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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 1 of 22 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NEUROCRINE BIOSCIENCES, INC.
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`Civil Action No.
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`
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`Plaintiff,
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`v.
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`SANDOZ INTERNATIONAL GMBH,
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`SANDOZ INC., SANDOZ AG, CRYSTAL
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`PHARMACEUTICAL (SUZHOU) CO., LTD.
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`and CRYSTAL PHARMATECH CO., LTD.
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`
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`Defendants.
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`
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`COMPLAINT FOR PATENT
`INFRINGEMENT
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`Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants
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`Sandoz Inc., Sandoz AG and Sandoz International GmbH (“Sandoz Int’l”) (collectively,
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`“Sandoz”), and Crystal Pharmaceutical (Suzhou) Co., Ltd. (“Crystal Suzhou”) and Crystal
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`Pharmatech Co., Ltd. (“Crystal Pharmatech”) (collectively “Crystal”) (all of the foregoing
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`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 of U.S. Patent Nos. 8,039,627, (“the
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`’627 patent”), 8,357,697 (“the ’697 patent”) and 11,311,532 (“the ’532 patent”) (collectively,
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`“the patents-in-suit”), arising under the United States patent laws, Title 35, United States Code,
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`§ 100 et. seq., including 35 U.S.C. §§ 271 and 281. This action relates to Defendants’ filing of
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`{01832679;v1 }
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 2 of 22 PageID #: 2
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`an Abbreviated New Drug Application (“ANDA”) No. 215962 under Section 505(j) of the
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`Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j), seeking U.S. Food and Drug
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`Administration (“FDA”) approval to manufacture, use, import, offer to sell and/or sell
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`valbenazine tosylate capsules, equivalent to 40 mg and 80 mg of valbenazine base (“Defendants’
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`generic products”) before the expiration of the patents-in-suit.
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`2.
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`Neurocrine filed a separate action involving the same ANDA No. 215962 in this
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`Court for patent infringement of U.S. Patent Nos. 10,065,952 (“the ’952 patent”), 10,844,058
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`(“the ’058 patent”), 10,851,103 (“the ’103 patent”), 10,851,104 (“the ’104 patent”), 10,857,137
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`(“the ’137 patent”), 10,857,148 (“the ’148 patent”), 10,874,648 (“the ’648 patent”), 10,906,902
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`(“the ’902 patent”), 10,906,903 (“the ’903 patent”), 10,912,771 (“the ’771 patent”), 10,919,892
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`(“the ’892 patent”), 10,940,141 (“the ’141 patent”) and 10,952,997 (“the ’997 patent”)
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`(collectively, “First Suit Patents”) in Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical
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`(Suzhou) Co., Ltd. et al., No. 1:21-cv-01067-MN (D. Del. filed July 23, 2021) (“the First Suit”),
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`which on April 19, 2022 was consolidated in this Court in Neurocrine Biosciences, Inc. v. Lupin
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`Limited et al., No. 1:21-cv-01042-MN (consolidated).
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`3.
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`The First Suit was filed in response to two letters from Crystal dated June 9, 2021
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`(“the First Notice Letter”) and June 11, 2011 (“the Second Notice Letter”), which stated that
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`ANDA No. 215962 contains certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV),
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`alleging that the claims of the First Suit patents are invalid, unenforceable or will not be
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`infringed by the manufacture, use, sale, offer for sale and/or importation of Defendants’ generic
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`products. The First Suit included counts of infringement of the First Suit Patents.
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`4.
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`Neurocrine also filed a separate action involving the same ANDA No. 215962 in
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`this Court for patent infringement of U.S. Patent Nos. 10,993,941 (“the ’941 patent”),
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 3 of 22 PageID #: 3
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`11,026,931 (“the ’931 patent”), 11,026,939 (“the ’939 patent”) and 11,040,029 (“the ’029
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`patent”) (collectively, “Second Suit Patents”) in Neurocrine Biosciences, Inc. v. Crystal
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`Pharmaceutical (Suzhou) Co., Ltd. et al., No. 1:21-cv-01464-MN (D. Del. filed Oct. 18, 2021)
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`(“the Second Suit”), which on April 19, 2022 was consolidated in this Court in Neurocrine
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`Biosciences, Inc. v. Lupin Limited et al., No. 1:21-cv-01042-MN (consolidated).
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`5.
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`The Second Suit was filed in response to a third letter from Crystal dated
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`September 3, 2021 (“the Third Notice Letter”), which stated that ANDA No. 215962 contains
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`certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the
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`Second Suit Patents are invalid, unenforceable and/or will not be infringed by the manufacture,
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`use, import, offer to sell and/or sale of Defendants’ generic products. The Second Suit included
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`counts of infringement of the Second Suit Patents.
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`6.
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`This complaint is filed in response to a new, fourth letter regarding ANDA No.
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`215962 purportedly from Sandoz dated July 14, 2022 (“the Fourth Notice Letter”), purporting
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`to include a “Paragraph IV Patent Certification Notice U.S. Patent Nos. [patents-in-suit] Sandoz
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`Inc. ANDA 215962 Ingrezza® (Valbenazine) Capsules 40 mg and 80 mg” pursuant to §
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`505(j)(2)(B)(iv) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j)(2)(B)(iv) and
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`21 C.F.R. § 314.95. The Fourth Notice Letter states that ANDA No. 215962 contains
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`certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the
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`patents-in-suit are invalid, unenforceable and/or will not be infringed by the manufacture, use,
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`import, offer to sell and/or sale of Defendants’ generic products.
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`
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`THE PARTIES
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`7.
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`Neurocrine is a corporation organized and existing under the laws of Delaware
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`with its corporate headquarters at 12780 El Camino Real, San Diego, CA 92130.
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`{01832679;v1 }
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`8.
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`Neurocrine is engaged in the business of researching, developing and bringing to
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`market innovative pharmaceutical products for the treatment of neurological, endocrine and
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`psychiatric disorders.
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`9.
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`Upon information and belief, Sandoz Int’l is a corporation organized under the
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`laws of Germany and its principal place of business is located at Industriestrasse 25, 83607
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`Holzkirchen, Germany.
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`10.
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`Upon information and belief, Sandoz Inc. is a corporation organized under the
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`laws of Delaware (file number 7944830) and its principal place of business is located at 100
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`College Rd. West, Princeton, NJ 08540. Upon information and belief, Sandoz Inc. is a wholly-
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`owned subsidiary of Sandoz Int’l.
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`11.
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`Upon information and belief, Sandoz AG is a corporation organized under the laws
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`of Switzerland and its principal place of business is located at Lichtstr. 35, CH-4056 Basel,
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`Switzerland. Upon information and belief, Sandoz AG is a wholly-owned subsidiary of Sandoz Int’l.
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`12.
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`Upon information and belief, Sandoz Inc. and Sandoz AG are generic
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`pharmaceutical companies that, in coordination with each other and Sandoz Int’l or at the
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`direction of Sandoz Int’l, develop, manufacture, market and distribute generic pharmaceutical
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`products for sale in the State of Delaware and throughout the United States.
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`13.
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`Upon information and belief, Crystal Suzhou is a corporation organized under
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`the laws of China and its principal place of business is located at B4-301, Biobay, 218 Xinghu
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`Street, Suzhou Industrial Park, China, 215123.
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`14.
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`Upon information and belief, Crystal Pharmatech is a corporation organized
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`under the laws of China and its principal place of business is located at B4-101, Biobay 218
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`Xinghu Street, Suzhou Industrial Park, Suzhou, Jiangsu Province, China, 215123.
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`{01832679;v1 }
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`15.
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`Upon information and belief, Crystal Suzhou is a wholly-owned subsidiary of
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`Crystal Pharmatech.
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`16.
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`Upon information and belief, Crystal Suzhou and Crystal Pharmatech are generic
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`pharmaceutical companies that, in coordination with each other or at the direction of Crystal
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`Pharmatech, develop, manufacture, market and distribute generic pharmaceutical products for
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`sale in the State of Delaware and throughout the United States.
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`
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`
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`17.
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`18.
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`JURISDICTION AND VENUE
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`This Court has personal jurisdiction over Sandoz Int’l. Upon information and
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`belief, Sandoz Int’l is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
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`Sandoz Int’l directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Sandoz
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`Int’l purposefully has conducted and continues to conduct business in this judicial district, and this
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`judicial district is a likely destination of Defendants’ generic products.
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`19.
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`This Court has personal jurisdiction over Sandoz Inc. Upon information and
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`belief, Sandoz Inc. is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
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`Sandoz Inc. directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Sandoz
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`Inc. purposefully has conducted and continues to conduct business in this judicial district, and this
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`judicial district is a likely destination of Defendants’ generic products.
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`{01832679;v1 }
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`20.
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`This Court has personal jurisdiction over Sandoz AG. Upon information and
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`belief, Sandoz AG is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
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`Sandoz AG directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Sandoz
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`AG purposefully has conducted and continues to conduct business in this judicial district, and this
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`judicial district is a likely destination of Defendants’ generic products.
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`21.
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`Upon information and belief, “Sandoz has grown into a leading global generics
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`business with annual sales of approximately USD 10 billion.” https://www.sandoz.com/about-
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`us/who-we-are/sandoz-brand (Company website, accessed Aug. 24, 2022). Upon information
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`and belief, Sandoz Int’l admits that it is “honored to be named [McKesson’s] 2019 Specialty
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`Generic Partner of the Year! It’s a privilege to be recognized for our efforts to expand patient
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`access to high-quality medicines in the US.” https://twitter.com/Sandoz_Global/status/
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`1144606420282855425?s=20 (accessed Aug. 24, 2022).
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`22.
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`Upon information and belief, Sandoz’s products are available in the U.S. See
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`https://www.us.sandoz.com/patients-customers/products (accessed Aug. 24, 2022).
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`23.
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`Upon information and belief, Sandoz Int’l, Sandoz AG and Sandoz Inc. hold
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`themselves out as a unitary entity and operate as a single integrated business with respect to the
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`regulatory approval, manufacturing, marketing, sale and distribution of generic pharmaceutical
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`products throughout the United States, including in this judicial district.
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`24.
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`This Court has personal jurisdiction over Crystal Suzhou. Upon information and
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`belief, Crystal Suzhou is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
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`{01832679;v1 }
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`Crystal Suzhou directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Crystal
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`Suzhou purposefully has conducted and continues to conduct business in this judicial district,
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`and this judicial district is a likely destination of Defendants’ generic products.
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`25.
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`This Court has personal jurisdiction over Crystal Pharmatech. Upon information
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`and belief, Crystal Pharmatech is in the business of manufacturing, marketing, importing and
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`selling pharmaceutical drug products, including generic drug products. Upon information and
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`belief, Crystal Pharmatech directly, or indirectly, develops, manufactures, markets and sells
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`generic drugs throughout the United States and in this judicial district. Upon information and
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`belief, Crystal Pharmatech purposefully has conducted and continues to conduct business in this
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`judicial district, and this judicial district is a likely destination of Defendants’ generic products.
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`26.
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`Upon information and belief, Crystal filed ANDA No. 215962. See The First
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`Suit, D.I. 1 at 16 (D. Del. Dec. 10, 2021) (“Crystal admits that it submitted ANDA No. 215962
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`to the FDA . . . .”)
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`27.
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`Upon information and belief, Crystal Suzhou states that it “is aimed to become
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`the best first-to-file (FTF) generic and 505B2 drug product development company” and that it
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`partners “with leading API manufacturers and generic drug companies in the world.”
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`https://www.linkedin.com/company/crystal-pharmaceutical-suzhou-co-ltd/about/
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`(accessed
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`August 24, 2022).
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`28.
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`Upon information and belief, Crystal Suzhou is the holder of FDA Drug Master
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`File No. 35195 for valbenazine tosylate.
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`29.
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`Upon information and belief, Crystal Suzhou and Crystal Pharmatech hold
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`themselves out as a unitary entity and operate as a single integrated business, alone and along
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`{01832679;v1 }
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`with partners, with respect to the regulatory approval, manufacturing, marketing, sale and
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`distribution of generic pharmaceutical products throughout the United States, including in this
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`judicial district.
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`30.
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`Upon information and belief, Crystal admits that it has an established generic
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`presence in the United States, having “supported 8 FTF ANDAs containing Paragraph IV
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`certifications.”
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`https://www.linkedin.com/company/crystal-pharmaceutical-suzhou-co-
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`ltd/about/ (accessed August 24, 2022). Upon information and belief, Crystal has at least one
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`research
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`and
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`development
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`facility
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`in
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`the
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`United
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`States.
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`See
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`https://www.crystalpharmatech.com/news_view.aspx?ContentID=38&t=15&page=1 (accessed
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`August 24, 2022).
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`31.
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`The filing of ANDA No. 215962 regarding the patents-in-suit relates to this
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`litigation and is substantially connected with this judicial district because it reliably and non-
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`speculatively predicts Defendants’ intent to market and sell Defendants’ generic products in this
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`judicial district.
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`32.
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`Defendants have taken the significant step of applying to the FDA for approval
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`to engage in future activities—including the marketing of its generic drugs—which, upon
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`information and belief, will be purposefully directed at the District of Delaware and elsewhere
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`throughout the United States. Upon information and belief, Defendants intend to direct sales of
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`Defendants’ generic drugs in this judicial district, among other places, once Defendants receive
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`the requested FDA approval to market Defendants’ generic products. Upon information and
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`belief, Defendants will engage in marketing of Defendants’ generic products in Delaware upon
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`approval of ANDA No. 215962.
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`{01832679;v1 }
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`33.
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`Upon information and belief, Defendants have thus been, and continue to be, joint
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`and prime actors in the drafting, submission, approval and maintenance of ANDA No. 215962.
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`34.
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`For these reasons and for other reasons that will be presented to the Court
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`if jurisdiction is challenged, the Court has personal jurisdiction over Defendants.
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`35.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Sandoz Int’l is incorporated in Germany and may be sued in any judicial district in the
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`United States.
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`36.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Sandoz AG is incorporated in Switzerland and may be sued in any judicial district in
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`the United States.
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`37.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Sandoz Inc. is incorporated in the state of Delaware.
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`38.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Crystal Suzhou is incorporated in China and may be sued in any judicial district in the
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`United States.
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`39.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Crystal Pharmatech is incorporated in China and may be sued in any judicial district in
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`the United States.
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`FACTUAL BACKGROUND
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`The NDA
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`40.
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`Neurocrine is the holder of New Drug Application (“NDA”) No. 209241 for
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`INGREZZA® (valbenazine) Capsules in 40, 60 and 80 mg dosage forms (“INGREZZA®
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`Capsules”).
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`{01832679;v1 }
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`41. The FDA approved NDA No. 209241 on April 11, 2017.
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`42.
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`INGREZZA® Capsules are prescription drugs approved for the treatment of tardive
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`dyskinesia. Valbenazine, which is present as the tosylate salt, is the active ingredient in
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`INGREZZA® Capsules.
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`43. Valbenazine Capsules are marketed in the United States under the trademark
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`INGREZZA®.
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`
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`The Patents-in-Suit
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`44. The United States Patent and Trademark Office (“the PTO”) issued the ’627 patent
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`on October 18, 2011, titled “Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11B-hexahydro-
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`2h-pyrido[2,1-a]isoquinolin-2-ol Compounds and Methods Relating Thereto.” A true and
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`correct copy of the ’627 patent is attached as Exhibit A.
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`45. Neurocrine owns the ’627 patent through assignment as recorded by the PTO at
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`Reel 020113, Frame 0451.
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`46. Neurocrine filed a Submission Pursuant to 37 C.F.R. § 1.765 for Patent Term
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`Extension Application Under 35 U.S.C. § 156, and the PTO has issued a Certificate Extending
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`Patent Term Under 35 U.S.C. 156, which is attached as Exhibit B. In Exhibit B, the PTO
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`certified that the term of the ’627 patent is extended by 552 days. Accordingly, the ’627 patent
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`will expire on April 11, 2031.
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`47. The ’627 patent is listed in Approved Drug Products with Therapeutic Equivalence
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`Evaluations (“the Orange Book”) in connection with NDA No. 209241 for INGREZZA®
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`Capsules.
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`48. The PTO issued the ’697 patent on January 22, 2013, titled “Substituted 3-
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`isobutyl-9,10-dimethoxy-1,3,4,6,7,11B-hexahydro-2h-pyrido[2,1-a]isoquinolin-2-ol
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`{01832679;v1 }
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`Compounds and Methods Relating Thereto.” A true and correct copy of the ’697 patent is
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`attached as Exhibit C.
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`49. Neurocrine owns the ’697 patent through assignment as recorded by the PTO at
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`Reel 048124, Frame 0753.
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`50. The ’697 patent currently expires on November 8, 2027.
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`51. The ’697 patent is listed in the Orange Book in connection with NDA No. 209241
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`for INGREZZA® Capsules.
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`52. The PTO issued the ’532 patent on April 26, 2022, titled “High Dosage
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`Valbenazine Formulation and Compositions, Methods, and Kits Related Thereto.” A true and
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`correct copy of the ’532 patent is attached as Exhibit D.
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`53. Neurocrine owns the ’532 patent through assignment as recorded by the PTO at
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`Reel 054171, Frame 0426.
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`54. The ’532 patent currently expires on September 18, 2038.
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`55. The ’532 patent is listed in the Orange Book in connection with NDA No. 209241
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`
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`for INGREZZA® Capsules.
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`The ANDA
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`56. Upon information and belief, Defendants submitted ANDA No. 215962 with the
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`FDA under 21 U.S.C. § 355(j) seeking FDA approval to manufacture, use, import, offer to sell
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`and/or sell in the United States Valbenazine Capsules, 40 mg and 80 mg (defined above as
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`“Defendants’ generic products”), which are generic versions of Neurocrine’s INGREZZA®
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`Capsules.
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`57. The Fourth Notice Letter states that ANDA No. 215962 contains certifications
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the patent-in-suit are
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`invalid, unenforceable and/or will not be infringed by the manufacture, use, import, offer to sell
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`and/or sale of Defendants’ generic products.
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`58. Plaintiff commenced this action within 45 days of receiving the Fourth Notice
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`Letter.
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`COUNT I
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`(INFRINGEMENT OF THE ’627 PATENT)
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`59. Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
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`60. Upon information and belief, Defendants filed ANDA No. 215962 seeking
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`approval to manufacture, use, import, offer to sell and/or sell Defendants’ generic products in
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`the United States before the expiration of the ’627 patent.
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`61. The Fourth Notice Letter states that Defendants’ ANDA No. 215962 was
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`amended to include, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. §
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`314.94(a)(12)(i)(A)(4), a certification alleging that the claims of the ’627 patent are invalid,
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`unenforceable and/or will not be infringed.
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`62. Upon information and belief, Defendants admit infringement of at least one claim
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`of the ’627 patent because the Fourth Notice Letter did not provide any non-infringement
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`allegation with respect to at least one claim of the ’627 patent.
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`63. Upon information and belief, in Defendants’ ANDA No. 215962, Defendants have
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`represented to the FDA that Defendants’ generic products are pharmaceutically and
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`therapeutically equivalent to Neurocrine’s INGREZZA® Capsules.
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`64. Defendants have actual knowledge of the ’627 patent, as evidenced at least by the
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`Fourth Notice Letter.
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`{01832679;v1 }
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`65. Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Defendants have
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`infringed at least one claim of the ’627 patent by submitting, or causing to be submitted, to the
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`FDA ANDA No. 215962, seeking approval to manufacture, use, import, offer to sell or sell
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`Defendants’ generic products before the expiration date of the ’627 patent.
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`66. Upon information and belief, if ANDA No. 215962 is approved, Defendants
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`intend to and will manufacture, use, import, offer to sell and/or sell Defendants’ generic products
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`in the United States.
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`67. Upon information and belief, if ANDA No. 215962 is approved, Defendants will
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`infringe one or more claims of the ’627 patent under § 271(a), either literally or under the
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`doctrine of equivalents, by making, using, offering to sell, selling and/or importing Defendants’
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`generic products, and/or by actively inducing infringement by others under § 271(b) and/or
`
`contributing to infringement under § 271(c), unless this Court orders that the effective date of
`
`any FDA approval of ANDA No. 215962 shall be no earlier than the expiration of the ’627
`
`patent.
`
`68. Upon information and belief, Defendants’ actions relating to Defendants’ ANDA
`
`No. 215962 complained of herein were done by and for the benefit of Defendants.
`
`69. Plaintiff will be irreparably harmed by Defendants’ infringing activities unless this
`
`Court enjoins those activities.
`
`70. Plaintiff does not have an adequate remedy at law.
`
`COUNT II
`
`(INFRINGEMENT OF THE ’697 PATENT)
`
`71. Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`
`
`{01832679;v1 }
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`72. Upon information and belief, Defendants filed ANDA No. 215962 seeking
`
`approval to manufacture, use, import, offer to sell and/or sell Defendants’ generic products in
`
`the United States before the expiration of the ’697 patent.
`
`73. The Fourth Notice Letter states that Defendants’ ANDA No. 215962 was amended
`
`with the FDA to include, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. §
`
`314.94(a)(12)(i)(A)(4), a certification alleging that the claims of the ’697 patent are invalid,
`
`unenforceable and/or will not be infringed.
`
`74. Upon information and belief, Defendants admit infringement of at least one claim
`
`of the ’697 patent because the Fourth Notice Letter did not provide any non-infringement
`
`allegation with respect to at least one claim of the ’697 patent.
`
`75. Upon information and belief, in Defendants’ ANDA No. 215962, Defendants have
`
`represented to the FDA that Defendants’ generic products are pharmaceutically and
`
`therapeutically equivalent to Neurocrine’s INGREZZA® Capsules.
`
`76. Defendants have actual knowledge of the ’697 patent, as evidenced by at least The
`
`Fourth Notice Letter.
`
`77. Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Defendants have
`
`infringed at least one claim of the ’697 patent by submitting, or causing to be submitted, to the
`
`FDA ANDA No. 215962, seeking approval to manufacture, use, import, offer to sell or sell
`
`Defendants’ generic products before the expiration date of the ’697 patent.
`
`78. Upon information and belief, if ANDA No. 215962 is approved, Defendants
`
`intend to and will manufacture, use, import, offer to sell and/or sell Defendants’ generic products
`
`in the United States.
`
`{01832679;v1 }
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 15 of 22 PageID #: 15
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`79. Upon information and belief, if ANDA No. 215962 is approved, Defendants will
`
`infringe one or more claims of the ’697 patent under § 271(a), either literally or under the
`
`doctrine of equivalents, by making, using, offering to sell, selling and/or importing Defendants’
`
`generic products, and/or by actively inducing infringement by others under § 271(b) and/or
`
`contributing to infringement under § 271(c), unless this Court orders that the effective date of
`
`any FDA approval of ANDA No. 215962 shall be no earlier than the expiration of the ’697
`
`patent.
`
`80. Upon information and belief, Defendants know, should know and intend that
`
`physicians will prescribe and patients will take Defendants’ generic products for which approval
`
`is sought in ANDA No. 215962, and therefore will infringe at least one claim of the ’697 patent.
`
`81. Upon information and belief, Defendants have knowledge of the ’697 patent and,
`
`by their proposed package insert for Defendants’ generic products, know or should know that
`
`Defendants will induce direct infringement of at least one claim of the ’697 patent, either
`
`literally or under the doctrine of equivalents.
`
`82. Upon information and belief, Defendants are aware and/or have knowledge that
`
`their proposed package insert will recommend, suggest, encourage and/or instruct others how to
`
`engage in an infringing use because healthcare professionals and/or patients will use
`
`Defendants’ generic products according to the instructions in the proposed package insert in a
`
`way that directly infringes at least one claim of the ’697 patent.
`
`83. Upon information and belief, Defendants’ actions relating to Defendants’ ANDA
`
`No. 215962 complained of herein were done by and for the benefit of Defendants.
`
`84. Plaintiff will be irreparably harmed by Defendants’ infringing activities unless this
`
`Court enjoins those activities.
`
`{01832679;v1 }
`
`
`15
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 16 of 22 PageID #: 16
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`
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`
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`85. Plaintiff does not have an adequate remedy at law.
`
`COUNT III
`
`(INFRINGEMENT OF THE ’532 PATENT)
`
`86. Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`87. Upon information and belief, Defendants filed ANDA No. 215962 seeking
`
`approval to manufacture, use, import, offer to sell and/or sell Defendants’ generic products in
`
`the United States before the expiration of the ’532 patent.
`
`88. The Fourth Notice Letter states that Defendants’ ANDA No. 215962 was
`
`amended with the FDA to include, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R.
`
`§ 314.94(a)(12)(i)(A)(4), a certification alleging that the claims of the ’532 patent are invalid,
`
`unenforceable and/or will not be infringed.
`
`89. Upon information and belief, in its ANDA No. 215962, Defendants have
`
`represented to the FDA that Defendants’ generic products are pharmaceutically and
`
`therapeutically equivalent to Neurocrine’s INGREZZA® Capsules.
`
`90. Defendants have actual knowledge of the ’532 patent, as evidenced by at least The
`
`Fourth Notice Letter.
`
`91. Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Defendants have
`
`infringed at least one claim of the ’532 patent by submitting, or causing to be submitted, to the
`
`FDA ANDA No. 215962, seeking approval to manufacture, use, import, offer to sell or sell
`
`Defendants’ generic products before the expiration date of the ’532 patent.
`
`92. Upon information and belief, if ANDA No. 215962 is approved, Defendants
`
`intend to and will manufacture, use, import, offer to sell and/or sell Defendants’ generic products
`
`in the United States.
`
`{01832679;v1 }
`
`
`16
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 17 of 22 PageID #: 17
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`
`93. Upon information and belief, if ANDA No. 215962 is approved, Defendants will
`
`infringe one or more claims of the ’532 patent under § 271(a), either literally or under the
`
`doctrine of equivalents, by making, using, offering to sell, selling and/or importing Defendants’
`
`generic products, and/or by actively inducing infringement by others under § 271(b) and/or
`
`contributing to infringement under § 271(c), unless this Court orders that the effective date of
`
`any FDA approval of ANDA No. 215962 shall be no earlier than the expiration of the ’532
`
`patent and any additional periods of exclusivity.
`
`94. Upon information and belief, Defendants know, should know and intend that
`
`physicians will prescribe and patients will take Defendants’ generic products for which approval
`
`is sought in ANDA No. 215962, and therefore will infringe at least one claim of the ’532 patent.
`
`95. Upon information and belief, Defendants have knowledge of the ’532 patent and,
`
`by their proposed package insert for Defendants’ generic products, know or should know that
`
`Defendants will induce direct infringement of at least one claim of the ’532 patent, either
`
`literally or under the doctrine of equivalents.
`
`96. Upon information and belief, Defendants are aware and/or have knowledge that
`
`their proposed package insert will recommend, suggest, encourage and/or instruct others how to
`
`engage in an infringing use because healthcare professionals and/or patients will use
`
`Defendants’ generic products according to the instructions in the proposed package insert in a
`
`way that directly infringes at least one claim of the ’532 patent.
`
`97. Upon information and belief, Defendants’ actions relating to Defendants’ ANDA
`
`No. 215962 complained of herein were done by and for the benefit of Defendants.
`
`98. Plaintiff will be irreparably harmed by Defendants’ infringing activities unless this
`
`Court enjoins those activities.
`
`{01832679;v1 }
`
`
`17
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`Case 1:22-cv-01124-UNA Document 1 Filed 08/26/22 Page 18 of 22 PageID #: 18
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`
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`99. Plaintiff does not have an adequate remedy at law.
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Plaintiff respectfully requests the following relief:
`
`A.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Defendants have
`
`infringed at least one claim of the ’627 patent through Defendants’ submission of ANDA No.
`
`215962 to the FDA seeking approval to manufacture, use, import, offer to sell and/or sell
`
`Defendants’ generic products in the United States before the expiration of the ’627 patent;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Defendants’
`
`making, using, offering to sell, selling or importing of Defendants’ generic products before the
`
`expiration of the ’627 patent will infringe, actively induce infringement and/or contribute to the
`
`infringement of at least one claim of the ’627 patent under 35 U.S.C. § 271(a), (b) and/or (c);
`
`C.
`
`The issuance of an order that the effective date of any FDA approval of
`
`Defendants’ generic products shall be no earlier than the expiration date of the ’627 patent and
`
`any additional periods of exclusivity, or any such later date as the Court may determine, in
`
`accordance with 35 U.S.C. § 271(e)(4)(A);
`
`D.
`
`T