Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 1 of 19 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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`Plaintiff,
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`
`
`v.
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`
`
`Civil Action No. ________
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`
`
`
`
`LUPIN LIMITED, LUPIN
`PHARMACEUTICALS, INC., LUPIN INC.
`and LUPIN ATLANTIS HOLDINGS S.A.
`
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants
`
`Lupin Limited, Lupin Pharmaceuticals, Inc. (“Lupin Pharmaceuticals”), Lupin Inc., and Lupin
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`Atlantis Holdings S.A. (“Lupin S.A.”) (collectively “Lupin” or “Defendants”), alleges 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. 11,026,931 (“the
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`’931 patent”), 11,026,939 (“the ’939 patent”) and 11,040,029 (“the ’029 patent”) (collectively,
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`“patents-in-suit”), arising under the United States patent laws, Title 35 United States Code, § 100
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`et. seq., including 35 U.S.C. §§ 271 and 281. This action relates to Lupin’s filing of an
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`Abbreviated New Drug Application (“ANDA”) No. 216064 under Section 505(j) of the Federal
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`Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration
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`(“FDA”) approval to manufacture, use, import, offer to sell and/or sell Valbenazine Tosylate
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`Capsule, eq. 40 mg base and eq. 80 mg base (“Lupin’s generic products”) before the expiration of
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`the patents-in-suit.
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`2.
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`Neurocrine filed a separate action involving the same ANDA No. 216064 in this
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`Court for patent infringement of U.S. Patent Nos. 8,039,627 (“the ’627 patent”), 8,357,697 (“the
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`’697 patent”), 10,065,952 (“the ’952 patent”), 10,844,058 (“the ’058 patent”), 10,851,103 (“the
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`’103 patent”), 10,851,104 (“the ’104 patent”), 10,857,137 (“the ’137 patent”), 10,857,148 (“the
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`’148 patent”), 10,874,648 (“the ’648 patent”), 10,906,902 (“the ’902 patent”), 10,906,903 (“the
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`’903 patent”), 10,912,771 (“the ’771 patent”), 10,919,892 (“the ’892 patent”), 10,940,141 (“the
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`’141 patent”), 10,952,997 (“the ’997 patent”) and 10,993,941 (“the ’941 patent”) (collectively,
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`“the First Suit Patents”) in Neurocrine Biosciences, Inc. v. Lupin Limited et al, No. 1:21-cv-01042-
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`MN (D. Del. filed July 16, 2021) (“the First Suit”).
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`3.
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`The First Suit was filed in response to a letter from Lupin dated June 3, 2021
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`(“Lupin’s First Notice Letter”), purporting to include a “Notice of Paragraph IV Certification
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`Regarding [the First Suit Patents] pursuant to § 505(j)(2)(B) of the Federal Food, Drug, and
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`Cosmetic Act and 21 C.F.R. § 314.95 for ANDA No. 216064.” The First Suit included counts of
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`infringement of the First Suit Patents.
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`4.
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`This complaint is filed in response to a new, second letter from Lupin dated August
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`17, 2021 (“Lupin’s Second Notice Letter”), purporting to include a “Notice of Paragraph IV
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`Certification Regarding [the patents-in-suit] Pursuant to Section 505(j)(2)(B) of the Federal Food,
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`Drug, and Cosmetic Act and 21 C.F.R. § 314.95 for ANDA No. 216064.” Lupin’s Second Notice
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`Letter stated that Lupin had filed ANDA No. 216064, seeking approval to manufacture, use,
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`import, offer to sell and/or sell Lupin’s generic products before expiration of the patents-in-suit.
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`THE PARTIES
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`5.
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`Neurocrine is a corporation organized and existing under the laws of Delaware with
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`its corporate headquarters at 12780 El Camino Real, San Diego, CA 92130.
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`6.
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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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`7.
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`Upon information and belief, Lupin Limited is a corporation organized under the
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`laws of India and its principal place of business is located at 3rd Floor, Kalpataru Inspire, Off
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`Western Express Highway, Santacruz (E), Mumbai 400 055, India.
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`8.
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`Upon information and belief, Lupin Pharmaceuticals is a corporation organized
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`under the laws of Delaware and its principal place of business is located at 111 S. Calvert Street,
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`Harborplace Tower, 21st Floor, Baltimore, MD 21202.
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`9.
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`Upon information and belief, Lupin Inc. is a corporation organized under the laws
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`of Delaware and its principal place of business is located at 111 S. Calvert Street, Harborplace
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`Tower, 21st Floor, Baltimore, MD 21202.
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`10.
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`Upon information and belief, Lupin S.A. is a corporation organized under the laws
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`of Switzerland and its principal place of business is located at Landis & Gyr – Strasse 1, 6300 Zug,
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`Switzerland.
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`11.
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`Upon information and belief, Lupin Pharmaceuticals is a wholly-owned subsidiary
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`of Lupin Limited.
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`12.
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`Upon information and belief, Lupin Inc. is a wholly-owned subsidiary of Nanomi
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`B.V. and Nanomi B.V. is a wholly-owned subsidiary of Lupin Limited.
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`13.
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`Upon information and belief, Lupin Pharmaceuticals, Lupin Inc. and Lupin S.A.
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`are generic pharmaceutical companies that, in coordination with each other and Lupin Limited or
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`at the direction of Lupin Limited, develop, manufacture, market and distribute generic
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`pharmaceutical products for sale in the State of Delaware and throughout the United States.
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`JURISDICTION AND VENUE
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`14.
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`15.
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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 Lupin Limited. Upon information and
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`belief, Lupin Limited 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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`Lupin Limited 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, Lupin
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`Limited purposefully has conducted and continues to conduct business in this judicial district, and
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`this judicial district is a likely destination of Lupin’s generic products.
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`16.
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`This Court has personal jurisdiction over Lupin Pharmaceuticals. Upon
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`information and belief, Lupin Pharmaceuticals is in the business of manufacturing, marketing,
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`importing and selling pharmaceutical drug products, including generic drug products. Upon
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`information and belief, Lupin Pharmaceuticals directly, or indirectly, develops, manufactures,
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`markets and sells generic drugs throughout the United States and in this judicial district. Upon
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`information and belief, Lupin Pharmaceuticals purposefully has conducted and continues to
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`conduct business in this judicial district, and this judicial district is a likely destination of Lupin’s
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`generic products.
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`17.
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`This Court has personal jurisdiction over Lupin Inc. Upon information and belief,
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`Lupin Inc. is in the business of manufacturing, marketing, importing and selling pharmaceutical
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`drug products, including generic drug products. Upon information and belief, Lupin Inc. directly,
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`or indirectly, develops, manufactures, markets and sells generic drugs throughout the United States
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`and in this judicial district. Upon information and belief, Lupin Inc. purposefully has conducted
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`and continues to conduct business in this judicial district, and this judicial district is a likely
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`destination of Lupin’s generic products.
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`18.
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`This Court has personal jurisdiction over Lupin S.A. Upon information and belief,
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`Lupin S.A. is in the business of manufacturing, marketing, importing and selling pharmaceutical
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`drug products, including generic drug products. Upon information and belief, Lupin S.A. directly,
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`or indirectly, develops, manufactures, markets and sells generic drugs throughout the United States
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`and in this judicial district. Upon information and belief, Lupin S.A. purposefully has conducted
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`and continues to conduct business in this judicial district, and this judicial district is a likely
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`destination of Lupin’s generic products.
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`19.
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`Upon information and belief, Lupin Limited states that it “is present in the US
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`through manufacturing, research and development, and commercial divisions for generics,
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`complex generics, biosimilars and branded pharmaceuticals” and that its “US revenues crossed $1
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`billion” in 2017-18. https://www.lupin.com/about-us/global-presence/ (accessed September 29,
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`2021).
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`20.
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`Upon information and belief, Lupin Limited is the holder of FDA Drug Master File
`
`No. 35246 for valbenazine tosylate.
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`21.
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`Upon information and belief, Lupin Limited, Lupin Pharmaceuticals, Lupin Inc.
`
`and Lupin S.A. hold themselves out as a unitary entity and operate as a single integrated business
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`with respect to the regulatory approval, manufacturing, marketing, sale and distribution of generic
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`pharmaceutical products throughout the United States, including in this judicial district.
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`22.
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`Upon information and belief, Lupin admits that it “has a strong and well-established
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`generic presence in the United States, having entered the U.S. market in 2003 and maintaining a
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`competitive edge in the list of top 5 generic pharmaceutical companies by prescriptions dispensed
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`since 2010.” https://www.lupin.com/US/about-us/ (accessed September 29, 2021). Upon
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`information and belief, Lupin has at least five offices and a manufacturing facility in the U.S.
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`https://www.lupin.com/about-us/global-presence/ (accessed September 29, 2021).
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`23.
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`Upon information and belief, Lupin is engaged in the submission and approval of
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`ANDAs for the U.S. market, admitting Lupin has “received more than 250 FDA approvals and
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`market[ed] a total of 180 generic products” and describes itself “as one of the fastest-growing
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`pharmaceutical companies in the U.S.” https://www.lupin.com/US/generics/ (accessed September
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`29, 2021).
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`24.
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`Lupin’s ANDA filing regarding the patents-in-suit relates to this litigation and is
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`substantially connected with this judicial district because it reliably and non-speculatively predicts
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`Lupin’s intent to market and sell Lupin’s generic products in this judicial district.
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`25.
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`Lupin has taken the significant step of applying to the FDA for approval to engage
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`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
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`United States. Upon information and belief, Lupin intends to direct sales of its generic drugs in
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`this judicial district, among other places, once Lupin receives the requested FDA approval to
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`market its generic products. Upon information and belief, Lupin will engage in marketing of its
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`proposed generic products in Delaware upon approval of its ANDA.
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`26.
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`Upon information and belief, Lupin Limited, Lupin Pharmaceuticals, Lupin Inc.
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`and Lupin S.A. have thus been, and continue to be, joint and prime actors in the drafting,
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`submission, approval and maintenance of ANDA No. 216064.
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`27.
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`For these reasons and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiciton over Lupin.
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`28.
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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 Lupin Limited is incorporated in India and may be sued in any judicial district in the
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`United States.
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`29.
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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 Lupin Pharmaceuticals is incorporated in the state of Delaware.
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`30.
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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 Lupin Inc. is incorporated in the state of Delaware.
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`31.
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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 Lupin S.A. is incorporated in Switzerland and may be sued in any judicial district in the
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`United States.
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`FACTUAL BACKGROUND
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`The NDA
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`32.
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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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`33.
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`34.
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`The FDA approved NDA No. 209241 on April 11, 2017.
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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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`35.
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`Valbenazine Capsules are marketed in the United States under the trademark
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`INGREZZA®.
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`The Patents-in-Suit
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`36.
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`The United States Patent and Trademark Office (“the PTO”) issued the ’931 patent
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`on June 8, 2021, titled “Methods for the Administration of Certain VMAT2 Inhibitors.” A true
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`and correct copy of the ’931 patent is attached as Exhibit A.
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`37.
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`Neurocrine owns the ’931 patent through assignment as recorded by the PTO at
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`Reel 055564, Frame 0388.
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`38.
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`39.
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`The ’931 patent currently expires on August 14, 2039.
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`The ’931 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® Capsules.
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`40.
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`The PTO issued the ’939 patent on June 8, 2021, titled “High Dosage Valbenazine
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`Formulation and Compositions, Methods, and Kits Related Thereto.” A true and correct copy of
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`the ’939 patent is attached as Exhibit B.
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`41.
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`Neurocrine owns the ’939 patent through assignment as recorded by the PTO at
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`Reel 054171, Frame 0426.
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`42.
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`43.
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`The ’939 patent currently expires on September 18, 2038.
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`The ’939 patent is listed in the Orange Book in connection with NDA No. 209241
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`for INGREZZA® Capsules.
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`44.
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`The PTO issued the ’029 patent on June 22, 2021, titled “Methods for the
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`Administration of Certain VMAT2 Inhibitors.” A true and correct copy of the ’029 patent is
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`attached as Exhibit C.
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`45.
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`Neurocrine owns the ’029 patent through assignment as recorded by the PTO at
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`Reel 052974, Frame 0736.
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`46.
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`The ’029 patent currently expires on October 10, 2037.
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`47.
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`The ’029 patent is listed in the Orange Book in connection with NDA No. 209241
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`for INGREZZA® Capsules.
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`The ANDA
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`48.
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`Upon information and belief, Lupin submitted ANDA No. 216064 with the FDA
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`under 21 U.S.C. § 355(j) seeking FDA approval to manufacture, use, import, offer to sell and/or
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`sell in the United States Valbenazine Tosylate Capsule, eq. 40 mg base and eq. 80 mg base (defined
`
`above as “Lupin’s generic products”), which are generic versions of Neurocrine’s INGREZZA®
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`Capsules.
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`49.
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`Lupin’s Second Notice Letter states that ANDA No. 216064 contains certifications
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the claims of the patents-in-suit are
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`invalid, unenforceable or will not be infringed by the manufacture, use or sale of Lupin’s generic
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`products.
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`50.
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`Plaintiff commenced this action within 45 days of receiving Lupin’s Second Notice
`
`Letter.
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`COUNT I
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`(INFRINGEMENT OF THE ’931 PATENT)
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`51.
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`52.
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`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
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`Upon information and belief, Lupin filed ANDA No. 216064 seeking approval to
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`manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United States
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`before the expiration of the ’931 patent.
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`53.
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`Lupin’s Second Notice Letter states that Lupin filed with the FDA, pursuant to
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`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
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`that the claims of the ’931 patent are invalid, unenforceable and/or will not be infringed.
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`54.
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`Upon information and belief, in its ANDA No. 216064, Lupin has represented to
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`the FDA that Lupin’s generic products are pharmaceutically and therapeutically equivalent to
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`Neurocrine’s INGREZZA® Capsules.
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`55.
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`Lupin has actual knowledge of the ’931 patent, as evidenced by Lupin’s Second
`
`Notice Letter.
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`56.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Lupin has infringed
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`at least one claim of the ’931 patent by submitting, or causing to be submitted, to the FDA ANDA
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`No. 216064, seeking approval to manufacture, use, import, offer to sell or sell Lupin’s generic
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`products before the expiration date of the ’931 patent.
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`57.
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`Upon information and belief, if ANDA No. 216064 is approved, Lupin intends to
`
`and will manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United
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`States.
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`58.
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`Upon information and belief, if ANDA No. 216064 is approved, Lupin will infringe
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`one or more claims of the ’931 patent under § 271(a), either literally or under the doctrine of
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`equivalents, by making, using, offering to sell, selling and/or importing Lupin’s generic products,
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`and/or by actively inducing infringement by others under § 271(b) and/or contributing to
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`infringement under § 271(c), unless this Court orders that the effective date of any FDA approval
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`of ANDA No. 216064 shall be no earlier than the expiration of the ’931 patent and any additional
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`periods of exclusivity.
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`59.
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`Upon information and belief, Lupin knows, should know and intends that
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`physicians will prescribe and patients will take Lupin’s generic products for which approval is
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`sought in ANDA No. 216064, and therefore will infringe at least one claim of the ’931 patent.
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`60.
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`Upon information and belief, Lupin has knowledge of the ’931 patent and, by its
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`proposed package insert for Lupin’s generic products, knows or should know that it will induce
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`direct infringement of at least one claim of the ’931 patent, either literally or under the doctrine of
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`equivalents.
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`61.
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`Upon information and belief, Lupin is aware and/or has knowledge that its proposed
`
`package insert will recommend, suggest, encourage and/or instruct others how to engage in an
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`infringing use because healthcare professionals and/or patients will use Lupin’s generic products
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`according to the instructions in the proposed package insert in a way that directly infringes at least
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`one claim of the ’931 patent.
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`62.
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`Upon information and belief, Lupin’s actions relating to Lupin’s ANDA No.
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`216064 complained of herein were done by and for the benefit of Lupin.
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`63.
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`Plaintiff will be irreparably harmed by Lupin’s infringing activities unless this
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`Court enjoins those activities.
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`64.
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`Plaintiff does not have an adequate remedy at law.
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`COUNT II
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`(INFRINGEMENT OF THE ’939 PATENT)
`
`65.
`
`66.
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`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
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`Upon information and belief, Lupin filed ANDA No. 216064 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United States
`
`before the expiration of the ’939 patent.
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`67.
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`Lupin’s Second Notice Letter states that Lupin 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.
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`68.
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`Upon information and belief, in its ANDA No. 216064, Lupin has represented to
`
`the FDA that Lupin’s generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
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`69.
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`Lupin has actual knowledge of the ’939 patent, as evidenced by Lupin’s Second
`
`Notice Letter.
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`70.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Lupin has infringed
`
`at least one claim of the ’939 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216064, seeking approval to manufacture, use, import, offer to sell or sell Lupin’s generic
`
`products before the expiration date of the ’939 patent.
`
`71.
`
`Upon information and belief, if ANDA No. 216064 is approved, Lupin intends to
`
`and will manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United
`
`States.
`
`72.
`
`Upon information and belief, if ANDA No. 216064 is approved, Lupin 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 Lupin’s 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. 216064 shall be no earlier than the expiration of the ’939 patent and any additional
`
`periods of exclusivity.
`
`73.
`
`Upon information and belief, Lupin knows, should know and intends that
`
`physicians will prescribe and patients will take Lupin’s generic products for which approval is
`
`sought in ANDA No. 216064, and therefore will infringe at least one claim of the ’939 patent.
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`74.
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`Upon information and belief, Lupin has knowledge of the ’939 patent and, by its
`
`proposed package insert for Lupin’s 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.
`
`75.
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`Upon information and belief, Lupin 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 Lupin’s generic products
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`according to the instructions in the proposed package insert in a way that directly infringes at least
`
`one claim of the ’939 patent.
`
`76.
`
`Upon information and belief, Lupin’s actions relating to Lupin’s ANDA No.
`
`216064 complained of herein were done by and for the benefit of Lupin.
`
`77.
`
`Plaintiff will be irreparably harmed by Lupin’s infringing activities unless this
`
`Court enjoins those activities.
`
`78.
`
`Plaintiff does not have an adequate remedy at law.
`
`COUNT III
`
`(INFRINGEMENT OF THE ’029 PATENT)
`
`79.
`
`80.
`
`Plaintiff realleges, and incorporates fully herein, each preceding paragraph.
`
`Upon information and belief, Lupin filed ANDA No. 216064 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United States
`
`before the expiration of the ’029 patent.
`
`81.
`
`Lupin’s Second Notice Letter states that Lupin 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.
`
`{01728833;v1 }
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`13
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`Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 14 of 19 PageID #: 14
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`
`
`82.
`
`Upon information and belief, Lupin admits infringement of at least one claim of the
`
`’029 patent because Lupin’s Second Notice Letter did not provide any non-infringement allegation
`
`with respect to at least one claim of the ’029 patent.
`
`83.
`
`Upon information and belief, in its ANDA No. 216064, Lupin has represented to
`
`the FDA that Lupin’s generic products are pharmaceutically and therapeutically equivalent to
`
`Neurocrine’s INGREZZA® Capsules.
`
`84.
`
`Lupin has actual knowledge of the ’029 patent, as evidenced by Lupin’s Second
`
`Notice Letter.
`
`85.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Lupin has infringed
`
`at least one claim of the ’029 patent by submitting, or causing to be submitted, to the FDA ANDA
`
`No. 216064, seeking approval to manufacture, use, import, offer to sell or sell Lupin’s generic
`
`products before the expiration date of the ’029 patent.
`
`86.
`
`Upon information and belief, if ANDA No. 216064 is approved, Lupin intends to
`
`and will manufacture, use, import, offer to sell and/or sell Lupin’s generic products in the United
`
`States.
`
`87.
`
`Upon information and belief, if ANDA No. 216064 is approved, Lupin will infringe
`
`one or more claims of the ’029 patent under § 271(a), either literally or under the doctrine of
`
`equivalents, by making, using, offering to sell, selling and/or importing Lupin’s 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. 216064 shall be no earlier than the expiration of the ’029 patent and any additional
`
`periods of exclusivity.
`
`{01728833;v1 }
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`14
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`

`

`Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 15 of 19 PageID #: 15
`
`
`
`88.
`
`Upon information and belief, Lupin knows, should know and intends that
`
`physicians will prescribe and patients will take Lupin’s generic products for which approval is
`
`sought in ANDA No. 216064, and therefore will infringe at least one claim of the ’029 patent.
`
`89.
`
`Upon information and belief, Lupin has knowledge of the ’029 patent and, by its
`
`proposed package insert for Lupin’s 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.
`
`90.
`
`Upon information and belief, Lupin 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 Lupin’s 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.
`
`91.
`
`Upon information and belief, Lupin’s actions relating to Lupin’s ANDA No.
`
`216064 complained of herein were done by and for the benefit of Lupin.
`
`92.
`
`Plaintiff will be irreparably harmed by Lupin’s infringing activities unless this
`
`Court enjoins those activities.
`
`93.
`
`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 Lupin has infringed at
`
`least one claim of the ’931 patent through Lupin’s submission of ANDA No. 216064 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Lupin’s generic products in
`
`the United States before the expiration of the ’931 patent;
`
`{01728833;v1 }
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`15
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`

`

`Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 16 of 19 PageID #: 16
`
`
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Lupin’s making,
`
`using, offering to sell, selling or importing of Lupin’s 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);
`
`C.
`
`The issuance of an order that the effective date of any FDA approval of Lupin’s
`
`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);
`
`D.
`
`The entry of a preliminary and/or permanent injunction, enjoining Lupin and all
`
`persons acting in concert with Lupin from manufacturing, using, offering for sale or selling
`
`Lupin’s generic products within the United States, or importing Lupin’s 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;
`
`E.
`
`The entry of a preliminary and/or permanent injunction, enjoining Lupin and all
`
`persons acting in concert with Lupin 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;
`
`F.
`
` The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Lupin has infringed at
`
`least one claim of the ’939 patent through Lupin’s submission of ANDA No. 216064 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Lupin’s generic products in
`
`the United States before the expiration of the ’939 patent;
`
`G.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Lupin’s making,
`
`using, offering to sell, selling or importing of Lupin’s generic products before the expiration of the
`
`{01728833;v1 }
`
`16
`
`

`

`Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 17 of 19 PageID #: 17
`
`
`
`’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);
`
`H.
`
`The issuance of an order that the effective date of any FDA approval of Lupin’s
`
`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);
`
`I.
`
`The entry of a preliminary and/or permanent injunction, enjoining Lupin and all
`
`persons acting in concert with Lupin from manufacturing, using, offering for sale or selling
`
`Lupin’s generic products within the United States, or importing Lupin’s generic products into the
`
`United States, until the expiration of the ’939 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 Lupin and all
`
`persons acting in concert with Lupin from seeking, obtaining or maintaining approval of the
`
`ANDA until the expiration of the ’939 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 Lupin has infringed at
`
`least one claim of the ’029 patent through Lupin’s submission of ANDA No. 216064 to the FDA
`
`seeking approval to manufacture, use, import, offer to sell and/or sell Lupin’s generic products in
`
`the United States before the expiration of the ’029 patent;
`
`L.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Lupin’s making,
`
`using, offering to sell, selling or importing of Lupin’s generic products before the expiration of the
`
`’029 patent will infringe, actively induce infringement and/or contribute to the infringement of at
`
`least one claim of the ’029 patent under 35 U.S.C. § 271(a), (b) and/or (c);
`
`{01728833;v1 }
`
`17
`
`

`

`Case 1:21-cv-01408-UNA Document 1 Filed 10/01/21 Page 18 of 19 PageID #: 18
`
`
`
`M.
`
`The issuance of an order that the effective date of any FDA approval of Lupin’s
`
`generic products shall be no earlier than the expiration date of the ’029 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 Lupin and all
`
`persons acting in concert with Lupin from manufacturing, using, offering for sale or selling
`
`Lupin’s generic products within the United States, or importing Lupin’s generic products into the
`
`United States, until the expiration of the ’029 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B)
`
`and 283;
`
`O.
`
`The entry of a preliminary and/or permanent injunction, enjoining Lupin and all
`
`persons acting in concert with Lupin from seeking, obtaining or maintaining approval of the
`
`ANDA until the expiration of the ’029 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and
`
`283;
`
`P.
`
`The issuance of a declaration that this is an exceptional case and an award to
`
`Plaintiff of their costs, expenses and disbursements in this action, including