Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 1 of 21 PageID: 1
`
`
`
`Guillermo C. Artiles
`Matthew A. Sklar
`Omar A. Bareentto
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`Tel: (973) 622-4444
`Fax: 973.624.7070
`gartiles@mccarter.com
`msklar@mccarter.com
`obareentto@mccarter.com
`
`Attorneys for Plaintiff
`Neurocrine Biosciences, Inc.
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`NEUROCRINE BIOSCIENCES, INC.
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`ZYDUS PHARMACEUTICALS (USA) INC.,
`ZYDUS WORLDWIDE DMCC, ZYDUS
`HEALTHCARE (USA) LLC and CADILA
`HEALTHCARE LIMITED
`
`
` Defendants.
`
`
`Civil Action No. ________
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants
`
`Zydus Pharmaceuticals (USA) Inc. (“Zydus Pharmaceuticals”), Zydus Worldwide DMCC
`
`(“Zydus Worldwide”), Zydus Healthcare (USA) LLC (“Zydus Healthcare”) and Cadila Healthcare
`
`Limited d/b/a Zydus Cadila (“Zydus Cadila”) (collectively “Zydus” or “Defendants”), alleges as
`
`follows:
`
`1
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 2 of 21 PageID: 2
`
`
`
`
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Patent Nos. 10,993,941 (“the
`
`’941 patent”), 11,026,931 (“the ’931 patent”), 11,026,939 (“the ’939 patent”) and 11,040,029 (“the
`
`’029 patent”) (collectively “the patents-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
`
`Zydus’ filing of an Abbreviated New Drug Application (“ANDA”) No. 216137 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 (“Zydus’ generic products”) before the expiration of the
`
`patents-in-suit.
`
`2.
`
`Neurocrine filed separate actions involving the same ANDA No. 216137 in this
`
`Court and the District of Delaware for patent 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. Zydus
`
`Pharmaceuticals (USA) Inc. et al, No. 2:21-cv-14447-KM-JSA (D.N.J. filed July 30, 2021) and
`
`Neurocrine Biosciences, Inc. v. Zydus Pharmaceuticals (USA) Inc. et al, C.A. No. 1:21-cv-01118-
`
`MN (D. Del. filed July 30, 2021) (collectively “the First Suits”).
`
`3.
`
`The First Suits were filed in response to a letter from Zydus dated June 15, 2021
`
`(“Zydus’ First Notice Letter”), purporting to include an exhibit titled “Zydus’s Detailed Factual
`
`and Legal Bases in Support of its Paragraph IV Certification for Valbenazine Capsules, 40 mg and
`
`80 mg.” Zydus’ First Notice Letter stated that Zydus had filed ANDA No. 216137, seeking
`
`2
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 3 of 21 PageID: 3
`
`
`
`
`
`approval to manufacture, use, import, offer to sell and/or sell Zydus’ generic products before the
`
`expiration of the First Suit Patents. The First Suits included counts of infringement of the First
`
`Suit Patents.
`
`4.
`
`This complaint is filed in response to a new, second letter from Zydus dated
`
`September 16, 2021 (“Zydus’ Second Notice Letter”), purporting to include an exhibit titled
`
`“Zydus’s Detailed Factual and Legal Bases in Support of its Paragraph IV Certification for
`
`Valbenazine Capsules, 40 mg and 80 mg.” Zydus’ Second Notice Letter stated that Zydus had
`
`filed ANDA No. 216137, seeking approval to manufacture, use, import, offer to sell and/or sell
`
`Zydus’ generic products before the expiration of the patents-in-suit.
`
`THE PARTIES
`
`5.
`
`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.
`
`6.
`
`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.
`
`7.
`
`Upon information and belief, Zydus Pharmaceuticals is a corporation organized
`
`under the laws of New Jersey and its principal place of business is located at 73 Route 31 N.,
`
`Pennington, New Jersey 08534.
`
`8.
`
`Upon information and belief, Zydus Worldwide is a corporation organized under
`
`the laws of the United Arab Emirates and its principal place of business is located at Armada
`
`Tower 2, P2, Cluster P, 9 Floor, Office 908, Al Thanyah 5, Hadaeq Mohammed Bin Rashid, Dubai,
`
`United Arab Emirates.
`
`3
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 4 of 21 PageID: 4
`
`
`
`
`
`9.
`
`Upon information and belief, Zydus Healthcare is a company organized under the
`
`laws of the state of Delaware and its principal place of business is located at 73 Route 31 N.,
`
`Pennington, NJ, 08534-3601.
`
`10.
`
`Upon information and belief, Zydus Cadila is a corporation organized under the
`
`laws of the Republic of India and its principal place of business is located at Zydus Corporate Park,
`
`Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway,
`
`Ahmedabad, Gandhinagar GJ 382481 IN.
`
`11.
`
`Upon information and belief, Zydus Pharmaceuticals is a subsidiary of Zydus
`
`Cadila.
`
`12.
`
`13.
`
`14.
`
`15.
`
`Upon information and belief, Zydus Worldwide is a subsidiary of Zydus Cadila.
`
`Upon information and belief, Zydus Healthcare is a subsidiary of Zydus Cadila.
`
`JURISDICTION AND VENUE
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`Plaintiff believes this case belongs in Delaware but is concurrently filing a case in
`
`this district out of an abundance of caution.
`
`16.
`
`This Court has personal jurisdiction over Zydus Pharmaceuticals because, upon
`
`information and belief, Zydus Pharmaceuticals directly, or indirectly, develops, manufactures,
`
`markets and sells generic drugs throughout the United States and in this judicial district.
`
`17.
`
`This Court has personal jurisdiction over Zydus Worldwide because, upon
`
`information and belief, Zydus Worldwide directly, or indirectly, develops, manufactures, markets
`
`and sells generic drugs throughout the United States and in this judicial district.
`
`18.
`
`Upon information and belief, Zydus Worldwide is the holder of ANDA No.
`
`216137.
`
`4
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 5 of 21 PageID: 5
`
`
`
`
`
`19.
`
`This Court has personal jurisdiction over Zydus Healthcare because, upon
`
`information and belief, Zydus Healthcare directly, or indirectly, develops, manufactures, markets
`
`and sells generic drugs throughout the United States and in this judicial district.
`
`20.
`
`This Court has personal jurisdiction over Zydus Cadila because, upon information
`
`and belief, Zydus Cadila directly, or indirectly, develops, manufactures, markets and sells generic
`
`drugs throughout the United States and in this judicial district.
`
`21.
`
`Upon information and belief, Zydus Pharmaceuticals, Zydus Worldwide, Zydus
`
`Healthcare and Zydus Cadila 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.
`
`22.
`
`Upon information and belief, Zydus Pharmaceuticals, Zydus Worldwide, Zydus
`
`Healthcare and Zydus Cadila have thus been, and continue to be, joint and prime actors in the
`
`drafting, submission, approval and maintenance of ANDA No. 216137.
`
`23.
`
`For these reasons and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Zydus.
`
`24.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Zydus Worldwide is incorporated in the United Arab Emirates and may be sued in any
`
`judicial district in the United States.
`
`25.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Zydus Pharmaceuticals is incorporated in the state of New Jersey.
`
`5
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 6 of 21 PageID: 6
`
`
`
`
`
`26.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because, upon information and belief, Zydus Healthcare’s principal place of business is located in
`
`New Jersey.
`
`27.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Zydus Cadila is incorporated in the Republic of India and may be sued in any judicial
`
`district in the United States.
`
`FACTUAL BACKGROUND
`
`The NDA
`
`28.
`
`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”).
`
`29.
`
`The FDA approved NDA No. 209241 on April 11, 2017.
`
`30.
`
`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
`
`INGREZZA® Capsules.
`
`31.
`
`Valbenazine Capsules are marketed in the United States under the trademark
`
`INGREZZA®.
`
`The Patents-in-Suit
`
`32.
`
`The United States Patent and Trademark Office (“the PTO”) issued the ’941 patent
`
`on May 4, 2021, titled “Methods for the Administration of Certain VMAT2 Inhibitors.” A true
`
`and correct copy of the ’941 patent is attached as Exhibit A.
`
`33.
`
`Neurocrine owns the ’941 patent through assignment as recorded by the PTO at
`
`Reel 053415, Frame 0390.
`
`6
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 7 of 21 PageID: 7
`
`
`
`34.
`
`35.
`
`The ’941 patent currently expires on October 10, 2037.
`
`The ’941 patent is listed in Approved Drug Products With Therapeutic Equivalence
`
`
`
`Evaluations (“the Orange Book”) in connection with NDA No. 209241 for INGREZZA® Capsules.
`
`36.
`
`The PTO issued the ’931 patent on June 8, 2021, titled “Methods for the
`
`Administration of Certain VMAT2 Inhibitors.” A true and correct copy of the ’931 patent is
`
`attached as Exhibit B.
`
`37.
`
`Neurocrine owns the ’931 patent through assignment as recorded by the PTO at
`
`Reel 055564, Frame 0388.
`
`38.
`
`39.
`
`The ’931 patent currently expires on August 14, 2039.
`
`The ’931 patent is listed in the Orange Book in connection with NDA No. 209241
`
`for INGREZZA® Capsules.
`
`40.
`
`The PTO issued the ’939 patent on June 8, 2021, titled “High Dosage Valbenazine
`
`Formulation and Compositions, Methods, and Kits Related Thereto.” A true and correct copy of
`
`the ’939 patent is attached as Exhibit C.
`
`41.
`
`Neurocrine owns the ’939 patent through assignment as recorded by the PTO at
`
`Reel 054171, Frame 0426.
`
`42.
`
`43.
`
`The ’939 patent currently expires on September 18, 2038.
`
`The ’939 patent is listed in the Orange Book in connection with NDA No. 209241
`
`for INGREZZA® Capsules.
`
`44.
`
`The PTO issued the ’029 patent on June 22, 2021, titled “Methods for the
`
`Administration of Certain VMAT2 Inhibitors.” A true and correct copy of the ’029 patent is
`
`attached as Exhibit D.
`
`7
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 8 of 21 PageID: 8
`
`
`
`
`
`45.
`
`Neurocrine owns the ’029 patent through assignment as recorded by the PTO at
`
`Reel 052974, Frame 0736.
`
`46.
`
`47.
`
`The ’029 patent currently expires on October 10, 2037.
`
`The ’029 patent is listed in the Orange Book in connection with NDA No. 209241
`
`for INGREZZA® Capsules.
`
`The ANDA
`
`48.
`
`Upon information and belief, Zydus submitted ANDA No. 216137 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 “Zydus’
`
`generic products”), which are generic versions of Neurocrine’s INGREZZA® Capsules.
`
`49.
`
`Zydus’ Second Notice Letter states that ANDA No. 216137 contains certifications
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the patents-in-suit are
`
`invalid, unenforceable and/or will not be infringed by the manufacture, use, import, offer to sell
`
`and/or sale of Zydus’ generic products.
`
`50.
`
`Plaintiff commenced this action within 45 days of receiving Zydus’ Second Notice
`
`Letter.
`
`51.
`
`52.
`
`COUNT I
`
`(INFRINGEMENT OF THE ’941 PATENT)
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`Upon information and belief, Zydus filed ANDA No. 216137 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United States
`
`before the expiration of the ’941 patent.
`
`8
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 9 of 21 PageID: 9
`
`
`
`
`
`53.
`
`Zydus’ Second Notice Letter states that Zydus 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 ’941 patent are invalid, unenforceable and/or will not be infringed.
`
`54.
`
`Upon information and belief, Zydus admits infringement of at least one claim of
`
`the ’941 patent because Zydus’ Second Notice Letter did not provide any non-infringement
`
`allegation with respect to at least one claim of the ’941 patent.
`
`55.
`
`Upon information and belief, in its ANDA No. 216137, Zydus has represented to
`
`the FDA that Zydus’ generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`56.
`
`Zydus has actual knowledge of the ’941 patent, as evidenced by Zydus’ Second
`
`Notice Letter.
`
`57.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed
`
`at least one claim of the ’941 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216137, seeking approval to manufacture, use, import, offer to sell or sell Zydus’ generic
`
`products before the expiration date of the ’941 patent.
`
`58.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus intends to
`
`and will manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United
`
`States.
`
`59.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus will infringe
`
`one or more claims of the ’941 patent under § 271(a), either literally or under the doctrine of
`
`equivalents, by making, using, offering to sell, selling and/or importing Zydus’ 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
`
`9
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 10 of 21 PageID: 10
`
`
`
`
`
`of ANDA No. 216137 shall be no earlier than the expiration of the ’941 patent and any additional
`
`periods of exclusivity.
`
`60.
`
`Upon information and belief, Zydus knows, should know and intends that
`
`physicians will prescribe and patients will take Zydus’ generic products for which approval is
`
`sought in ANDA No. 216137, and therefore will infringe at least one claim of the ’941 patent.
`
`61.
`
`Upon information and belief, Zydus has knowledge of the ’941 patent and, by its
`
`proposed package insert for Zydus’ generic products, knows or should know that it will induce
`
`direct infringement of at least one claim of the ’941 patent, either literally or under the doctrine of
`
`equivalents.
`
`62.
`
`Upon information and belief, Zydus 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 Zydus’ generic
`
`products according to the instructions in the proposed package insert in a way that directly
`
`infringes at least one claim of the ’941 patent.
`
`63.
`
`Upon information and belief, Zydus’ actions relating to Zydus’ ANDA No. 216137
`
`complained of herein were done by and for the benefit of Zydus.
`
`64.
`
`Plaintiff will be irreparably harmed by Zydus’ infringing activities unless this Court
`
`enjoins those activities.
`
`65.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT II
`
`(INFRINGEMENT OF THE ’931 PATENT)
`
`66.
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`10
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 11 of 21 PageID: 11
`
`
`
`
`
`67.
`
`Upon information and belief, Zydus filed ANDA No. 216137 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United States
`
`before the expiration of the ’931 patent.
`
`68.
`
`Zydus’ Second Notice Letter states that Zydus 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 ’931 patent are invalid, unenforceable and/or will not be infringed.
`
`69.
`
`Upon information and belief, in its ANDA No. 216137, Zydus has represented to
`
`the FDA that Zydus’ generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`70.
`
`Zydus has actual knowledge of the ’931 patent, as evidenced by Zydus’ Second
`
`Notice Letter.
`
`71.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed
`
`at least one claim of the ’931 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216137, seeking approval to manufacture, use, import, offer to sell or sell Zydus’ generic
`
`products before the expiration date of the ’931 patent.
`
`72.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus intends to
`
`and will manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United
`
`States.
`
`73.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus will infringe
`
`one or more claims of the ’931 patent under § 271(a), either literally or under the doctrine of
`
`equivalents, by making, using, offering to sell, selling and/or importing Zydus’ 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
`
`11
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 12 of 21 PageID: 12
`
`
`
`
`
`of ANDA No. 216137 shall be no earlier than the expiration of the ’931 patent and any additional
`
`periods of exclusivity.
`
`74.
`
`Upon information and belief, Zydus knows, should know and intends that
`
`physicians will prescribe and patients will take Zydus’ generic products for which approval is
`
`sought in ANDA No. 216137, and therefore will infringe at least one claim of the ’931 patent.
`
`75.
`
`Upon information and belief, Zydus has knowledge of the ’931 patent and, by its
`
`proposed package insert for Zydus’ generic products, knows or should know that it will induce
`
`direct infringement of at least one claim of the ’931 patent, either literally or under the doctrine of
`
`equivalents.
`
`76.
`
`Upon information and belief, Zydus 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 Zydus’ generic
`
`products according to the instructions in the proposed package insert in a way that directly
`
`infringes at least one claim of the ’931 patent.
`
`77.
`
`Upon information and belief, Zydus’ actions relating to Zydus’ ANDA No. 216137
`
`complained of herein were done by and for the benefit of Zydus.
`
`78.
`
`Plaintiff will be irreparably harmed by Zydus’ infringing activities unless this Court
`
`enjoins those activities.
`
`79.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT III
`
`(INFRINGEMENT OF THE ’939 PATENT)
`
`80.
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`12
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 13 of 21 PageID: 13
`
`
`
`
`
`81.
`
`Upon information and belief, Zydus filed ANDA No. 216137 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United States
`
`before the expiration of the ’939 patent.
`
`82.
`
`Zydus’ Second Notice Letter states that Zydus 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 ’939 patent are invalid, unenforceable and/or will not be infringed.
`
`83.
`
`Upon information and belief, in its ANDA No. 216137, Zydus has represented to
`
`the FDA that Zydus’ generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`84.
`
`Zydus has actual knowledge of the ’939 patent, as evidenced by Zydus’ Second
`
`Notice Letter.
`
`85.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed
`
`at least one claim of the ’939 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216137, seeking approval to manufacture, use, import, offer to sell or sell Zydus’ generic
`
`products before the expiration date of the ’939 patent.
`
`86.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus intends to
`
`and will manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United
`
`States.
`
`87.
`
`Upon information and belief, if ANDA No. 216137 is approved, Zydus will infringe
`
`one or more claims of the ’939 patent under § 271(a), either literally or under the doctrine of
`
`equivalents, by making, using, offering to sell, selling and/or importing Zydus’ 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
`
`13
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 14 of 21 PageID: 14
`
`
`
`
`
`of ANDA No. 216137 shall be no earlier than the expiration of the ’939 patent and any additional
`
`periods of exclusivity.
`
`88.
`
`Upon information and belief, Zydus knows, should know and intends that
`
`physicians will prescribe and patients will take Zydus’ generic products for which approval is
`
`sought in ANDA No. 216137, and therefore will infringe at least one claim of the ’939 patent.
`
`89.
`
`Upon information and belief, Zydus has knowledge of the ’939 patent and, by its
`
`proposed package insert for Zydus’ generic products, knows or should know that it will induce
`
`direct infringement of at least one claim of the ’939 patent, either literally or under the doctrine of
`
`equivalents.
`
`90.
`
`Upon information and belief, Zydus 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 Zydus’ generic
`
`products according to the instructions in the proposed package insert in a way that directly
`
`infringes at least one claim of the ’939 patent.
`
`91.
`
`Upon information and belief, Zydus’ actions relating to Zydus’ ANDA No. 216137
`
`complained of herein were done by and for the benefit of Zydus.
`
`92.
`
`Plaintiff will be irreparably harmed by Zydus’ infringing activities unless this Court
`
`enjoins those activities.
`
`93.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT IV
`
`(INFRINGEMENT OF THE ’029 PATENT)
`
`94.
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`14
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 15 of 21 PageID: 15
`
`
`
`
`
`95.
`
`Upon information and belief, Zydus filed ANDA No. 216137 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United States
`
`before the expiration of the ’029 patent.
`
`96.
`
`Zydus’ Second Notice Letter states that Zydus 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 ’029 patent are invalid, unenforceable and/or will not be infringed.
`
`97.
`
`Upon information and belief, Zydus admits infringement of at least one claim of
`
`the ’029 patent because Zydus’ Second Notice Letter did not provide any non-infringement
`
`allegation with respect to at least one claim of the ’029 patent.
`
`98.
`
`Upon information and belief, in its ANDA No. 216137, Zydus has represented to
`
`the FDA that Zydus’ generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`99.
`
`Zydus has actual knowledge of the ’029 patent, as evidenced by Zydus’ Second
`
`Notice Letter.
`
`100. Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Zydus has infringed
`
`at least one claim of the ’029 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216137, seeking approval to manufacture, use, import, offer to sell or sell Zydus’ generic
`
`products before the expiration date of the ’029 patent.
`
`101. Upon information and belief, if ANDA No. 216137 is approved, Zydus intends to
`
`and will manufacture, use, import, offer to sell and/or sell Zydus’ generic products in the United
`
`States.
`
`102. Upon information and belief, if ANDA No. 216137 is approved, Zydus will infringe
`
`one or more claims of the ’029 patent under § 271(a), either literally or under the doctrine of
`
`15
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 16 of 21 PageID: 16
`
`
`
`
`
`equivalents, by making, using, offering to sell, selling and/or importing Zydus’ 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. 216137 shall be no earlier than the expiration of the ’029 patent and any additional
`
`periods of exclusivity.
`
`103. Upon information and belief, Zydus knows, should know and intends that
`
`physicians will prescribe and patients will take Zydus’ generic products for which approval is
`
`sought in ANDA No. 216137, and therefore will infringe at least one claim of the ’029 patent.
`
`104. Upon information and belief, Zydus has knowledge of the ’029 patent and, by its
`
`proposed package insert for Zydus’ generic products, knows or should know that it will induce
`
`direct infringement of at least one claim of the ’029 patent, either literally or under the doctrine of
`
`equivalents.
`
`105. Upon information and belief, Zydus 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 Zydus’ generic
`
`products according to the instructions in the proposed package insert in a way that directly
`
`infringes at least one claim of the ’029 patent.
`
`106. Upon information and belief, Zydus’ actions relating to Zydus’ ANDA No. 216137
`
`complained of herein were done by and for the benefit of Zydus.
`
`107. Plaintiff will be irreparably harmed by Zydus’ infringing activities unless this Court
`
`enjoins those activities.
`
`108. Plaintiff does not have an adequate remedy at law.
`
`16
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 17 of 21 PageID: 17
`
`
`
`
`
`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 Zydus has infringed at
`
`least one claim of the ’941 patent through Zydus’ submission of ANDA No. 216137 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Zydus’ generic products in
`
`the United States before the expiration of the ’941 patent;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Zydus’ making,
`
`using, offering to sell, selling or importing of Zydus’ generic products before the expiration of the
`
`’941 patent will infringe, actively induce infringement and/or contribute to the infringement of at
`
`least one claim of the ’941 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 Zydus’
`
`generic products shall be no earlier than the expiration date of the ’941 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.
`
`The entry of a preliminary and/or permanent injunction, enjoining Zydus and all
`
`persons acting in concert with Zydus from manufacturing, using, offering for sale or selling Zydus’
`
`generic products within the United States, or importing Zydus’ generic products into the United
`
`States, until the expiration of the ’941 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`E.
`
`The entry of a preliminary and/or permanent injunction, enjoining Zydus and all
`
`persons acting in concert with Zydus from seeking, obtaining or maintaining approval of the
`
`ANDA until the expiration of the ’941 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`17
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 18 of 21 PageID: 18
`
`
`
`
`
`F.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Zydus has infringed at
`
`least one claim of the ’931 patent through Zydus’ submission of ANDA No. 216137 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Zydus’ generic products in
`
`the United States before the expiration of the ’931 patent;
`
`G.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Zydus’ making,
`
`using, offering to sell, selling or importing of Zydus’ generic products before the expiration of the
`
`’931 patent will infringe, actively induce infringement and/or contribute to the infringement of at
`
`least one claim of the ’931 patent under 35 U.S.C. § 271(a), (b) and/or (c);
`
`H.
`
`The issuance of an order that the effective date of any FDA approval of Zydus’
`
`generic products shall be no earlier than the expiration date of the ’931 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);
`
`I.
`
`The entry of a preliminary and/or permanent injunction, enjoining Zydus and all
`
`persons acting in concert with Zydus from manufacturing, using, offering for sale or selling Zydus’
`
`generic products within the United States, or importing Zydus’ generic products into the United
`
`States, until the expiration of the ’931 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`J.
`
`The entry of a preliminary and/or permanent injunction, enjoining Zydus and all
`
`persons acting in concert with Zydus from seeking, obtaining or maintaining approval of the
`
`ANDA until the expiration of the ’931 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`K.
`
` The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Zydus has infringed at
`
`least one claim of the ’939 patent through Zydus’ submission of ANDA No. 216137 to the FDA
`
`18
`
`

`

`Case 3:21-cv-19466 Document 1 Filed 10/29/21 Page 19 of 21 PageID: 19
`
`
`
`
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Zydus’ generic products in
`
`the United States before the expiration of the ’939 patent;
`
`L.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Zydus’ making,
`
`using, offering to sell, selling or importing of Zydus’ generic products before the expiration of the
`
`’939 patent will infringe, actively induce infringement and/or contribute to the infringement of at
`
`least one claim of the ’939 patent under 35 U.S.C. § 271(a), (b) and/or (c);
`
`M.
`
`The issuance of an order that the effective date of any FDA approval of Zydus’
`
`generic products shall be no earlier than the expiration date of the ’939 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);
`
`N.
`
`The entry of a preliminary and/or permanent injunction, enjoining Zydus and all
`
`persons acting in concert with Zydus from m