Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 1 of 28 PageID: 1
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`
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`
`
`CELGENE CORPORATION,
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`
`
`
`Plaintiff,
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`
`v.
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`
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`TORRENT PHARMACEUTICALS LTD.
`and TORRENT PHARMA INC.,
`
`
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`Defendants.
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`
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`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
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`Complaint against Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (together, “Torrent” or
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`“Defendants”), 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, 35 U.S.C. §100, et seq., arising from Torrent Pharmaceuticals Ltd. and Torrent Pharma
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`Inc.’s submission of Abbreviated New Drug Application (“ANDA”) No. 213405 (“Torrent’s
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`ANDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to
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`manufacture, use, import, distribute, offer to sell, and/or sell generic versions of Celgene’s
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`Revlimid® drug products prior to the expiration of United States Patent Nos. 7,189,740 (“the
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`1
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`

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`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 2 of 28 PageID: 2
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`’740 patent”), 7,465,800 (“the ’800 patent”), 7,855,217 (“the ’217 patent”), 7,968,569 (“the ’569
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`patent”), 8,404,717 (“the ’717 patent”), 8,530,498 (“the ’498 patent”), 8,648,095 (“the ’095
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`patent”), 9,056,120 (“the ’120 patent”), 9,101,621 (“the ’621 patent”), and 9,101,622 (“the ’622
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`patent”) (collectively, “the patents-in-suit”), all owned by Celgene.
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`The Parties
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`2.
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`Plaintiff Celgene is a biopharmaceutical company committed to improving the
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`lives of patients worldwide. Celgene focuses on, and invests heavily in, the discovery and
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`development of products for the treatment of severe and life-threatening conditions. Celgene is a
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`world leader in the treatment of many such diseases, including cancer. Celgene is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 86 Morris Avenue, Summit, New Jersey 07901.
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`3.
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`On information and belief, Defendant Torrent Pharmaceuticals Ltd. (“TPL”) is a
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`corporation organized and existing under the laws of India, with its principal place of business at
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`Off. Ashram Road, Ahmedabad 380009, Gujarat, India.
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`4.
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`On information and belief, Defendant Torrent Pharma Inc. (“TPI”) is a
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`corporation organized and existing under the laws of Delaware, with its principal place of
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`business at 150 Allen Road, Suite 102, Basking Ridge, New Jersey 07920.
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`5.
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`On information and belief, TPI is a wholly owned subsidiary of TPL.
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`The Patents-in-Suit
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`6.
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`On December 16, 2008, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’800 patent, entitled, “Polymorphic Forms of 3-(4-
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`amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,” to Celgene as assignee. A copy
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`of the ’800 patent is attached hereto as Exhibit A.
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`2
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`7.
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`On December 21, 2010, the USPTO duly and lawfully issued the ’217 patent,
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`entitled, “Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-
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`dione,” to Celgene as assignee. A copy of the ’217 patent is attached hereto as Exhibit B.
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`8.
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`On June 28, 2011, the USPTO duly and lawfully issued the ’569 patent, entitled,
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`“Methods For Treatment of Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-
`
`yl)-piperidine-2,6-dione,” to Celgene as assignee. A copy of the ’569 patent is attached hereto as
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`Exhibit C.
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`9.
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`On September 10, 2013, the USPTO duly and lawfully issued the ’498 patent,
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`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydroisoindol-
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`2-yl)piperidine-2,6-dione,” to Celgene as assignee. A copy of the ’498 patent is attached hereto
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`as Exhibit D.
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`10.
`
`On February 11, 2014, the USPTO duly and lawfully issued the ’095 patent,
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`entitled, “Methods For Treating Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-
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`dihydroisoindol-2-yl)-piperidine-2,6-dione In Combination With Proteasome Inhibitor,” to
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`Celgene as assignee. A copy of the ’095 patent is attached hereto as Exhibit E.
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`11.
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`On August 11, 2015, the USPTO duly and lawfully issued the ’621 patent,
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`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydro-
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`isoindol-2-yl)-piperidine-2,6-dione After Stem Cell Transplantation,” to Celgene as assignee. A
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`copy of the ’621 patent is attached hereto as Exhibit F.
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`12.
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`On August 11, 2015, the USPTO duly and lawfully issued the ’622 patent,
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`entitled, “Methods For Treating Newly Diagnosed Multiple Myeloma 3-(4-amino-1-oxo-1,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione In Combination With Dexamethasone,” to Celgene
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`as assignee. A copy of the ’622 patent is attached hereto as Exhibit G.
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`3
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`13.
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`On March 13, 2007, the USPTO duly and lawfully issued the ’740 patent,
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`entitled, “Methods of Using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for
`
`the Treatment and Management of Myelodysplastic Syndromes,” to Celgene as assignee. A
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`copy of the ’740 patent is attached hereto as Exhibit H.
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`14.
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`On March 26, 2013, the USPTO duly and lawfully issued the ’717 patent,
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`entitled, “Methods of Treating Myelodysplastic Syndromes Using Lenalidomide,” to Celgene as
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`assignee. A copy of the ’717 patent is attached hereto as Exhibit I.
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`15.
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`On June 16, 2015, the USPTO duly and lawfully issued the ’120 patent, entitled,
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`“Methods of Treating Myelodysplastic Syndromes with a Combination Therapy Using
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`Lenalidomide and Azacitidine,” to Celgene as assignee. A copy of the ’120 patent is attached
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`hereto as Exhibit J.
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`The Revlimid® Drug Product
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`16.
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`Celgene holds an approved New Drug Application (“NDA”) under Section 505(a)
`
`of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for lenalidomide
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`capsules (NDA No. 021880), which it sells under the trade name Revlimid®. The claims of the
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`patents-in-suit cover, inter alia, solid forms of lenalidomide, pharmaceutical compositions
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`containing lenalidomide, and methods of use and administration of lenalidomide or
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`pharmaceutical compositions containing lenalidomide.
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`17.
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`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-in-
`
`suit are listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
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`Evaluations” (the “Orange Book”), with respect to Revlimid®.
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`4
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`18.
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`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
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`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
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`adult patients with multiple myeloma (MM), in combination with dexamethasone.
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`19.
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`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
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`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
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`adult patients with MM, as maintenance following autologous hematopoietic stem cell
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`transplantation (auto-HSCT).
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`20.
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`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
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`other healthcare workers, and patients to administer Revlimid® for the treatment of, inter alia,
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`adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk
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`myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without
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`additional cytogenetic abnormalities.
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`21.
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`The labeling for Revlimid® instructs and encourages physicians, pharmacists,
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`other healthcare workers, and patients to administer Revlimid® according to one or more of the
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`methods claimed in the patents-in-suit.
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`Acts Giving Rise To This Suit
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`22.
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`Pursuant to Section 505 of the FFDCA, TPI and TPL, together, submitted
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`Torrent’s ANDA seeking approval to engage in the commercial manufacture, use, sale, offer for
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`sale, or importation into the United States of 10 mg, 20 mg, and 25 mg lenalidomide capsules
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`(“Torrent’s Proposed Products”) before the patents-in-suit expire.
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`23.
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`On information and belief, following FDA approval of Torrent’s ANDA, TPI and
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`TPL will make, use, sell, or offer to sell Torrent’s Proposed Products throughout the United
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`States, or import such generic products into the United States.
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`5
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`24.
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`On information and belief, in connection with the submission of Torrent’s ANDA
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`as described above, TPI and TPL provided written certifications to the FDA pursuant to Section
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`505 of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Torrent’s Paragraph IV Certification”),
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`alleging that the claims of the ’740, ’800, ’217, ’569, ’717, ’498, ’095, ’120, and ’622 patents are
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`invalid and/or will not be infringed by the activities described in Torrent’s ANDA.
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`25.
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`No earlier than May 10, 2021, TPI and TPL sent a written notice of their
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`Paragraph IV Certification to Celgene (“Torrent’s Notice Letter”). Torrent’s Notice Letter
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`alleged that the claims of the ’740, ’800, ’217, ’569, ’717, ’498, ’095, ’120, and ’622 patents are
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`invalid and/or will not be infringed by the activities described in Torrent’s ANDA. Torrent’s
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`Notice Letter also informed Celgene that Torrent seeks approval to market Torrent’s Proposed
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`Products before the patents-in-suit expire. Torrent specifically directed Torrent’s Notice Letter
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`to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
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`Jurisdiction and Venue
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`26.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`27.
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`This Court has personal jurisdiction over TPI by virtue of, inter alia, its
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`systematic and continuous contacts with the State of New Jersey. On information and belief, TPI
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`maintains a regular and established, physical place of business in Basking Ridge, New Jersey.
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`On information and belief, TPI is registered with the State of New Jersey’s Division of Revenue
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`and Enterprise Services as a business operating in New Jersey under Business ID No.
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`0400474439. On information and belief, TPI is registered with the State of New Jersey’s
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`Department of Health as a drug manufacturer and wholesaler under Registration No. 5003857.
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`By virtue of its physical presence in New Jersey, this Court has personal jurisdiction over TPI.
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`6
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`On information and belief, TPI purposefully has conducted and continues to conduct business in
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`this Judicial District.
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`28.
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`On information and belief, TPI is in the business of, among other things,
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`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
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`including generic drug products, throughout the United States, including in this Judicial District.
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`On information and belief, TPI also prepares and/or aids in the preparation and submission of
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`ANDAs to the FDA, including Torrent’s ANDA.
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`29.
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`On information and belief, this Judicial District is a likely destination for the
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`generic drug products described in Torrent’s ANDA.
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`30.
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`On information and belief, TPI derives substantial revenue from directly or
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`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
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`used in generic pharmaceutical products sold throughout the United States, including in this
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`Judicial District.
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`31.
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`On information and belief, TPL derives substantial revenue from directly or
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`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
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`used in generic pharmaceutical products sold throughout the United States, including in this
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`Judicial District.
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`32.
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`This Court has personal jurisdiction over TPL because, inter alia, it: (1) has
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`purposefully availed itself of the privilege of doing business in New Jersey, including directly or
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`indirectly through its subsidiary, agent, and/or alter ego, TPI, a company with its principal place
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`of business in New Jersey; and (2) maintains extensive and systematic contacts with the State of
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`New Jersey, including through the marketing, distribution, and/or sale of generic pharmaceutical
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`drugs in New Jersey including through, directly or indirectly, TPI.
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`7
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`33.
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`This Court also has personal jurisdiction over TPI and TPL because, inter alia,
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`they have committed an act of patent infringement under 35 U.S.C. § 271(e)(2), including
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`sending notice of the ANDA submission to Celgene in the State of New Jersey. On information
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`and belief, TPI and TPL intend a future course of conduct that includes acts of patent
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`infringement in New Jersey. These acts have led and will continue to lead to foreseeable harm
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`and injury to Celgene in New Jersey and in this Judicial District.
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`34.
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`In the alternative, this Court has personal jurisdiction over TPL because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Celgene’s claims arise
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`under federal law; (b) TPL is a foreign defendant not subject to general personal jurisdiction in
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`the courts of any state; and (c) TPL has sufficient contacts with the United States as a whole,
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`including, but not limited to, preparing and submitting ANDAs to the FDA and/or
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`manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over TPL
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`satisfies due process.
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`35.
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`On information and belief, TPI and TPL work in privity and/or concert either
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`directly or indirectly through one or more of their wholly owned subsidiaries with respect to the
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`regulatory approval, manufacturing, use, importation, marketing, offer for sale, sale, and
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`distribution of generic pharmaceutical products throughout the United States, including in this
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`Judicial District.
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`36.
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`On information and belief, each of TPI and TPL actively participated in the
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`submission of Torrent’s ANDA. On information and belief, TPI will work in privity and/or
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`concert with TPL and/or other related entities towards the regulatory approval, manufacturing,
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`use, importation, marketing, offer for sale, sale, and distribution of generic pharmaceutical
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`8
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`products, including Torrent’s Proposed Products, throughout the United States, including in New
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`Jersey and in this Judicial District, prior to the expiration of the patents-in-suit.
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`37.
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`On information and belief, TPI intends to benefit directly if Torrent’s ANDA is
`
`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
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`drug products that are the subject of Torrent’s ANDA.
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`38.
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`On information and belief, TPL intends to benefit directly if Torrent’s ANDA is
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`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
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`drug products that are the subject of Torrent’s ANDA.
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`39.
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`On information and belief, TPI acts at the direction, and for the benefit, of TPL
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`and is controlled and/or dominated by TPL.
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`40.
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`On information and belief, TPI and TPL act, operate, and/or hold themselves out
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`to the public as a single integrated business.
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`41.
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`On information and belief, TPI and TPL have consented to or not contested
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`personal jurisdiction in this Court and have filed counterclaims in such cases. See, e.g., Amgen
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`Inc. v. Torrent Pharm. Ltd., No. 18-11156, D.I. 16 (D.N.J. Aug. 29, 2018); Sumitomo Dainippon
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`Pharma Co., Ltd., et al. v. Aurobindo Pharma Ltd., et al., No. 18-2620, D.I. 84 (D.N.J. Apr. 12,
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`2018); Takeda Pharm. Ltd., et al. v. Torrent Pharm. Ltd., et al., No. 17-3186, D.I. 12 (D.N.J.
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`July 7, 2017).
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`42.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and/or
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`1400(b).
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`Count I: Infringement of the ’740 Patent
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`43.
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`Celgene repeats and realleges the allegations of the preceding paragraphs as if
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`fully set forth herein.
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`44.
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`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
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`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
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`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’740 patent, constitutes infringement of one or more of the claims of that patent
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`under 35 U.S.C. § 271(e)(2)(A).
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`45.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’740 patent.
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`46.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will infringe one or more claims of the ’740 patent under 35 U.S.C. § 271(a) by making,
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`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
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`States.
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`47.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will induce infringement of one or more claims of the ’740 patent under 35 U.S.C. § 271(b)
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`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
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`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
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`will intentionally encourage acts of direct infringement with knowledge of the ’740 patent and
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`knowledge that their acts are encouraging infringement.
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`48.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will contributorily infringe one or more claims of the ’740 patent under 35 U.S.C. § 271(c)
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`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
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`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
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`10
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`more claims of the ’740 patent and that there is no substantial non-infringing use for Torrent’s
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`Proposed Products.
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`49.
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`Celgene will be substantially and irreparably damaged and harmed if TPI and
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`TPL’s infringement of the ’740 patent is not enjoined.
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`50.
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`51.
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`Celgene does not have an adequate remedy at law.
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`This case is an exceptional one, and Celgene is entitled to an award of its
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`reasonable attorneys’ fees under 35 U.S.C. § 285.
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`Count II: Infringement of the ’800 Patent
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`52.
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`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
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`53.
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`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
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`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
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`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’800 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
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`54.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’800 patent.
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`55.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
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`States.
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`56.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will induce infringement of one or more claims of the ’800 patent under 35 U.S.C. § 271(b)
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`11
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`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
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`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
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`will intentionally encourage acts of direct infringement with knowledge of the ’800 patent and
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`knowledge that their acts are encouraging infringement.
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`57.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
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`TPL will contributorily infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
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`more claims of the ’800 patent and that there is no substantial non-infringing use for Torrent’s
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`Proposed Products.
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`58.
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`Celgene will be substantially and irreparably damaged and harmed if TPI and
`
`TPL’s infringement of the ’800 patent is not enjoined.
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`59.
`
`60.
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`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
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`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’217 Patent
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`61.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`62.
`
`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
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`12
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`expiration of the ’217 patent, constitutes infringement of one or more of the claims of that patent
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`under 35 U.S.C. § 271(e)(2)(A).
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`63.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’217 patent.
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`64.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will infringe one or more claims of the ’217 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
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`States.
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`65.
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`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will induce infringement of one or more claims of the ’217 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
`
`will intentionally encourage acts of direct infringement with knowledge of the ’217 patent and
`
`knowledge that their acts are encouraging infringement.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will contributorily infringe one or more claims of the ’217 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
`
`more claims of the ’217 patent and that there is no substantial non-infringing use for Torrent’s
`
`Proposed Products.
`
`67.
`
`Celgene will be substantially and irreparably damaged and harmed if TPI and
`
`TPL’s infringement of the ’217 patent is not enjoined.
`
`
`
`13
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`

`

`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 14 of 28 PageID: 14
`
`
`
`68.
`
`69.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count IV: Infringement of the ’569 Patent
`
`70.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`71.
`
`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’569 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`72.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’569 patent.
`
`73.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will infringe one or more claims of the ’569 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
`
`States.
`
`74.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will induce infringement of one or more claims of the ’569 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
`
`will intentionally encourage acts of direct infringement with knowledge of the ’569 patent and
`
`knowledge that their acts are encouraging infringement.
`
`
`
`14
`
`

`

`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 15 of 28 PageID: 15
`
`
`
`75.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will contributorily infringe one or more claims of the ’569 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
`
`more claims of the ’569 patent and that there is no substantial non-infringing use for Torrent’s
`
`Proposed Products.
`
`76.
`
`Celgene will be substantially and irreparably damaged and harmed if TPI and
`
`TPL’s infringement of the ’569 patent is not enjoined.
`
`77.
`
`78.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’717 Patent
`
`79.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`80.
`
`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’717 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`81.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’717 patent.
`
`
`
`15
`
`

`

`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 16 of 28 PageID: 16
`
`
`
`82.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will infringe one or more claims of the ’717 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
`
`States.
`
`83.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will induce infringement of one or more claims of the ’717 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
`
`will intentionally encourage acts of direct infringement with knowledge of the ’717 patent and
`
`knowledge that their acts are encouraging infringement.
`
`84.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will contributorily infringe one or more claims of the ’717 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
`
`more claims of the ’717 patent and that there is no substantial non-infringing use for Torrent’s
`
`Proposed Products.
`
`85.
`
`Celgene will be substantially and irreparably damaged and harmed if TPI and
`
`TPL’s infringement of the ’717 patent is not enjoined.
`
`86.
`
`87.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`
`
`16
`
`

`

`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 17 of 28 PageID: 17
`
`
`
`Count VI: Infringement of the ’498 Patent
`
`88.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`89.
`
`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’498 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`90.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’498 patent.
`
`91.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will infringe one or more claims of the ’498 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the United
`
`States.
`
`92.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will induce infringement of one or more claims of the ’498 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Torrent’s ANDA, TPI and TPL
`
`will intentionally encourage acts of direct infringement with knowledge of the ’498 patent and
`
`knowledge that their acts are encouraging infringement.
`
`93.
`
`Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will contributorily infringe one or more claims of the ’498 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Torrent’s Proposed Products in the
`
`
`
`17
`
`

`

`Case 2:21-cv-12927 Document 1 Filed 06/23/21 Page 18 of 28 PageID: 18
`
`
`
`United States. On information and belief, TPI and TPL have had and continue to have
`
`knowledge that Torrent’s Proposed Products are especially adapted for a use that infringes one or
`
`more claims of the ’498 patent and that there is no substantial non-infringing use for Torrent’s
`
`Proposed Products.
`
`94.
`
`Celgene will be substantially and irreparably damaged and harmed if TPI and
`
`TPL’s infringement of the ’498 patent is not enjoined.
`
`95.
`
`96.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VII: Infringement of the ’095 Patent
`
`97.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`98.
`
`TPI and TPL’s submission of their ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Torrent’s Proposed Products, prior to the
`
`expiration of the ’095 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`99.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’095 patent.
`
`100. Unless enjoined by this Court, upon FDA approval of Torrent’s ANDA, TPI and
`
`TPL will infringe on