Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 1 of 18 PageID: 1
`
`Donald A. Robinson
`Keith J. Miller
`Justin T. Quinn
`ROBINSON MILLER LLC
`One Newark Center, 19th Floor
`Newark, NJ 07102
`(973) 690-5400
`
`Imron T. Aly (pro hac vice application to be filed)
`SCHIFF HARDIN LLP
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`(312) 258-5500
`
`John K. Hsu (pro hac vice application to be filed)
`SCHIFF HARDIN LLP
`901 K Street NW, Suite 700
`Washington, DC 20001
`
`Gina M. Bassi (pro hac vice application to be filed)
`Christine W. Feller (pro hac vice application to be filed)
`Ahmed M.T. Riaz
`SCHIFF HARDIN LLP
`666 Fifth Avenue, Suite 1700
`New York, NY 10103
`
`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`CA No. _______________________
`
`
`
`
`FRESENIUS KABI USA, LLC,
`
`
`Plaintiff,
`
`v.
`
`DR. REDDY’S LABORATORIES, INC., DR.
`REDDY’S LABORATORIES, LTD.,
`
`
`Defendants.
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`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 2 of 18 PageID: 2
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`COMPLAINT
`
`Plaintiff Fresenius Kabi USA, LLC (“Fresenius Kabi”), by its undersigned attorneys, for
`
`its complaint against Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories,
`
`Ltd. (collectively “DRL”), hereby alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, in response to the submission of an Abbreviated New Drug
`
`Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”), seeking approval
`
`to manufacture and sell a generic version of levothyroxine sodium powder for injection prior to
`
`the expiration of U.S. Patent Nos. 9,006,289 (“the ’289 Patent”), 9,168,238 (“the ’238 Patent”)
`
`and 9,168,239 (“the ’239 Patent”).
`
`THE PARTIES
`
`2.
`
`Plaintiff Fresenius Kabi is a corporation organized and existing under the laws of
`
`the state of Delaware, having its corporate headquarters at Three Corporate Drive, Lake Zurich,
`
`Illinois 60047.
`
`3.
`
`On information and belief, Dr. Reddy’s Laboratories, Inc. is a corporation
`
`organized and existing under the laws of the state of New Jersey, having its corporate
`
`headquarters at 107 College Road East, Princeton, NJ 08540. On information and belief, Dr.
`
`Reddy’s Laboratories, Inc. manufactures and/or distributes numerous generic drugs for sale and
`
`use throughout the United States, including in this judicial district. Upon information and belief,
`
`Dr. Reddy’s Laboratories, Inc. also prepares and/or aids in the preparation and submission of
`
`Abbreviated New Drug Applications (“ANDA”) to the FDA.
`
`-2-
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`

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`4.
`
`On information and belief, Dr. Reddy’s Laboratories, Ltd. is an Indian
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`corporation organized and existing under the laws of India, having its corporate headquarters at
`
`8-2-337, Road No. 3, Banjara Hills, Hyderabad – 500034, Andhra Pradesh, India. Upon
`
`information and belief, Dr. Reddy’s Laboratories, Ltd. is in the business of manufacturing and/or
`
`distributing numerous generic drugs for sale and use throughout the United States, including in
`
`this judicial district.
`
`JURISDICTION AND VENUE
`
`5.
`
`This action for patent infringement arises under 35 U.S.C. § 1 et seq. generally
`
`and 35 U.S.C. § 271 specifically.
`
`6.
`
`This Court has subject matter jurisdiction over this dispute pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`7.
`
`Personal jurisdiction over Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. is proper because, upon information and belief, each directly, or through its
`
`affiliates and agents, develops, formulates, manufactures, markets, and sells pharmaceutical drug
`
`products, including generic drug products, throughout the United States and in this judicial
`
`district. Upon information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. has each committed, aided, abetted, induced, contributed to, and/or
`
`participated in the commission of, a tortious act of patent infringement directly, or through its
`
`affiliates and agents, that has led to foreseeable harm and injury to Plaintiff in New Jersey. Upon
`
`information and belief, Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s Laboratories, Ltd,
`
`through Dr. Reddy’s Laboratories, Ltd., has purposefully conducted and continues to conduct
`
`business in New Jersey, including by maintaining Dr. Reddy’s Laboratories, Inc.’s corporate
`
`headquarters in New Jersey, and, as a result, New Jersey is a likely destination of Dr. Reddy’s
`
`Laboratories, Inc.’s and Dr. Reddy’s Laboratories, Ltd.’s generic products.
`
`-3-
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`8.
`
`Upon information and belief, personal jurisdiction is also proper over Dr. Reddy’s
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. because they have purposely availed
`
`themselves of the rights and benefits of the laws of the State of New Jersey, having engaged in
`
`systematic and continuous contacts with the State of New Jersey and having previously
`
`submitted to personal jurisdiction in this Court, including in the following case: Dexcel Pharma
`
`Technologies Ltd., et al. v. Dr. Reddy’s Laboratories, Ltd. et al., Case No. 1:2015-cv-08042.
`
`9.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`THE PATENTS-IN-SUIT
`
`10.
`
`The ’289 Patent, entitled “Levothyroxine Formulations,” was duly and legally
`
`issued on April 14, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as the
`
`inventors. A true and correct copy of the ’289 Patent is attached hereto as Exhibit A.
`
`11.
`
`The ’238 Patent, entitled “Levothyroxine Formulations,” was duly and legally
`
`issued on October 27, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as
`
`the inventors. A true and correct copy of the ’238 Patent is attached hereto as Exhibit B.
`
`12.
`
`The ’239 Patent, entitled “Levothyroxine Formulations,” was duly and legally
`
`issued on October 27, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as
`
`the inventors. A true and correct copy of the ’239 Patent is attached hereto as Exhibit C.
`
`13.
`
`Plaintiff Fresenius Kabi is the assignee and lawfully owns all rights, title, and
`
`interest in the ’289 Patent, the ’238 Patent, and the ’239 Patent (“the patents-in-suit”), including
`
`the right to sue and to recover for past infringement thereof.
`
`14.
`
`The FDA issues a publication entitled Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”).
`
`15.
`
`Fresenius Kabi is the holder of New Drug Application (“NDA”) No. 202231 for
`
`Levothyroxine Sodium, which the FDA approved on June 24, 2011. In accordance with 21
`
`-4-
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`

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`U.S.C. § 355(b)(1), the ’289 Patent, the ’238 Patent, and the ’239 Patent are each listed in the
`
`Orange Book in connection with approved NDA No. 202231, as patents “with respect to which a
`
`claim of patent infringement could reasonably be asserted if a person not licensed by the owner
`
`engaged in the manufacture, use, or sale” of Fresenius Kabi’s NDA drug product.
`
`16.
`
`Fresenius Kabi currently sells in the United States Levothyroxine Sodium.
`
`According to the Orange Book, the ’289 Patent is currently not due to expire until October 3,
`
`2032; the ’238 Patent is currently not due to expire until August 29, 2032; and the ’239 Patent is
`
`also currently not due to expire until August 29, 2032.
`
`DRL’S ANDA NO. 208837
`
`17.
`
`On information and belief, DRL submitted ANDA No. 208837 to the FDA under
`
`§ 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), seeking FDA
`
`approval to engage in the commercial manufacture, use, importation, offer for sale, or sale of
`
`generic 100 mcg/vial levothyroxine sodium for injection (the “ANDA Product”).
`
`18.
`
`On information and belief, ANDA No. 208837 contains a Paragraph IV
`
`certification that the ’289 Patent, the ’238 Patent, and the ’239 Patent are invalid, unenforceable,
`
`and/or will not be infringed by the commercial manufacture, use, or sale of the drug product
`
`described by DRL’s ANDA No. 208837.
`
`19.
`
`20.
`
`On information and belief, DRL is the owner of ANDA No. 208837.
`
`On information and belief, if ANDA No. 208837 is approved by the FDA before
`
`the expiration of the ’289 Patent, the ’238 Patent, and/or the ’239 Patent, DRL will begin
`
`manufacturing, using, importing, offering for sale, and/or selling the ANDA Product, despite the
`
`patents.
`
`-5-
`
`

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`21.
`
`On information and belief, if ANDA No. 208837 is approved by the FDA, DRL
`
`will begin marketing the ANDA Product for treatment of myxedema coma, and doctors and
`
`patients will use the ANDA Product for the indications marketed by DRL.
`
`22.
`
`Pursuant to FDA regulation 21 C.F.R. § 314.94, in order to secure FDA approval,
`
`the ANDA Product’s dosage strength must have the same strength as one of the approved
`
`dosages for Fresenius Kabi’s NDA levothyroxine sodium products (“the NDA products”). In
`
`addition, the ANDA Product must be bioequivalent to the NDA products.
`
`23.
`
`Fresenius Kabi received a letter (“the Notice Letter”), purporting to be a Notice of
`
`Certification for ANDA No. 208837 under Section 505(j)(2)(B) of the Federal Food, Drug, and
`
`Cosmetic Act, 21 U.S.C. § 355(j)(2)(B), and 21 CFR § 314.95(c). The Paragraph IV
`
`certifications alleged that the claims of the ’289 Patent, the ’238 Patent, and the ’239 Patent are
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale
`
`of the ANDA Product.
`
`24.
`
`On information and belief, ANDA No. 208837 seeks approval of a generic
`
`levothyroxine product that is the same, or substantially the same, as Fresenius Kabi’s
`
`commercially marketed and approved Levothyroxine Sodium product.
`
`25.
`
`On information and belief, DRL was aware of the ’289 Patent, the ’238 Patent,
`
`and the ’239 Patent when ANDA No. 208837 was submitted to the FDA, containing the above-
`
`described Paragraph IV certifications concerning the patents-in-suit.
`
`COUNT I: INFRINGEMENT OF THE ’289 PATENT – ANDA SUBMISSION
`
`26.
`
`27.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-25 above.
`
`The submission of ANDA No. 208837, including a Paragraph IV certification
`
`regarding the ’289 Patent, was an act of infringement by DRL of one or more claims of the ’289
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`-6-
`
`

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`28.
`
`On information and belief, the use of the ANDA Product in accordance with and
`
`as directed by the instructions contained in the proposed package insert of DRL’s ANDA No.
`
`208837 is covered by one or more claims of the ’289 Patent.
`
`29.
`
`On information and belief, DRL’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Product before the expiration of the ’289 Patent would
`
`infringe, contribute to the infringement of, and/or induce the infringement of one or more claims
`
`of the ’289 Patent.
`
`30.
`
`On information and belief, the use of DRL’s ANDA Product in accordance with
`
`and as directed by DRL’s proposed labeling will infringe one or more claims of the ’289 Patent.
`
`31.
`
`On information and belief, by seeking approval to distribute the ANDA Product
`
`with their proposed labeling, DRL intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that DRL knows will infringe one or more claims of
`
`the ’289 Patent.
`
`32.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’289 Patent immediately
`
`following approval of ANDA No. 208837.
`
`33.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, contribute to the infringement of one or more claims of the ’289 Patent immediately
`
`following approval of ANDA No. 208837.
`
`34.
`
`On information and belief, DRL knows that its ANDA No. 208837 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’289 Patent, and that the DRL ANDA Product and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`-7-
`
`

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`35.
`
`On information and belief, DRL’s actions through the licensing, manufacture, use,
`
`import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to ANDA No.
`
`208837 will directly infringe, contributorily infringe, and/or induce infringement of at least one
`
`claim of the ’289 patent.
`
`36.
`
`On information and belief, DRL has been aware of the existence of the ’289
`
`Patent since before the submission of ANDA No. 208837.
`
`37.
`
`On information and belief, DRL has no reasonable basis for believing that its
`
`ANDA Product will not infringe one or more valid claims of the ’289 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. DRL posited no theory of non-
`
`infringement in its Notice Letter concerning the ’289 Patent.
`
`38.
`
`39.
`
`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Product with their proposed labeling immediately following approval of ANDA
`
`No. 208837 and before the expiration of the ’289 Patent.
`
`40.
`
`The acts of infringement by DRL set forth above will cause Fresenius Kabi
`
`irreparable harm for which it has no adequate remedy at law, and those acts will continue unless
`
`enjoined by this Court.
`
`41.
`
`Fresenius Kabi is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including, inter alia, an order of this Court that the FDA set the effective date of approval for
`
`DRL’s ANDA No. 208837 to be a date which is not any earlier than the expiration date of the
`
`’289 Patent, including any extensions of that date.
`
`COUNT II: INFRINGEMENT OF THE ’289 PATENT – DECLARATORY JUDGMENT
`
`42.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-41 above.
`
`-8-
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`

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`43.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`44.
`
`There is an actual case or controversy such that the Court may entertain Fresenius
`
`Kabi’s request for declaratory relief consistent with Article III of the United States Constitution,
`
`and this actual case or controversy requires a declaration of rights by this Court.
`
`45.
`
`DRL has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import DRL’s generic levothyroxine sodium
`
`product before the expiration of the ’289 patent, including DRL’s filing of ANDA No. 208837.
`
`46.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of DRL’s generic levothyroxine sodium product by DRL will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’289
`
`patent.
`
`47.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and DRL as to liability for the infringement of
`
`the ’289 patent claims. DRL’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from DRL’s threatened imminent actions.
`
`48.
`
`Fresenius Kabi is entitled to declaratory judgment that DRL’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of DRL’s generic levothyroxine sodium
`
`product will constitute infringement of one or more claims of the ’289 patent under one or more
`
`provisions of 35 U.S.C. § 271, including §§ 271(a), (b), and/or (c).
`
`COUNT III: INFRINGEMENT OF THE ’238 PATENT – ANDA SUBMISSION
`
`49.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-48 above.
`
`-9-
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`

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`50.
`
`The submission of ANDA No. 208837 including a Paragraph IV certification
`
`regarding the ’238 Patent was an act of infringement by DRL of one or more claims of the ’238
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`51.
`
`On information and belief, the use of ANDA Product in accordance with and as
`
`directed by the instructions contained in the proposed package insert of DRL’s ANDA No.
`
`208837 is covered by one or more claims of the ’238 Patent.
`
`52.
`
`On information and belief, DRL’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Product before the expiration of the ’238 Patent would
`
`infringe, contribute to the infringement of, and/or induce the infringement of one or more claims
`
`of the ’238 Patent.
`
`53.
`
`On information and belief, the use of DRL’s ANDA Product in accordance with
`
`and as directed by DRL’s proposed labeling will infringe one or more claims of the ’238 Patent.
`
`54.
`
`On information and belief, by seeking approval to distribute the ANDA Product
`
`with their proposed labeling, DRL intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that DRL knows will infringe one or more claims of
`
`the ’238 Patent.
`
`55.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’238 Patent immediately
`
`following approval of ANDA No. 208837.
`
`56.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, contribute to the infringement of one or more claims of the ’238 Patent immediately
`
`following approval of ANDA No. 208837.
`
`-10-
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`

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`57.
`
`On information and belief, DRL knows that its ANDA No. 208837 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’238 Patent, and that the DRL ANDA Product and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`58.
`
`On information and belief, DRL’s actions through the licensing, manufacture, use,
`
`import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to ANDA No.
`
`208837 will directly infringe, contributorily infringe, and/or induce infringement of at least one
`
`claim of the ’238 patent.
`
`59.
`
`On information and belief, DRL has been aware of the existence of the’238 Patent
`
`since before the submission of ANDA No. 208837.
`
`60.
`
`On information and belief, DRL has no reasonable basis for believing that its
`
`ANDA Product will not infringe one or more valid claims of the ’238 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. DRL posited no theory of non-
`
`infringement in its Notice Letter concerning the ’238 Patent.
`
`61.
`
`62.
`
`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Product with their proposed labeling immediately following approval of ANDA
`
`No. 208837 and before the expiration of the ’238 Patent.
`
`63.
`
`The acts of infringement by DRL set forth above will cause Fresenius Kabi
`
`irreparable harm for which it has no adequate remedy at law, and those acts will continue unless
`
`enjoined by this Court.
`
`-11-
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`

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`64.
`
`Fresenius Kabi is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including, inter alia, an order of this Court that the FDA set the effective date of approval for
`
`DRL’s ANDA No. 208837 to be a date which is not any earlier than the expiration date of the
`
`’238 Patent, including any extensions of that date.
`
`COUNT IV: INFRINGEMENT OF THE ’238 PATENT – DECLARATORY JUDGMENT
`
`65.
`
`66.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-64 above.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`67.
`
`There is an actual case or controversy such that the Court may entertain Fresenius
`
`Kabi’s request for declaratory relief consistent with Article III of the United States Constitution,
`
`and this actual case or controversy requires a declaration of rights by this Court.
`
`68.
`
`DRL has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import DRL’s generic levothyroxine sodium
`
`product before the expiration of the ’238 patent, including DRL’s filing of ANDA No. 208837.
`
`69.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of DRL’s generic levothyroxine sodium product by DRL will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’238
`
`patent.
`
`70.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and DRL as to liability for the infringement of
`
`the ’238 patent claims. DRL’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from DRL’s threatened imminent actions.
`
`71.
`
`Fresenius Kabi is entitled to declaratory judgment that DRL’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of DRL’s generic levothyroxine sodium
`
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`

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`product will constitute infringement of one or more claims of the ’238 patent under one or more
`
`provisions of 35 U.S.C. § 271, including §§ 271(a), (b), and/or (c).
`
`COUNT V: INFRINGEMENT OF THE ’239 PATENT – ANDA SUBMISSION
`
`72.
`
`73.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-71 above.
`
`The submission of ANDA No. 208837 including a Paragraph IV certification
`
`regarding the ’239 Patent was an act of infringement by DRL of one or more claims of the ’239
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`74.
`
`On information and belief, the use of ANDA Product in accordance with and as
`
`directed by the instructions contained in the proposed package insert of DRL’s ANDA No.
`
`208837 is covered by one or more claims of the ’239 Patent.
`
`75.
`
`On information and belief, DRL’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Product before the expiration of the ’239 Patent would
`
`infringe, contribute to the infringement of, and/or induce the infringement of one or more claims
`
`of the ’239 Patent.
`
`76.
`
`On information and belief, the use of DRL’s ANDA Product in accordance with
`
`and as directed by DRL’s proposed labeling will infringe one or more claims of the ’239 Patent.
`
`77.
`
`On information and belief, by seeking approval to distribute the ANDA Product
`
`with their proposed labeling, DRL intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that DRL knows will infringe one or more claims of
`
`the ’239 Patent.
`
`78.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’239 Patent immediately
`
`following approval of ANDA No. 208837.
`
`-13-
`
`

`

`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 14 of 18 PageID: 14
`
`79.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to, and will, contribute to the infringement of one or more claims of the ’239 Patent immediately
`
`following approval of ANDA No. 208837.
`
`80.
`
`On information and belief, DRL knows that its ANDA No. 208837 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’239 Patent, and that the DRL ANDA Product and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`81.
`
`On information and belief, DRL’s actions through the licensing, manufacture, use,
`
`import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to ANDA No.
`
`208837 will directly infringe, contributorily infringe, and/or induce infringement of at least one
`
`claim of the ’239 patent.
`
`82.
`
`On information and belief, DRL has been aware of the existence of the’239 Patent
`
`since before the submission of ANDA No. 208837.
`
`83.
`
`On information and belief, DRL has no reasonable basis for believing that its
`
`ANDA Product will not infringe one or more valid claims of the ’239 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. DRL posited no theory of non-
`
`infringement in its Notice Letter concerning the ’239 Patent.
`
`84.
`
`85.
`
`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`On information and belief, unless enjoined by this Court, DRL plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Product with their proposed labeling immediately following approval of ANDA
`
`No. 208837 and before the expiration of the ’239 Patent.
`
`-14-
`
`

`

`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 15 of 18 PageID: 15
`
`86.
`
`The acts of infringement by DRL set forth above will cause Fresenius Kabi
`
`irreparable harm for which it has no adequate remedy at law, and those acts will continue unless
`
`enjoined by this Court.
`
`87.
`
`Fresenius Kabi is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including, inter alia, an order of this Court that the FDA set the effective date of approval for
`
`DRL’s ANDA No. 208837 to be a date which is not any earlier than the expiration date of the
`
`’239 Patent, including any extensions of that date.
`
`COUNT VI: INFRINGEMENT OF THE ’239 PATENT – DECLARATORY JUDGMENT
`
`88.
`
`89.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-87 above.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`90.
`
`There is an actual case or controversy such that the Court may entertain Fresenius
`
`Kabi’s request for declaratory relief consistent with Article III of the United States Constitution,
`
`and this actual case or controversy requires a declaration of rights by this Court.
`
`91.
`
`DRL has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import DRL’s generic levothyroxine sodium
`
`product before the expiration of the ’239 patent, including DRL’s filing of ANDA No. 208837.
`
`92.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of DRL’s generic levothyroxine sodium product by DRL will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’239
`
`patent.
`
`93.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and DRL as to liability for the infringement of
`
`-15-
`
`

`

`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 16 of 18 PageID: 16
`
`the ’239 patent claims. DRL’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from DRL’s threatened imminent actions.
`
`94.
`
`Fresenius Kabi is entitled to declaratory judgment that DRL’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of DRL’s generic levothyroxine sodium
`
`product will constitute infringement of one or more claims of the ’239 patent under one or more
`
`provisions of 35 U.S.C. § 271, including §§ 271(a), (b), and/or (c).
`
`RELIEF SOUGHT
`
`WHEREFORE, Fresenius Kabi respectfully requests the following relief:
`
`A.
`
`B.
`
`Judgment in favor of Fresenius Kabi and against DRL;
`
`Judgment that DRL has infringed, literally or by the doctrine of
`
`equivalents, each of the ’289 Patent, the ’238 Patent, and the ’239 Patent by the submission of
`
`ANDA No. 208837, and that the commercial importation, sale, offer for sale, use, and/or
`
`manufacture of the ANDA Product, in the United States, would infringe, induce infringement of,
`
`and/or contribute to the infringement of each of the ’289 Patent, the ’238 Patent, and the ’239
`
`Patent;
`
`C.
`
`Judgment, pursuant to 35 U.S.C. § 271(e)(4)(A) and other provisions of 35
`
`U.S.C. § 271, that the effective date of approval of ANDA No. 207670 under § 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), shall be a date not earlier than the
`
`latest date of expiration of the ’289 Patent, the ’238 Patent, or the ’239 Patent, plus any
`
`additional periods of exclusivity;
`
`D.
`
`A preliminary and permanent injunction, pursuant to 35 U.S.C. §§ 271 and
`
`283 and Federal Rule of Civil Procedure 65, enjoining DRL, and its officers, partners, agents,
`
`servants, employees, parents, subsidiaries, divisions, affiliate corporations, other related business
`
`entities and all other persons acting in concert, participation, or in privity with them, and their
`
`-16-
`
`

`

`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 17 of 18 PageID: 17
`
`successors and assigns, from any commercial manufacture, use, offer to sell, or sale within the
`
`United States, or importation into the United States, of any ANDA Product, and any product that
`
`is similar to or only colorably different from those products, before the latest date of expiration
`
`of any of the ’289 Patent, the ’238 Patent, and the ’239 Patent, and any additional periods of
`
`exclusivity;
`
`E.
`
`A declaration that this is an exceptional case and an award to Fresenius
`
`Kabi of its reasonable attorneys’ fees and expenses, as provided by 35 U.S.C. §§ 271(e)(4) and
`
`285;
`
`F.
`
`Damages or other monetary relief, including prejudgment interest, if DRL
`
`engages in the commercial manufacture, use, offering to sell, sale, marketing, distribution, or
`
`importation of ANDA Product, or any other products that the use of which would infringe the
`
`’289 Patent, the ’238 Patent, and/or the ’239 Patent, or the inducement of or contribution to the
`
`foregoing, prior to the expiration of the ’289 Patent, the ’238 Patent, and the ’239 Patent;
`
`G.
`
`An award of pre-judgment and post-judgment interest on each and every
`
`award;
`
`H.
`
`An award of Fresenius Kabi’s taxable costs in bringing and prosecuting
`
`this action; and
`
`I.
`
`Such other and further relief to Fresenius Kabi as this Court may deem
`
`just and proper.
`
`-17-
`
`

`

`Case 2:16-cv-01542-KM-MAH Document 1 Filed 03/18/16 Page 18 of 18 PageID: 18
`
`
`
`s/ Donald A. Robinson
`Donald A. Robinson
`Keith J. Miller
`Justin T. Quinn
`ROBINSON MILLER LLC
`One Newark Center, 19th Floor
`Newark, NJ 07102
`(973) 690-5400
`
`
`
` Attorneys for Plaintiff
` Fresenius Kabi USA, LLC
`
`
`
`By:
`
`
`
`
`
`Dated: March 18, 2016
`
`
`
`OF COUNSEL
`Imron T. Aly (pro hac vice application to be
`filed)
`SCHIFF HARDIN LLP
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`(312) 258-5500
`
`John K. Hsu (pro hac vice application to be
`filed)
`SCHIFF HARDIN LLP
`901 K Street NW, Suite 700
`Washington, DC 20001
`
`Gina M. Bassi (pro hac vice application to be
`filed)
`Christine W. Feller (pro hac vice application to
`be filed)
`Ahmed M.T. Riaz
`SCHIFF HARDIN LLP
`666 Fifth Avenue, Suite 1700
`New York, NY 10103
`
`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
`
`
`
`
`
`-18-
`
`