Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 1 of 22 PageID: 1
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`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,
`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.
`
`Einar Stole
`Edward H. Rippey
`Enrique Longton
`Erica N. Andersen
`COVINGTON & BURLING LLP
`1201 Pennsylvania Avenue, NW
`Washington, DC 20004-2401
`(202) 662-6000
`
`Of Counsel for Plaintiffs AstraZeneca AB and
`AstraZeneca LP
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`Stephen M. Hash
`Stephen C. Stout
`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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`
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`CIVIL ACTION NO.
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`COMPLAINT FOR
`PATENT INFRINGEMENT
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`ASTRAZENECA AB, ASTRAZENECA LP,
`KBI-E INC., and POZEN INC.,
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`Plaintiffs,
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`v.
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`DR. REDDY’S LABORATORIES, INC. and
`DR. REDDY’S LABORATORIES, LTD.,
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`
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`Defendants.
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 2 of 22 PageID: 2
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`Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E Inc., and Pozen Inc. (collectively,
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`“Plaintiffs”), by their attorneys, for their Complaint against Dr. Reddy’s Laboratories, Inc. and
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`Dr. Reddy’s Laboratories, Ltd. (collectively, “Defendants”), allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement arising under the patent laws of the
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`United States, 35 U.S.C. § 100 et seq., and in particular under 35 U.S.C. § 271(e). This action
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`relates to Abbreviated New Drug Application (“ANDA”) No. 204206 filed by or for the benefit
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`of Defendants with the United States Food and Drug Administration (“FDA”) for approval to
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`market generic versions of Plaintiffs’ VIMOVO® pharmaceutical products that are sold in the
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`United States.
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`THE PARTIES
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`2.
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`Plaintiff AstraZeneca AB (“AZ AB”) is a corporation operating and existing
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`under the laws of Sweden, with its principal place of business at S-151 85 Södertälje, Sweden.
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`3.
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`Plaintiff AstraZeneca LP (“AZ LP”) is a limited partnership operating and
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`existing under the laws of the State of Delaware, with its principal place of business at 1800
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`Concord Pike, Wilmington, Delaware 19803.
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`4.
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`Plaintiff KBI-E Inc. (“KBI-E”) is a corporation operating and existing under the
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`laws of the State of Delaware, with its principal place of business in Wilmington, Delaware.
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`5.
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`Plaintiff Pozen Inc. (“Pozen”) is a corporation operating and existing under the
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`laws of the State of Delaware, with its principal place of business at 1414 Raleigh Road, Chapel
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`Hill, North Carolina 27517.
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`6.
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`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,
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`2
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`with its principal place of business at 200 Somerset Corporate Boulevard, Bridgewater, New
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`Jersey 08807 (Somerset County).
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`7.
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`On information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. (“Dr.
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`Reddy’s Ltd.”) is a corporation operating and existing under the laws of India, with its principal
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`place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, 500 034, India.
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`8.
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`On information and belief, Dr. Reddy’s Inc. is a wholly-owned subsidiary of Dr.
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`Reddy’s Ltd.
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`BACKGROUND
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`The NDA
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`9.
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`AZ LP is the holder of New Drug Application (“NDA”) No. 022511 for
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`VIMOVO® (naproxen and esomeprazole magnesium) Delayed Release Tablets, in 375 mg
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`(naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg (esomeprazole
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`magnesium) dosage forms.
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`10.
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`VIMOVO® is a prescription drug approved for use to relieve the signs and
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`symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the
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`risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment
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`with non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen and esomeprazole magnesium
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`are the active ingredients in VIMOVO®.
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`The Patents-In-Suit
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`11.
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`United States Patent No. 6,926,907 (“the ’907 patent”), entitled “Pharmaceutical
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`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
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`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
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`3
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`inhibitor and a NSAID (claims 1-21, and 53-55), and a method of treating a patient for pain or
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`inflammation comprising administration of the aforementioned compositions (claims 22-52). A
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`true and correct copy of the ’907 patent is attached as Exhibit A.
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`12.
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`Pozen owns the ’907 patent by assignment. AZ AB is Pozen’s exclusive licensee
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`under the ’907 patent. The ’907 patent will expire on February 28, 2023.
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`13.
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`United States Patent No. 5,714,504 (“the ’504 patent”), entitled “Compositions,”
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`was duly and legally issued by the United States Patent and Trademark Office on February 3,
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`1998. The claims of the ’504 patent are directed to pharmaceutical formulations for oral
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`administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy-
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`2[[4-methoxy-3,5-dimethyl-2-pyridinylmethyl)sulfinyl]-1H-benzimidazole (claims 1-5), and
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`methods of inhibiting gastric acid secretion comprising the oral administration of pharmaceutical
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`formulations of the alkaline salts of esomeprazole (claims 6, 7 and 10) and esomeprazole (8 and
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`9). A true and correct copy of the ’504 patent is attached as Exhibit B.
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`14.
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`AZ AB owns the ’504 patent by assignment. KBI-E is AZ AB’s exclusive
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`licensee under the ’504 patent. The ’504 patent will expire on February 3, 2015, and pediatric
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`exclusivity relating to the ‘504 patent will expire on August 3, 2015.
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`15.
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`United States Patent No. 7,745,466 (“the ’466 patent”), entitled “Form of S-
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`omeprazole,” was duly and legally issued by the United States Patent and Trademark Office on
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`June 29, 2010. The claims of the ’466 patent are directed to pharmaceutical compositions
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`comprising a first and second active ingredient and a pharmaceutically acceptable carrier,
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`wherein the first active ingredient is a magnesium salt of S-omeprazole trihydrate (claims 1-15),
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`and methods for treating gastric acid related conditions comprising administration of the
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`4
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 5 of 22 PageID: 5
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`aforementioned compositions (claim 16). A true and correct copy of the ’466 patent is attached
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`as Exhibit C.
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`16.
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`AZ AB owns the ’466 patent by assignment. KBI-E is AZ AB’s exclusive
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`licensee under the ’466 patent. The ‘466 patent will expire on October 13, 2018.
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`17.
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`United States Patent No. 7,411,070 (“the ’070 patent”), entitled “Form of S-
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`omeprazole,” was duly and legally issued by the United States Patent and Trademark Office on
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`August 12, 2008. The claims of the ’070 patent are directed to magnesium salts of S-omeprazole
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`trihydrate (claims 1-2), and processes for the preparation of the aforementioned magnesium salts
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`of S-omeprazole trihydrate (claims 3-4). A true and correct copy of the ’070 patent is attached as
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`Exhibit D.
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`18.
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`AZ AB owns the ’070 patent by assignment. KBI-E is AZ AB’s exclusive
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`licensee under the ’070 patent. The ’070 patent will expire on May 25, 2018, and pediatric
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`exclusivity relating to the ‘070 patent will expire on November 25, 2018.
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`19.
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`United States Patent No. 6,369,085 (“the ’085 patent”), entitled “Form of S-
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`omperazole,” 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
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`trihydrate (claims 1-3), processes for the preparation of the aforementioned magnesium salts of
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`S-omeprazole trihydrate (claims 4-10), pharmaceutical compositions comprising the
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`aforementioned magnesium salts of S-omeprazole trihydrate (claim 11), and methods of treating
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`gastric acid related conditions comprising administration of the aforementioned magnesium salts
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`of S-omeprazole trihydrate (claim 12). A true and correct copy of the ’085 patent is attached as
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`Exhibit E.
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`20.
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`AZ AB owns the ’085 patent by assignment. KBI-E is AZ AB’s exclusive
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`5
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`licensee under the ’085 patent. The ’085 patent will expire on May 25, 2018, and pediatric
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`exclusivity relating to the ’085 patent will expire on November 25, 2018.
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`The ANDA
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`21.
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`On information and belief, Defendants filed ANDA No. 204206 with the FDA
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`under 21 U.S.C. § 355(j) to obtain FDA approval for the commercial manufacture, use, import,
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`offer for sale, and sale in the United States of naproxen and esomeprazole magnesium delayed
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`release tablets containing 375 mg or 500 mg of naproxen and 20.71 mg esomeprazole
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`magnesium (“Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets”),
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`which are generic versions of Plaintiffs’ VIMOVO® Delayed Release Tablets in 375 mg
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`(naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg (esomeprazole
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`magnesium) strengths, respectively.
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`22.
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`By letter dated November 20, 2012 (the “ANDA Notice Letter”), Defendants
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`notified Plaintiffs that Defendants had filed ANDA No. 204206 seeking approval to market Dr.
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`Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets, and that Defendants
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`were providing information to Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R.
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`§ 314.95.
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`JURISDICTION AND VENUE
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`23.
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`Subject matter jurisdiction over this action is proper pursuant to the provisions of
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`Title 28, United States Code, Sections 1331 and 1338(a).
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`24.
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`On information and belief, Dr. Reddy’s Inc. is a corporation organized and
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`existing under the laws of the State of New Jersey. By virtue of its incorporation in New Jersey,
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`this Court has personal jurisdiction over Dr. Reddy’s Inc.
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`25.
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`On information and belief, Defendants are in the business of developing,
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`formulating, manufacturing, marketing, offering to sell, selling and commercializing
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`6
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`pharmaceutical products.
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`26.
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`On information and belief, Dr. Reddy’s Ltd., either directly or through one or
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`more of its wholly owned subsidiaries and/or agents, develops, manufactures, distributes,
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`markets, offers to sell, and sells generic drug products for sale and use throughout the United
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`States, including within this judicial district.
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`27.
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`On information and belief, Dr. Reddy’s Inc., with the assistance and/or at the
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`direction of Dr. Reddy’s Ltd., develops, manufactures, distributes, markets, offers to sell, and
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`sells generic drug products for sale and use throughout the United States, including within this
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`judicial district.
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`28.
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`On information and belief, Defendants acted in concert to develop Dr. Reddy’s
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`Naproxen and Esomeprazole Magnesium Delayed Release Tablets, and to seek approval from
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`the FDA to sell Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets
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`throughout the United States, including within this judicial district.
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`29.
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`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. 204206.
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`30.
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`On information and belief and as stated in the ANDA Notice Letter, the FDA
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`received ANDA No. 204206 from Dr. Reddy’s Ltd. and Dr. Reddy’s Inc.
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`31.
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`In its ANDA Notice Letter, Defendants stated that the name and address of its
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`agent in the United States authorized to accept service of process for Defendants for purposes of
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`an infringement action based upon its ANDA Notice Letter is Lee Banks, Dr. Reddy’s
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`Laboratories Inc., 200 Somerset Corporate Blvd., Floor 7, Bridgewater, New Jersey 08807.
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`32.
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`By naming Lee Banks, Dr. Reddy’s Laboratories Inc., 200 Somerset Corporate
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`Blvd., Floor 7, Bridgewater, New Jersey 08807 as their agent, Defendants have consented to
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`7
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`jurisdiction in the State of New Jersey for this action.
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`33.
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`On information and belief, by virtue of, inter alia, Dr. Reddy’s Ltd.’s relationship
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`with Dr. Reddy’s Inc. in connection with the preparation and/or filing of ANDA No. 204206; Dr.
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`Reddy’s Ltd.’s designation of Lee Banks, Dr. Reddy’s Laboratories Inc., 200 Somerset
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`Corporate Blvd., Floor 7, Bridgewater, New Jersey 08807 as its agent for service of process; and
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`the sales-related activities of Defendants in New Jersey, including but not limited to the
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`substantial, continuous, and systematic distribution, marketing, and/or sales of pharmaceutical
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`products to residents of New Jersey, this Court has personal jurisdiction over Dr. Reddy’s Ltd.
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`34.
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`On information and belief, Defendants have previously been sued in this district
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`and have not challenged personal jurisdiction. See, e.g., AstraZeneca AB et al. v. Dr. Reddy’s
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`Laboratories, Inc. et al., Civ. Action No. 3:11-cv-02317-JAP-DEA (D.N.J); Wyeth LLC v. Dr.
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`Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc., Civ. Action No. 3:10-cv-04551-FLW-DEA
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`(D.N.J.); Albany Molecular Research, Inc. v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s Labs.,
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`Inc., Civ. Action No. 2:09-cv-04638-GEB-MCA (D.N.J.); Sepracor, Inc. v. Teva Pharm. USA,
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`Inc., et al., Civ. Action No. 2:09-cv-01302-DMC-MF (D.N.J.); Hoffman-La Roche Inc. v. Dr.
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`Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc., Civ. Action No. 2:08-cv-04055-SRC-MAS
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`(D.N.J.); and AstraZeneca AB et al. v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc., Civil
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`Action No. 3:08-cv-00328-JAP-TJB (D.N.J.).
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`35.
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`On information and belief, both Defendants Dr. Reddy’s Ltd. and Dr. Reddy’s
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`Inc. have admitted that each is subject to personal jurisdiction in this district. See, e.g.,
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`AstraZeneca UK Ltd. and AstraZeneca Pharms. LP v. Dr. Reddy’s Labs., Ltd. and Dr. Reddy’s
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`Labs., Inc., 3:08-cv-03237-MLC-TJB (D.N.J.), Answer to Complaint, ¶ 8 (Jul. 11, 2008).
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`36.
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`On information and belief, Defendants have availed themselves of the jurisdiction
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 9 of 22 PageID: 9
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`of this court by initiating litigation in this district. See, e.g., Dr. Reddy’s Labs., Ltd. and Dr.
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`Reddy’s Labs., Inc. v. Eli Lilly & Co., Civ. Action No. 3:09-0192-GEB-LHG (D.N.J.); and Dr.
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`Reddy’s Labs., Ltd. and Dr. Reddy’s Labs., Inc. v. AstraZeneca AB et al., Civil Action No. 3:08-
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`cv-02496-JAP-TJB (D.N.J.).
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`37.
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`On information and belief, by virtue of, inter alia, Defendants’ continuous and
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`systematic contacts with New Jersey, including but not limited to the above-described contacts,
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`and the actions on behalf of Defendants in connection with ANDA No. 204206, this Court has
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`personal jurisdiction over Defendants. These activities satisfy due process and confer personal
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`jurisdiction over Defendants consistent with New Jersey law.
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`38.
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`Venue is proper in this District pursuant to the provisions of Title 28, United
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`States Code, Sections 1391(c) and (d), and 1400(b).
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`COUNT I
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`(INFRINGEMENT OF THE ’907 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
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`Plaintiffs incorporate by reference paragraphs 1-38 of this Complaint as if fully
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`39.
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`set forth herein.
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`40.
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`By their ANDA Notice Letter, Defendants informed Plaintiffs that as part of their
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`ANDA they had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`(“Paragraph IV”) with respect to the ’907 patent. This statutory section requires, inter alia,
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`certification by the ANDA applicant that the subject patent, here the ’907 patent, “is invalid or
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`will not be infringed by the manufacture, use, or sale of the new drug for which the application is
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`submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also requires a Paragraph IV notice to
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`“include a detailed statement of the factual and legal basis of the opinion of the applicant that the
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`patent is not valid or will not be infringed.” The FDA Rules and Regulations (21 C.F.R. §
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`9
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 10 of 22 PageID: 10
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`314.95(c)) specify, inter alia, that a Paragraph IV notification must include “[a] detailed
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`statement of the factual and legal basis of applicant’s opinion that the patent is not valid,
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`unenforceable, or will not be infringed.” The detailed statement is to include “(i) [f]or each
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`claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is
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`not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or unenforceable, a full
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`and detailed explanation of the grounds supporting the allegation.”
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`41.
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`On information and belief, at the time the ANDA Notice Letter, Defendants were
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`aware of the statutory provisions and regulations referred to in paragraph 40, above.
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`42.
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`Defendants have infringed one or more claims of the ’907 patent under 35 U.S.C.
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`§ 271(e)(2), either literally or under the doctrine of equivalents, by filing their ANDA seeking
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`approval from the FDA to engage in the commercial manufacture, use or sale of a drug claimed
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`in this patent, prior to the expiration of the ’907 patent.
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`43.
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`On information and belief, the commercial manufacture, use, sale, offer for sale,
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`or importation into the United States of Dr. Reddy’s Naproxen and Esomeprazole Magnesium
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`Delayed Release Tablets, if approved by the FDA, will constitute direct infringement of claims
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`1, 5, 9-17, and 53-55 of the ’907 patent.
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`44.
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`On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium
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`Delayed Release Tablets, if approved, will be prescribed and administered to human patients to
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`relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis,
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`and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach
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`ulcers from treatment with NSAIDs, which uses will constitute direct infringement of claims 22,
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`23, 35, 48, and 50-52 of the ’907 patent. On information and belief, these uses will occur with
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`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,
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`with knowledge and specific intent that these uses will be in contravention of Plaintiffs’ rights
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`under the ’907 patent.
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`45.
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`On information and belief, Dr. Reddy’s Naproxen and Esomeprazole Magnesium
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`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
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`risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment
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`with NSAIDs by inhibiting gastric acid secretion. On information and belief, Defendants are
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`aware that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release Tablets are so
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`made or so adapted. On information and belief, Defendants are aware that Dr. Reddy’s
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`Naproxen and Esomeprazole Magnesium Delayed Release Tablets, if approved, will be used in
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`contravention of Plaintiffs’ rights under the ’907 patent.
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`46.
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
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`remedy at law.
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`COUNT II
`(INFRINGEMENT OF THE ’504 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
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`47.
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`Plaintiffs incorporate by reference paragraphs 1-38 of this Complaint as if fully
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`
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`set forth herein.
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`48.
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`By their ANDA Notice Letter, Defendants informed Plaintiffs that as part of their
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`ANDA they had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`(“Paragraph IV”) with respect to the ’504 patent. This statutory section requires, inter alia,
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`certification by the ANDA applicant that the subject patent, here the ’504 patent, “is invalid or
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`will not be infringed by the manufacture, use, or sale of the new drug for which the application is
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`11
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 12 of 22 PageID: 12
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`submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also requires a Paragraph IV notice to
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`“include a detailed statement of the factual and legal basis of the opinion of the applicant that the
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`patent is not valid or will not be infringed.” The FDA Rules and Regulations (21 C.F.R. §
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`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,
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`unenforceable, or will not be infringed.” The detailed statement is to include “(i) [f]or each
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`claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is
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`not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or unenforceable, a full
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`and detailed explanation of the grounds supporting the allegation.”
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`49.
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`On information and belief, at the time the ANDA Notice Letter, Defendants were
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`aware of the statutory provisions and regulations referred to in paragraph 48, above.
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`50.
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`Defendants’ ANDA Notice Letter, which is required by statute and regulation to
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`provide a full and detailed explanation regarding non-infringement (see paragraph 48 above),
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`does not allege and does not address non-infringement of claims 1-3, 5-7, and 10 of the ’504
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`patent. By not addressing non-infringement of claims 1-3, 5-7, and 10 of the ’504 patent,
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`Defendants admit that Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed Release
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`Tablets meet all limitations in claims 1-3, 5-7, and 10 of the ’504 patent.
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`51.
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`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.
`
`
`
`12
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`

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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 13 of 22 PageID: 13
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`
`
`52.
`
`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.
`
`53.
`
`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.
`
`54.
`
`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.
`
`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.
`
`
`
`13
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 14 of 22 PageID: 14
`
`
`
`COUNT III
`(INFRINGEMENT OF THE ’466 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`56.
`
`Plaintiffs incorporate by reference paragraphs 1-38 of this Complaint as if fully
`
`
`
`set forth herein.
`
`57.
`
`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.
`
`58.
`
`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.
`
`59.
`
`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 anti-
`
`inflammatory 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
`
`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.
`
`60.
`
`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.
`
`
`
`14
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`

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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 15 of 22 PageID: 15
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`
`
`61.
`
`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 ’070 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`62.
`
`Plaintiffs incorporate by reference paragraphs 1-38 of this Complaint as if fully
`
`
`
`set forth herein.
`
`63.
`
`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 ’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 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.”
`
`64.
`
`On information and belief, at the time the ANDA Notice Letter was served,
`
`Defendants were aware of the statutory provisions and regulations referred to in paragraph 63,
`
`above.
`
`
`
`15
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 16 of 22 PageID: 16
`
`
`
`65.
`
`Defendants’ ANDA Notice Letter, which is required by statute and regulation to
`
`provide a full and detailed explanation regarding invalidity (see paragraph 63 above), does not
`
`allege and does not address invalidity of claims 2 and 4 of the ’070 patent.
`
`66.
`
`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.
`
`67.
`
`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.
`
`68.
`
`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.
`
`69.
`
`On information and belief, the manufacture, use and sale of Dr. Reddy’s
`
`Naproxen and Esomeprazole Magnesium Delayed Release Tablets infringe the ’070 patent
`
`claims.
`
`70.
`
`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 ’085 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`71.
`
`Plaintiffs incorporate by reference paragraphs 1-38 of this Complaint as if fully
`
`
`
`set forth herein.
`
`
`
`16
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 17 of 22 PageID: 17
`
`
`
`72.
`
`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 ’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.”
`
`73.
`
`On information and belief, at the time the ANDA Notice Letter was served,
`
`Defendants were aware of the statutory provisions and regulations referred to in paragraph 72,
`
`above.
`
`74.
`
`Defendants’ ANDA Notice Letter, which is required by statute and regulation to
`
`provide a full and detailed explanation regarding invalidity (see paragraph 72 above), does not
`
`allege invalidity of any claims of the ’085 patent.
`
`75.
`
`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
`
`
`
`17
`
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`Case 3:13-cv-00091-MLC-DEA Document 1 Filed 01/04/13 Page 18 of 22 PageID: 18
`
`
`
`