if fully
`
`set forth herein.
`
`40.
`
`On information and belief, the making, using, selling, and/or offering for sale in
`
`the United States of Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed-Release
`
`Tablets described in Defendants’ ANDA No. 204206 infringes the ’285 patent.
`
`41.
`
`Defendants have infringed the ’285 patent under 35 U.S.C. § 271(e)(2), either
`
`literally or under the doctrine of equivalents, by filing their ANDA and continuing to seek
`
`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 ’285 patent.
`
`42.
`
`On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium
`
`Delayed-Release Tablets contain the pharmaceutical composition patented in the ’285 patent,
`
`constitute a material part of the inventions of the ’285 patent, are especially made or especially
`
`adapted for use in an infringement of the ’285 patent, and are not staple articles or commodities
`
`of commerce suitable for substantial noninfringing use. Upon information and belief,
`
`Defendants are aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed-
`
`Release Tablets are so made or so adapted. Upon 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 ’285 patent.
`
`
`
`9
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`

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`
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`43.
`
`On information and belief, Defendants have previously filed patent certifications
`
`in association with their ANDA No. 204206 seeking, inter alia, FDA final approval prior to
`
`November 27, 2014. The ’285 patent has an expiration date of May 31, 2022. Therefore, on
`
`further information and belief, Defendants are currently pursuing FDA final approval of their
`
`ANDA No. 204206 prior to the expiration date of the ’285 patent.
`
`44.
`
`Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii), Defendants should file a patent
`
`certification in their pending ANDA No. 204206 with respect to the ’285 patent, and Defendants
`
`must make a Paragraph IV Certification with respect to the ’285 patent if Defendants continue to
`
`seek FDA final approval of their ANDA No. 204206 prior to May 31, 2022. On information and
`
`belief, Defendants’ above-described activities are continuing and constitute an act of
`
`infringement of the ’285 patent under 35 U.S.C. § 271(e)(2).
`
`45.
`
`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 infringe the ’285 patent claims.
`
`50.
`
`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. 204206 by Defendants infringes
`
`one or more claims of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A);
`
`
`
`10
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 12 of 17 PageID: 2811
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`
`
`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. 204206 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
`
`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. 204206 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.
`
`F.
`
`Attorneys’ fees in this action pursuant to 35 U.S.C. § 285;
`
`Costs and expenses in this action; and
`
`G.
`
`Such further and other relief as this Court may deem just and proper.
`
`Respectfully submitted,
`
`By: 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 Horizon Pharma,
`Inc. and Pozen Inc.
`
`
`
`11
`
`
`
`Dated: February 25, 2014
`
`
`
`
`
`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 13 of 17 PageID: 2812
`
`
`
`Stephen M. Hash
`Stephen C. Stout
`Deirdre Dorval
`Shannon M. Kidd
`VINSON & ELKINS LLP
`2801 Via Fortuna, Suite 100
`Austin, TX 78746-7568
`(512) 542-8400
`
`Of Counsel for Plaintiff Pozen Inc.
`
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5000
`
`
`
`
`
`Of Counsel for Plaintiff Horizon Pharma,
`Inc.
`
`
`
`12
`
`
`
`
`
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`
`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 14 of 17 PageID: 2813
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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 the
`
`subject of the following actions:
`
`ASTRAZENECA AB et al. v. DR. REDDY’S LABS. INC., et al., C.A. No. 3:11-cv-02317-
`JAP-DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. DR. REDDY’S LABS. INC. et al, C.A. No. 3:13-cv-00091-
`JAP-DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. DR. REDDY’S LABS. INC. et al, C.A. No. 3:13-cv-06157-
`JAP-DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. LUPIN LTD., et al., C.A. No. 3:11-cv-04275-JAP-DEA
`(D.N.J.);
`
`ASTRAZENECA AB et al. v. LUPIN LTD., et al., C.A. No. 3:13-cv-06315-JAP-DEA
`(D.N.J.);
`
`ASTRAZENECA AB et al. v. ANCHEN PHARMS., INC., C.A. No. 3:11-cv-06348-JAP-
`DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. WATSON LABORATORIES, INC.- FLORIDA, et al., C. A.
`No. 3:13-cv-03038-JAP-DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. WATSON LABORATORIES, INC.- FLORIDA, et al., C. A.
`No. 3:13-cv-06318-JAP-DEA (D.N.J.);
`
`ASTRAZENECA AB et al. v. MYLAN PHARMACEUTICALS et al., C.A. No. 3:13-cv-
`04022-JAP-DEA (D.N.J.)
`
`ASTRAZENECA AB et al. v. MYLAN PHARMACEUTICALS et al., C.A. No. 3:13-cv-
`06316-JAP-DEA (D.N.J.)
`
`ASTRAZENECA AB, et al. v. MYLAN LABORATORIES LTD. et al., C.A. No. 3:12-cv-
`01378-JAP-TJB (D.N.J.);
`
`ASTRAZENECA AB et al. v. WATSON LABORATORIES, INC. - FLORIDA et al., C.A.
`No. 3:13-cv-01669-JAP-TJB (D.N.J.); and
`
`ASTRAZENECA AB et al. v. WOCKHARDT LIMITED et al., C.A. No. 3:13-cv-04854-
`JAP-TJB (D.N.J.).
`
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`13
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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 15 of 17 PageID: 2814
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`
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`
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`The foregoing cases involve products that contain an esomeprazole magnesium
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`formulation. The matter in controversy involves the same esomeprazole magnesium
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`formulations. All of these cases have been assigned to Hon. Joel A. Pisano, U.S.D.J. The DRL,
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`Lupin, and Anchen cases have been consolidated for discovery purposes and have been assigned
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`to Magistrate Judge Arpert.
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`
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`Therefore, for the sake of judicial economy and with regard to Judge Pisano’s and Judge
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`Arpert’s familiarity of the patents asserted in the matter in controversy, Plaintiffs believe these
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`cases and the matter in controversy are all related. Accordingly, Plaintiffs respectfully request
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`that the matter in controversy be assigned to Judge Pisano and Magistrate Judge Arpert.
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`
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`Dated: February 25, 2014
`
`Respectfully submitted,
`
`
`
`By: 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 Horizon Pharma,
`Inc. and Pozen Inc.
`
`Stephen M. Hash
`Stephen C. Stout
`Deirdre Dorval
`Shannon M. Kidd
`VINSON & ELKINS LLP
`2801 Via Fortuna, Suite 100
`Austin, TX 78746-7568
`(512) 542-8400
`
`Of Counsel for Plaintiff Pozen Inc.
`
`
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`14
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`

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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 16 of 17 PageID: 2815
`
`
`
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5000
`
`
`
`Of Counsel for Plaintiff Horizon Pharma,
`Inc.
`
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`15
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`Case 3:13-cv-00091-MLC-DEA Document 62 Filed 02/25/14 Page 17 of 17 PageID: 2816
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`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that true copies of the foregoing First Amended
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`Complaint for Patent Infringement, Certification Pursuant to L. Civ. R. 11.2, and supporting
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`documents were caused to be served on February 25, 2014, by electronic mail and/or the ECF
`
`By: s/ John E. Flaherty
`John E. Flaherty
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Counsel for Plaintiffs Horizon Pharma,
`Inc. and Pozen Inc.
`
`16
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`system upon all counsel of record.
`
`
`Dated: February 25, 2014

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