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Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 1 of 17 PageID #: 1
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`FRESENIUS KABI USA, LLC,
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`Plaintiff,
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`v.
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`MAIA PHARMACEUTICALS, INC.,
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`Defendant.
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`C.A. No. _______________________
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`
`COMPLAINT
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`Plaintiff Fresenius Kabi USA, LLC (“Fresenius Kabi”), by its undersigned attorneys, for
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`its complaint against Maia Pharmaceuticals, Inc. (“Maia”), hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, in response to the submission of an Abbreviated New Drug
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`Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”), seeking approval
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`to manufacture and sell a generic version of levothyroxine sodium powder for injection prior to
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`the expiration of U.S. Patent Nos. 9,006,289 (“the ’289 Patent”), 9,168,238 (“the ’238 Patent”)
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`and 9,168,239 (“the ’239 Patent”).
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`THE PARTIES
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`2.
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`Plaintiff Fresenius Kabi is a corporation organized and existing under the laws of
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`the state of Delaware, having its corporate headquarters at Three Corporate Drive, Lake Zurich,
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`Illinois 60047.
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`3.
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`On information and belief, Maia Pharmaceuticals, Inc. is a corporation organized
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`and existing under the laws of the state of Delaware, having its corporate headquarters at 707
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`State Road, Suite 104, Princeton, NJ 08540. On information and belief, Maia Inc. manufactures
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`and/or distributes numerous generic drugs for sale and use throughout the United States,
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`including in this judicial district. Upon information and belief, Maia Inc. also prepares and/or
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`aids in the preparation and submission of Abbreviated New Drug Applications (“ANDA”) to the
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`FDA.
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`JURISDICTION AND VENUE
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`4.
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`This action for patent infringement arises under 35 U.S.C. § 1 et seq. generally
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`and 35 U.S.C. § 271 specifically.
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`5.
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`This Court has subject matter jurisdiction over this dispute pursuant to 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`6.
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`This Court has personal jurisdiction over Maia by virtue of the fact that it is a
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`Delaware corporation and has systematic contacts with the State of Delaware. Personal
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`jurisdiction over Maia is also proper because, upon information and belief, Maia, directly or
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`through its affiliates and agents, develops, formulates, manufactures, markets, and sells
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`pharmaceutical drug products, including generic drug products, throughout the United States and
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`in this judicial district. Further, upon information and belief, Maia has committed, aided,
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`abetted, induced, contributed to, and/or participated in the commission of, a tortious act of patent
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`infringement that has led to foreseeable harm and injury to Plaintiff in Delaware. Upon
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`information and belief, Maia has purposefully conducted and continues to conduct business in
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`Delaware, and, as a result, Delaware is a likely destination of Maia’s generic products.
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`7.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`-2-
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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 3 of 17 PageID #: 3
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`
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`THE PATENTS-IN-SUIT
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`8.
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`The ’289 Patent, entitled “Levothyroxine Formulations,” was duly and legally
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`issued on April 14, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as the
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`inventors. A true and correct copy of the ’289 Patent is attached hereto as Exhibit A.
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`9.
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`The ’238 Patent, entitled “Levothyroxine Formulations,” was duly and legally
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`issued on October 27, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as
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`the inventors. A true and correct copy of the ’238 Patent is attached hereto as Exhibit B.
`
`10.
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`The ’239 Patent, entitled “Levothyroxine Formulations,” was duly and legally
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`issued on October 27, 2015, naming Zhi-Qiang Jiang, Arunya Usayapant, and George Monen as
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`the inventors. A true and correct copy of the ’239 Patent is attached hereto as Exhibit C.
`
`11.
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`Plaintiff Fresenius Kabi is the assignee and lawfully owns all rights, title, and
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`interest in the ’289 Patent, the ’238 Patent, and the ’239 Patent (“the patents-in-suit”), including
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`the right to sue and to recover for past infringement thereof.
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`12.
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`The FDA issues a publication entitled Approved Drug Products with Therapeutic
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`Equivalence Evaluations (the “Orange Book”).
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`13.
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`Fresenius Kabi is the holder of New Drug Application (“NDA”) No. 202231 for
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`Levothyroxine Sodium, which the FDA approved on June 24, 2011. In accordance with 21
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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
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`Orange Book in connection with approved NDA No. 202231, as patents “with respect to which a
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`claim of patent infringement could reasonably be asserted if a person not licensed by the owner
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`engaged in the manufacture, use, or sale” of Fresenius Kabi’s NDA drug product.
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`14.
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`Fresenius Kabi currently sells in the United States Levothyroxine Sodium.
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`According to the Orange Book, the ’289 Patent is currently not due to expire until October 3,
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`-3-
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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 4 of 17 PageID #: 4
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`2032; the ’238 Patent is currently not due to expire until August 29, 2032; and the ’239 Patent is
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`also currently not due to expire until August 29, 2032.
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`MAIA’S ANDA NO. 208749
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`15.
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`On information and belief, Maia submitted ANDA No. 208749 to the FDA under
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`§ 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), seeking FDA
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`approval to engage in the commercial manufacture, use, importation, offer for sale, or sale of
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`generic 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial levothyroxine sodium for injection (the
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`“ANDA Products”).
`
`16.
`
`On information and belief, ANDA No. 208749 contains a Paragraph IV
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`certification that the ’289 Patent, the ’238 Patent, and the ’239 Patent are invalid, unenforceable,
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`and/or will not be infringed by the commercial manufacture, use, or sale of the drug product
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`described by Maia’s ANDA No. 208749.
`
`17.
`
`18.
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`On information and belief, Maia is the owner of ANDA No. 208749.
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`On information and belief, if ANDA No. 208749 is approved by the FDA before
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`the expiration of the ’289 Patent, the ’238 Patent, and/or the ’239 Patent, Maia will begin
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`manufacturing, using, importing, offering for sale, and/or selling the ANDA Products, despite
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`the patents.
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`19.
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`On information and belief, if ANDA No. 208749 is approved by the FDA, Maia
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`will begin marketing the ANDA Products for treatment of myxedema coma, and doctors and
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`patients will use the ANDA Products for the indications marketed by Maia.
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`20.
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`Pursuant to FDA regulation 21 C.F.R. § 314.94, in order to secure FDA approval,
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`the ANDA Products’ dosage strengths must have the same strength as one of the approved
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`dosages for Fresenius Kabi’s NDA levothyroxine sodium products (“the NDA products”). In
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`addition, the ANDA Products must be bioequivalent to the NDA products.
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`-4-
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`21.
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`Fresenius Kabi received a letter (“the Notice Letter”), purporting to be a Notice of
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`Certification for ANDA No. 208749 under Section 505(j)(2)(B) of the Federal Food, Drug, and
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`Cosmetic Act, 21 U.S.C. § 355(j)(2)(B), and 21 CFR § 314.95(c). The Paragraph IV
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`certifications alleged that the claims of the ’289 Patent, the ’238 Patent, and the ’239 Patent are
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`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale
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`of the ANDA Products.
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`22.
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`On information and belief, ANDA No. 208749 seeks approval of a generic
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`levothyroxine product that is the same, or substantially the same, as Fresenius Kabi’s
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`commercially marketed and approved Levothyroxine Sodium product.
`
`23.
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`On information and belief, Maia was aware of the ’289 Patent, the ’238 Patent,
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`and the ’239 Patent when ANDA No. 208749 was submitted to the FDA, containing the above-
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`described Paragraph IV certifications concerning the patents-in-suit.
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`COUNT I: INFRINGEMENT OF THE ’289 PATENT – ANDA SUBMISSION
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`24.
`
`25.
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`Fresenius Kabi incorporates and realleges paragraphs 1-23 above.
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`The submission of ANDA No. 208749, including a Paragraph IV certification
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`regarding the ’289 Patent, was an act of infringement by Maia of one or more claims of the ’289
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`26.
`
`On information and belief, the use of the ANDA Products in accordance with and
`
`as directed by the instructions contained in the proposed package insert of Maia’s ANDA No.
`
`208749 is covered by one or more claims of the ’289 Patent.
`
`27.
`
`On information and belief, Maia’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Products 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.
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`-5-
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`28.
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`On information and belief, the use of Maia’s ANDA Products in accordance with
`
`and as directed by Maia’s proposed labeling will infringe one or more claims of the ’289 Patent.
`
`29.
`
`On information and belief, by seeking approval to distribute the ANDA Products
`
`with their proposed labeling, Maia intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that Maia knows will infringe one or more claims of
`
`the ’289 Patent.
`
`30.
`
`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’289 Patent immediately
`
`following approval of ANDA No. 208749.
`
`31.
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`On information and belief, unless enjoined by this Court, Maia plans and intends
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`to, and will, contribute to the infringement of one or more claims of the ’289 Patent immediately
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`following approval of ANDA No. 208749.
`
`32.
`
`On information and belief, Maia knows that its ANDA No. 208749 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’289 Patent, and that the Maia ANDA Products and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`33.
`
`On information and belief, Maia’s actions through the licensing, manufacture,
`
`use, import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to
`
`ANDA No. 208749 will directly infringe, contributorily infringe, and/or induce infringement of
`
`at least one claim of the ’289 patent.
`
`34.
`
`On information and belief, Maia has been aware of the existence of the’289 Patent
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`since before the submission of ANDA No. 208749.
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`-6-
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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 7 of 17 PageID #: 7
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`35.
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`On information and belief, Maia has no reasonable basis for believing that its
`
`ANDA Products will not infringe one or more valid claims of the ’289 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. Maia posited no theory of non-
`
`infringement in its Notice Letter concerning the ’289 Patent.
`
`36.
`
`37.
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`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
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`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Products with their proposed labeling immediately following approval of ANDA
`
`No. 208749 and before the expiration of the ’289 Patent.
`
`38.
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`The acts of infringement by Maia 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.
`
`39.
`
`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
`
`Maia’s ANDA No. 208749 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
`
`40.
`
`41.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-39 above.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`42.
`
`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.
`
`-7-
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`

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`43. Maia has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Maia’s generic levothyroxine sodium
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`product before the expiration of the ’289 patent, including Maia’s filing of ANDA No. 208749.
`
`44.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Maia’s generic levothyroxine sodium product by Maia will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’289
`
`patent.
`
`45.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and Maia as to liability for the infringement of
`
`the ’289 patent claims. Maia’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from Maia’s threatened imminent actions.
`
`46.
`
`Fresenius Kabi is entitled to declaratory judgment that Maia’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of Maia’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
`
`47.
`
`48.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-46 above.
`
`The submission of ANDA No. 208749 including a Paragraph IV certification
`
`regarding the ’238 Patent was an act of infringement by Maia of one or more claims of the ’238
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`49.
`
`On information and belief, the use of ANDA Products in accordance with and as
`
`directed by the instructions contained in the proposed package insert of Maia’s ANDA No.
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`208749 is covered by one or more claims of the ’238 Patent.
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`-8-
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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 9 of 17 PageID #: 9
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`50.
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`On information and belief, Maia’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Products 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.
`
`51.
`
`On information and belief, the use of Maia’s ANDA Products in accordance with
`
`and as directed by Maia’s proposed labeling will infringe one or more claims of the ’238 Patent.
`
`52.
`
`On information and belief, by seeking approval to distribute the ANDA Products
`
`with their proposed labeling, Maia intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that Maia knows will infringe one or more claims of
`
`the ’238 Patent.
`
`53.
`
`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’238 Patent immediately
`
`following approval of ANDA No. 208749.
`
`54.
`
`On information and belief, unless enjoined by this Court, Maia 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. 208749.
`
`55.
`
`On information and belief, Maia knows that its ANDA No. 208749 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’238 Patent, and that the Maia ANDA Products and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`56.
`
`On information and belief, Maia’s actions through the licensing, manufacture,
`
`use, import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to
`
`-9-
`
`

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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 10 of 17 PageID #: 10
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`
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`ANDA No. 208749 will directly infringe, contributorily infringe, and/or induce infringement of
`
`at least one claim of the ’238 patent.
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`57.
`
`On information and belief, Maia has been aware of the existence of the’238 Patent
`
`since before the submission of ANDA No. 208749.
`
`58.
`
`On information and belief, Maia has no reasonable basis for believing that its
`
`ANDA Products will not infringe one or more valid claims of the ’238 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. Maia posited no theory of non-
`
`infringement in its Notice Letter concerning the ’238 Patent.
`
`59.
`
`60.
`
`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Products with their proposed labeling immediately following approval of ANDA
`
`No. 208749 and before the expiration of the ’238 Patent.
`
`61.
`
`The acts of infringement by Maia 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.
`
`62.
`
`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
`
`Maia’s ANDA No. 208749 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
`
`63.
`
`64.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-62 above.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`-10-
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`

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`65.
`
`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.
`
`66. Maia has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Maia’s generic levothyroxine sodium
`
`product before the expiration of the ’238 patent, including Maia’s filing of ANDA No. 208749.
`
`67.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Maia’s generic levothyroxine sodium product by Maia will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’238
`
`patent.
`
`68.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and Maia as to liability for the infringement of
`
`the ’238 patent claims. Maia’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from Maia’s threatened imminent actions.
`
`69.
`
`Fresenius Kabi is entitled to declaratory judgment that Maia’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of Maia’s generic levothyroxine sodium
`
`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
`
`70.
`
`71.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-69 above.
`
`The submission of ANDA No. 208749 including a Paragraph IV certification
`
`regarding the ’239 Patent was an act of infringement by Maia of one or more claims of the ’239
`
`Patent under 35 U.S.C. § 271(e)(2).
`
`-11-
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`

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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 12 of 17 PageID #: 12
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`72.
`
`On information and belief, the use of ANDA Products in accordance with and as
`
`directed by the instructions contained in the proposed package insert of Maia’s ANDA No.
`
`208749 is covered by one or more claims of the ’239 Patent.
`
`73.
`
`On information and belief, Maia’s commercial importation, manufacture, use,
`
`sale, and/or offer for sale of the ANDA Products 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.
`
`74.
`
`On information and belief, the use of Maia’s ANDA Products in accordance with
`
`and as directed by Maia’s proposed labeling will infringe one or more claims of the ’239 Patent.
`
`75.
`
`On information and belief, by seeking approval to distribute the ANDA Products
`
`with their proposed labeling, Maia intends to cause others, specifically, for example, medical
`
`professionals and patients, to perform acts that Maia knows will infringe one or more claims of
`
`the ’239 Patent.
`
`76.
`
`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to, and will, actively induce infringement of one or more claims of the ’239 Patent immediately
`
`following approval of ANDA No. 208749.
`
`77.
`
`On information and belief, unless enjoined by this Court, Maia 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. 208749.
`
`78.
`
`On information and belief, Maia knows that its ANDA No. 208749 and its
`
`proposed labeling are especially made or adapted for use in infringing one or more claims of the
`
`’239 Patent, and that the Maia ANDA Products and their proposed labeling are not suitable for
`
`any noninfringing use.
`
`-12-
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`

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`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 13 of 17 PageID #: 13
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`
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`79.
`
`On information and belief, Maia’s actions through the licensing, manufacture,
`
`use, import, offer for sale, and/or sale a generic levothyroxine sodium product pursuant to
`
`ANDA No. 208749 will directly infringe, contributorily infringe, and/or induce infringement of
`
`at least one claim of the ’239 patent.
`
`80.
`
`On information and belief, Maia has been aware of the existence of the’239 Patent
`
`since before the submission of ANDA No. 208749.
`
`81.
`
`On information and belief, Maia has no reasonable basis for believing that its
`
`ANDA Products will not infringe one or more valid claims of the ’239 Patent and no reasonable
`
`basis for believing that the infringed claims are invalid. Maia posited no theory of non-
`
`infringement in its Notice Letter concerning the ’239 Patent.
`
`82.
`
`83.
`
`This case is “exceptional,” as that term is used in 35 U.S.C. § 285.
`
`On information and belief, unless enjoined by this Court, Maia plans and intends
`
`to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation
`
`of the ANDA Products with their proposed labeling immediately following approval of ANDA
`
`No. 208749 and before the expiration of the ’239 Patent.
`
`84.
`
`The acts of infringement by Maia 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.
`
`85.
`
`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
`
`Maia’s ANDA No. 208749 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
`
`86.
`
`Fresenius Kabi incorporates and realleges paragraphs 1-85 above.
`
`-13-
`
`

`

`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 14 of 17 PageID #: 14
`
`
`
`87.
`
`Fresenius Kabi brings claims arising under the Declaratory Judgment Act, 28
`
`U.S.C. §§ 2201 and 2202.
`
`88.
`
`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.
`
`89. Maia has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Maia’s generic levothyroxine sodium
`
`product before the expiration of the ’239 patent, including Maia’s filing of ANDA No. 208749.
`
`90.
`
`On information and belief, any commercial manufacture, use, offer for sale, sale,
`
`and/or importation of Maia’s generic levothyroxine sodium product by Maia will directly
`
`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’239
`
`patent.
`
`91.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Fresenius Kabi and Maia as to liability for the infringement of
`
`the ’239 patent claims. Maia’s actions have created for Fresenius Kabi a reasonable
`
`apprehension of irreparable harm and loss resulting from Maia’s threatened imminent actions.
`
`92.
`
`Fresenius Kabi is entitled to declaratory judgment that Maia’s future commercial
`
`manufacture, use, offer for sale, sale, and/or import of Maia’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.
`
`Judgment in favor of Fresenius Kabi and against Maia;
`
`-14-
`
`

`

`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 15 of 17 PageID #: 15
`
`
`
`B.
`
`Judgment that Maia 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. 208749, and that the commercial importation, sale, offer for sale, use, and/or
`
`manufacture of the ANDA Products, 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 Maia, 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
`
`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 Products, 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;
`
`-15-
`
`

`

`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 16 of 17 PageID #: 16
`
`
`
`F.
`
`Damages or other monetary relief, including prejudgment and post-
`
`judgment interest, if Maia engages in the commercial manufacture, use, offering to sell, sale,
`
`marketing, distribution, or importation of ANDA Products, 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.
`
`
`
`-16-
`
`

`

`Case 1:16-cv-00237-GMS Document 1 Filed 04/07/16 Page 17 of 17 PageID #: 17
`
`
`
`
`Dated: April 7, 2016
`
`OF COUNSEL:
`
`Imron T. Aly
`SCHIFF HARDIN LLP
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`(312) 258-5500
`
`John K. Hsu
`SCHIFF HARDIN LLP
`901 K Street NW, Suite 700
`Washington, DC 20001
`
`Gina M. Bassi
`Christine W. Feller
`Ahmed M.T. Riaz
`SCHIFF HARDIN LLP
`666 Fifth Avenue, Suite 1700
`New York, NY 10103
`
`
`
`
`
`
`Respectfully submitted,
`
`FARNAN LLP
`
`
`
`/s/ Brian E. Farnan
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 North Market Street, 12th Floor
`Wilmington, Delaware 19801
`Telephone: (302) 777-0300
`Facsimile: (302) 777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
`
`
`
`
`
`
`
`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
`
`-17-
`
`

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