Case 2:19-cv-16484 Document 1 Filed 08/08/19 Page 1 of 17 PageID: 1
`
`Keith J. Miller
`Justin T. Quinn
`Michael J. Gesualdo
`ROBINSON MILLER LLC
`Ironside Newark
`110 Edison Place, Suite 302
`Newark, New Jersey 07102
`(973) 690-5400 (Telephone)
`kmiller@rwmlegal.com
`jquinn@rwmlegal.com
`mgesualdo@rwmlegal.com
`
`Attorneys for Plaintiffs
`Janssen Pharmaceuticals, Inc. and Janssen
`Pharmaceutica NV
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`JANSSEN PHARMACEUTICALS, INC. and
`JANSSEN PHARMACEUTICA NV,
`
`Plaintiffs,
`
`v.
`
`MYLAN LABORATORIES LIMITED, MYLAN
`PHARMACEUTICALS INC., and MYLAN
`INSTITUTIONAL LLC,
`
`Defendants.
`
`Civil Action No. ___________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`(Filed Electronically)
`
`Janssen Ex. 2001
`Mylan v. Janssen
`IPR2020-00440
`
`

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`Plaintiffs Janssen Pharmaceuticals, Inc. (“JPI”) and Janssen Pharmaceutica NV
`
`(“JPN”) (collectively “Plaintiffs” or “Janssen”), for their Complaint against Defendants Mylan
`
`Laboratories Limited (“Mylan Labs”), Mylan Pharmaceuticals, Inc. (“Mylan Pharmaceuticals”),
`
`and Mylan Institutional LLC (“Mylan Institutional”) (collectively “Defendants” or “Mylan”),
`
`hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for infringement of United States Patent No.
`
`9,439,906 (the “’906 Patent”).
`
`2.
`
`This action relates to the submission of an Abbreviated New Drug
`
`Application (“ANDA”) by Mylan to the United States Food and Drug Administration (“FDA”)
`
`seeking approval to market a generic version of JPI’s Invega Sustenna® brand products prior to
`
`the expiration of the ’906 Patent.
`
`THE PARTIES
`
`3.
`
`JPI is a corporation organized and existing under the laws of the
`
`Commonwealth of Pennsylvania, having its principal place of business at 1125 Trenton-
`
`Harbourton Road, Titusville, New Jersey 08560.
`
`4.
`
`JPN is a corporation organized and existing under the laws of Belgium,
`
`having its principal place of business at Turnhoutseweg, 30, B-2340, Beerse, Belgium.
`
`5.
`
`On information and belief, Mylan Labs is a corporation organized and
`
`existing under the laws of India, having a place of business at Plot No. 564/A/22, Road No. 92,
`
`Jubilee Hills, 500034, Hyderabad, India. Upon information and belief, Mylan Labs is an agent
`
`or affiliate of Mylan Pharmaceuticals and Mylan Institutional.
`
`6.
`
`On information and belief, Mylan Pharmaceuticals is a corporation
`
`organized and existing under the laws of West Virginia, having a place of business at 781
`
`Janssen Ex. 2001
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`Chestnut Ridge Road, Morgantown, West Virginia 26505. Upon information and belief, Mylan
`
`Pharmaceuticals is an agent or affiliate of Mylan Labs and Mylan Institutional.
`
`7.
`
`On information and belief, Mylan Institutional is a limited liability
`
`company organized and existing under the laws of Delaware, having a place of business at 4901
`
`Hiawatha Drive, Rockford, Illinois 61003. Upon information and belief, Mylan Institutional is
`
`an agent or affiliate of Mylan Labs and Mylan Pharmaceuticals.
`
`8.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals are pharmaceutical companies that develop, manufacture, market, and distribute
`
`pharmaceutical products, including generic pharmaceutical products, for sale in the State of New
`
`Jersey and throughout the United States.
`
`9.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals are wholly-owned subsidiaries of Mylan Inc., a corporation organized under the
`
`laws of Pennsylvania, with a principal place of business at 1000 Mylan Boulevard, Canonsburg,
`
`Pennsylvania 15317.
`
`10.
`
`On information and belief, Mylan Inc. is a wholly-owned subsidiary of
`
`Mylan N.V., a corporation organized under the laws of the Netherlands, with a place of business
`
`at Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire AL10 9UL, England.
`
`11.
`
`On information and belief, Mylan Labs is acting on behalf of itself and on
`
`behalf of Mylan Pharmaceuticals and Mylan Institutional with respect to Mylan’s ANDA No.
`
`213124.
`
`JURISDICTION AND VENUE
`
`12.
`
`This is an action for patent infringement arising under the Patent Laws of
`
`the United States, 35 U.S.C. § 271(e)(2), including an action seeking declaratory judgment
`
`pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02.
`
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`13.
`
`This Court has jurisdiction over the subject matter of this action pursuant
`
`to 28 U.S.C. §§ 1331 and 1338(a).
`
`14.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
`
`§ 1400(b).
`
`Mylan Labs
`
`15.
`
`This Court has personal jurisdiction over Mylan Labs because, inter alia,
`
`Mylan Labs has committed an act of patent infringement under 35 U.S.C. § 271(e)(2) and
`
`intends a future course of conduct that includes acts of patent infringement in New Jersey. These
`
`acts have led and will lead to foreseeable harm and injury to Plaintiffs in New Jersey. For
`
`example, on information and belief, following approval of ANDA No. 213124, Mylan Labs will,
`
`directly or through its affiliates Mylan Pharmaceuticals and/or Mylan Institutional, make, use,
`
`import, sell, and/or offer for sale its proposed generic versions of JPI’s Invega Sustenna® brand
`
`products in the United States, including in New Jersey, prior to the expiration of the ’906 Patent.
`
`16.
`
`Exercising personal jurisdiction over Mylan Labs in this district would not
`
`be unreasonable given Mylan Labs’ contacts in this district and the interest in this district of
`
`resolving disputes related to products to be sold herein.
`
`17.
`
`This Court also has personal jurisdiction over Mylan Labs because Mylan
`
`Labs has purposefully availed itself of the rights and benefits of New Jersey law by engaging in
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Mylan Labs regularly and continuously transacts business within New Jersey, either directly or
`
`through its affiliates—including Mylan Pharmaceuticals and Mylan Institutional—including by
`
`selling pharmaceutical products in New Jersey. On information and belief, Mylan Labs derives
`
`substantial revenue from the sale of those products in New Jersey and has availed itself of the
`
`privilege of conducting business within New Jersey.
`
`3
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`18.
`
`On information and belief, Mylan Labs, either directly or indirectly
`
`through Mylan Institutional or Mylan Pharmaceuticals, is in the business of formulating,
`
`manufacturing, marketing, and selling generic prescription pharmaceutical drugs that it
`
`distributes in New Jersey and throughout the United States.
`
`19.
`
`This Court also has personal jurisdiction over Mylan Labs because, inter
`
`alia, this action arises from the actions of Mylan Labs directed toward New Jersey. For
`
`example, Mylan Labs’ counsel sent a letter dated June 28, 2019 to JPI, a corporation with its
`
`principal place of business in this Judicial District, stating that Mylan Labs had submitted ANDA
`
`No. 213124 seeking approval to commercially manufacture, use, sell, offer for sale, and/or
`
`import its proposed generic versions of JPI’s Invega Sustenna® brand products prior to the
`
`expiration of the ’906 Patent. If Mylan Labs succeeds in obtaining FDA approval, it would sell
`
`its proposed generic versions of JPI’s Invega Sustenna® brand products in New Jersey and other
`
`states, either directly or through its affiliates Mylan Pharmaceuticals and/or Mylan Institutional,
`
`causing injury to Plaintiffs in New Jersey.
`
`20. Mylan Labs has conceded that venue is proper over Mylan Labs in patent
`
`cases in this Judicial District in at least the following District of New Jersey action: Valeant
`
`Pharmaceuticals et al. v. Mylan Pharmaceuticals, Inc., Civil Action No. 18-cv-14305.
`
`21. Mylan Labs has consented to or did not contest the jurisdiction of this
`
`Court in at least the following District of New Jersey actions: Valeant Pharmaceuticals
`
`International, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al., Civil Action No. 2:15-cv-8180;
`
`Baxter Healthcare Corp., et al. v. Agila Specialties Private Limited, et al., Civil Action No. 1:14-
`
`cv-7094; Horizon Pharma, Inc. et al. v. Mylan Pharmaceuticals, Inc., et al., Civil Action No.
`
`4
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`3:15-cv-3327; and Astrazeneca AB, et al. v. Mylan Pharmaceuticals, Inc., et al., Civil Action No.
`
`3:13-cv-4022.
`
`22.
`
`In the alternative, this Court has personal jurisdiction over Mylan Labs
`
`because the requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met.
`
`Mylan Institutional
`
`23.
`
`On information and belief, Mylan Institutional, either directly or indirectly
`
`through Mylan Labs and/or Mylan Pharmaceuticals, is in the business of formulating,
`
`manufacturing, marketing, and selling generic prescription pharmaceutical drugs that it
`
`distributes in New Jersey and throughout the United States.
`
`24.
`
`This Court has personal jurisdiction over Mylan Institutional because,
`
`inter alia, Mylan Institutional has committed an act of patent infringement under 35 U.S.C.
`
`§ 271(e)(2) and intends a future course of conduct that includes acts of patent infringement in
`
`New Jersey. These acts have led and will lead to foreseeable harm and injury to Plaintiffs in
`
`New Jersey. For example, on information and belief, following approval of ANDA No. 213124,
`
`Mylan Institutional will, directly or through its affiliates Mylan Pharmaceuticals and/or Mylan
`
`Labs, make, use, import, sell, and/or offer for sale its proposed generic versions of JPI’s Invega
`
`Sustenna® brand products in the United States, including in New Jersey, prior to the expiration
`
`of the ’906 Patent.
`
`25.
`
`Exercising personal jurisdiction over Mylan Institutional in this district
`
`would not be unreasonable given Mylan Institutional’s contacts in this district and the interest in
`
`this district of resolving disputes related to products to be sold herein.
`
`26.
`
`This Court also has personal jurisdiction over Mylan Institutional because
`
`Mylan Institutional has purposefully availed itself of the rights and benefits of New Jersey law
`
`by engaging in systematic and continuous contacts with the State of New Jersey. On information
`
`5
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`and belief, Mylan Institutional regularly and continuously transacts business within New Jersey,
`
`either directly or through its affiliates—including Mylan Pharmaceuticals and Mylan Labs—
`
`including by selling pharmaceutical products in New Jersey. On information and belief, Mylan
`
`Institutional derives substantial revenue from the sale of those products in New Jersey and has
`
`availed itself of the privilege of conducting business within New Jersey.
`
`27.
`
`On information and belief, Mylan Institutional has substantial, continuous
`
`and systematic contacts with New Jersey, is registered to do business in New Jersey, has
`
`appointed a registered agent in New Jersey for receipt of service of process, and is registered as a
`
`drug manufacturer and wholesaler in New Jersey.
`
`28.
`
`This Court also has personal jurisdiction over Mylan Institutional because,
`
`inter alia, this action arises from the actions of Mylan Institutional directed toward New Jersey,
`
`either directly or through Mylan Labs and/or Mylan Pharmaceuticals. For example, Mylan Labs’
`
`counsel sent a letter dated June 28, 2019 to JPI, a corporation with its principal place of business
`
`in this Judicial District, stating that Mylan Labs had submitted ANDA No. 213124 seeking
`
`approval to commercially manufacture, use, sell, offer for sale, and/or import its proposed
`
`generic versions of JPI’s Invega Sustenna® brand products prior to the expiration of the ’906
`
`Patent. If Mylan Labs succeeds in obtaining FDA approval, Mylan Institutional would sell its
`
`proposed generic versions of JPI’s Invega Sustenna® brand products in New Jersey and other
`
`states, either directly or through its affiliates Mylan Pharmaceuticals and/or Mylan Labs, causing
`
`injury to Plaintiffs in New Jersey.
`
`29. Mylan Institutional has consented to or did not contest the jurisdiction of
`
`this Court in at least the following District of New Jersey action: Astrazeneca Pharmaceuticals
`
`LP, et al., v. Mylan Institutional LLC, Civil Action No. 1:16-cv-4612.
`
`6
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`Mylan Pharmaceuticals
`
`30.
`
`On information and belief, Mylan Pharmaceuticals, either directly or
`
`indirectly through Mylan Labs or Mylan Pharmaceuticals, is in the business of formulating,
`
`manufacturing, marketing, and selling generic prescription pharmaceutical drugs that it
`
`distributes in New Jersey and throughout the United States.
`
`31.
`
`On information and belief, Mylan Pharmaceuticals has substantial,
`
`continuous, and systematic contacts with New Jersey, including, but not limited to, the direction
`
`of operation and management of Mylan Labs and Mylan Institutional.
`
`32.
`
`This Court has personal jurisdiction over Mylan Pharmaceuticals because,
`
`inter alia, Mylan Pharmaceuticals has committed an act of patent infringement under 35 U.S.C.
`
`§ 271(e)(2) and intends a future course of conduct that includes acts of patent infringement in
`
`New Jersey. These acts have led and will lead to foreseeable harm and injury to Plaintiffs in
`
`New Jersey. For example, on information and belief, following approval of ANDA No. 213124,
`
`Mylan Pharmaceuticals will, directly or through its affiliates Mylan Institutional or Mylan Labs,
`
`make, use, import, sell, and/or offer for sale its proposed generic versions of JPI’s Invega
`
`Sustenna® brand products in the United States, including in New Jersey, prior to the expiration
`
`of the ’906 Patent.
`
`33.
`
`Exercising personal jurisdiction over Mylan Pharmaceuticals in this
`
`district would not be unreasonable given Mylan Pharmaceuticals’ contacts in this district and the
`
`interest in this district of resolving disputes related to products to be sold herein.
`
`34.
`
`This Court also has personal jurisdiction over Mylan Pharmaceuticals
`
`because Mylan Pharmaceuticals has purposefully availed itself of the rights and benefits of New
`
`Jersey law by engaging in systematic and continuous contacts with the State of New Jersey. On
`
`information and belief, Mylan Pharmaceuticals regularly and continuously transacts business
`
`7
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`within New Jersey, either directly or through its affiliates—including Mylan Institutional and
`
`Mylan Labs—including by selling pharmaceutical products in New Jersey. On information and
`
`belief, Mylan Pharmaceuticals derives substantial revenue from the sale of those products in
`
`New Jersey and has availed itself of the privilege of conducting business within New Jersey.
`
`35.
`
`On information and belief, Mylan Pharmaceuticals has substantial,
`
`continuous and systematic contacts with New Jersey, is registered to do business in New Jersey,
`
`has appointed a registered agent in New Jersey for receipt of service of process, and is registered
`
`as a drug manufacturer and wholesaler in New Jersey.
`
`36.
`
`This Court also has personal jurisdiction over Mylan Pharmaceuticals
`
`because, inter alia, this action arises from the actions of Mylan Pharmaceuticals directed toward
`
`New Jersey, either directly or through Mylan Labs and/or Mylan Institutional. For example,
`
`Mylan Labs’ counsel sent a letter dated June 28, 2019 to JPI, a corporation with its principal
`
`place of business in this Judicial District, stating that Mylan Labs had submitted ANDA No.
`
`213124 seeking approval to commercially manufacture, use, sell, offer for sale, and/or import its
`
`proposed generic versions of JPI’s Invega Sustenna® brand products prior to the expiration of
`
`the ’906 Patent. If Mylan Labs succeeds in obtaining FDA approval, Mylan Pharmaceuticals
`
`would sell its proposed generic versions of JPI’s Invega Sustenna® brand products in New
`
`Jersey and other states, either directly or through its affiliates Mylan Labs and/or Mylan
`
`Institutional, causing injury to Plaintiffs in New Jersey. Furthermore, upon information and
`
`belief, Mylan Pharmaceuticals is Mylan Labs’ authorized agent with respect to ANDA No.
`
`213124.
`
`37. Mylan Pharmaceuticals has consented to or did not contest the jurisdiction
`
`of this Court in at least the following District of New Jersey actions: Valeant Pharmaceuticals
`
`8
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`International, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al., Civil Action No. 2:15-cv-8180;
`
`Baxter Healthcare Corp., et al. v. Agila Specialties Private Limited, et al., Civil Action No. 1:14-
`
`cv-7094; Horizon Pharma, Inc. et al. v. Mylan Pharmaceuticals, Inc., et al., Civil Action No.
`
`3:15-cv-3327; Astrazeneca AB, et al. v. Mylan Pharmaceuticals, Inc., et al., Civil Action No.
`
`3:13-cv-4022; and Janssen Products, L.P. et al. v. Lupin Limited, et al., Civil Action No. 2:10-
`
`cv-5954.
`
`Mylan Labs, Mylan Institutional, and Mylan Pharmaceuticals
`
`38.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals, along with other subsidiaries of Mylan N.V., hold themselves out as a single
`
`entity for the purposes of manufacturing, selling, marketing, distribution, and importation of
`
`generic drug products in New Jersey and throughout the United States.
`
`39.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals employ people and maintain a regular and established office in New Jersey,
`
`including at least at 110 Allen Road, Basking Ridge, New Jersey 07920.
`
`40.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals are agents of each other with respect to formulating, manufacturing, packaging,
`
`marketing and/or selling pharmaceutical products throughout the United States and will do the
`
`same with respect to the product for which they have sought approval from the FDA in ANDA
`
`No. 213124.
`
`41.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals are acting in concert with each other with respect to formulating,
`
`manufacturing, packaging, marketing, and/or selling pharmaceutical products throughout the
`
`United States and will do the same with respect to the product for which they have sought
`
`approval from the FDA in ANDA No. 213124.
`
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`42.
`
`On information and belief, Mylan Pharmaceuticals and Mylan
`
`Institutional, together with their affiliate and/or agent Mylan Labs, filed the Mylan ANDA with
`
`the FDA that is at issue in this patent infringement suit.
`
`43.
`
`On information and belief, Mylan Labs, Mylan Institutional, and Mylan
`
`Pharmaceuticals, alone and/or together with each other as affiliates and/or agents, have
`
`committed, or aided, abetted, actively induced, contributed to, or participated in the commission
`
`of an act of patent infringement under 35 U.S.C. § 271(e)(2) that has led and/or will lead to
`
`foreseeable harm and injury to Plaintiffs, including JPI, which is a New Jersey company, in New
`
`Jersey.
`
`THE PATENT-IN-SUIT
`
`44.
`
`On September 13, 2016, the ’906 Patent, titled “Dosing Regimen
`
`Associated with Long Acting Injectable Paliperidone Esters” was duly and legally issued to JPN
`
`as assignee. A copy of the ’906 Patent is attached as Exhibit A.
`
`45.
`
`JPI holds approved NDA No. 022264 for paliperidone palmitate extended
`
`release injectable suspension, which is prescribed and sold under the trademark Invega
`
`Sustenna®.
`
`46.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’906 Patent is listed in the United
`
`States FDA publication titled Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (also known as the “Orange Book”) as covering JPI’s Invega Sustenna® brand
`
`paliperidone palmitate extended release suspension products.
`
`47.
`
`Invega Sustenna® is indicated for treatment of schizophrenia in adults and
`
`treatment of schizoaffective disorder in adults as a monotherapy and as an adjunct to mood
`
`stabilizers or antidepressants.
`
`10
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`COUNT I: INFRINGEMENT OF THE ’906 PATENT
`BY MYLAN’S ANDA FOR INVEGA SUSTENNA®
`
`48.
`
`49.
`
`Plaintiffs re-allege paragraphs 1-47 as if fully set forth herein.
`
`An actual controversy exists between the parties as to whether Mylan’s
`
`proposed sale of its generic paliperidone palmitate extended-release injectable suspension
`
`products infringes at least one claim, including claim 1, of the ’906 Patent.
`
`50.
`
`By letter dated June 28, 2019 (“Mylan Notice Letter”), Mylan Labs
`
`notified Plaintiffs that it had submitted ANDA No. 213124 to the FDA under § 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). The Notice Letter stated that ANDA
`
`No. 213124 seeks the FDA approval necessary to engage in the commercial manufacture, use,
`
`sale, offer for sale in, and/or importation into the United States, including the State of New
`
`Jersey, of generic paliperidone palmitate extended-release injectable suspension products prior to
`
`the expiration of certain of JPN’s Orange Book listed patents. ANDA No. 213124 specifically
`
`seeks FDA approval to market generic versions of JPI’s Invega Sustenna® brand paliperidone
`
`palmitate extended-release injectable suspension products in 39 mg, 78 mg, 117 mg, 156 mg, and
`
`234 mg doses prior to the expiration of the ’906 Patent.
`
`51.
`
`ANDA No. 213124 includes a Paragraph IV Certification that the claims
`
`of the ’906 Patent are invalid, unenforceable, and/or not infringed.
`
`52.
`
`The Mylan Notice Letter was sent to Plaintiffs via overnight mail on July
`
`1, 2019 and received by Plaintiffs on July 2, 2019. Plaintiffs commenced this action within 45
`
`days of the date of receipt of Mylan’s Notice Letter.
`
`53.
`
`The Mylan Notice Letter purports to include a Notice of Certification for
`
`ANDA No. 213124 under 37 C.F.R. § 314.95(c)(6) as to the ’906 Patent. The Mylan Notice
`
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`Letter did not include a detailed statement of allegations of non-infringement as to at least one
`
`claim of the ’906 Patent.
`
`54. Mylan has actual knowledge of the ’906 Patent, as shown by the Mylan
`
`Notice Letter.
`
`55.
`
`On information and belief, Mylan’s generic products, if approved and
`
`marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim,
`
`including at least claim 1 of the ’906 Patent, under at least one of 35 U.S.C. § 271(a), (b), and/or
`
`(c).
`
`56.
`
`On information and belief, under 35 U.S.C. § 271(e)(2)(A), Mylan has
`
`infringed at least one claim, including at least claim 1, of the ’906 Patent by submitting, or
`
`causing to be submitted, to the FDA ANDA No. 213124 seeking approval to manufacture, use,
`
`import, offer to sell or sell Mylan’s generic products before the expiration date of the ’906
`
`Patent. Upon information and belief, the products described in ANDA No. 213124 would
`
`infringe, either literally or under the doctrine of equivalents, at least one claim, including at least
`
`claim 1 of the ’906 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`57.
`
`On information and belief, physicians and/or patients will directly infringe
`
`at least one claim, including at least claim 1, of the ’906 Patent by use of Mylan’s generic
`
`products upon approval.
`
`58.
`
`On information and belief, upon approval, Mylan will take active steps to
`
`encourage the use of Mylan’s generic products by physicians and/or patients with the knowledge
`
`and intent that Mylan’s generic products will be used by physicians and/or patients in a manner
`
`that infringes at least one claim, including at least claim 1, of the ’906 Patent for the pecuniary
`
`benefit of Mylan. Pursuant to 21 C.F.R. § 314.94, Mylan is required to copy the FDA-approved
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`Case 2:19-cv-16484 Document 1 Filed 08/08/19 Page 14 of 17 PageID: 14
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`Invega Sustenna® labeling. Mylan specifically intends its generic paliperidone palmitate
`
`products to be used according to its proposed labeling in a manner that infringes at least one
`
`claim, including at least claim 1, of the ’906 Patent. Upon information and belief, Mylan will
`
`thus induce the infringement of at least one claim, including at least claim 1 of the ’906 Patent.
`
`59.
`
`On information and belief, if the FDA approves ANDA No. 213124,
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`Mylan will sell or offer to sell its generic products specifically labeled for use in practicing at
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`least one claim, including at least claim 1 of the ’906 Patent, wherein Mylan’s generic products
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`are a material part of the claimed invention, wherein Mylan knows that physicians will prescribe
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`and patients will use Mylan’s generic products in accordance with the instructions and/or label
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`provided by Mylan in practicing at least one claim, including at least claim 1 of the ’906 Patent,
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`and wherein Mylan’s generic paliperidone palmitate extended-release injectable suspension
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`products are not staple articles or commodities of commerce suitable for substantial non-
`
`infringing use. Mylan’s generic paliperidone palmitate extended-release injectable suspension
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`products are specifically designed for use in a manner that infringes at least one claim, including
`
`at least claim 1, of the ’906 Patent. On information and belief, Mylan will thus contribute to the
`
`infringement of at least one claim, including at least claim 1 of the ’906 Patent.
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`60.
`
`On information and belief, the actions described in this Complaint relating
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`to Mylan’s ANDA No. 213124 were done by and for the benefit of Mylan.
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`61.
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`Plaintiffs will be irreparably harmed by Mylan’s infringing activities
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`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
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`law.
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`62.
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`This case is an exceptional one, and Plaintiffs are entitled to an award of
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`their reasonable attorneys’ fees under 35 U.S.C. § 285.
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`Case 2:19-cv-16484 Document 1 Filed 08/08/19 Page 15 of 17 PageID: 15
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`WHEREFORE, Plaintiffs respectfully pray for the following relief:
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`PRAYER FOR RELIEF
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`A.
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`Enter judgment under 35 U.S.C. § 271(e)(2)(A) that Mylan has infringed at least
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`one claim of the ’906 Patent through Mylan’s submission of ANDA No. 213124
`
`to the FDA to obtain approval to manufacture, use, import, offer to sell, and sell
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`Mylan’s proposed generic versions of JPI’s Invega Sustenna® brand product
`
`identified in this Complaint in the United States before the expiration of the ’906
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`Patent;
`
`B.
`
`Enter judgment under 35 U.S.C. § 271(a), (b), and/or (c) that Mylan’s commercial
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`manufacture use, offer for sale, or sale within the United States, or importation
`
`into the United States of Mylan’s proposed generic versions of JPI’s Invega
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`Sustenna® brand products identified in this Complaint, prior to the expiration of
`
`the ’906 Patent, constitutes infringement of one or more claims of the ’906 Patent
`
`under 35 U.S.C. § 271(a), (b), or (c);
`
`C.
`
`Order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any approval
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`of ANDA No. 213124 be a date that is not earlier than the expiration date of the
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`’906 Patent, or such later date as the Court may determine;
`
`D.
`
`Order that Mylan, its affiliates, officers, agents, servants, and employees, and
`
`those persons in active concert or participation with Mylan, are preliminarily and
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`permanently enjoined from commercially manufacturing, using, importing,
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`offering for sale, and selling Mylan’s proposed generic versions of JPI’s Invega
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`Sustenna® brand products identified in this Complaint, and any other product that
`
`infringes or contributes to the infringement of the ’906 Patent, prior to the
`
`expiration of the ’906 Patent, or such later date as the Court may determine;
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`Case 2:19-cv-16484 Document 1 Filed 08/08/19 Page 16 of 17 PageID: 16
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`E.
`
`If Mylan engages in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation into the United States of the proposed generic versions of JPI’s
`
`Invega Sustenna® brand products identified in this Complaint prior to the
`
`expiration of the ’906 Patent, a Judgment awarding damages to Plaintiffs resulting
`
`from such infringement with interest;
`
`F.
`
`Declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
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`award Plaintiffs their costs, expenses, and disbursements in this action, including
`
`reasonable attorneys’ fees; and
`
`G.
`
`Award such further and other relief that the Court deems proper and just.
`
`Dated: August 8, 2019
`
`s/Keith J. Miller__________________________
`Keith J. Miller (kmiller@rwmlegal.com)
`Justin T. Quinn (jquinn@rwmlegal.com)
`Michael Gesualdo (mgesuldo@rwmlegal.com)
`ROBINSON MILLER LLC
`Ironside Newark
`110 Edison Place, Suite 302
`Newark, New Jersey 07102
`(973) 690-5400 (Telephone)
`(973) 466-2760 (Facsimile)
`
`Attorneys for Plaintiffs Janssen Pharmaceuticals,
`Inc. and Janssen Pharmaceutica NV
`
`Of counsel:
`Barbara L. Mullin (bmullin@pbwt.com)
`Aron Fischer (afischer@pbwt.com)
`Zhiqiang Liu (zliu@pbwt.com)
`PATTERSON BELKNAP WEBB &
`TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`(212) 336-2000 (Telephone)
`(212) 336-2222 (Facsimile)
`
`Attorneys for Plaintiffs Janssen Pharmaceuticals,
`Inc. and Janssen Pharmaceutica NV
`
`15
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`IPR2020-00440
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`Case 2:19-cv-16484 Document 1 Filed 08/08/19 Page 17 of 17 PageID: 17
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
`
`Pursuant to Local Civil Rule 11.2, I hereby certify that the matter in controversy in this
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`case is not the subject of any action pending in any court, or of any pending arbitration or
`
`administrative proceeding, except for the prior matter Janssen Pharmaceuticals, Inc., et al. v.
`
`Teva Pharmaceuticals USA, Inc., Civil Action No. 2:18-cv-00734 (CCC) (MF), in this Judicial
`
`District, which involves the same plaintiffs and the same patent.
`
`Dated: August 8, 2019
`
`s/ Keith J. Miller_________________
`Keith J. Miller
`ROBINSON MILLER LLC
`Ironside Newark
`110 Edison Place, Suite 302
`Newark, New Jersey 07102
`(973) 690-5400 (Telephone)
`(973) 466-2760 (Facsimile)
`
`Attorneys for Plaintiffs Janssen
`Pharmaceuticals, Inc. and Janssen
`Pharmaceutica NV
`
`Janssen Ex. 2001
`Mylan v. Janssen
`IPR2020-00440
`
`