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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 1 of 13 PageID #: 1
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`NEUROCRINE BIOSCIENCES, INC.
`
`
`Plaintiff,
`
`
`
`v.
`
`
`TEVA PHARMACEUTICALS, INC., TEVA
`PHARMACEUTICALS DEVELOPMENT,
`INC., TEVA PHARMACEUTICALS USA,
`INC. and TEVA PHARMACEUTICAL
`INDUSTRIES LTD.
`
`Defendants.
`
`Civil Action No.
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants
`
`Teva Pharmaceuticals, Inc. (“Teva Pharmaceuticals”), Teva Pharmaceuticals Development, Inc.
`
`(“Teva Development”), Teva Pharmaceuticals USA, Inc. (“Teva USA”) and Teva Pharmaceutical
`
`Industries Ltd. (“Teva Industries”) (collectively “Teva” or “Defendants”), alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Patent No. 11,311,532 (“the
`
`’532 patent” or “the patent-in-suit”), arising under the United States patent laws, Title 35, United
`
`States Code, § 100 et. seq., including 35 U.S.C. §§ 271 and 281. This action relates to Teva’s
`
`filing of an Abbreviated New Drug Application (“ANDA”) No. 215984 under Section 505(j) of
`
`the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j), seeking U.S. Food and Drug
`
`Administration (“FDA”) approval to manufacture, use, import, offer to sell and/or sell Valbenazine
`
`Capsules, 40 mg and 80 mg (“Teva’s generic products”) before the expiration of the patent-in-suit.
`
`2.
`
`Neurocrine filed three separate actions involving the same ANDA No. 215984 in
`
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 2 of 13 PageID #: 2
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`this Court for patent infringement. The first suit alleged infringement of U.S. Patent Nos.
`
`10,065,952 (“the ’952 patent”), 10,844,058 (“the ’058 patent”), 10,851,103 (“the ’103 patent”),
`
`10,851,104 (“the ’104 patent”), 10,857,137 (“the ’137 patent”), 10,857,148 (“the ’148 patent”),
`
`
`
`10,874,648 (“the ’648 patent”), 10,906,902 (“the ’902 patent”), 10,906,903 (“the ’903 patent”),
`
`10,912,771 (“the ’771 patent”), 10,919,892 (“the ’892 patent”), 10,940,141 (“the ’141 patent”) and
`
`10,952,997 (“the ’997 patent”) (collectively, “First Suit Patents”) in Neurocrine Biosciences, Inc.
`
`v. Teva Pharmaceuticals, Inc. et al., No. 1:21-cv-01043-MN (D. Del. filed July 16, 2021) (“the
`
`First Suit”). The second suit alleged infringement of U.S. Patent No. 10,993,941 (“the ’941 patent”
`
`or “Second Suit Patent”) in Neurocrine Biosciences, Inc. v. Teva Pharmaceuticals, Inc. et al., No.
`
`1:21-cv-01148-MN (D. Del. filed August 6, 2021) (“the Second Suit”). The third suit alleged
`
`infringement of U.S. Patent Nos. 11,026,931 (“the ’931 patent”), 11,026,939 (“the ’939 patent”)
`
`and 11,040,029 (“the ’029 patent”) (collectively, “Third Suit Patents”) in Neurocrine Biosciences,
`
`Inc. v. Teva Pharmaceuticals, Inc. et al., No. 1:22-cv-00092-MN (D. Del. filed January 21, 2022)
`
`(“the Third Suit”).
`
`3.
`
`The First Suit was filed in response to a letter from Teva dated June 3, 2021
`
`(“Teva’s First Notice Letter”), purporting to include a “Notice of ANDA No. 215984 Valbenazine
`
`Capsules, 40 mg and 80 mg; With Paragraph IV Certification Concerning [the First Suit Patents].”
`
`The First Suit included counts of infringement of the First Suit Patents. Teva’s First Notice Letter
`
`defined Teva as Teva Development.
`
`4.
`
`The Second Suit was filed in response to a second letter from Teva dated June 24,
`
`2021 (“Teva’s Second Notice Letter”), purporting to include a “Notice of ANDA No. 215984
`
`Valbenazine Capsules, 40 mg and 80 mg; With Paragraph IV Certification Concerning [the Second
`
`Suit Patent].” The Second Suit included a count of infringement of the Second Suit Patent. Teva’s
`
`Second Notice Letter defined Teva as Teva Development.
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 3 of 13 PageID #: 3
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`5.
`
`The Third Suit was filed in response to a third letter from Teva dated December 9,
`
`2021 (“Teva’s Third Notice Letter”), purporting to include a “Notice of ANDA No. 215984
`
`Valbenazine Capsules, 40 mg and 80 mg; With Paragraph IV Certification Concerning [the Third
`
`Suit Patents].” The Third Suit included counts of infringement of the Third Suit Patents. Teva’s
`
`Third Notice Letter defined Teva as Teva Development.
`
`6.
`
`This complaint is filed in response to a new, fourth letter from Teva dated June 9,
`
`2022 (“Teva’s Fourth Notice Letter”), purporting to include a “Notice of ANDA No. 215984
`
`Valbenazine Capsules, 40 mg and 80 mg; With Paragraph IV Certification Concerning [the ’532
`
`patent]” pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R.
`
`§ 314.95. Teva’s Fourth Notice Letter stated that Teva had filed ANDA No. 215984, seeking
`
`approval to manufacture, use, import, offer to sell and/or sell Teva’s generic products before the
`
`expiration of the patent-in-suit. Teva’s Fourth Notice Letter defined Teva as Teva Development.
`
`
`
`THE PARTIES
`
`7.
`
`Neurocrine is a corporation organized and existing under the laws of Delaware with
`
`its corporate headquarters at 12780 El Camino Real, San Diego, CA 92130.
`
`8.
`
`Neurocrine is engaged in the business of researching, developing and bringing to
`
`market innovative pharmaceutical products for the treatment of neurological, endocrine and
`
`psychiatric disorders.
`
`9.
`
`Upon information and belief, Teva Development was incorporated in Delaware on
`
`October 23, 2020, under File Number 3960741.
`
`10.
`
`Upon information and belief, Teva Pharmaceuticals was incorporated in Delaware
`
`on October 23, 2020, under File Number 3960741.
`
`11.
`
`In its January 5, 2022 answers in the First Suit and Second Suit Teva stated that “Teva
`
`Development was incorporated on October 23, 2020 and became Teva [Pharmaceuticals,] Inc.
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 4 of 13 PageID #: 4
`
`
`through a name change on June 23, 2021.” Defendants Teva Pharmaceuticals, Inc., Teva
`
`Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc.’s Answer, Affirmative
`
`Defenses, and Counterclaims to Complaint at 4, Neurocrine Biosciences, Inc. v. Teva
`
`Pharmaceuticals, Inc. et al., No. 1:21-cv-01148-MN (D. Del. 2021), D.I. 13; Defendants Teva
`
`Pharmaceuticals, Inc., Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA,
`
`Inc.’s Answer, Affirmative Defenses, and Counterclaims to Complaint at 4, Neurocrine
`
`Biosciences, Inc. v. Teva Pharmaceuticals, Inc. et al., No. 1:21-cv-01043-MN (D. Del. 2021), D.I.
`
`12. In its May 31, 2022 answer in the Third Suit Teva stated that “Teva Development was
`
`incorporated in Delaware on October 23, 2020, under File Number 3960741. Teva further admits
`
`that Teva Development became Teva Pharmaceuticals[, Inc.] through a name change on June 23,
`
`2021.” Defendants Teva Pharmaceuticals, Inc., Teva Pharmaceuticals Development, Inc. and
`
`Teva Pharmaceuticals USA, Inc.’s Answer, Affirmative Defenses, and Counterclaims to
`
`Complaint at 5, Neurocrine Biosciences, Inc. v. Lupin Ltd. et al., No. 1:21-cv-01042-MN (D. Del.
`
`2022) (consolidated), D.I. 44. In Teva’s Fourth Notice Letter, however, Teva once again identifies
`
`Teva Development as the entity providing notice and further states that FDA has assigned “Teva’s
`
`ANDA,” where “Teva” is defined as “Teva Development,” to be ANDA No. 215984.
`
`12.
`
`Upon information and belief, Teva Pharmaceuticals is a corporation organized
`
`under the laws of Delaware and its principal place of business is located at 400 Interpace Parkway,
`
`Suite A1, Parsippany, NJ 07054.
`
`13.
`
`Upon information and belief, Teva Development is a corporation organized under
`
`the laws of Delaware and its principal place of business is located at 400 Interpace Parkway, Suite
`
`A1, Parsippany, NJ 07054.
`
`14.
`
`Upon information and belief, Teva USA is a corporation organized under the laws
`
`of Delaware and its principal place of business is located at 400 Interpace Parkway, Suite A1,
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 5 of 13 PageID #: 5
`
`
`Parsippany, NJ 07054.
`
`15.
`
`Upon information and belief, Teva Industries is a corporation organized under the
`
`laws of Israel and its principal place of business is located at 5 Basel Street, Petach Tikva, 49131,
`
`Israel.
`
`16.
`
`Upon information and belief, Teva Pharmaceuticals is a wholly-owned subsidiary
`
`of Teva Industries.
`
`17.
`
`Upon information and belief, Teva Development is a wholly-owned subsidiary of
`
`Teva Industries.
`
`18.
`
`Upon information and belief, Teva USA is a wholly-owned subsidiary of Teva
`
`Industries.
`
`19.
`
`Upon information and belief, Teva Pharmaceuticals, Teva Development and Teva
`
`USA are generic pharmaceutical companies that, in coordination with each other and Teva
`
`Industries or at the direction of Teva Industries, develop, manufacture, market and distribute
`
`generic pharmaceutical products for sale in the State of Delaware and throughout the United States.
`
`
`
`
`
`20.
`
`21.
`
`JURISDICTION AND VENUE
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`This Court has personal jurisdiction over Teva Pharmaceuticals. Upon information
`
`and belief, Teva Pharmaceuticals is in the business of manufacturing, marketing, importing and
`
`selling pharmaceutical drug products, including generic drug products. Upon information and
`
`belief, Teva Pharmaceuticals directly, or indirectly, develops, manufactures, markets and sells
`
`generic drugs throughout the United States and in this judicial district. Upon information and
`
`belief, Teva Pharmaceuticals purposefully has conducted and continues to conduct business in this
`
`judicial district, and this judicial district is a likely destination of Teva’s generic products.
`
`22.
`
`This Court has personal jurisdiction over Teva Development. Upon information
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`{01822782;v1 }
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 6 of 13 PageID #: 6
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`and belief, Teva Development is in the business of manufacturing, marketing, importing and
`
`selling pharmaceutical drug products, including generic drug products. Upon information and
`
`belief, Teva Development directly, or indirectly, develops, manufactures, markets and sells generic
`
`drugs throughout the United States and in this judicial district. Upon information and belief, Teva
`
`Development purposefully has conducted and continues to conduct business in this judicial district,
`
`and this judicial district is a likely destination of Teva’s generic products.
`
`23.
`
`This Court has personal jurisdiction over Teva USA. Upon information and belief,
`
`Teva USA is in the business of manufacturing, marketing, importing and selling pharmaceutical
`
`drug products, including generic drug products. Upon information and belief, Teva USA directly,
`
`or indirectly, develops, manufactures, markets and sells generic drugs throughout the United States
`
`and in this judicial district. Upon information and belief, Teva USA purposefully has conducted
`
`and continues to conduct business in this judicial district, and this judicial district is a likely
`
`destination of Teva’s generic products.
`
`24.
`
`Upon information and belief, Teva USA states that it “is the leading generic drug
`
`company in the United States.” https://www.tevausa.com/about-teva/ (accessed July 19, 2022).
`
`25.
`
`This Court has personal jurisdiction over Teva Industries. Upon information and
`
`belief, Teva Industries is in the business of manufacturing, marketing, importing and selling
`
`pharmaceutical drug products, including generic drug products. Upon information and belief, Teva
`
`Industries directly, or indirectly, develops, manufactures, markets and sells generic drugs
`
`throughout the United States and in this judicial district. Upon information and belief, Teva
`
`Industries purposefully has conducted and continues to conduct business in this judicial district,
`
`and this judicial district is a likely destination of Teva’s generic products.
`
`26.
`
`Upon information and belief, Teva Industries is the holder of FDA Drug Master
`
`File No. 35290 for valbenazine tosylate.
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 7 of 13 PageID #: 7
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`27.
`
`Upon information and belief, Teva Pharmaceuticals, Teva Development, Teva
`
`USA and Teva Industries hold themselves out as a unitary entity and operate as a single integrated
`
`business with respect to the regulatory approval, manufacturing, marketing, sale and distribution
`
`of generic pharmaceutical products throughout the United States, including in this judicial district.
`
`28.
`
`Upon information and belief, Teva admits that “1 of every 9 prescriptions in the
`
`US” is filled with a Teva product. https://www.tevapharm.com/teva-worldwide/ (accessed July
`
`19, 2022). Upon information and belief, Teva has at least 30 locations across the U.S. and its
`
`territories. https://businessfacilities.com/2018/07/teva-pharmaceuticals-moving-u-s-headquarters-
`
`parsippany-troy-hills-new-jersey/ (accessed July 19, 2022). Upon information and belief, Teva
`
`admits it has at least 100 pending first-to-file ANDAs in the U.S. and at least 270 product
`
`registrations pending FDA approval.
`
`https://www.tevapharm.com/globalassets/scs-files---
`
`global/teva-infographic-files/teva_infographic_english_may2020.pdf (accessed July 19, 2022).
`
`29.
`
`Upon information and belief, Teva is engaged in the submission and approval of
`
`ANDAs for the U.S. market, admitting Teva has “over 100 pending first-to-files in the U.S.” See,
`
`e.g., https://www.tevausa.com/news-and-media/press-releases/teva-wins-generic-uceris-patent-
`
`trial/ (accessed July 19, 2022).
`
`30.
`
`Teva’s ANDA filing regarding the patent-in-suit relates to this litigation and is
`
`substantially connected with this judicial district because it reliably and non-speculatively predicts
`
`Teva’s intent to market and sell Teva’s generic products in this judicial district.
`
`31.
`
`Teva has taken the significant step of applying to the FDA for approval to engage
`
`in future activities—including the marketing of its generic drugs—which, upon information and
`
`belief, will be purposefully directed at the District of Delaware and elsewhere throughout the
`
`United States. Upon information and belief, Teva intends to direct sales of its generic drugs in this
`
`judicial district, among other places, once Teva receives the requested FDA approval to market its
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`{01822782;v1 }
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 8 of 13 PageID #: 8
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`generic products. Upon information and belief, Teva will engage in marketing of its proposed
`
`generic products in Delaware upon approval of its ANDA.
`
`32.
`
`Upon information and belief, Teva Pharmaceuticals, Teva Development, Teva
`
`USA and Teva Industries have thus been, and continue to be, joint and prime actors in the drafting,
`
`submission, approval and maintenance of ANDA No. 215984.
`
`33.
`
`For these reasons and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Teva.
`
`34.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Teva Industries is incorporated in Israel and may be sued in any judicial district in the
`
`United States.
`
`35.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Teva Pharmaceuticals is incorporated in the state of Delaware.
`
`36.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Teva Development is incorporated in the state of Delaware.
`
`37.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Teva USA is incorporated in the state of Delaware.
`
`FACTUAL BACKGROUND
`
`The NDA
`
`38.
`
`Neurocrine is the holder of New Drug Application (“NDA”) No. 209241 for
`
`INGREZZA® (valbenazine) Capsules in 40, 60 and 80 mg dosage forms (“INGREZZA®
`
`Capsules”).
`
`39.
`
`40.
`
`The FDA approved NDA No. 209241 on April 11, 2017.
`
`INGREZZA® Capsules are prescription drugs approved for the treatment of tardive
`
`
`
`
`
`
`
`
`
`dyskinesia. Valbenazine, which is present as the tosylate salt, is the active ingredient in
`8
`{01822782;v1 }
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 9 of 13 PageID #: 9
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`INGREZZA® Capsules.
`
`41.
`
`Valbenazine Capsules are marketed in the United States under the trademark
`
`INGREZZA®.
`
`The Patent-in-Suit
`
`42. The United States Patent and Trademark Office (“the PTO”) issued the ’532 patent
`
`on April 26, 2022, titled “High Dosage Valbenazine Formulation and Compositions, Methods, and Kits
`
`Related Thereto.” A true and correct copy of the ’532 patent is attached as Exhibit A.
`
`43.
`
`Neurocrine owns the ’532 patent through assignment as recorded by the PTO at
`
`Reel 054171, Frame 0426.
`
`44.
`
`45.
`
`The ’532 patent currently expires on September 18, 2038.
`
`The ’532 patent is listed in Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (“the Orange Book”) in connection with NDA No. 209241 for INGREZZA® Capsules.
`
`The ANDA
`
`46.
`
`Upon information and belief, Teva submitted ANDA No. 215984 with the FDA
`
`under 21 U.S.C. § 355(j) seeking FDA approval to manufacture, use, import, offer to sell and/or
`
`sell in the United States Valbenazine Capsules, 40 mg and 80 mg (defined above as “Teva’s generic
`
`products”), which are generic versions of Neurocrine’s INGREZZA® Capsules.
`
`47.
`
`Teva’s Fourth Notice Letter states that ANDA No. 215984 contains certifications
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the patent-in-suit are
`
`invalid, unenforceable or will not be infringed by the manufacture, use, import, offer to sell and/or
`
`sale of Teva’s generic products.
`
`48.
`
`Plaintiff commenced this action within 45 days of receiving Teva’s Fourth
`
`Notice Letter.
`
`
`
`
`
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`{01822782;v1 }
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`49.
`
`50.
`
`COUNT I
`
`(INFRINGEMENT OF THE ’532 PATENT)
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`Upon information and belief, Teva filed ANDA No. 215984 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Teva’s generic products in the United States
`
`before the expiration of the ’532 patent.
`
`51.
`
`Teva’s Fourth Notice Letter states that Teva filed with the FDA, 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.
`
`52.
`
`Upon information and belief, in its ANDA No. 215984, Teva has represented to the
`
`FDA that Teva’s generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`53.
`
`Teva has actual knowledge of the ’532 patent, as evidenced by at least Teva’s Fourth
`
`Notice Letter.
`
`54.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Teva has infringed
`
`at least one claim of the ’532 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 215984, seeking approval to manufacture, use, import, offer to sell or sell Teva’s generic
`
`products before the expiration date of the ’532 patent.
`
`55.
`
`Upon information and belief, if ANDA No. 215984 is approved, Teva intends to
`
`and will manufacture, use, import, offer to sell and/or sell Teva’s generic products in the United
`
`States.
`
`56.
`
`Upon information and belief, if ANDA No. 215984 is approved, Teva 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 Teva’s generic products,
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`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. 215984 shall be no earlier than the expiration of the ’532 patent and any additional
`
`periods of exclusivity.
`
`57.
`
`Upon information and belief, Teva knows, should know and intends that physicians
`
`will prescribe and patients will take Teva’s generic products for which approval is sought in
`
`ANDA No. 215984, and therefore will infringe at least one claim of the ’532 patent.
`
`58.
`
`Upon information and belief, Teva has knowledge of the ’532 patent and, by its
`
`proposed package insert for Teva’s generic products, knows or should know that it will induce
`
`direct infringement of at least one claim of the ’532 patent, either literally or under the doctrine of
`
`equivalents.
`
`59.
`
`Upon information and belief, Teva is aware and/or has knowledge that its 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 Teva’s 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.
`
`60.
`
`Upon information and belief, Teva’s actions relating to Teva’s ANDA No. 215984
`
`complained of herein were done by and for the benefit of Teva.
`
`61.
`
`Plaintiff will be irreparably harmed by Teva’s infringing activities unless this Court
`
`enjoins those activities.
`
`62.
`
`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 Teva has infringed at
`
`
`
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 12 of 13 PageID #: 12
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`least one claim of the ’532 patent through Teva’s submission of ANDA No. 215984 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Teva’s generic products in
`
`the United States before the expiration of the ’532 patent;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Teva’s making,
`
`using, offering to sell, selling or importing of Teva’s generic products before the expiration of the
`
`’532 patent will infringe, actively induce infringement and/or contribute to the infringement of at
`
`least one claim of the ’532 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 Teva’s
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`generic products shall be no earlier than the expiration date of the ’532 patent and any additional
`
`periods of exclusivity, or any such later date as the Court may determine, in accordance with
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`35 U.S.C. § 271(e)(4)(A);
`
`D.
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`The entry of a preliminary and/or permanent injunction, enjoining Teva and all
`
`persons acting in concert with Teva from manufacturing, using, offering for sale or selling Teva’s
`
`generic products within the United States, or importing Teva’s generic products into the United
`
`States, until the expiration of the ’532 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`E.
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`The entry of a preliminary and/or permanent injunction, enjoining Teva and all
`
`persons acting in concert with Teva from seeking, obtaining or maintaining approval of the ANDA
`
`until the expiration of the ’532 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and 283;
`
`F.
`
`The issuance of a declaration that this is an exceptional case and an award to
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`Plaintiff of their costs, expenses and disbursements in this action, including reasonable attorney
`
`fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4);
`
`G.
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`An award to Plaintiff of any further appropriate relief under 35 U.S.C. § 271(e)(4);
`
`
`
`and
`
`
`{01822782;v1 }
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`12
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`Case 1:22-cv-00965-UNA Document 1 Filed 07/22/22 Page 13 of 13 PageID #: 13
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`
`H.
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`An award to Plaintiff of any further and additional relief that this Court deems just
`
`and proper.
`
`
`
`ASHBY & GEDDES
`
`/s/ Steven J. Balick
`
`
`
`Steven J. Balick (#2114)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`amayo@ashby-geddes.com
`Attorneys for Plaintiff Neurocrine
`Biosciences, Inc.
`
`
`
`
`
`
`
`
`
`Of Counsel:
`
`James B. Monroe
`Erin M. Sommers
`Lauren J. Dowty
`Jeanette M. Roorda
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4431
`(202) 408-4000
`
`Dated: July 22, 2022
`
`{01822782;v1 }
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`13
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