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`PFIZER INC., C.P. PHARMACEUTICALS
`INTERNATIONAL C.V., PF PRISM C.V.,
`PBG PUERTO RICO LLC and PF PRISM
`IMB B.V.,
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`
`
`AUROBINDO PHARMA LTD. and
`AUROBINDO PHARMA USA, INC.,
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`v.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`)
`)
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`Plaintiffs,
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`Defendants.
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`C.A. No. ____________________
`
`COMPLAINT
`
`Pfizer Inc., C.P. Pharmaceuticals International C.V., PF PRISM C.V., PBG Puerto Rico
`
`LLC, and PF PRISM IMB B.V. (collectively “Plaintiffs” or “Pfizer”) for their Complaint
`
`against Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. (collectively “Defendants”
`
`or “Aurobindo”) allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action by Pfizer against Aurobindo for infringement of United States
`
`Patent No. 6,965,027 (“the ’027 patent”) and United States Reissue Patent No. RE41,783 (“the
`
`RE’783 patent”).
`
`2.
`
`This action arises out of Aurobindo Pharma Ltd.’s filing of Abbreviated New Drug
`
`Application (“ANDA”) No. 215356 seeking approval by the United States Food and Drug
`
`Administration (“FDA”) to sell generic copies of Pfizer’s 5 mg and 10 mg Xeljanz® (tofacitinib)
`
`tablets prior to the expiration of the ’027 and RE’783 patents. Aurobindo’s ANDA products are
`
`referred to hereinafter individually as “Aurobindo 5 mg Generic Tablets” and “Aurobindo 10 mg
`
`Generic Tablets” and collectively as “Aurobindo 5 mg and 10 mg Generic Tablets.”
`
`
`
`
`
`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 2 of 14 PageID #: 2
`
`
`
`THE PARTIES
`
`3.
`
`Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of
`
`Delaware and having a place of business at 235 East 42nd Street, New York, New York 10017.
`
`4.
`
`Plaintiff C.P. Pharmaceuticals International C.V. is a limited partnership
`
`(commanditaire vennootschap) organized under the laws of the Netherlands, having a place of
`
`business at Rivium Westlaan 142, 2909 LD, Capelle aan den IJssel, the Netherlands. Pfizer Inc.
`
`is the ultimate parent company of C.P. Pharmaceuticals International C.V.
`
`5.
`
`Plaintiff PF PRISM C.V. is a limited partnership (commanditaire vennootschap)
`
`organized under the laws of the Netherlands, having its registered seat in Rotterdam, the
`
`Netherlands, having its business address at Rivium Westlaan 142, 2909 LD, Capelle aan den IJssel,
`
`the Netherlands, and registered at the Trade Register held by the Chamber of Commerce in
`
`Rotterdam, the Netherlands, under number 51840456. Pfizer Inc. is the ultimate parent company
`
`of PF PRISM C.V.
`
`6.
`
`Plaintiff PBG Puerto Rico LLC is a limited liability company organized and
`
`existing under the laws of Puerto Rico and having its principal place of business at Professional
`
`Offices Park V, 996 San Roberto Street, 4th Floor, San Juan, Puerto Rico 00926. Pfizer Inc. is the
`
`ultimate parent company of PBG Puerto Rico LLC.
`
`7.
`
`Plaintiff PF PRISM IMB B.V. is a private limited liability company (besloten
`
`vennootschap) under the law of the Netherlands, having its registered seat in Rotterdam, the
`
`Netherlands, and having its business address at Rivium Westlaan 142, 2909 LD, Capelle aan den
`
`IJssel, the Netherlands. Pfizer Inc. is the ultimate parent company of PF PRISM IMB B.V.
`
`8.
`
`On information and belief, defendant Aurobindo Pharma Ltd. is a company
`
`organized and existing under the laws of India, having its principal place of business at Plot No.
`
`2, Maitrivihar, Ameerpet, Hyderabad-500038, Telangana, India.
`
`2
`
`
`
`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 3 of 14 PageID #: 3
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`
`
`9.
`
`On information and belief, defendant Aurobindo Pharma USA, Inc. is a company
`
`organized and existing under the laws of Delaware, having its principal place of business at
`
`279 Princeton Hightstown Road, East Windsor, NJ 08520. On information and belief, Aurobindo
`
`Pharma Ltd. is the ultimate parent company of Aurobindo Pharma USA, Inc. On information and
`
`belief, Aurobindo Pharma USA, Inc. is the U.S. agent for Aurobindo Pharma Ltd.
`
`JURISDICTION AND VENUE
`
`10.
`
`This action arises under the patent laws of the United States, Title 35, United States
`
`Code. The Court has subject matter jurisdiction over this action pursuant to the provisions of
`
`28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`11.
`
`12.
`
`This Court has personal jurisdiction over Defendants.
`
`This Court has personal jurisdiction over Defendants by virtue of the fact, inter
`
`alia, that Aurobindo Pharma USA, Inc. is a Delaware corporation and Aurobindo Pharma Ltd. is
`
`the ultimate parent company of Aurobindo Pharma USA, Inc.
`
`13.
`
`Aurobindo Pharma USA, Inc. is a wholly-owned subsidiary of Aurobindo Pharma
`
`Ltd.
`
`
`
`(https://www.aurobindo.com/wp-content/uploads/2020/08/Aurobindo-Pharma-Limited-
`
`Annual-Report-2019-20.pdf, at 95, last accessed on Jan. 5, 2021). On information and belief,
`
`Aurobindo Pharma Ltd., directly or through its subsidiary Aurobindo Pharma USA, Inc.,
`
`manufactures, markets, imports, and sells generic drugs for distribution in Delaware and
`
`throughout the United States.
`
`14.
`
`On information and belief, Defendants are agents of each other and/or work in
`
`concert with each other on the development, obtaining of regulatory approval, manufacture,
`
`marketing, sale, and/or distribution of generic drugs, including the proposed Aurobindo 5 mg and
`
`10 mg Generic Tablets.
`
`3
`
`
`
`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 4 of 14 PageID #: 4
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`
`
`15.
`
`On information and belief, if ANDA No. 215356 is approved, Aurobindo 5 mg and
`
`10 mg Generic Tablets will, among other things, be marketed and distributed in Delaware,
`
`prescribed by physicians practicing in Delaware, dispensed by pharmacies located in Delaware,
`
`and/or used by patients in Delaware.
`
`16.
`
`Aurobindo’s infringing activities with respect to its filing of ANDA No. 215356
`
`and its intent to commercialize and sell Aurobindo 5 mg and 10 mg Generic Tablets have led
`
`and/or will lead to foreseeable harm and injury to Plaintiffs, including Pfizer Inc., which is
`
`incorporated in Delaware.
`
`17.
`
`On information and belief, Defendants maintain substantial, systematic, and
`
`continuous contacts with Delaware. Aurobindo Pharma USA, Inc.’s website states that the
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`company has earned its “reputation by building an extremely robust company, ensuring
`
`AuroControl through vertical integration [and] multiple manufacturing units in . . . the U.S. ”
`
`(https://www.aurobindousa.com/company/investors/, last accessed on Jan. 5, 2021). Aurobindo
`
`Pharma Ltd.’s 2019-2020 annual report states that the company has so far “[f]iled 586 ANDAs
`
`with USFDA and received approval for 425 ANDAs, including 28 tentative approvals,” and refers
`
`to Aurobindo’s “core geographies such as USA.”
`
`
`
`(https://www.aurobindo.com/wp-
`
`content/uploads/2020/08/Aurobindo-Pharma-Limited-Annual-Report-2019-20.pdf, at 6, 11, last
`
`accessed on Jan. 5, 2021). As of March 31, 2020, Aurobindo claims to be “the second largest
`
`generics company in the US in terms of prescriptions (Rx) dispensed as per IQVIA data.” (Id. at
`
`67).
`
`18.
`
`In the alternative, this Court has jurisdiction over Aurobindo Pharma Ltd. under
`
`Federal Rule of Civil Procedure 4(k)(2). Aurobindo Pharma Ltd. has contacts with the United
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`States by, inter alia, having filed ANDA No. 215356 with the FDA.
`
`4
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`
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 5 of 14 PageID #: 5
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`
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`19.
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`Venue is proper in this judicial district pursuant to the provisions of 28 U.S.C.
`
`§§ 1391 and 1400(b).
`
`Xeljanz
`
`BACKGROUND
`
`20.
`
`The active ingredient in Pfizer’s Xeljanz product is tofacitinib citrate. Xeljanz
`
`contains tofacitinib citrate in an amount equivalent to 5 mg and 10 mg of tofacitinib base in tablets
`
`formulated for twice-daily administration.
`
`21.
`
`The FDA-approved Prescribing Information for Xeljanz states that tofacitinib
`
`citrate has the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]
`
`pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate
`
`(1:1).
`
`22.
`
`Tofacitinib citrate is an inhibitor of Janus kinases (“JAKs”) and is indicated for the
`
`treatment of adult patients with moderately to severely active rheumatoid arthritis who have had
`
`an inadequate response or intolerance to methotrexate, for the treatment of adult patients with
`
`active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or
`
`other disease-modifying antirheumatic drugs (DMARDs), for the treatment of adult patients with
`
`moderately to severely active ulcerative colitis who have had an inadequate response or who are
`
`intolerant to TNF blockers, and for the treatment of active polyarticular course of juvenile
`
`idiopathic arthritis (pcJIA) in patients 2 years of age and older.
`
`Orange Book Listing for Xeljanz
`
`23.
`
`PF PRISM C.V. holds approved New Drug Application (“NDA”) No. 203214 for
`
`EQ 5 and EQ 10 mg base tofacitinib citrate tablets, which Pfizer sells under the registered name
`
`Xeljanz.
`
`5
`
`
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 6 of 14 PageID #: 6
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`
`
`24.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and the regulations the FDA has promulgated
`
`pursuant thereto, the ’027 and RE’783 patents are listed in the FDA publication titled “Approved
`
`Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for the Xeljanz
`
`NDA.
`
`25.
`
`The Orange Book lists the expiration date for the ’027 patent as March 25, 2023,
`
`and the expiration date for the RE’783 patent as December 8, 2025.
`
`The ’027 Patent
`
`26.
`
`On November 15, 2005, the USPTO issued the ’027 patent, titled “Crystalline 3-
`
`{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-
`
`propionitrile citrate.” The ’027 patent is duly and legally assigned to Pfizer Inc. A copy of the
`
`’027 patent is attached hereto as Exhibit A.
`
`27.
`
`28.
`
`C.P. Pharmaceuticals International C.V. is the exclusive licensee of the ’027 patent.
`
`C.P. Pharmaceuticals International C.V. conveyed rights under the ’027 patent to
`
`Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer PFE Ireland Pharmaceuticals Holding 1
`
`B.V.
`
`29.
`
`Pfizer Pharmaceuticals LLC has conveyed its rights to the ’027 patent to PBG
`
`Puerto Rico LLC.
`
`30.
`
`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
`
`’027 patent to PF PRISM IMB B.V.
`
`The RE’783 Patent
`
`31.
`
`On September 28, 2010, the USPTO issued the RE’783 patent, titled “Pyrrolo[2,3-
`
`d]pyrimidine Compounds.” The RE’783 patent is a reissue of U.S. Patent No. 6,627,754, which
`
`issued on September 30, 2003. The RE’783 patent is duly and legally assigned to Pfizer Inc. A
`
`copy of the RE’783 patent is attached hereto as Exhibit B.
`
`6
`
`
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 7 of 14 PageID #: 7
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`
`
`32.
`
`On December 14, 2016, the United States Patent and Trademark Office (“USPTO”)
`
`issued a Notice of Final Determination extending the expiration date of the RE’783 patent to
`
`December 8, 2025.
`
`33.
`
`C.P. Pharmaceuticals International C.V. is the exclusive licensee of the RE’783
`
`patent.
`
`34.
`
`C.P. Pharmaceuticals International C.V. conveyed rights under the RE’783 patent
`
`to Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer PFE Ireland Pharmaceuticals Holding
`
`1 B.V.
`
`35.
`
`Pfizer Pharmaceuticals LLC has conveyed its rights to the RE’783 patent to PBG
`
`Puerto Rico LLC.
`
`36.
`
`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
`
`RE’783 patent to PF PRISM IMB B.V.
`
`Aurobindo’s ANDA
`
`37.
`
`By letter dated November 25, 2020 (the “Aurobindo Notice Letter”), and received
`
`by Pfizer on November 30, 2020, Aurobindo notified Pfizer that it had filed ANDA No. 215356
`
`with the FDA, seeking approval under the Federal Food, Drug and Cosmetic Act to market and
`
`sell Aurobindo 5 mg and 10 mg Generic Tablets -- generic copies of Xeljanz (tofacitinib citrate
`
`EQ 5 mg and EQ 10 mg tablets) -- prior to the expiration of the ’027 and RE’783 patents. The
`
`Aurobindo Notice Letter describes the Aurobindo 5 mg and 10 mg Generic Tablets as “tofacitinib
`
`citrate tablets in 5 mg and 10 mg strengths.”
`
`38.
`
`The Aurobindo Notice Letter states that ANDA No. 215356 seeks “to obtain
`
`approval to engage in the commercial manufacture, use or sale of” Aurobindo 5 mg and 10 mg
`
`Generic Tablets prior to the expiration of the ’027 and RE’783 patents.
`
`7
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 8 of 14 PageID #: 8
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`
`
`39.
`
`The Aurobindo Notice Letter asserts that ANDA No. 215356 contains a “Paragraph
`
`IV” certification under 21 U.S.C. § 355(j)(2)(B)(iv)(II) alleging that the ’027 and RE’783 patents
`
`“are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or
`
`sale of” Aurobindo 5 mg and 10 mg Generic Tablets.
`
`40.
`
`Attached to the Aurobindo Notice Letter was Aurobindo’s Detailed Factual and
`
`Legal Basis for Aurobindo’s Paragraph IV Certification regarding U.S. Patent Nos. 6,965,027 and
`
`RE41,783 (“Aurobindo’s Detailed Statement”) asserting the purported factual and legal bases for
`
`Aurobindo’s contention that the ’027 and RE’783 patents are invalid and/or will not be infringed
`
`by the commercial manufacture, use, or sale of Aurobindo 5 mg and 10 mg Generic Tablets.
`
`41.
`
`Aurobindo’s Detailed Statement alleges that all claims of the ’027 and RE’783
`
`patents are invalid. Aurobindo’s Detailed Statement does not contain a noninfringement argument
`
`with respect to either the ’027 patent or the RE’783 patent.
`
`42.
`
`On information and belief, Aurobindo Pharma Ltd. and Aurobindo Pharma USA,
`
`Inc. collaborated and acted in concert in the decision to prepare and file and in the preparation and
`
`filing of ANDA No. 215356.
`
`43.
`
`On information and belief, upon approval of ANDA No. 215356, Aurobindo will
`
`sell and distribute Aurobindo 5 mg and 10 mg Generic Tablets throughout the United States.
`
`COUNT I
`(Infringement of the ’027 Patent by Aurobindo 5 mg Generic Tablets)
`
`44.
`
`The allegations of paragraphs 1-43 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`45.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Aurobindo’s filing of ANDA No. 215356
`
`seeking approval to market Aurobindo 5 mg Generic Tablets is an act of infringement of at least
`
`claim 1 of the ’027 patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`8
`
`
`
`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 9 of 14 PageID #: 9
`
`
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`inter alia, an order of this Court that the effective date of approval for ANDA No. 215356 be a
`
`date which is not earlier than the expiration date of the ’027 patent.
`
`46.
`
`Aurobindo had knowledge of the ’027 patent when it submitted ANDA No. 215356
`
`to the FDA.
`
`47.
`
`On information and belief, upon FDA approval, Aurobindo intends to engage in the
`
`manufacture, use, offer for sale, sale, and/or importation of Aurobindo 5 mg Generic Tablets and
`
`will thereby infringe at least claim 1 of the ’027 patent.
`
`48.
`
`The foregoing actions by Aurobindo constitute and/or would constitute
`
`infringement of at least claim 1 of the ’027 patent.
`
`49.
`
`Pfizer will be substantially and irreparably harmed if Aurobindo is not enjoined
`
`from infringing the ’027 patent. Pfizer has no adequate remedy at law.
`
`COUNT II
`(Infringement of the ’027 Patent by Aurobindo 10 mg Generic Tablets)
`
`50.
`
`The allegations of paragraphs 1-49 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`51.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Aurobindo’s filing of ANDA No. 215356
`
`seeking approval to market Aurobindo 10 mg Generic Tablets is an act of infringement of at least
`
`claim 1 of the ’027 patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`inter alia, an order of this Court that the effective date of approval for ANDA No. 215356 be a
`
`date which is not earlier than the expiration date of the ’027 patent.
`
`52.
`
`Aurobindo had knowledge of the ’027 patent when it submitted ANDA No. 215356
`
`to the FDA.
`
`9
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 10 of 14 PageID #: 10
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`
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`53.
`
`On information and belief, upon FDA approval, Aurobindo intends to engage in the
`
`manufacture, use, offer for sale, sale, and/or importation of Aurobindo 10 mg Generic Tablets and
`
`will thereby infringe at least claim 1 of the ’027 patent.
`
`54.
`
`The foregoing actions by Aurobindo constitute and/or would constitute
`
`infringement of at least claim 1 of the ’027 patent.
`
`55.
`
`Pfizer will be substantially and irreparably harmed if Aurobindo is not enjoined
`
`from infringing the ’027 patent. Pfizer has no adequate remedy at law.
`
`COUNT III
`(Infringement of the RE’783 Patent by Aurobindo 5 mg Generic Tablets)
`
`56.
`
`The allegations of paragraphs 1-55 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`57.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Aurobindo’s filing of ANDA No. 215356
`
`seeking approval to market Aurobindo 5 mg Generic Tablets is an act of infringement of at least
`
`claim 4 of the RE’783 patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including, inter alia, an order of this Court that the effective date of approval for ANDA No.
`
`215356 be a date which is not earlier than the expiration date of the RE’783 patent.
`
`58.
`
`Aurobindo had knowledge of the RE’783 patent when it submitted ANDA No.
`
`215356 to the FDA.
`
`59.
`
`On information and belief, upon FDA approval, Aurobindo intends to engage in the
`
`manufacture, use, offer for sale, sale, and/or importation of Aurobindo 5 mg Generic Tablets and
`
`will thereby infringe at least claim 4 of the RE’783 patent.
`
`60.
`
`The foregoing actions by Aurobindo constitute and/or would constitute
`
`infringement of at least claim 4 of the RE’783 patent.
`
`10
`
`
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 11 of 14 PageID #: 11
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`
`
`61.
`
`Pfizer will be substantially and irreparably harmed if Aurobindo is not enjoined
`
`from infringing the RE’783 patent. Pfizer has no adequate remedy at law.
`
`COUNT IV
`(Infringement of the RE’783 Patent by Aurobindo 10 mg Generic Tablets)
`
`62.
`
`The allegations of paragraphs 1-61 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`63.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Aurobindo’s filing of ANDA No. 215356
`
`seeking approval to market Aurobindo 10 mg Generic Tablets is an act of infringement of at least
`
`claim 4 of the RE’783 patent entitling Pfizer to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including, inter alia, an order of this Court that the effective date of approval for ANDA No.
`
`215356 be a date which is not earlier than the expiration date of the RE’783 patent.
`
`64.
`
`Aurobindo had knowledge of the RE’783 patent when it submitted ANDA No.
`
`215356 to the FDA.
`
`65.
`
`On information and belief, upon FDA approval, Aurobindo intends to engage in the
`
`manufacture, use, offer for sale, sale, and/or importation of Aurobindo 10 mg Generic Tablets and
`
`will thereby infringe at least claim 4 of the RE’783 patent.
`
`66.
`
`The foregoing actions by Aurobindo constitute and/or would constitute
`
`infringement of at least claim 4 of the RE’783 patent.
`
`67.
`
`Pfizer will be substantially and irreparably harmed if Aurobindo is not enjoined
`
`from infringing the RE’783 patent. Pfizer has no adequate remedy at law.
`
`COUNT V
`(Aurobindo Pharma USA, Inc.’s Inducing of Infringement by Aurobindo Pharma Ltd.)
`
`68.
`
`The allegations of paragraphs 1-67 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`11
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 12 of 14 PageID #: 12
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`
`
`69.
`
`On information and belief, Aurobindo Pharma USA, Inc. actively and knowingly
`
`caused to be submitted, assisted with, participated in, contributed to, and/or directed the
`
`submission by Aurobindo Pharma Ltd. of ANDA No. 215356 to the FDA, knowing of the ’027
`
`and RE’783 patents.
`
`70.
`
`The filing of ANDA No. 215356 by Aurobindo Pharma Ltd. constituted direct
`
`infringement under 35 U.S.C. § 271(e). On information and belief, under 35 U.S.C. §§ 271(b) and
`
`271(e)(2)(A), Aurobindo Pharma USA, Inc. induced the infringement of the ’027 and RE’783
`
`patents by actively and knowingly causing to be submitted, and/or assisting with, participating in,
`
`contributing to, and/or directing the submission of ANDA No. 215356 to the FDA knowing that
`
`the submission of ANDA No. 215356 would constitute direct infringement of the ’027 and RE’783
`
`patents.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Pfizer requests the following relief:
`
`A.
`
`A judgment that Aurobindo Pharma Ltd.’s submission of ANDA No. 215356 was
`
`an act of infringement and that Aurobindo’s making, using, offering to sell, selling,
`
`or importing Aurobindo 5 mg and 10 mg Generic Tablets prior to the expiration of
`
`the ’027 and RE’783 patents will infringe each of those patents;
`
`B.
`
`A judgment that defendant Aurobindo Pharma USA, Inc.’s knowing and purposeful
`
`activities causing to be submitted, and/or assisting with, participating in,
`
`contributing to, and/or directing the filing of ANDA No. 215356, knowing that its
`
`submission would constitute direct infringement, induced infringement of the ’027
`
`and RE’783 patents;
`
`C.
`
`A judgment that the effective date of any FDA approval for Aurobindo to make,
`
`use, offer for sale, sell, market, distribute, or import Aurobindo 5 mg and 10 mg
`
`12
`
`
`
`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 13 of 14 PageID #: 13
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`
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`Generic Tablets be no earlier than the dates on which the ’027 and RE’783 patents
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`expire, or the later expiration of any exclusivity to which Pfizer is or becomes
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`entitled;
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`D.
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`A permanent injunction enjoining Aurobindo, its officers, agents, servants, and
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`employees, and those persons in active concert or participation with any of them,
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`from making, using, selling, offering for sale, marketing, distributing, or importing
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`Aurobindo 5 mg and 10 mg Generic Tablets, and from inducing or contributing to
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`any of the foregoing, prior to the expiration of the ’027 and RE’783 patents, or the
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`later expiration of any exclusivity to which Pfizer is or becomes entitled;
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`E.
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`A judgment that this case is an exceptional case under 35 U.S.C. § 285, entitling
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`Pfizer to an award of its reasonable attorneys’ fees for bringing and prosecuting this
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`action;
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`F.
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`G.
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`An award of Pfizer’s costs and expenses in this action; and
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`Such further and additional relief as this Court deems just and proper.
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`13
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`Case 1:21-cv-00022-UNA Document 1 Filed 01/11/21 Page 14 of 14 PageID #: 14
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Megan E. Dellinger
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`
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`Jack B. Blumenfeld (#1014)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mdellinger@mnat.com
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`Attorneys for Plaintiffs
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`OF COUNSEL:
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`Aaron Stiefel
`Daniel P. DiNapoli
`Stephanie Piper
`Michael Sapiro
`ARNOLD & PORTER KAYE SCHOLER LLP
`250 West 55th Street
`New York, NY 10019-9710
`(212) 836-8000
`
`Soumitra Deka
`DLA PIPER LLP (US)
`555 Mission Street
`Suite 2400
`San Francisco, CA 94105-2933
`(415) 836-2500
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`January 11, 2021
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`14
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