`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ________
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`
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`))))))))))))
`
`COMPLAINT
`
`IMPAX LABORATORIES, INC.,
`ASTRAZENECA AB, and
`ASTRAZENECA UK LIMITED,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`LANNETT HOLDINGS, INC. and
`LANNETT COMPANY, INC.,
`
`
`Defendants.
`
`Plaintiffs Impax Laboratories, Inc., AstraZeneca AB, and AstraZeneca UK Limited
`
`(collectively “Plaintiffs”), by way of their Complaint against Defendants Lannett Holdings, Inc.
`
`and Lannett Company, Inc. (collectively, “Lannett”), allege as follows:
`
`THE PARTIES
`
`1.
`
`Impax Laboratories, Inc. is a Delaware corporation with its headquarters at 30831
`
`Huntwood Avenue, Hayward, CA 94544.
`
`2.
`
`Impax Pharmaceuticals, the branded products division of Impax Laboratories,
`
`Inc., is a neurology-focused specialty pharmaceutical company dedicated to developing products
`
`for unmet needs in the treatment of central nervous system disorders.
`
`3.
`
`AstraZeneca AB is a Swedish corporation having its principal place of business at
`
`Karlebyhus, Astraallén, Södertälje, SE-151 85, Sweden.
`
`4.
`
`AstraZeneca UK Limited is an English corporation having its headquarters at 2
`
`Kingdom Street, Paddington, London, W2 6BD, England.
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 2 of 13 PageID #: 2
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`5.
`
`On information and belief, Defendant Lannett Holdings, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware having its principal place of
`
`business at 103 Foulk Road, Suite 202, Wilmington, DE 19803.
`
`6.
`
`On information and belief, Defendant Lannett Company, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware having its principal place of
`
`business at 13200 Townsend Road, Philadelphia, PA 19154.
`
`7.
`
`On information and belief, Lannett Company, Inc. is the parent company of
`
`Lannett Holdings, Inc.
`
`8.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`manufacture and sell various generic drug products and conduct business throughout the United
`
`States, including in the State of Delaware.
`
`NATURE OF THE ACTION
`
`9.
`
`This is a civil action for infringement of U.S. Patent Nos. 6,750,237 (“the ’237
`
`patent”) and 7,220,767 (“the ’767 patent”) arising under the United States Patent Laws, Title 35,
`
`United States Code, § 100, et seq., and in particular under 35 U.S.C. § 271. This action relates to
`
`Abbreviated New Drug Application (“ANDA”) No. 206350, which Lannett filed or caused to be
`
`filed under 21 U.S.C. § 355(j) with the U.S. Food and Drug Administration (“FDA”), for
`
`approval to market a generic copy of Plaintiffs’ Zomig® Nasal Spray product, which is sold in
`
`the United States.
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`JURISDICTION AND VENUE
`
`10.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a),
`
`2201, and 2202.
`
`11.
`
`On information and belief, this Court has personal jurisdiction over Lannett
`
`Holdings, Inc. and Lannett Company, Inc.
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`12.
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`On information and belief, Lannett Holdings, Inc. is a Delaware corporation. On
`
`information and belief, Lannett Holdings, Inc. has a registered agent in Delaware (located at The
`
`CSC Entity Services, LLC, 2711 Centerville Road Suite 400, Wilmington, DE 19808) for the
`
`receipt of service of process.
`
`13.
`
`On information and belief, Lannett Company, Inc. is a Delaware corporation. On
`
`information and belief, Lannett Company, Inc. has a registered agent in Delaware (located at The
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`Office Service Company 203 NE Front St, Ste 101, Milford, DE 19963) for the receipt of service
`
`of process.
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`14.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`operate as an integrated business.
`
`15.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
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`share common officers and directors and are agents of each other and/or work in concert with
`
`each other with respect to the development, regulatory approval, marketing, sale, and distribution
`
`of pharmaceutical products throughout the United States, including in Delaware.
`
`16.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`together formulate, develop, market, and sell active pharmaceutical ingredients (APIs), solid
`
`dosage forms, pharmaceutical formulations, and/or pharmaceutical products containing such
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`APIs or pharmaceutical formulations (collectively “Lannett’s products”) that they distribute in
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`Delaware and throughout the United States.
`
`17.
`
`On information and belief, Lannett Holdings, Inc., and Lannett Company, Inc.
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`together routinely file, and/or aid, abet, contribute to, and/or participate in the filing of, ANDAs
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`to seek FDA approval to market their products in the United States, including in Delaware.
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 4 of 13 PageID #: 4
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`18.
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`On information and belief, Lannett Holdings, Inc. is a wholly owned subsidiary of
`
`Lannett Company, Inc. On information and belief, Lannett Company, Inc., acting either alone or
`
`in concert with Lannett Holdings, Inc., either directly or through one or more of its subsidiaries,
`
`agents, and/or distributors, markets, sells, and/or distributes pharmaceutical products in
`
`Delaware.
`
`19.
`
`On information and belief, Lannett Company, Inc. holds current and valid
`
`“Distributor/Manufacturer CSR” (DM-0009166) and “Pharmacy-Wholesale” (A-4-0001963)
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`licenses in Delaware.
`
`20.
`
`On information and belief, Lannett Company, Inc. directs, authorizes, cooperates,
`
`participates, and/or assists Lannett Holdings, Inc. with the marketing, selling, and/or distributing
`
`pharmaceutical products in Delaware. On information and belief, the acts of Lannett Holdings,
`
`Inc. complained of herein were done at the direction of, with the authorization of, and/or with the
`
`cooperation, participation, and assistance of Lannett Company, Inc.
`
`21.
`
`On information and belief, this judicial district is a likely destination of products
`
`that will be manufactured and sold as a result of FDA approval of Lannett’s ANDA No. 206350,
`
`which is the subject of this lawsuit.
`
`22.
`
`On information and belief, Lannett Holdings, Inc. and Lannett Company, Inc.
`
`have committed, or aided, abetted, contributed to, and/or participated in the commission of the
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`tortious act of patent infringement that has led to foreseeable harm and injury to Plaintiffs
`
`including Impax Laboratories, Inc., a Delaware corporation.
`
`23.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b).
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 5 of 13 PageID #: 5
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`FACTUAL BACKGROUND
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`A.
`
`Zomig®
`
`24.
`
`AstraZeneca Pharmaceuticals LP is the holder of approved New Drug Application
`
`(“NDA”) No. 021450 for the manufacture and sale of zolmitriptan nasal spray, 5 mg/spray, used
`
`for the acute treatment of migraine with or without aura in adults, which Impax Laboratories,
`
`Inc., through its branded products division Impax Pharmaceuticals, distributes under the
`
`trademark Zomig® Nasal Spray.
`
`B.
`
`The ’237 Patent
`
`25.
`
`The
`
`’237 patent, which claims pharmaceutical
`
`formulations containing
`
`zolmitriptan, was duly and legally issued by the U.S. Patent and Trademark Office (“PTO”) on
`
`June 15, 2004. AstraZeneca AB and AstraZeneca UK Limited own all rights, title, and interest
`
`in the ’237 patent and have the right to sue for infringement thereof. AstraZeneca lists the ’237
`
`patent in the Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange
`
`Book”) for NDA No. 021450. A true and correct copy of the ’237 patent is attached as
`
`Exhibit A.
`
`26.
`
`Impax Laboratories, Inc. holds an exclusive license under the ’237 patent and also
`
`has rights to commercialize zolmitriptan in the United States under a Distribution, License,
`
`Development and Supply Agreement with AstraZeneca UK Limited. Impax Laboratories, Inc.
`
`has the right to sue for infringement of the ’237 patent.
`
`C.
`
`The ’767 Patent
`
`27.
`
`The
`
`’767 patent, which claims pharmaceutical
`
`formulations containing
`
`zolmitriptan, was duly and legally issued by the United States Patent and Trademark Office
`
`(“PTO”) on May 22, 2007. AstraZeneca AB and AstraZeneca UK Limited own all rights, title,
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`5
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 6 of 13 PageID #: 6
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`and interest in the ’767 patent and have the right to sue for infringement thereof. AstraZeneca
`
`lists the ’767 patent in the Orange Book for NDA No. 021450. A true and correct copy of the
`
`’767 patent is attached as Exhibit B.
`
`28.
`
`Impax Laboratories, Inc. holds an exclusive license under the ’767 patent and also
`
`has rights to commercialize zolmitriptan in the United States under a Distribution, License,
`
`Development and Supply Agreement with AstraZeneca UK Limited. Impax Laboratories, Inc.
`
`has the right to sue for infringement of the ’767 patent.
`
`D.
`
`Lannett’s ANDA No. 206350
`
`29.
`
`On information and belief, Lannett filed or caused to be filed with the FDA
`
`ANDA No. 206350 under 21 U.S.C. § 355(j)(2)(B), seeking FDA approval to market generic
`
`zolmitriptan nasal spray, 5 mg/spray (“Lannett’s Generic Product”), in the United States.
`
`Lannett’s Generic Product is a generic copy of Zomig® Nasal Spray.
`
`30.
`
`ANDA No. 206350
`
`contains
`
`a
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`certification pursuant
`
`to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”), alleging that the claims of the ’237 and
`
`’767 patents are invalid.
`
`31.
`
`On or about June 16, 2014, AstraZeneca received a letter sent on behalf of
`
`Lannett, dated June 13, 2014, purporting to be a “Notification of Certification” for ANDA
`
`No. 206350 (“Lannett’s Notice Letter”) pursuant to section 505(j)(2)(b)(iv) of the Federal Food,
`
`Drug and Cosmetic Act and 21 C.F.R. § 314.95. Lannett’s Notice Letter notified AstraZeneca
`
`that Lannett had filed ANDA No. 206350, seeking approval to market Lannett’s Generic Product
`
`before the expiration of the ’237 and ’767 patents. The Notice Letter does not identify any
`
`alleged grounds of non-infringement of the ’237 or ’767 patents.
`
`32.
`
`Plaintiffs commenced this action within 45 days of receiving Lannett’s Notice
`
`Letter.
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`33.
`
`34.
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`COUNT I
`(INFRINGEMENT OF U.S. PATENT NO. 6,750,237 B1)
`
`Paragraphs 1–32 are incorporated herein by reference.
`
`On information and belief, Lannett, through Lannett Holdings, Inc., filed ANDA
`
`No. 206350 to obtain approval to manufacture, use, and market Lannett’s Generic Product in the
`
`United States before the expiration of the ’237 patent. On information and belief, ANDA
`
`No. 206350 identifies Lannett as the manufacturer of the generic zolmitriptan nasal spray,
`
`5 mg/spray. On information and belief, Lannett 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 ’237 patent are invalid.
`
`35.
`
`On information and belief, in its ANDA No. 206350, Lannett has represented to
`
`the FDA that Lannett’s Generic Product is pharmaceutically and therapeutically equivalent to
`
`Zomig® Nasal Spray.
`
`36.
`
`Under 35 U.S.C. § 271(e)(2)(A), Lannett’s submission to the FDA of ANDA
`
`No. 206350, seeking approval for the commercial manufacture, use, or sale of Lannett’s Generic
`
`Product before the expiration of the ’237 patent, constitutes infringement of at least one claim of
`
`the ’237 patent, either literally or under the doctrine of equivalents.
`
`37.
`
`The filing of the ANDA by Lannett through Lannett Holdings, Inc. constituted
`
`direct infringement of the ’237 patent under 35 U.S.C. § 271(e).
`
`38.
`
`Under 35 U.S.C. § 271(e)(2)(A), Lannett Company, Inc. induced the infringement
`
`of the ’237 patent by actively and knowingly causing ANDA No. 206350 to be submitted, and/or
`
`assisting with, participating in, contributing to, and/or directing the submission of the ANDA,
`
`knowing that the submission would constitute direct infringement of the ’237 patent.
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`{00880547;v1 }
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`39.
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`Upon FDA approval of ANDA No. 206350, Lannett will infringe one or more
`
`claims of the ’237 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, selling, and/or importing Lannett’s Generic Product,
`
`unless this Court orders that the effective date of any FDA approval of ANDA No. 206350 shall
`
`be no earlier than the expiration of the ’237 patent and any additional periods of exclusivity.
`
`40.
`
`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
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`actively inducing infringement of the ’237 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
`
`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
`
`adequate remedy at law.
`
`COUNT II
`(INFRINGEMENT OF U.S. PATENT NO. 7,220,767 B2)
`
`Paragraphs 1–40 are incorporated herein by reference.
`
`On information and belief, Lannett, through Lannett Holdings, Inc., filed ANDA
`
`41.
`
`42.
`
`No. 206350 to obtain approval to manufacture, use, and market Lannett’s Generic Product in the
`
`United States before the expiration of the ’767 patent. On information and belief, ANDA
`
`No. 206350 identifies Lannett as the manufacturer of the generic zolmitriptan nasal spray,
`
`5 mg/spray. On information and belief, Lannett 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 ’767 patent are invalid.
`
`43.
`
`On information and belief, in its ANDA No. 206350, Lannett has represented to
`
`the FDA that Lannett’s Generic Product is pharmaceutically and therapeutically equivalent to
`
`Zomig® Nasal Spray.
`
`44.
`
`Under 35 U.S.C. § 271(e)(2)(A), Lannett’s submission to the FDA of ANDA
`
`No. 206350 seeking approval for the commercial manufacture, use, or sale of Lannett’s Generic
`
`{00880547;v1 }
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`
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`Product before the expiration of the ’767 patent, constitutes infringement of at least one claim of
`
`the ’767 patent, either literally or under the doctrine of equivalents.
`
`45.
`
`The filing of the ANDA by Defendants through Lannett Holdings, Inc. constituted
`
`direct infringement of the ’767 patent under 35 U.S.C. § 271(e).
`
`46.
`
`Under 35 U.S.C. § 271(e)(2)(A), Lannett Company, Inc. induced the infringement
`
`of the ’767 patent by actively and knowingly causing ANDA No. 206350 to be submitted, and/or
`
`assisting with, participating in, contributing to, and/or directing the submission of the ANDA to
`
`the FDA, knowing that the submission would constitute direct infringement of the ’767 patent.
`
`47.
`
`Upon FDA approval of ANDA No. 206350, Lannett will infringe one or more
`
`claims of the ’767 patent, either literally or under the doctrine of equivalents under 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, selling, and/or importing Lannett’s Generic Product,
`
`unless this Court orders that the effective date of any FDA approval of ANDA No. 206350 shall
`
`be no earlier than the expiration of the ’767 patent and any additional periods of exclusivity.
`
`48.
`
`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
`
`actively inducing infringement of the ’767 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
`
`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
`
`adequate remedy at law.
`
`COUNT III
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 6,750,237 B1)
`
`Paragraphs 1–48 are incorporated herein by reference.
`
`This Count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`49.
`
`50.
`
`2202.
`
`51.
`
`On information and belief, if the FDA approves ANDA No. 206350, Lannett
`
`Holdings, Inc., in concert with Lannett Company, Inc., will market, offer for sale, sell, and/or
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`{00880547;v1 }
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 10 of 13 PageID #: 10
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`
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`import Lannett’s Generic Product in the United States, which will constitute direct infringement
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`of at least one claim of the ’237 patent under 35 U.S.C. § 271(a). On information and belief, that
`
`marketing, offering for sale, sale, and/or importation will occur with Lannett Company, Inc.’s
`
`specific intent and encouragement, and will be conduct that Lannett Company, Inc. knows or
`
`should know will occur. On information and belief, Lannett Company, Inc. will actively induce,
`
`encourage, aid, and abet that conduct, with knowledge and specific intent that the conduct will
`
`violate Plaintiffs’ rights under the ’237 patent.
`
`52.
`
`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
`
`actively inducing infringement of the ’237 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
`
`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
`
`adequate remedy at law.
`
`53.
`
`As a result of the foregoing facts, a concrete, substantial, and continuing
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`justiciable controversy exists between Plaintiffs and Lannett as to liability for infringement of the
`
`’237 patent. Lannett’s actions have created in Plaintiffs a reasonable apprehension of irreparable
`
`harm and loss resulting from Lannett’s threatened imminent actions. This substantial controversy
`
`between Plaintiffs and Lannett has sufficient immediacy and reality to establish declaratory
`
`judgment jurisdiction relating to Lannett’s threatened infringement of the ’237 patent.
`
`
`
`COUNT IV
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 7,220,767 B2)
`
`Paragraphs 1–53 are incorporated herein by reference.
`
`This Count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`54.
`
`55.
`
`2202.
`
`56.
`
`On information and belief, if the FDA approves ANDA No. 206350, Lannett
`
`Holdings, Inc., in concert with Lannett Company, Inc., will market, offer for sale, sell, and/or
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 11 of 13 PageID #: 11
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`
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`import Lannett’s Generic Product in the United States, which will constitute direct infringement
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`of at least one claim of the ’767 patent under 35 U.S.C. § 271(a). On information and belief, that
`
`marketing, offering for sale, sale, and/or importation will occur with Lannett Company, Inc.’s
`
`specific intent and encouragement, and will be conduct that Lannett Company, Inc. knows or
`
`should know will occur. On information and belief, Lannett Company, Inc. will actively induce,
`
`encourage, aid, and abet that conduct, with knowledge and specific intent that the conduct will
`
`violate Plaintiffs’ rights under the ’767 patent.
`
`57.
`
`Plaintiffs will be irreparably harmed if Lannett is not enjoined from infringing or
`
`actively inducing infringement of the ’767 patent. Pursuant to 35 U.S.C. § 283, Plaintiffs are
`
`entitled to a permanent injunction against further infringement. Plaintiffs do not have an
`
`adequate remedy at law.
`
`58.
`
`As a result of the foregoing facts, a concrete, substantial, and continuing
`
`justiciable controversy exists between Plaintiffs and Lannett as to liability for infringement of the
`
`’767 patent. Lannett’s actions have created in Plaintiffs a reasonable apprehension of irreparable
`
`harm and loss resulting from Lannett’s threatened imminent actions. This substantial controversy
`
`between Plaintiffs and Lannett has sufficient immediacy and reality to establish declaratory
`
`judgment jurisdiction relating to Lannett’s threatened infringement of the ’767 patent.
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`
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`REQUEST FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
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`the entry of judgment that the claims of the ’237 and ’767 patents are
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`valid;
`
`B.
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`the entry of judgment that Lannett’s submission of ANDA 206350 was an
`
`act of infringement, and that its making, using, offering to sell, selling or
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`
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`importing Lannett’s Generic Product before the expiration of the ’237 and
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`’767 patents will infringe those patents;
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`C.
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`the entry of judgment that Lannett Company, Inc.’s knowing and
`
`purposeful conduct in causing ANDA 206350 to be submitted, and/or
`
`assisting with, participating in, contributing to, and/or directing its filing,
`
`knowing that its submission would constitute direct infringement, induced
`
`infringement of the ’237 and ’767 patents;
`
`D.
`
`the entry of an order that the effective date of any FDA approval of
`
`Lannett’s Generic Product shall be no earlier than the expiration of
`
`the ’237 and ’767 patents and any additional periods of exclusivity, in
`
`accordance with 35 U.S.C. § 271(e)(4)(A);
`
`E.
`
`the entry of a permanent injunction, enjoining Lannett, and all persons
`
`acting in concert with Lannett, from commercially manufacturing, using,
`
`offering for sale, or selling Lannett’s Generic Product within the United
`
`States, or importing Lannett’s Generic Product into the United States, until
`
`the expiration of the ’237 and ’767 patents and any additional periods of
`
`exclusivity, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and 283;
`
`F.
`
`a declaration that this is an exceptional case and an award to Plaintiffs 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.
`
`an award to Plaintiffs of any further appropriate relief under 35 U.S.C.
`
`§ 271(e)(4); and
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`Case 1:14-cv-00999-RGA Document 1 Filed 07/30/14 Page 13 of 13 PageID #: 13
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`
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`H.
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`an award to Plaintiffs of any further and additional relief that the Court
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`deems just and proper.
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`
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`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`
`Steven J. Balick (I.D. #2114)
`Tiffany Geyer Lydon (I.D. #3950)
`Andrew C. Mayo (I.D. #5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`tlydon@ashby-geddes.com
`amayo@ashby-geddes.com
`
`
`Attorneys for Impax Laboratories, Inc.,
`AstraZeneca AB, and AstraZeneca UK Limited
`
`
`13
`
`
`
`OF COUNSEL:
`
`Michael J. Flibbert
`Danielle A. Duszczyszyn
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`L. Scott Burwell
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Two Freedom Square
`11955 Freedom Drive
`Reston, VA 20190-5675
`(571) 203-2700
`
`Nishla Keiser
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Two Seaport Lane
`6th Floor
`Boston, MA 02210-2001
`(617) 646-1600
`
`July 30, 2014
`{00880547;v1 }