Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 1 of 10 PageID #: 1
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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.,
`
`
`
`
`
`MICRO LABS, LTD. and
`MICRO LABS USA INC.,
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`v.
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`C.A. No. ____________________
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Plaintiffs,
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`Defendants.
`
`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
`
`Micro Labs, Ltd. and Micro Labs USA Inc. (collectively “Defendants” or “Micro Labs”) allege as
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`follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action by Pfizer against Micro Labs for infringement of United States
`
`Patent No. RE41,783 (“the RE’783 patent”) and United States Patent No. 6,965,027 (“the ’027
`
`patent”).
`
`2.
`
`This action arises out of Micro Labs, Ltd.’s filing of Abbreviated New Drug
`
`Application (“ANDA”) No. 209738 as amended, seeking approval by the United States Food and
`
`Drug Administration (“FDA”) to sell generic copies of Pfizer’s 10 mg Xeljanz® (tofacitinib) tablets
`
`prior to the expiration of the RE’783 and ’027 patents. Micro Labs’ proposed 10 mg tofacitinib
`
`product is referred to hereinafter as “Micro Labs 10 mg Generic Tablets.”
`
`
`
`
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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.,
`
`
`
`
`
`MICRO LABS, LTD. and
`MICRO LABS USA INC.,
`
`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`C.A. No. ____________________
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`Plaintiffs,
`
`Defendants.
`
`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
`
`Micro Labs, Ltd. and Micro Labs USA Inc. (collectively “Defendants” or “Micro Labs”) allege as
`
`follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action by Pfizer against Micro Labs for infringement of United States
`
`Patent No. RE41,783 (“the RE’783 patent”) and United States Patent No. 6,965,027 (“the ’027
`
`patent”).
`
`2.
`
`This action arises out of Micro Labs, Ltd.’s filing of Abbreviated New Drug
`
`Application (“ANDA”) No. 209738 as amended, seeking approval by the United States Food and
`
`Drug Administration (“FDA”) to sell generic copies of Pfizer’s 10 mg Xeljanz® (tofacitinib) tablets
`
`prior to the expiration of the RE’783 and ’027 patents. Micro Labs’ proposed 10 mg tofacitinib
`
`product is referred to hereinafter as “Micro Labs 10 mg Generic Tablets.”
`
`
`
`
`
`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 2 of 10 PageID #: 2
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`
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`THE PARTIES
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`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 its business
`
`address 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 laws 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 Micro Labs, Ltd. is a company organized and
`
`existing under the laws of India, having its principal place of business at 31 Race Course Road,
`
`Bangalore, India 560 001.
`
`2
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`
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 3 of 10 PageID #: 3
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`
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`9.
`
`On information and belief, defendant Micro Labs USA Inc. is a company organized
`
`and existing under the laws of New Jersey, having its principal place of business at 106 Allen
`
`Road, Suite 102, Basking Ridge, NJ 07920.
`
`10.
`
`On information and belief, Micro Labs, Ltd. is the ultimate parent company of
`
`Micro Labs USA Inc. On information and belief, Micro Labs USA Inc. is the U.S. agent for Micro
`
`Labs, Ltd.
`
`JURISDICTION AND VENUE
`
`11.
`
`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
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`28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`12.
`
`This Court has personal jurisdiction over Defendants and venue is proper in this
`
`action in that counsel for Micro Labs has represented to Pfizer that for the purposes of this litigation
`
`Micro Labs will not object to personal jurisdiction or venue in this judicial district.
`
`Xeljanz
`
`BACKGROUND
`
`13.
`
`The active ingredient in Pfizer’s Xeljanz product is tofacitinib citrate. Pfizer
`
`markets Xeljanz tablets that contain tofacitinib citrate in an amount equivalent to 10 mg of
`
`tofacitinib base.
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`14.
`
`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).
`
`3
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 4 of 10 PageID #: 4
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`
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`15.
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`Tofacitinib citrate is an inhibitor of Janus kinases (“JAKs”) and is indicated, inter
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`alia, 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.
`
`Orange Book Listing for Xeljanz
`
`16.
`
`PF PRISM C.V. holds approved New Drug Application (“NDA”) No. 203214 for,
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`inter alia, EQ 10 mg base tofacitinib citrate tablets, which Pfizer sells under the registered name
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`Xeljanz. The 10 mg Xeljanz tablets are approved for the treatment of ulcerative colitis.
`
`17.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and the regulations the FDA has promulgated
`
`pursuant thereto, the RE’783 and ’027 patents are listed in the FDA publication titled “Approved
`
`Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for the Xeljanz
`
`NDA.
`
`18.
`
`The Orange Book lists the expiration date for the RE’783 patent as December 8,
`
`2025, and the expiration date for the ’027 patent as March 25, 2023.
`
`The RE’783 Patent
`
`19.
`
`On September 28, 2010, the United States Patent and Trademark Office (“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
`
`A.
`
`20.
`
`On December 14, 2016, the USPTO issued a Notice of Final Determination
`
`extending the expiration date of the RE’783 patent to December 8, 2025.
`
`21.
`
`C.P. Pharmaceuticals International C.V. is the exclusive licensee of the RE’783
`
`patent.
`
`4
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 5 of 10 PageID #: 5
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`
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`22.
`
`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.
`
`23.
`
`Pfizer Pharmaceuticals LLC has conveyed its rights to the RE’783 patent to PBG
`
`Puerto Rico LLC.
`
`24.
`
`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
`
`RE’783 patent to PF PRISM IMB B.V.
`
`The ’027 Patent
`
`25.
`
`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 B.
`
`26.
`
`27.
`
`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.
`
`28.
`
`Pfizer Pharmaceuticals LLC has conveyed its rights to the ’027 patent to PBG
`
`Puerto Rico LLC.
`
`29.
`
`Pfizer PFE Ireland Pharmaceuticals Holding 1 B.V. has conveyed its rights to the
`
`’027 patent to PF PRISM IMB B.V.
`
`Micro Labs’ ANDA
`
`30.
`
`By letter dated February 1, 2021 (the “Micro Labs Notice Letter”), and received by
`
`Pfizer on February 2, 2021, Micro Labs notified Pfizer that it had submitted to the FDA an
`
`amendment to ANDA No. 209738, seeking approval under the Federal Food, Drug and Cosmetic
`
`5
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 6 of 10 PageID #: 6
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`
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`Act to market and sell Micro Labs 10 mg Generic Tablets -- generic copies of Xeljanz (tofacitinib
`
`citrate EQ 10 mg tablets) -- prior to the expiration of the RE’783 and ’027 patents.
`
`31.
`
`On information and belief, Micro Labs 10 mg Generic Tablets will contain
`
`tofacitinib citrate as the active ingredient.
`
`32.
`
`On information and belief, Micro Labs, Ltd. holds DMF No. 30621 for tofacitinib
`
`citrate.
`
`33.
`
`The Micro Labs Notice Letter states that Micro Labs has amended ANDA No.
`
`209738 “to obtain approval to engage in the commercial manufacture, use or sale of” Micro Labs
`
`10 mg Generic Tablets prior to the expiration of the RE’783 and ’027 patents.
`
`34.
`
`The Micro Labs Notice Letter asserts that ANDA No. 209738 as amended contains
`
`a “Paragraph IV” certification under 21 U.S.C. § 355(j)(2)(A) alleging that the RE’783 and ’027
`
`patents “are invalid, unenforceable and/or will not be infringed by the commercial manufacture,
`
`use or sale of” Micro Labs 10 mg Generic Tablets.
`
`35.
`
`Attached to the Micro Labs Notice Letter was Micro Labs’ Detailed Statement for
`
`ANDA 209738 (“Micro Labs’ Detailed Statement”) asserting the purported factual and legal bases
`
`for Micro Labs’ contention that the RE’783 and ’027 patents are invalid, unenforceable, and/or
`
`will not be infringed by the commercial manufacture, use, or sale of Micro Labs 10 mg Generic
`
`Tablets.
`
`36. Micro Labs’ Detailed Statement alleges that all claims of the RE’783 and ’027
`
`patents are invalid. Micro Labs’ Detailed Statement does not contain a noninfringement argument
`
`with respect to either the RE’783 patent or the ’027 patent.
`
`6
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`
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 7 of 10 PageID #: 7
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`
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`37.
`
`On information and belief, Micro Labs, Ltd. and Micro Labs USA Inc. collaborated
`
`and acted in concert in the decision to prepare and file and in the preparation and filing of ANDA
`
`No. 209738 as amended.
`
`38.
`
`On information and belief, upon approval of ANDA No. 209738 as amended, Micro
`
`Labs will sell and distribute Micro Labs 10 mg Generic Tablets throughout the United States.
`
`COUNT I
`(Infringement of the RE’783 Patent by Micro Labs 10 mg Generic Tablets)
`
`39.
`
`The allegations of paragraphs 1-38 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`40.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Micro Labs, Ltd.’s filing of ANDA No.
`
`209738 as amended, seeking approval to market Micro Labs 10 mg Generic Tablets before the
`
`expiration of the RE’783 patent 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. 209738 as amended be a date which
`
`is not earlier than the expiration date of the RE’783 patent.
`
`41. Micro Labs had knowledge of the RE’783 patent when it submitted ANDA No.
`
`209738 as amended to the FDA.
`
`42.
`
`On information and belief, upon FDA approval, Micro Labs intends to engage in
`
`the manufacture, use, offer for sale, sale, and/or importation of Micro Labs 10 mg Generic Tablets
`
`and will thereby infringe at least claim 4 of the RE’783 patent.
`
`43.
`
`The foregoing actions by Micro Labs constitute and/or would constitute
`
`infringement of at least claim 4 of the RE’783 patent.
`
`44.
`
`Pfizer will be substantially and irreparably harmed if Micro Labs is not enjoined
`
`from infringing the RE’783 patent. Pfizer has no adequate remedy at law.
`
`7
`
`
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 8 of 10 PageID #: 8
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`
`
`COUNT II
`(Infringement of the ’027 Patent by Micro Labs 10 mg Generic Tablets)
`
`45.
`
`The allegations of paragraphs 1-44 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`46.
`
`Pursuant to 35 U.S.C. § 271(e)(2)(A), Micro Labs, Ltd.’s filing of ANDA No.
`
`209738 as amended, seeking approval to market Micro Labs 10 mg Generic Tablets before the
`
`expiration of the ’027 patent 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. 209738 as amended be a date which is not earlier
`
`than the expiration date of the ’027 patent.
`
`47. Micro Labs had knowledge of the ’027 patent when it submitted ANDA No.
`
`209738 as amended to the FDA.
`
`48.
`
`On information and belief, upon FDA approval, Micro Labs intends to engage in
`
`the manufacture, use, offer for sale, sale, and/or importation of Micro Labs 10 mg Generic Tablets
`
`and will thereby infringe at least claim 1 of the ’027 patent.
`
`49.
`
`The foregoing actions by Micro Labs constitute and/or would constitute
`
`infringement of at least claim 1 of the ’027 patent.
`
`50.
`
`Pfizer will be substantially and irreparably harmed if Micro Labs is not enjoined
`
`from infringing the ’027 patent. Pfizer has no adequate remedy at law.
`
`COUNT III
`(Micro Labs USA Inc.’s Inducing of Infringement by Micro Labs, Ltd.)
`
`51.
`
`The allegations of paragraphs 1-50 above are repeated and re-alleged as if set forth
`
`fully herein.
`
`8
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 9 of 10 PageID #: 9
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`
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`52.
`
`On information and belief, Micro Labs USA Inc. actively and knowingly caused to
`
`be submitted, assisted with, participated in, contributed to, and/or directed the submission by Micro
`
`Labs, Ltd. of ANDA No. 209738 as amended to the FDA, knowing of the RE’783 and ’027 patents.
`
`53.
`
`The filing by Micro Labs, Ltd. of ANDA No. 209738 as amended, constituted direct
`
`infringement under 35 U.S.C. § 271(e)(2)(A). On information and belief, under 35 U.S.C.
`
`§§ 271(b) and 271(e)(2)(A), Micro Labs USA Inc. induced the infringement of the RE’783 and
`
`’027 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. 209738 as amended
`
`to the FDA, knowing that the submission of ANDA No. 209738 as amended would constitute
`
`direct infringement of the RE’783 and ’027 patents.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Pfizer requests the following relief:
`
`A.
`
`A judgment that Micro Labs, Ltd.’s submission of ANDA No. 209738 as amended,
`
`was an act of infringement and that Micro Labs’ making, using, offering to sell, selling, or
`
`importing Micro Labs 10 mg Generic Tablets prior to the expiration of the RE’783 and ’027 patents
`
`will infringe each of those patents;
`
`B.
`
`A judgment that Micro Labs 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. 209738 as amended, knowing that its submission would constitute direct
`
`infringement, induced infringement of the RE’783 and ’027 patents;
`
`C.
`
`A judgment that the effective date of any FDA approval for Micro Labs to make,
`
`use, offer for sale, sell, market, distribute, or import Micro Labs 10 mg Generic Tablets be no
`
`earlier than the dates on which the RE’783 and ’027 patents expire, or the later expiration of any
`
`exclusivity to which Pfizer is or becomes entitled;
`
`9
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`Case 1:21-cv-00361-UNA Document 1 Filed 03/11/21 Page 10 of 10 PageID #: 10
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`
`
`D.
`
`A permanent injunction enjoining Micro Labs, its officers, agents, servants, and
`
`employees, and those persons in active concert or participation with any of them, from making,
`
`using, selling, offering for sale, marketing, distributing, or importing Micro Labs 10 mg Generic
`
`Tablets, and from inducing or contributing to any of the foregoing, prior to the expiration of the
`
`RE’783 and ’027 patents, or the later expiration of any exclusivity to which Pfizer is or becomes
`
`entitled;
`
`E.
`
`A judgment that this case is an exceptional case under 35 U.S.C. § 285, entitling
`
`Pfizer to an award of its reasonable attorneys’ fees for bringing and prosecuting this action;
`
`F.
`
`G.
`
`An award of Pfizer’s costs and expenses in this action; and
`
`Such further and additional relief as this Court deems just and proper.
`
`
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Megan E. Dellinger
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Megan E. Dellinger (#5739)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`mdellinger@morrisnichols.com
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`OF COUNSEL:
`
`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
`
`March 11, 2021
`
`
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`10
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